UNITED
STATES


SECURITIES
AND EXCHANGE COMMISSION


Washington,
D.C. 20549





FORM
10-K





x
ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934




For the
fiscal year ended December
31, 2009





o TRANSITION REPORT UNDER
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934




For the
transition period from _________________ to __________________




Commission
file number: 000-51774





ProUroCare
      Medical Inc.(Exact
      name of registrant as specified in its charter)Nevada
                20-1212923(State
      or other jurisdiction
                (IRS
      Employerof
      incorporation)
                Identification
      No.)6440 Flying Cloud Drive, Suite 101, Eden Prairie,
      MN
                55344(Address
      of principal executive offices)
                (Zip
      Code)Registrant’s
      telephone number, including area code
                952-476-9093(Former
      name or former address, if changed since last
  report.)





Securities
registered pursuant to Section 12(b) of the Exchange Act:  None




Securities
registered pursuant to Section 12(g) of the Act:





Common Stock $0.00001 par value; Common Stock
      WarrantsUnits, consisting of one share of Common Stock and
      one Warrant





Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act.


 ̈
Yes     x No




Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or 15(d) of the Act.


 ̈YesxNo




Indicate
by check mark whether the issuer (1) filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act during the past 12 months (or
for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90
days. xYes ̈No




Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the
preceding 12 months (or for such shorter period that the registrant was required
to submit and post such
files).  ̈Yes ̈No




Indicate
by check mark if disclosure of delinquent filers in response to Item 405 of
Regulation S-K (§229.405 of this chapter) is not contained herein, and will not
be contained, to the best of registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form
10-K  ̈




Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company.  See the definitions of “large accelerated filer,”
“accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.




Large
      accelerated filer  ̈
                  Accelerated
      filer  ̈Non-accelerated
      filer  ̈
                  Smaller
      reporting company x





Indicate
by check mark whether the registrant is a shell company (as defined by Rule
12b-2 of the Exchange Act).


 ̈YesxNo




State the
aggregate market value of the voting and non-voting common equity held by
non-affiliates computed by reference to the price at which the common equity was
sold, or the average bid and asked price of such common equity, as of the last
business day of the registrant’s most recently completed second fiscal
quarter. $6,136,378 as of June 30,
2009




Indicate
the number of shares outstanding of each of the registrant’s classes of common
equity, as of the latest practicable date.


11,370,321
common shares and 1,525,156 Units at March 26, 2010









INTRODUCTORY
CAUTIONARY STATEMENT
  This
Annual Report on Form 10-K includes forward-looking statements within the
meaning of the Securities Exchange Act of 1934, as amended (the "Exchange Act").
These statements are based on management’s current beliefs and assumptions and
on information currently available to us. Forward-looking statements include,
among others, the information concerning possible or assumed future results of
operations of ProUroCare Medical Inc. and its subsidiary (the "Company,” “we,”
“us,” or “our”) set forth in Part II, Item 7, "Management's Discussion and
Analysis of Financial Condition and Results of Operation" and elsewhere in this
Annual Report. Forward-looking statements also include statements where the
words "may,”" "will,” "should,” "could,” "expect,” "anticipate,” "intend,”
"plan,” "believe,” "estimate,” "predict,” "potential,” or similar expressions
are used. Forward-looking statements are not guarantees of future performance.
Our future actual results and shareholder values may likely differ materially
from those expressed in these forward-looking statements. We caution you not to
put undue reliance on any forward-looking statements included in this document.
See Part I, Item 1A, “Risk Factors Associated with our Business, Operations, and
Securities.”





TABLE OF
CONTENTS




PagePART IITEM
      1:
                                  BUSINESS
                                  1ITEM
      1A:
                                  RISK
      FACTORS
                                  14ITEM
      1B:
                                  UNRESOLVED
      STAFF COMMENTS
                                  25ITEM
      2:
                                  PROPERTIES
                                  25ITEM
      3:
                                  LEGAL
      PROCEEDINGS
                                  26PART IIITEM
      4:
                                  RESERVED
                                  26ITEM
      5:
                                  MARKET
      FOR COMMON EQUITY, RELATED STOCKHOLDER MATTERSAND
      ISSUER PURCHASES OF EQUITY SECURITIES
                                  26ITEM
      6:
                                  SELECTED
      FINANCIAL DATA
                                  27ITEM
      7:
                                  MANAGEMENT’S
      DISCUSSION AND ANALYSIS OF FINANCIALCONDITION
      AND RESULTS OF OPERATIONS
                                  27ITEM
      7A:
                                  QUANTITATIVE
      AND QUALITATTIVE DISCLOSURES ABOUT MARKET RISK
                                  33ITEM
      8:
                                  FINANCIAL
      STATEMENTS AND SUPPLEMENTARY DATA
                                  F-1ITEM
      9:
                                  CHANGES
      IN AND DISAGREEMENTS WITH ACCOUNTANTSON
      ACCOUNTING AND FINANCIAL DISCLOSURES
                                  34ITEM
      9A(T):
                                  CONTROLS
      AND PROCEDURES
                                  34ITEM
      9B:
                                  OTHER
      INFORMATION
                                  35PART IIIITEM
      10:
                                  DIRECTORS,
      EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
                                  35ITEM
      11:
                                  EXECUTIVE
      COMPENSATION
                                  37ITEM
      12:
                                  SECURITY
      OWNERSHIP OF CERTAIN BENEFICIAL OWNERS ANDMANAGEMENT
      AND RELATED STOCKHOLDER MATTERS
                                  40ITEM
      13:
                                  CERTAIN
      RELATIONSHIPS AND RELATED TRANSACTIONS,AND
      DIRECTOR INDEPENDENCE
                                  42ITEM
      14:
                                  PRINCIPAL
      ACCOUNTANT FEES AND SERVICES
                                  43PART IVITEM
      15:
                                  EXHIBITS,
      FINANCIAL STATEMENT SCHEDULES
                                  44SIGNATURES
                                  48





PART I





ITEM
1:  BUSINESS




Overview




We have
developed and intend to market an innovative prostate imaging system known as
the ProUroScanTM System.  The ProUroScan System incorporates our new
proprietary elasticity imaging technology to create a “map” and an electronic
record of the prostate.




The
ProUroScan System is an imaging system designed for use as an aid to the
physician in visualizing and documenting abnormalities in the prostate that have
been previously detected by a digital rectal exam (“DRE”). As an adjunct to DRE,
the ProUroScan System will be used following an abnormal DRE to generate a
real-time image and map of the prostate.  The final composite image is
saved as a permanent electronic record and can be conveniently retrieved to view
previous test results.




Our
approach to imaging is based on the fact that most abnormalities in otherwise
homogenous organ tissue are less elastic than normal tissue.  The
ProUroScan’s unique technology uses measurements of relative tissue elasticity
as detected by mechanical sensors and interpreted by mathematical algorithms to
create images, rather than using ultrasound or other alternative
technologies.  Using the system’s specially designed rectal probe,
physicians can quickly and cost-effectively visualize the prostate gland and
document specific areas of concern.  The real-time map can be saved as a
permanent electronic record.




Our
imaging technology is based on work originally performed by Artann Laboratories
Inc. (“Artann”), a scientific technology company based in Trenton, New Jersey,
that is focused on early-stage technology development. In 2002, we licensed the
rights to this technology and since then have worked with Artann on its
development. In September 2006, Artann was awarded a $3 million Small Business
Innovation Research Phase II Competitive Renewal grant from the National
Institute of Health and the National Cancer Institute to help advance the
development and application for clearance of the ProUroScan System by the U.S.
Food and Drug Administration (“FDA”).  In July 2008, the Company entered
into new license and development and commercialization agreements with Artann
relating to their existing technology and know-how and all future technology
developed by Artann in our field of use. After we obtain FDA clearance, it is
our intent to expand our working relationship with Artann to include their
participation in the development and licensing of additional
technologies.


The
ProUroScan System is not currently marketed or sold and has not yet been cleared
for marketing by the FDA. On November 18, 2009, a 510(k) application for market
clearance was filed with the FDA that incorporated a basic mapping and data
maintenance claim. On March 29, 2010, Artann received a letter from the FDA
regarding its pending 510(k) for the ProUroScan System. The letter notified
Artann that the FDA could not determine whether the device is substantially
equivalent to the listed predicates in the 510(k) application. The FDA
specifically noted the lack of a comparable predicate device for use as an aid
in documenting abnormalities of the prostate detected by DRE.  Artann
intends to discuss this letter and its findings with the FDA as soon as it can
and also plans to discuss why Artann believes there is a suitable
predicate.  If the ProUroScan System is not found to be substantially
equivalent because a suitable predicate cannot be identified, the FDA may
indicate that the product may be appropriate for Evaluation of Automatic Class
III Designation because it is deemed to be a low risk device.  This
provision which is also known as a “de novo” or a “risk based” classification is
intended to allow low risk devices to be marketed under a 510(k) when there is
no adequate predicate.  Information supporting the de novo application
as a low risk device would then be combined with the previously submitted 510(k)
and submitted to FDA for review.
  Once FDA
clearance is obtained on our current generation ProUroScan System, we intend to
have the systems manufactured by one or more FDA-regulated contract
manufacturers and market the system in cooperation with a to be
determined  medical device company that has an established worldwide
presence in the urology market.


Once FDA
clearance is obtained on our current generation ProUroScan System, we intend to
have the systems manufactured by one or more FDA-regulated contract
manufacturers and market the system in cooperation with a to be
determined  medical device company that has an established worldwide
presence in the urology market.




We have
identified a market need to be able to visualize and create an electronic record
or map that can show the position of abnormalities in the prostate gland. We
believe the ProUroScan System will offer a solution that meets these needs and
that will enable physicians to monitor and compare images of the prostate over
time (assuming we apply for and obtain FDA approval or clearance for this
indication).




We
believe the ProUroScan System’s existing technology provides a platform on which
to develop multiple future generation systems. In the future, following our
initial FDA 510(k) clearance, we intend to work with Artann to develop and
introduce enhanced versions and additional indications for this
technology.  For example, we plan to study and develop an enhanced version
of the system that may be able to monitor changes in prostate tissue over time,
guide prostate biopsies and assess changes in prostate size following drug
treatment for benign prostate hyperplasia (“BPH”).  Future generation
systems will require us to obtain regulatory approval or clearance for use of
the ProUroScan System for additional related indications and file additional
submissions with the FDA if we are to obtain expanded labeling
claims.




Corporate
Information




ProUroCare
Inc. (“PUC”) was incorporated in 1999 as a Minnesota corporation.  In
January 2002, PUC licensed the rights to certain advanced prostate mechanical
imaging technology, and became engaged in the business of developing this
technology for assessing characteristics of the prostate.  In 2004, through
a reverse merger transaction with Global Internet Communications (“Global”), a
Nevada corporation, PUC became the wholly owned and sole operating subsidiary of
Global, which was then renamed ProUroCare Medical Inc.


1




Our
executive offices are located at 6440 Flying Cloud Drive, Suite 101, Eden
Prairie, Minnesota 55344. Our telephone number is (952) 476-9093, and our
Internet site is www.prourocare.com.




Market
Focus—Prostate Disease




Prostate
cancer is the most common form of cancer and the second leading cause of cancer
death in men. According to the National Cancer Institute, more than
192,000 men were expected to be diagnosed with prostate cancer and over
28,000 were expected to die from the disease in 2009. Currently, there are
approximately 42 million men in the U.S. over the age of 50. For men in
this age category, the standard of care to screen for the presence of prostate
cancer is to have a physical exam each year in which two tests are routinely
performed: the DRE and the Prostate Specific Antigen (“PSA”) blood test.
Although used for many years, the specificity of these tests has been widely
questioned. Data from community based studies suggest that the positive
predictive value of a DRE for prostate cancer is 15% to 30% and varies
relatively little with age. For elevated PSA levels between 4 and 10ng/mL,
the positive predictive value is approximately 20%. For studies in which
biopsies were done when the results of either test were abnormal, 18% to
26% of screened patients had suspicious results, cancer was actually detected in
approximately 4% of screened patients and the positive predictive value of the
tests combined was 15% to 21%. In another study involving 6,630 volunteers,
the combination of DRE and PSA detected 26% more cancers than PSA alone.
Although PSA and DRE provide some positive predictive value, neither of these
tests creates a physical or visual record of the abnormality or its position in
the prostate.




We
believe there is a market need to be able to visualize and create an electronic
record (map) that can show the relative size and position of abnormalities in
the prostate gland. We believe that the ProUroScan System offers a solution that
meets these needs and one that will enable physicians to monitor and compare
images of the prostate over time (assuming we apply for and obtain FDA approval
or clearance for this indication). With additional development and further FDA
approvals, we believe the ProUroScan System may eventually be used to guide
prostate biopsy and assess the effect of medical treatments of BPH.




Prostate
Cancer Screening and Diagnosis




The two
most common screening tests for identifying prostate cancer are the DRE and the
PSA. These tests have been used for years, but have often been criticized for
their lack of specificity and selectivity.




In a DRE
exam, a physician wearing a latex glove inserts a lubricated finger into the
rectum to palpate the prostate gland to detect abnormalities. The clinician must
rely on his or her experience and sensitivity of touch to estimate the size of
the prostate and detect irregularities in shape or hardness. There is
significant subjectivity inherent in the DRE exam which can be negatively
affected by poor examiner training, lack of experience or poor ability to
interpret the results, as well as other patient related limitations including
excessive obesity, patient discomfort and unusual anatomical positioning of the
prostate.




Data from
community-based studies indicate that the positive predictive value of a DRE in
detecting cancer is 15% to 30% and varies relatively little with age. In a
Scandinavian study, the positive predictive value of DRE was found to be only
22% to 29%. According to the Eighth Edition of Campbell’s Urology, a DRE
has only fair reproducibility even with experienced examiners and the test
misses a substantial proportion of cancers before they become advanced and less
amenable to treatment.




The other
primary screening test for detecting prostate cancer is the measurement of PSA
in serum. The advantages offered by PSA testing are its simplicity,
objectivity, reproducibility and low level of invasiveness. Although PSA is
specific to prostate tissue, it is not specific to prostate cancer. Older men
that have benign enlargement of the prostate and acute prostatitis often have
elevated PSA levels. Serum levels of PSA can also be elevated for a period
of time after transrectal needle biopsy, acute urinary retention and prostate
surgery. Because of the prevalence of these conditions in men over the age
of 50, the positive predictive value of PSA measurements decreases with
age.




In
clinical practice, a PSA level greater than 4ng/mL is generally considered an
abnormal result. Recent community-based studies show that PSA levels
greater than 4ng/mL are seen in about 15% of men who are older than
50 years of age. The probability, or positive predictive value, that a man
who is older than 50 having prostate cancer if his PSA level is elevated is
approximately 20% to 30%. However, the likelihood of cancer depends on the
degree of elevation in the PSA levels. For levels between 4 and 10ng/mL, the
positive predictive value is about 20 percent. This value increases to
between 42 percent and 64 percent if the PSA level is greater
than 10ng/nL. Despite these variances, PSA testing has increased the
detection rate of early-stage prostate cancers, which are more curable than
late-stage cancers.


2




Most
clinicians have adopted the strategy of performing both tests in combination,
which has been shown to increase the combined predictive value. In fact, in a
large study of volunteers, the combination of DRE and PSA detected 26% more
cancers than PSA alone. However, because of the significant risk of prostate
cancer, prostate biopsy is recommended for all men who have DRE abnormalities,
regardless of PSA level, because 25% of men with cancer have
PSA levels less than 4mg/nL.




A patient
with a positive DRE or an elevated PSA is typically referred to a urologist for
further diagnosis. The urologist will usually perform a prostate biopsy to
obtain tissue samples for microscopic analysis. The prostate is biopsied by a
needle that is guided by ultrasound into the prostate through the rectal wall.
Since the existence and exact location of possible cancerous tissue is not
known, the urologist will usually take 10 to 14 samples in a scattered pattern
throughout the prostate in an attempt to find the suspect tissue. The tissue
samples are then sent to a laboratory for analysis and interpretation, and the
results are reported several days later. If the results are negative or
indeterminate, the urologist may suggest a second biopsy procedure, or that the
patient increase the frequency of future screening examinations. According to
Oregon Health and Science University, approximately one million patients are
biopsied each year in the United States, but only approximately 25% of biopsy
procedures performed detect the presence of cancer.




The
treatment path for patients who test positive for prostate cancer depends on
many variables, including age, location and pathology of the cancerous tissue
and general health of the patient. Generally, a younger, otherwise healthy
patient will elect to have the prostate removed to eliminate the possibility
that it might spread beyond the prostate. Older, less healthy patients may elect
not to undergo surgery, and instead monitor the disease closely by semi-annual
PSA and DRE exams, and annual biopsies. This monitoring regimen is commonly
referred to as “active surveillance.” Some patients may elect radiation or drug
treatments, in addition to necessary ongoing active surveillance. The National
Cancer Institute estimates that there are approximately two million men
alive who have a history of cancer of the prostate. On this basis, we estimate
that the number of men over the last decade that have elected against prostate
removal and thus are undergoing ongoing active surveillance exceeds one
million.




The
ProUroScan Prostate Imaging System




The
ProUroScan System is an imaging system designed for use as an aid to the
physician in visualizing and documenting abnormalities in the prostate.  As
an adjunctive tool to DRE, it will be used after a physician identifies
abnormalities during a DRE examination. The first generation system will
provide a map or record of the pressures that are generated from palpation of
the posterior surface of the prostate using a sensor probe. The system’s
operation is based on measurement of the stress pattern created when the probe
is pressed against the prostate through the rectal wall. Temporal and spatial
changes in the stress pattern provide information on the elastic structure of
the gland and allow two-dimensional reconstruction of prostate anatomy and
visualization of prostate mechanical properties. The data acquired allow the
calculation of prostate features such as size and shape. The prostate image is
displayed on a screen that allows physicians to visualize tissue abnormalities
in the prostate gland. In addition to the real time visual image, the results
are stored electronically as a digital record.




The
ProUroScan System consists of arrays of pressure sensors mounted on a probe, a
central processing unit, proprietary software and image construction algorithms,
and a color monitor. The probe is specially designed for the rectal anatomy to
minimize patient discomfort. It is ergonomic for the clinician and similar to a
traditional DRE for the patient. The probe utilizes highly sensitive pressure
sensors located on the face of the probe head to palpate the prostate. The
probe’s positioning system ensures that the person administering the scan
examines the entire surface of the prostate, and assists prostate image
construction.




To
perform a scan, the clinician inserts the tip of the probe into the patient’s
rectum and palpates the prostate. As the prostate is palpated, a color image of
the prostate is produced and displayed on the computer monitor, along with
indicators of the amount of pressure being applied to help guide the clinician.
Differences in tissue density or elasticity will be depicted in real time on a
color monitor.


3


ProUroScan
System Status




The first
generation ProUroScan System has been tested in laboratory experiments on
prostate models and in a pre-clinical study. In addition, the system was used
for over two years and on approximately 168 patients at the Robert Wood Johnson
Medical Center in New Brunswick, New Jersey.  In March 2008, an article
authored by Artann scientists and published in the peer- reviewed journal Urology reported that in 84%
of the cases in this pre-clinical study, the ProUroScan System was able to
construct a real-time color image and map of the prostate.




Under the
terms of its contract with us, Artann is responsible for submitting and
obtaining the initial 510(k) clearance for the ProUroScan System for the basic
mapping and data maintenance claim. In April 2008, representatives from Artann
met with the FDA to solicit feedback from the agency regarding the proposed
clinical testing that the FDA will require to support a 510(k). Based on these
discussions between Artann and representatives from the FDA, we believe that the
ProUroScan System with a basic mapping and data maintenance claim will be
regulated by the FDA as a Class II device. Class II devices typically are
cleared for marketing by the FDA through a 510(k) application.  Once
cleared and upon ProUroCare’s first commercial sale of a ProUroScan System,
Artann will transfer the 510(k) to ProUroCare.




On
September 25, 2009, we completed a multi-site clinical study of the ProUroScan
imaging system designed to provide documentation to the FDA of the system’s
effectiveness in visualizing and documenting abnormalities of the prostate
detected by DRE.  The trial included a final patient count of 56 patients
assessed at the following medical centers:





·
            Veterans
      Affairs Medical Center, Minneapolis,
MN;


·
            Robert
      Wood Johnson Medical School Division of Urology, New Brunswick,
      NJ;


·
            Mayo
      Clinic, Rochester, MN;


·
            AccuMed
      Research Associates, Garden City, NY;
and


·
            Urological
      Associates of Lancaster, Lancaster,
PA.




In
November 2009, Artann submitted to the FDA a 510(k) application for clearance to
market this technology in the U.S. On March 29, 2010, Artann received a letter
from the FDA regarding the pending 510(k) for the ProUroScan System. The letter
notified Artann that the FDA could not determine whether the device is
substantially equivalent to the listed predicates in the 510(k) application. The
FDA specifically noted the lack of a comparable predicate device for use as an
aid in documenting abnormalities of the prostate detected by
DRE.  Artann intends to discuss this letter and its findings with the
FDA as soon as it can and also plans to discuss why Artann believes there is a
suitable predicate.  If the ProUroScan System is not found to be
substantially equivalent because a suitable predicate cannot be identified, the
FDA may indicate that the product may be appropriate for Evaluation of Automatic
Class III Designation because it is deemed to be a low risk
device.  This provision which is also known as a “de novo” or a “risk
based” classification is intended to allow low risk devices to be marketed under
a 510(k) when there is no adequate predicate.  Information supporting
the de novo application as a low risk device would then be combined with the
previously submitted 510(k) and submitted to FDA for review.  If the
FDA does not deem the device to be low risk, a Premarket Approval (“PMA”) could
be required.  Such an application may take more time to prepare and
review and be more comprehensive than the 510(k) or de novo clearance
process.




Planned
Development of the ProUroScan System




We
believe that the ProUroScan System’s existing technology provides a platform on
which to develop multiple future generation systems. Once 510(k) clearance is
obtained for a basic mapping and data maintenance claim, the 510(k) will be
transferred to us from Artann.  In the future, we intend to work with
Artann to develop more enhanced labeling claims and product features. Future
generation systems will require us to obtain regulatory approval or clearance
for use of the ProUroScan System for additional prostate related indications and
file additional submissions with the FDA to obtain expanded labeling claims.
Such regulatory clearances or approvals may require us to perform additional
clinical studies. Future generations of the ProUroScan System may also require
us to secure rights to additional intellectual property.




Active Surveillance




We
believe that one of the more valuable future applications for the ProUroScan
System, assuming we obtain any necessary FDA clearance or approval, will be to
allow physicians to monitor changes in the prostate over time. The ProUroScan
System is designed to produce a digital image of the prostate showing the size
and symmetry of the prostate and the location of abnormalities within the
prostate. The ProUroScan System creates a digital record of the exam that can be
stored and used for comparison to subsequent exams. We believe its ability to
digitally store not only the scan results but all of the individual pressure
readings taken during the course of the procedure should facilitate a
quantitative analysis of the progression of the disease over time. By comparing
the data taken in a baseline examination to subsequent examinations during the
course of active surveillance, we believe the urologist will gain valuable
information about changes in the patient’s condition that can influence their
decision to pursue additional treatment or continue surveillance. We believe
that this expanded use of the ProUroScan System will provide consistent mapping
over time as compared to variations resulting from differences in technique and
experience of clinicians performing DREs. We believe this will enable physicians
to compare and contrast the patient’s results from exam to exam, and to get
second opinions on the patient’s status in regards to the diagnosis without an
additional office visit. We believe that comparisons of multiple scans over time
will also enable physicians to make longitudinal assessments of the patient’s
disease.


4




Three-Dimensional Imaging




We
believe that another future enhancement of the current generation system may be
the capability to identify the specific three-dimensional location of lesions
found in the prostate. This can be accomplished by creating a three-dimensional
image of the position of the lesions allowing physicians to rotate the image to
assist in identifying the actual position of the lesion in the prostate gland.
We believe that having this capability may prove helpful in providing a
diagnosis of the patient’s condition in conjunction with other commercially
available diagnostic tools.




Guiding Biopsy




We
believe that use of three-dimensional imaging may facilitate guiding biopsy
needles to specific areas in the prostate where suspicious lesions. Having this
capability increases the likelihood of finding cancerous tissue while also
potentially minimizing the number of biopsies that are taken on an individual
patient. According to Oregon Health and Science University, approximately one
million patients are biopsied each year in the United States, but only
25 percent of biopsy procedures performed detect the presence of
cancer.




Evaluating Drug Treatment for BPH
Patients




For
patients who have symptoms of BPH, we believe that future generations of the
ProUroScan System may also be used to monitor changes in prostate size before
and during the course of drug treatments, allowing physicians to more quickly
assess the effectiveness of alternative therapeutic approaches. Assuming future
FDA approval or clearance is granted, use of the ProUroScan System in patients
diagnosed with BPH will allow physicians to monitor changes in the size and
volume of the prostate following treatment with drugs or other tissue reducing
technologies. Timely, accurate assessment of prostate volume changes and the
effectiveness of treatment should enable physicians to recommend alternative
treatments sooner than current assessment methods, and thus provide more
immediate relief to patients.




Marketing
and Distribution




Our
business plan is built on the premise that the map and physical record created
by the ProUroScan System will become a valuable tool in assisting physicians and
patients in understanding the scope of the abnormalities that are identified
with a DRE.




Current
Procedural Terminology (“CPT”) codes are used by physicians and other providers
to submit claims. We anticipate that the ProUroScan System would be covered by
Medicare as a diagnostic test for patients who have clinical signs or symptoms
of disease. At the outset, however, there will not be a unique CPT code for the
ProUroScan procedure. During this period of time, physicians will have the
option of submitting claims under a “miscellaneous” CPT code with proper
documentation. We also expect to use a “patient pay” model in which the patient
would pay directly for the cost of the scan. During the first year or two
following market entry, we will collect the clinical and economic data necessary
in order to apply for a unique CPT code from the American Medical Association
(“AMA”).  Our initial commercial rollout will focus on urologists in the
United States. By focusing on urologists, we expect to establish the clinical
and economic value of the scan for patients, and to demonstrate to both private
and government payors the rationale and parameters for establishing a
CPT code and that the scan should be covered and adequately
reimbursed.




We
believe that the cost of establishing our own direct sales force of sufficient
size and with the capability to commercialize the ProUroScan System worldwide
would require a considerable period of time and significant funding.  As an
effective way to develop our understanding of different international markets
and accelerate sales and marketing activities we plan to establish a
distribution agreement with a large urology or diagnostic products
company.  We believe that establishing such a relationship would allow us
to penetrate markets more quickly and afford us an opportunity to obtain
additional financial support in the form of licensing fees, equity investments
and “in kind assistance” from key functional groups within the licensing
organization.  We have begun exploring marketing opportunities with four of
the eight to ten potential partner companies we have targeted.




In the
United States, in advance of establishing such a distribution agreement, we plan
to hire a small direct sales force that will focus on large urology practices in
major metro markets.  The concentration of large urology group practices in
the U.S. enables us to access a disproportionate number of physicians with a
highly targeted sales force.  Once a distribution partner has been
identified and a distribution agreement put in place, our sales force will be
used in business-to-business support to the partnering organization.  They
will also be used to assist in the initial analysis and development of other
markets.


5


We
anticipate that, in time, the majority of our revenue will be generated from
testing fees bundled together with the sale of disposable supplies consumed in
the scanning process.  Additional revenue will be generated by the sale of
ProUroScan Systems, which likely will be placed in clinics under a variety of
programs, which may include outright sales, operating leases, financing leases
or arrangements where payments are based upon the usage of the
system.




Manufacturing




The
ProUroScan System has two major proprietary hardware components: a central
processor and a rectal probe. There are also certain off-the-shelf components
that presently are widely available. Artann has provided five clinical prostate
imaging systems used in performing clinical trials and for contract
manufacturing assessment. Artann will transfer ownership of these units to us
upon the date of first commercial sale of the ProUroScan System.




We have
recently contracted with Logic (Minneapolis, MN), a contract engineering and
manufacturing firm that is Quality Systems Regulation (“QSR”) compliant, to
initiate production on the first commercial ProUroScan Systems. The QSR requires
manufacturers, including certain third-party manufacturers, to follow stringent
design, testing, control, documentation and other quality assurance procedures
during all aspects of the manufacturing process. Because of the unique nature of
the two major proprietary components of the ProUroScan System, it is likely that
one or more additional third party manufacturers will be chosen to assemble the
certain components or sub-assemblies. Our goal is to reduce the cost of
producing systems over the first two years, taking advantage of manufacturing
scale and purchasing discounts, as well as engineering changes designed to
eliminate components and reduce component costs.




ProUroScan
System Development Partner




The
ProUroScan System is based on work originally performed by Artann and its
affiliate, ArMed LLC. In 2002, we licensed the rights to this technology
developed by Artann from its owner, Profile LLC (“Profile”), a technology
holding company, and since then have worked with Artann and our other technology
partners on its development. In April 2008, we acquired the patents, patent
applications and other know-how associated with this technology previously
licensed from Profile. In July 2008, we entered into two new agreements
with Artann relating to this technology, namely, a license agreement (the
“Artann License Agreement”) and a development and commercialization agreement
(the “Artann Development Agreement”).  In December 2008 and November 2009,
we amended these agreements to revise the effective dates of the agreements and
alter the timing of certain payments to be made under the agreements.  We
have expensed $2,240,000 and $598,000 for research and development activities in
2009 and 2008, respectively, primarily for contracted work performed by Artann
under the Artann Development Agreement.




Under the
Artann License Agreement, Artann has granted us an exclusive, worldwide,
sub-licensable license to certain patent applications and other know-how needed
to make, use and market certain mechanical imaging products for the diagnosis or
treatment of urologic disorders of the prostate, kidney or liver. Artann also
agreed to transfer to us possession of five clinical prostate imaging systems
and grant us full access to all relevant documentation thereto. As an upfront
license fee pursuant to the Artann License Agreement, on January 14, 2009 we
paid Artann $600,000 in cash and $500,000 in shares of our common stock. 
In addition, we have agreed to pay Artann:




• 
    a royalty fee equal to 4% of the first $30,000,000 of net
cumulative sales of licensed products, 3% of the next $70,000,000 of net
cumulative sales and 2% of net cumulative sales over $100,000,000;
and




• 
    a technology royalty fee of 1% of net sales of the prostate
imaging system products through the earlier of December 31, 2016 or the
date of last commercial sale of such products.




The
combined royalties are subject to a minimum annual royalty equal to $50,000 per
year for each of the first two years after FDA clearance for commercial sale and
$100,000 per year for each year thereafter until termination or expiration of
the Artann License Agreement. We also agreed to grant Artann a non-exclusive,
fully paid, sub-licensable, worldwide license to our patents, patent
applications and know-how relating to the manufacture, use or sale of any
mechanical imaging system for the diagnosis or treatment of disorders of the
female breast.


6


Under the
Artann Development Agreement, we will collaborate with Artann to develop,
commercialize and market prostate imaging systems. Artann will conduct and
complete all pre-clinical activities and testing on the prostate imaging system,
conduct clinical trials, prepare and submit FDA regulatory submissions and
provide hardware and software development, refinement and debugging services to
ready the prostate imaging system for commercial sale. For these development
services, we paid Artann:




•
            $250,000
      in cash upon initiation of the clinical study to support the basic mapping
      and data maintenance claim;




•
            $250,000
      in cash as a milestone payment upon completion of that study and
      submission of the 510(k) application to support the basic mapping and data
      maintenance claim;




•
            monthly
      retainer fees totaling $285,000 for technical advice and training by
      Artann personnel; and.




•
            769,231
      shares of our common stock as a milestone payment upon submission of the
      510(k) application, on March 15, 2010 (the $1,565,000 value of these
      shares was accrued for issuance as of December 31,
  2009).




Future
payments due to Artann under the Artann Development Agreement, as amended,
include:




•
            $750,000
      in cash and $1,000,000 in shares of our common stock upon FDA clearance
      that allows the ProUroScan System to be commercially sold in the United
      States (subject to reduction of the number of shares by 10% for each full
      month that FDA clearance is delayed after March 23, 2010);
    and




•
            a
      monthly retainer fee for technical advice and training by Artann personnel
      of $15,000 per month for each of the first five months of
      2010.




Under the
Artann Development Agreement, Artann will also facilitate the transfer of
commercial production to our contract manufacturer, Logic.




The
Artann License Agreement and the Artann Development Agreement each became
effective on December 23, 2008. Under the Artann License Agreement, we have
a 30-day cure period from the date of receipt of written notice from Artann of a
breach of our payment obligations under either the Artann License Agreement or
Artann Development Agreement. If we have not cured such payment breach within
five days of receipt of the Artann notice, the exclusive licenses convert to
non-exclusive licenses, however, neither party may sub-license or grant
additional licenses for a period of 60 days after receipt of such notice.
Under the Artann Development Agreement, we have a 60-day cure period from the
date of receipt of written notice from Artann of a breach of our payment
obligations under either the Artann License Agreement or the Artann Development
Agreement. If we do not cure a breach of our payment obligations by the end of
the 30-day cure period, the licenses granted under the Artann License Agreement
will terminate.  Subject to earlier termination due to breach, bankruptcy
and certain other events, the Artann License Agreement will terminate upon
expiration of all royalty obligations, and the Artann Development Agreement will
terminate on its third anniversary, subject to renewal for additional one year
terms upon mutual agreement of us and Artann.




Intellectual
Property




Our
objective as a medical device company is to effectively and aggressively obtain,
maintain and enforce patent protection for our products, formulations,
processes, methods and other proprietary technologies, preserve our trade
secrets and licenses, and operate without infringing the proprietary rights of
other parties both in the United States and in all other countries where we may
do business. We seek to obtain, where appropriate and financially feasible, the
broadest intellectual property protection possible for our products, proprietary
information and proprietary technology through a combination of contractual
arrangements, licenses, and patents, both in the United States and throughout
the rest of the world.




We also
depend upon the skills, knowledge and experience of scientific and technical
personnel that we hire or outside organizations with whom we contract, as well
as our advisors and consultants. To help protect our proprietary know-how that
is not patentable, and for inventions for which patents may be difficult to
enforce, we rely on trade-secret protection and confidentiality agreements. To
this end, it is our practice to require employees, consultants, advisors and
other contractors, as appropriate, to enter into confidentiality agreements that
prohibit the disclosure of confidential information and, where applicable,
require disclosure and assignment to us of the ideas, developments, discoveries
and inventions important to our business.


7


We own
patents, patent applications and know-how associated with mechanical
prostate-imaging systems. These patents and patent applications relate to
real-time mechanical imaging of the prostate (patent expires in 2021), a method
and device for mechanical imaging of the prostate (patent expires in 2012), an
intracavity ultrasonic device for elasticity imaging (patent expires in 2012), a
method and device for elasticity imaging (patent expires in 2013), an apparatus
for measuring mechanical parameters of the prostate and for imaging the prostate
(patent expires in 2012), a device for palpation and mechanical imaging of the
prostate (patent expires in 2012), and a method for using a transrectal probe to
mechanically image the prostate gland (patent expires in 2012). Together, our
mechanical imaging technology is protected by seven U.S. patents, seven
foreign patents (six foreign patents expire in 2017 and one foreign patent
expires in 2022), four foreign patent applications and, along with the Artann
patent applications discussed below, is the basis for the imaging technology
used in our ProUroScan System. We own similar patents, patent applications and
know-how associated with breast imaging. However, we do not intend to pursue any
such applications within our near-term business plan. Under the Artann License
Agreement, we agreed to grant Artann a non-exclusive, fully paid license to
make, use or sell any imaging system for the diagnosis or treatment of disorders
of the human breast.




Additionally,
Artann has one U.S. patent and three U.S. patent applications (filed in May
2005, June 2005 and June 2008) that are licensed to us under the Artann License
Agreement.  The U.S. patent, which will expire in 2024, is a design patent
relating to a calibration chamber for a prostate mechanical imaging probe. 
The U.S. patent applications relate to a method and device for real-time
mechanical imaging of a prostate, a method and dual-array transducer probe for
real-time mechanical imaging of a prostate and a design for a prostate
mechanical imaging probe.




Third-Party
Reimbursement




In the
U.S., health care providers that use the ProUroScan System will generally rely
on third-party payors, including private payors and governmental payors such as
Medicare and Medicaid, to cover and reimburse all or part of the cost of using
the ProUroScan System. Consequently, sales of the ProUroScan System depend in
part on the availability of coverage and reimbursement from third-party payors.
The manner in which reimbursement is sought and obtained varies based upon the
type of payor involved and the setting in which the procedure is furnished. In
general, third-party payors will provide coverage and reimbursement for
medically reasonable and necessary procedures and tests. Most payors, however,
will not pay separately for capital equipment, such as the ProUroScan System.
Instead, payment for the cost of using the capital equipment is considered to be
covered as part of payments received for performing the procedure. In
determining payment rates, third-party payors increasingly are scrutinizing the
amount charged for medical procedures.




Medicare and Medicaid




In order
for Medicare to cover procedures using the ProUroScan System as screening, the
Secretary of Health and Human Services (the “Secretary”) would need to add the
scan to the list of appropriate procedures for prostate cancer screening or the
procedure would need to be appropriately recommended by the United States
Preventative Services Task Force (“USPSTF”) and added through the national
coverage determination (“NCD”) process.




We
anticipate that the ProUroScan System may be covered by Medicare as a diagnostic
test for patients who have clinical signs or symptoms of disease. We anticipate
that the first generation of the ProUroScan System will be used to map the
prostate and to maintain historical records for future tracking for men who have
an abnormal DRE or other signs or symptoms of disease. Thus, providers who
perform prostate mapping using the first generation ProUroScan System likely
will seek Medicare coverage as a diagnostic, rather than a screening test,
presuming that the patient presents with a sign or symptom of disease. Even as a
diagnostic test, however, CMS or its contractors could determine that procedures
using the ProUroScan System are not medically necessary and therefore decide not
to cover them.




Regardless
of how they are covered, we anticipate that procedures using the ProUroScan
System will be reimbursed either based upon the value of their unique billing
and procedure code or as part of an office visit. Until a unique billing and
procedure code is established, we expect that providers will be able to bill for
the procedure using a miscellaneous CPT code. Claims submitted under a
miscellaneous code are processed manually and the provider must include
additional information to be used by the payor in determining the medical
appropriateness of the procedure. The lack of a unique, permanent CPT code
could slow market uptake of the ProUroScan System.




In order
to apply for a new, unique code, an application must be submitted to the AMA’s
CPT Editorial Panel. The process of obtaining a new CPT code typically
takes one or two years. Once a new CPT code is created, the AMA’s Relative
Value Scale Update Committee (“RUC”) recommends relative value units (“RVUs”)
for it. CMS then takes these recommendations into account when establishing the
Medicare Physician Fee Schedule values. The amount of reimbursement the provider
receives generally depends on the RVUs assigned to the procedure multiplied by a
conversion factor. Most private payors also base their payment rates based on
the RVUs adopted by CMS. There is a risk that the reimbursement rate that
results from this process could be insufficient, hampering our ability to market
and sell the ProUroScan System.


8


Initially,
we anticipate using a “patient pay model” for physicians to receive payment for
performing the ProUroScan System procedure. Under a patient pay model, in the
absence of coverage from their health insurance, patients pay for the scan out
of their own funds. Medicare beneficiaries would sign an Advanced Beneficiary
Notice (“ABN”) that would allow the provider to collect from the patient. Only
one in four biopsies performed based on an abnormal PSA reading reveal prostate
cancer, and only 50 percent of suspicious lesions found by DRE presented
cancer on prostate biopsy. Given these statistics, in cases where patients have
abnormal DRE or PSA test results or when a test result may not be clear, there
is a high incentive to seek additional information so that patients can make an
informed and reasonable decision for themselves and their family. We believe
that a sufficient number of patients will be willing to pay for the ProUroScan
System procedure out of their personal funds to support the launch of our
product in advance of receiving favorable coverage decisions from third-party
insurers. The concept of a patient pay model has been used successfully for a
few other procedures (e.g., computer-aided detection (“CAD”) for
mammography), and we expect this to be our approach for generating revenues
during at least the early phases of product rollout. As described above,
providers also will be able to bill under a miscellaneous CPT code until a
unique CPT code is created for the ProUroScan System
procedure.




Commercial Insurers




Many
private payors look to Medicare as a guideline in setting their coverage
policies and payment amounts. Unlike the Medicare program, however, private
payors have no statutory impediment to covering screening tests. They do tend to
seek guidance from USPSTF recommendations, however. The current coverage
policies of these private payors may differ from the Medicare program, and the
payment rates they make may be higher, lower or the same as the Medicare
program. If CMS or other agencies decrease or limit reimbursement payments for
physicians, this may affect coverage and reimbursement determinations by many
private payors. Additionally, some private payors do not follow the Medicare
guidelines, and those payors may reimburse only a portion of the costs
associated with the use of our products, or not at all.




Competition




Although
we expect competition to intensify in the prostate imaging and prostate disease
diagnostic market, we are not aware of any competitive product currently being
sold based on the same technology platform with comparable real-time color
images or other product features that the ProUroScan System provides. In
addition, we do not expect to market the ProUroScan System as a general
screening tool, and therefore will not be positioning the system to compete
directly with currently available screening tests, including the DRE and PSA
tests. The ProUroScan System will be positioned as an “adjunctive” tool
following an abnormal DRE to create a map of the prostate and an electronic
record of the image. More specifically, the proposed indication for use of the
ProUroScan System is for use as an aid to the physician in visualizing and
documenting abnormalities of the prostate detected by a DRE.




Another
test that uses inferred data to identify prostate cancer, yet to be approved in
the United States, is the PCA3 Marker (the “PCA3”). The PCA3 is a
non-coding ribonucleic acid (“RNA”) believed to be a more accurate marker of
prostate cancer than currently used diagnostics tests. The PCA3 marker was
licensed in 2000 by DiagnoCure Inc. of Quebec, Canada. In 2003, DiagnoCure
granted a worldwide license to Gen-Probe, based in San Diego, CA, for the
development and licensing of a second generation PCA3-based test using their
proprietary platform. In 2006, Gen-Probe made the test available in analyte
specific reagent format to U.S. laboratories and launched a full CE-marked
PCA3 test in Europe. Although this test has not been approved in the United
States, it potentially represents a significant advance in the development of
more sophisticated and sensitive detection methods for identifying early stage
prostate cancer. Gene fusion is another discovery that may lead to a test that
potentially will be used to diagnose prostate cancer more accurately than
current tests as well as predict prognosis. Gen-Probe has licensed this
technology as well.




In
contrast to the DRE, PSA and PCA3 tests, the ProUroScan System creates a visual
and physical record of the prostate gland. We will seek expanded labeling claims
on future generations of the ProUroScan System so that it can also be used to
conduct ongoing monitoring and surveillance of the status of the abnormalities
found by either a DRE or with the ProUroScan System. We believe that the current
generation of the ProUroScan System will have several features that are
complementary to a traditional DRE examination, such as:


9




•
            it
      is designed to produce a real-time color image of the prostate;
      and




•
            it
      is designed to enable physicians to electronically store the images in
      patient files.




Aside
from large-scale imaging modalities such as magnetic resonance imaging, computed
tomography and nuclear medicine, which due to their cost and limited
availability will not be direct competitors of the ProUroScan System, the only
imaging system in common use for prostates is the transrectal ultrasound
(“TRUS”). TRUS is employed by urologists following the referral of a patient
that has had a positive result from a DRE or PSA test, primarily to guide the
placement of prostate biopsy needles. We believe that the ProUroScan System will
be easier to operate and require less training than TRUS. We also believe it
will be less costly to acquire and maintain in a traditional medical office
setting.




Subject
to FDA clearance or approval, we believe that future uses of the ProUroScan
System will include providing a permanent record of the prostate that can be
used to identify changes over time. Nevertheless, technology is rapidly changing
in the prostate imaging and the prostate disease diagnostic market, and other
technology could come to market potentially displacing the ProUroScan
System.




Government
Regulation




The
ProUroScan System is subject to the Federal Food, Drug, and Cosmetic Act
(“FDCA”) as implemented and enforced by the FDA and by comparable agencies in
various states and various foreign countries. To ensure that medical products
distributed domestically and internationally are safe and effective for their
intended use, FDA and comparable authorities in other countries have imposed
regulations that govern, among other things, the following activities that we or
our third-party manufacturers and suppliers perform or will
perform:




•
            product
      design and development;




•
            product
      testing;




•
            product
      manufacturing;




•
            product
      labeling;




•
            product
      storage;




•
            premarket
      clearance or approval;




•
            advertising
      and promotion;




•
            product
      marketing, sales and distribution;
and




•
            post-market
      surveillance reporting death or serious injuries and medical device
      reporting.




Pervasive
and Continuing Regulation




After a
device is placed on the market, numerous regulatory requirements apply. These
include:




•
            product
      listing and establishment registration, which helps facilitate FDA
      inspections and other regulatory
action;




•
            QSR,
      which requires manufacturers, including third-party manufacturers, to
      follow stringent design, testing, control, documentation and other quality
      assurance procedures during all aspects of the manufacturing
      process;




•
            labeling
      regulations and FDA prohibitions against the promotion of products for
      uncleared, unapproved or off-label use or
  indication;




•
            clearance
      of product modifications that could significantly affect safety or
      efficacy or that would constitute a major change in intended use of our
      cleared devices;




•
            approval
      of product modifications that affect the safety or effectiveness of our
      approved devices;


10




•
            medical
      device reporting regulations, which require that manufacturers comply with
      FDA requirements to report if their device may have caused or contributed
      to a death or serious injury, or has malfunctioned in a way that would
      likely cause or contribute to a death or serious injury if the malfunction
      of the device or a similar device were to
recur;




•
            post-approval
      restrictions or conditions, including post-approval study
      commitments;




•
            post-market
      surveillance regulations, which apply when necessary to protect the public
      health or to provide additional safety and effectiveness data for the
      device; and




•
            the
      FDA’s recall authority, whereby it can ask, or under certain conditions
      order, device manufacturers to recall from the market a product that is in
      violation of governing laws and
regulations.




Advertising
and promotion of medical devices, in addition to being regulated by the FDA, are
also regulated by the Federal Trade Commission and by state regulatory and
enforcement authorities. Recently, promotional activities for FDA-regulated
products of other companies have been the subject of enforcement action brought
under healthcare reimbursement laws and consumer protection statutes. In
addition, under the federal Lanham Act and similar state laws, competitors and
others can initiate litigation relating to advertising claims. In addition, we
are required to meet regulatory requirements in countries outside the U.S.,
which can change rapidly with relatively short notice. If the FDA determines
that our promotional materials or training constitutes promotion of an
unapproved or uncleared use, it could request that we modify our training or
promotional materials or subject us to regulatory or enforcement actions,
including the issuance of an untitled letter, a warning letter, injunction,
seizure, civil fine or criminal penalties. It is also possible that other
federal, state or foreign enforcement authorities might take action if they
consider our promotional or training materials to constitute promotion of an
unapproved use, which could result in significant fines or penalties under other
statutory authorities, such as laws prohibiting false claims for reimbursement.
In that event, our reputation could be damaged and adoption of the products
would be impaired.




Furthermore,
our products could be subject to voluntary recall if we or the FDA determine,
for any reason, that our products pose a risk of injury or are otherwise
defective. Moreover, the FDA can order a mandatory recall if there is a
reasonable probability that our device would cause serious adverse health
consequences or death.




The FDA
has broad post-market and regulatory enforcement powers. Our facilities and the
manufacturing facilities of our subcontractors will be subject to unannounced
inspections by the FDA to determine our level of compliance with the QSR and
other regulations. Failure by us or by our third-party manufacturers and
suppliers to comply with applicable regulatory requirements can result in
enforcement action by the FDA or other regulatory authorities, which may result
in sanctions including, but not limited to:




•
            warning
      letters or untitled letters;




•
            fines
      and civil penalties;




•
            unanticipated
      expenditures to address or defend such
actions;




•
            delays
      in clearing or approving, or refusal to clear or approve, our
      products;




•
            withdrawal
      or suspension of approval of our products or those of our third-party
      suppliers by the FDA or other regulatory
bodies;




•
            product
      recall or seizure;




•
            orders
      for physician notification or device repair, replacement or
      refund;




•
            interruption
      of production;




•
            operating
      restrictions;


11




•
            injunctions;
      and




•
            criminal
      prosecution.




Regulation of the ProUroScan
System




The
ProUroScan System is being developed under development contracts with Artann. We
are implementing a regulatory strategy to obtain 510(k) clearance of the
ProUroScan System for a basic mapping and data maintenance claim and for the
ProUroScan System to serve as an adjunct to a DRE. We believe that this basic
mapping and data maintenance claim reflects the current needs of the market and
the capabilities of the system. Based on discussions between Artann and
representatives from the FDA, we believe that the ProUroScan System with a basic
mapping and data maintenance claim will be regulated by the FDA as a Class II
device. Class II devices typically are cleared for marketing by the FDA
through a 510(k) application.




On March
29, 2010, Artann received a letter from the FDA regarding the pending 510(k) for
the ProUroScan System. The letter notified Artann that the FDA could not
determine whether the device is substantially equivalent to the listed
predicates in the 510(k) application. The FDA specifically noted the lack of a
comparable predicate device for use as an aid in documenting abnormalities of
the prostate detected by DRE.  If the ProUroScan System is not found
to be substantially equivalent because a suitable predicate cannot be
identified, the FDA may indicate that the product may be appropriate for
Evaluation of Automatic Class III Designation because it is deemed to be a low
risk device.  This provision which is also known as a “de novo” or a
“risk based” classification is intended to allow low risk devices to be marketed
under a 510(k) when there is no adequate predicate.  Information
supporting the de novo application as a low risk device would then be combined
with the previously submitted 510(k) and submitted to the FDA for
review.  If the FDA does not deem the device to be low risk, a PMA
could be required.  Such an application may take more time to prepare
and review and be more comprehensive than the 510(k) or de novo clearance
process.





Depending
on the exact nature of future claims, the approval process may require more
extensive clinical studies and possibly the submission of a PMA.




Once we
obtain FDA approval for the ProUroScan System, or obtain FDA clearance
or approval for future products, the manufacturing, sale and performance of our
products will be subject to the ongoing FDA regulation and inspection processes
as described above.




Fraud and Abuse Laws




Because
of the significant federal funding involved in Medicare and Medicaid, Congress
and the states have enacted, and actively enforce, a number of laws whose
purpose is to eliminate fraud and abuse in federal health care programs. Once we
commercialize the ProUroScan System, our business is subject to compliance with
these laws.




Anti-Kickback Statutes and Federal
False Claims Act




The
federal healthcare programs Anti-Kickback Statute prohibits persons from
knowingly and willfully soliciting, offering, receiving or providing
remuneration, directly or indirectly, in exchange for or to induce either the
referral of an individual, or the furnishing or arranging for a good or service,
for which payment may be made under a federal healthcare program such as
Medicare or Medicaid. The definition of “remuneration” has been broadly
interpreted to include anything of value, including for example gifts,
discounts, the furnishing of free supplies, equipment or services, credit
arrangements, payments of cash and waivers of payments. Several courts have
interpreted the statute’s intent requirement to mean that if any one purpose of
an arrangement involving remuneration is to induce referrals of federal
healthcare covered business, the statute has been violated. Penalties for
violations include criminal penalties and civil sanctions such as fines,
imprisonment and possible exclusion from Medicare, Medicaid and other federal
healthcare programs. In addition, some kickback allegations have been claimed to
violate the Federal False Claims Act, discussed in more detail
below.




The
Anti-Kickback Statute is broad and prohibits many arrangements and practices
that are lawful in businesses outside of the healthcare industry. Recognizing
that the Anti-Kickback Statute is broad and may technically prohibit many
innocuous or beneficial arrangements, Congress authorized the Office of
Inspector General of the U.S. Department of Health and Human Services, or
OIG, to issue a series of regulations, known as “safe harbors.” These safe
harbors, issued by the OIG beginning in July 1991, set forth provisions
that, if all their applicable requirements are met, will assure healthcare
providers and other parties that they will not be prosecuted under the
Anti-Kickback Statute. The failure of a transaction or arrangement to fit
precisely within one or more safe harbors does not necessarily mean that it is
illegal or that prosecution will be pursued. However, conduct and business
arrangements that do not fully satisfy each applicable safe harbor may result in
increased scrutiny by government enforcement authorities such as the
OIG.




Many
states have adopted laws similar to the Anti-Kickback Statute. Some of these
state prohibitions apply to referral of patients for healthcare items or
services reimbursed by any source, not only the Medicare and Medicaid
programs.


12




Government
officials have focused their enforcement efforts on marketing of healthcare
services and products, among other activities, and recently have brought cases
against companies, and certain sales, marketing and executive personnel, for
allegedly offering unlawful inducements to potential or existing customers in an
attempt to procure their business.




Another
development affecting the healthcare industry is the increased use of the
Federal Civil False Claims Act (the “False Claims Act”) and, in particular,
actions brought pursuant to the False Claims Act’s “whistleblower” or “qui tam” provisions. The
False Claims Act imposes liability on any person or entity who, among other
things, knowingly presents, or causes to be presented, a false or fraudulent
claim for payment by a federal healthcare program. The qui tam provisions of the
False Claims Act allow a private individual to bring actions on behalf of the
federal government alleging that the defendant has submitted a false claim to
the federal government and to share in any monetary recovery. In recent years,
the number of suits brought against healthcare providers by private individuals
has increased dramatically. In addition, various states have enacted false claim
laws analogous to the False Claims Act, although many of these state laws apply
where a claim is submitted to any third-party payor and not merely a federal
healthcare program.




When an
entity is determined to have violated the False Claims Act, it may be required
to pay up to three times the actual damages sustained by the government, plus
civil penalties of $5,500 to $11,000 for each separate false claim. There are
many potential bases for liability under the False Claims Act. Liability arises,
primarily, when an entity knowingly submits, or causes another to submit, a
false claim for reimbursement to the federal government. The False Claims Act
has been used to assert liability on the basis of inadequate care, kickbacks and
other improper referrals, and improper use of Medicare numbers when detailing
the provider of services, in addition to the more predictable allegations as to
misrepresentations with respect to the services rendered. In addition, companies
have been prosecuted under the False Claims Act in connection with alleged
off-label promotion of products. Our future activities relating to the reporting
of wholesale or estimated retail prices for our products, the reporting of
discount and rebate information and other information affecting federal, state
and third-party reimbursement of our products, and the sale and marketing of our
products, may be subject to scrutiny under these laws. We are unable to predict
whether we would be subject to actions under the False Claims Act or a similar
state law, or the impact of such actions. However, the costs of defending such
claims, as well as any sanctions imposed, could significantly affect our
financial performance.




HIPAA and Other Fraud and Privacy
Regulations




Among
other things, the Health Insurance Portability and Accountability Act of 1996,
or HIPAA, created two new federal crimes: healthcare fraud and false statements
relating to healthcare matters. The HIPAA health care fraud statute prohibits,
among other things, knowingly and willfully executing, or attempting to execute,
a scheme to defraud any healthcare benefit program, including private payors. A
violation of this statute is a felony and may result in fines, imprisonment
and/or exclusion from government-sponsored programs. The HIPAA false statements
statute prohibits, among other things, knowingly and willfully falsifying,
concealing or covering up a material fact or making any materially false,
fictitious or fraudulent statement or representation in connection with the
delivery of or payment for healthcare benefits, items or services. A violation
of this statute is a felony and may result in fines and/or
imprisonment.




In
addition to creating the two new federal healthcare crimes, regulations
implementing HIPAA also establish uniform standards governing the conduct of
certain electronic healthcare transactions and protecting the security and
privacy of individually identifiable health information maintained or
transmitted by healthcare providers, health plans and healthcare clearinghouses,
which are referred to as “covered entities.” Three standards have been
promulgated under HIPAA’s regulations: the Standards for Privacy of Individually
Identifiable Health Information, which restrict the use and disclosure of
certain individually identifiable health information, the Standards for
Electronic Transactions, which establish standards for common healthcare
transactions, such as claims information, plan eligibility, payment information
and the use of electronic signatures, and the Security Standards, which require
covered entities to implement and maintain certain security measures to
safeguard certain electronic health information. Although we are not a covered
entity and therefore not directly subject to these standards, we expect that our
customers generally will be covered entities and may ask us to contractually
comply with certain aspects of these standards, particularly because we expect
that the ProUroScan System will store patient information and scan results. The
government intended this legislation to reduce administrative expenses and
burdens for the healthcare industry; however, our compliance with certain
provisions of these standards entails significant costs for us.




In
addition to federal regulations issued under HIPAA, some states have enacted
privacy and security statutes or regulations that, in some cases, are more
stringent than those issued under HIPAA. In those cases, it may be necessary to
modify our planned operations and procedures to comply with the more stringent
state laws. If we fail to comply with applicable state laws and regulations, we
could be subject to additional sanctions.


13




Employees




We
currently have two full-time employees, and expect to conduct much of our
research and development, market research, clinical and regulatory function, and
other business operations through the use of a variety of consultants and
medical-device development contractors. We have found that using consultants and
contractors to perform these functions during our development stages has allowed
us to engage specialized talent and capabilities as needed by the business while
providing the flexibility to engage them as our financial resources have
permitted.  As we begin our entry into the market during the 2010, we
anticipate hiring employees in the areas of marketing, sales and sales training,
quality assurance, engineering, software development and administration. Some or
all of these functions may be performed by contracted individuals or consultants
as management deems most effective. We are conducting our research and
development activities related to our acquired technologies and proposed
products on a contract basis with Artann and Logic.




ITEM
      1A.
            RISK
      FACTORS





Important
Notices to Investors; Safe Harbor Statement





Statements
in this Annual Report on Form 10-K which are not purely historical are
forward-looking statements. These statements with respect to the goals, plan
objectives, intentions, expectations, financial condition, results of
operations, future performance and business of our Company, including, without
limitation: (i) our ability to successfully complete all clinical trials and
commercial development of our products and secure all necessary federal and
other regulatory approvals to introduce and market our products in the United
States and around the world; (ii) our ability to fund our working capital needs
over the next 12 to 24 months; (iii) our ability to successfully introduce our
products into the medical device markets; and (iv) all statements preceded by,
followed by or that include the words "may," "would," "could," "should,"
"expects," "projects," "anticipates," "believes," "estimates," "plans,"
"intends," "targets" or similar expressions. For these statements, the Company
claims the protection of the safe harbor for forward-looking statements
contained in the Private Securities Litigation Reform Act of 1995.





Forward-looking
statements involve inherent risks and uncertainties, and important factors (many
of which are beyond our control) that could cause actual results to differ
materially from those set forth in the forward-looking statements, including the
following, in addition to those contained in our Company's reports on file with
the Securities and Exchange Commission: general economic or industry conditions,
nationally and in the physician, urology and medical device communities in which
we intend to do business; our ability to fund our working capital needs over the
next 12 to 24 months; our ability to complete the development of our existing
and proposed products on a timely basis if at all; legislation or regulatory
requirements, including our securing all FDA and other regulatory approvals on a
timely basis, if at all, prior to being able to market and sell our products in
the United States; competition from larger and more well established medical
device and other competitors; the development of products that may be superior
to the products offered by us; securing and protecting our intellectual property
and assets and enforcing breaches of the same; clinical results not anticipated
by management of the Company; the quality or composition of our products and the
strength and reliability of our contract vendors and partners; ability to raise
capital to fund our 2009 and 2010 working capital needs and launch our products
into the marketplace in subsequent years; changes in accounting principles,
policies or guidelines; financial or political instability; acts of war or
terrorism; and other economic, competitive, governmental, regulatory and
technical factors affecting our operations, proposed products and
prices.





Accordingly,
results actually achieved may differ materially from expected results in these
statements.  Forward-looking statements speak only as of the date they are
made.  We do not undertake, and specifically disclaim, any obligation to
update any forward-looking statements to reflect events or circumstances
occurring after the date of such statements.


14




Risk
Factors Associated with our Business, Operations and Securities




We
are a development stage company. We have no operating history and our business
plan has not yet been fully tested. We anticipate incurring future losses and
may continue incurring losses after our products are completed, regulatory
clearance or approval is secured and our products are introduced and accepted in
the United States and worldwide markets.




We are a
development-stage company. We have yet to commence active operations to
manufacture or sell any products associated with the proprietary urology-based
imaging technologies that we intend to market. We have no prior operating
history from which to evaluate our likelihood of success in operating our
business, generating any revenues or achieving profitability. As of December 31,
2009, we have generated no revenue and have recorded losses since inception of
approximately $28 million. There can be no assurance that our plans for
developing and marketing our urology-based products will be successful, or that
we will ever attain significant sales or profitability. We anticipate that we
will incur losses in the near future.




We
have a history of operating losses and have received a “going-concern”
qualification from our independent registered public accounting
firm.




We have
incurred operating losses and negative cash flows from operations since
inception. As of December 31, 2009, we had an accumulated deficit of
approximately $27.9 million. We have not yet generated any revenues. These
factors, among others, raise substantial doubt about our ability to continue as
a going concern. Our consolidated financial statements included in this Annual
Report on Form 10-K do not include any adjustments related to recoverability and
classification of asset carrying amounts or the amount and classification of
liabilities that might result should we be unable to continue as a going
concern.




Our
independent registered public accounting firm included an explanatory paragraph
in their report on our financial statements indicating that such deficit
accumulated during the development stage raises substantial doubt as to our
ability to continue as a going concern. The likelihood of our success must be
considered in light of the expenses, difficulties and delays frequently
encountered in connection with development stage businesses and the competitive
environment in which we will operate. Our ability to achieve profitability is
dependent in large part on obtaining FDA clearance or approval for the
ProUroScan System, implementing a “patient pay” sales model, achieving third
party coverage and reimbursement, establishing distribution channels, forming
relationships with third-party manufacturers and gaining market acceptance of
the ProUroScan System. There can be no assurance that the Company will
successfully market the ProUroScan System or operate profitably.




If
adequate funds are not available on a timely basis, we could potentially be
forced to cease operations.




If
adequate funds are not available on a timely basis, or are not available on
acceptable terms, we may be unable to repay our existing debt, to fund
expansion, or to develop or enhance our products. Until such time as we are able
to enter the market and achieve positive cash flow from operations, we will
continue to depend on our ability to obtain additional new investment to fund
operations.  Ultimately, if adequate financing is not obtained, we could
potentially be forced to cease operations.




Our
assets are pledged to secure $1,300,000 of senior bank notes and $643,000 of
notes issued to investors and a bank and, as a result, are not available to
secure other senior debt financing. Upon the occurrence of an event of default,
the bank’s security interests in our assets will be assigned to guarantors of
the bank notes and the holders of such $643,000 of promissory
notes.




Our
$1,300,000 senior debt financing through Crown Bank, Minneapolis, Minnesota, has
required us to pledge all of our assets and certain licenses, as well as to
provide personal guarantees of certain shareholders. In addition, we have issued
a total of $643,000 of promissory notes to three individual investors and a bank
that have subordinated interests in all of our assets and certain
licenses.  Due to such security interests, we will not be in a position in
the future to pledge our assets to secure any debt or lending facility, in the
event we desire or need to borrow such funds on a secured lending basis. It is
doubtful that we would be able to obtain significant additional debt financing
on an unsecured basis.




Moreover,
under the terms and conditions of the Crown Bank facility and our agreement with
the facility’s guarantors, in the event of any default by us with our senior
lender that causes the personal guarantees to be called and honored, all of the
bank’s security interests in our assets shall be assigned to such guarantors,
pro rata, in consideration of such breach and obligation to pay under the
respective guarantees. In addition, the holders and guarantor of $643,000 of
promissory notes have a security interest in our assets in the event of a
default under the note. Thus, our common shareholders, and any existing and
future investors in our common stock, would, if the foregoing breach and
circumstances occurred, not have access or recourse to the assets and
collateral, and thus, would likely face a complete loss of their investment in
the Company.


15




We
will need additional financing, and any such financing will likely be dilutive
to our existing shareholders.




We will
need additional financing to fund operations while we ramp up production of the
ProUroScan System and begin to enter the market.  We will also need funding
to pay, for example, the $750,000 payment due to Artann upon achieving the
FDA 510(k) clearance milestone.  If we fail to secure a distribution
partner on terms acceptable to us, or at all, we could be required to undertake
distribution activity at our expense, which could significantly increase our
capital requirements and may delay the commercialization of our
products.




As of
March 26, 2010, we had approximately $575,000 of cash on hand and 
5,760,436 outstanding redeemable warrants.  These warrants have an exercise
price of $1.30 per share.  We currently have the right to redeem 4,515,607
of these warrants, and may redeem the remaining 1,244,829 warrants once the last
sale price of our common stock equals or exceeds $4.00 per share for a period of
10 consecutive trading days.  If all of the redeemable warrants are
exercised pursuant to such redemptions, we could realize approximately $7.5
million.  There can be no assurance that we will be able to redeem the
warrants, or how much would be realized if such redemptions were
made.




We are
actively pursuing other potential near-term sources of funding to provide the
working capital needed to repay our existing debt and to fund a commercial
launch into the urology market.  These potential sources include additional
loans or guaranteed bank debt, working with lenders to extend the maturity dates
of existing debt and one or more rounds of private placements of debt or equity
securities and cash advances from shareholders.




If
additional funds are raised by the issuance of convertible debt or equity
securities, such as the issuance of stock or the issuance and exercise of
warrants or the issuance and conversion of convertible debt, then existing
shareholders will experience dilution in their ownership interest. If additional
funds are raised by the issuance of debt or certain equity instruments, we may
become subject to certain operational limitations, and such securities may have
rights senior to those of existing holders of common stock. There can be no
assurance that we will be successful in obtaining such additional financing, if
needed. Additional financing may not be available to us, may not be available on
favorable terms and will likely be dilutive to existing
shareholders.




We
are relying upon Artann to obtain 510(k) clearance of the ProUroScan System.
There is no guarantee that the FDA will grant timely 510(k) clearance of the
ProUroScan System, if at all, and failure to obtain such timely clearance would
adversely affect our ability to market that product and expand utilization of
the technology in other prostate applications or in other soft tissue organs in
the body, which may affect our ability to grow our business.




The
ProUroScan System is subject to regulation by the FDA and by comparable agencies
in various foreign countries. The process of complying with the requirements of
the FDA and comparable agencies is costly, time consuming and burdensome. We
believe the ProUroScan System with a basic mapping and data maintenance claim
will be regulated by the FDA as a Class II device and will require the clearance
of a 510(k) application. On November 18, 2009, Artann submitted the
510(k).  On March 29, 2010, Artann received a letter from the FDA
regarding the pending 510(k) for the ProUroScan System. The letter notified
Artann that FDA could not determine whether the device is substantially
equivalent to the listed predicates in the 510(k) application. The FDA
specifically noted the lack of a comparable predicate device for use as an aid
in documenting abnormalities of the prostate detected by DRE.  If the
ProUroScan System is not found to be substantially equivalent because a suitable
predicate cannot be identified, the FDA may indicate that the product may be
appropriate for Evaluation of Automatic Class III Designation because it is
deemed to be a low risk device.  This provision which is also known as
a “de novo” or a “risk based” classification is intended to allow low risk
devices to be marketed under a 510(k) when there is no adequate
predicate.
  There is
no guarantee that the FDA will grant 510(k) clearance or designate the
ProUroScan System as a class II device in a timely manner, if at all. Failure to
obtain clearance for the ProUroScan System would require Artann to re-apply for
510(k) clearance with additional supporting data or information, or for a
different labeling claim, submit a Premarket Approval Application (a “PMA”) for
FDA approval, or abandon the product. Even if FDA 510(k) clearance is received,
Artann may encounter significant delays in receiving such clearance. If
unexpected clearance delays occur, or if Artann needs to re-apply for FDA
clearance or submit a PMA, it could have a material adverse effect on our
business as Artann is to transfer such clearance or approval to us once we make
the first commercial sale of the ProUroScan System. If such delays occur, we
would need to obtain additional financing to continue
operations.


16




Even
if clearance from the FDA is obtained, our products may not be commercially
viable or may not be accepted by the marketplace.




Even if
the FDA grants market clearance of the ProUroScan System and we are able to
successfully develop future products, we may not be able to contract for the
manufacture of such products in commercial quantities at prices that will be
commercially viable. Further, there is risk that the ProUroScan System and our
future products may not prove to be as effective as currently available medical
or diagnostic products or those developed in the future. The inability to
successfully complete development of a product or application or a determination
by us, for financial, technical or other reasons not to complete development of
any product or application, particularly in instances in which we have made
sufficient capital expenditures, could have a material adverse effect on our
business. With respect to the ProUroScan System, under our current Artann
Development Agreement, Artann is to transfer the 510(k) to us once we make the
first commercial sale of the ProUroScan System. If we are not able to procure a
commercial sale of at least one ProUroScan System, Artann would not be obligated
to transfer the 510(k) to us and might not do so, thus inhibiting our ability to
develop future generations of the product.




Even if
successfully developed, the ProUroScan System and our future products will be
competing against other imaging and diagnostic products in the medical device
marketplace, including those developed in the future that may render the
ProUroScan System obsolete. The DRE, in combination with a PSA test, is part of
today’s “standard of care” to evaluate patients over the age of 50 for prostate
cancer or other ailments relating to the prostate. In addition, other modalities
that can be used for diagnostic imaging include transrectal ultrasound, magnetic
resonance imaging, computed tomography and nuclear medicine. Therefore, there
can be no assurance that physicians, providers, patients, third party payors or
the medical device market, in general, will accept our products.




There
is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our
future products and claims and failure to obtain necessary clearances or
approvals for our future products and claims would adversely affect our ability
to expand utilization of the technology in other prostate applications or in
other soft tissue organs in the body, which may affect our ability to grow our
business.




In the
future, we may seek to obtain additional indications for use of the ProUroScan
System beyond the basic mapping and data maintenance claim, as well as clearance
and approval of new products. Some of these expanded claims and future products
may require FDA clearance of a 510(k). Other claims and future products will
require FDA approval of a PMA. Moreover, some of our future products and the
additional claims on the ProUroScan System we may seek may require clinical
trials to support regulatory approval, and we may not successfully complete
these clinical trials. The FDA may not approve or clear these future products,
or future generations of the ProUroScan System for the indications that are
necessary or desirable for successful commercialization. Indeed, the FDA may
refuse our requests for 510(k) clearance or PMA approval of new products.
Failure to receive clearance or approval for additional claims for the
ProUroScan System, or for our future products, would have an adverse effect on
our ability to expand our business.




Clinical
trials necessary to support our future products and claims will be expensive and
may require the enrollment of large numbers of patients, and suitable patients
may be difficult to identify and recruit. These trials may require the
submission of an investigational device exemption, for which there is no
guarantee that the FDA will approve. Delays or failures in our clinical trials
will prevent us from commercializing any modified or new products and will
adversely affect our business, operating results and prospects.




Initiating
and completing clinical trials necessary to support 510(k)s or PMAs for future
generations of the ProUroScan System will be time consuming and expensive and
the outcome uncertain. Moreover, the results of early clinical trials are not
necessarily predictive of future results, and any product we advance into
clinical trials may not have favorable results in later clinical
trials.




Conducting
successful clinical studies may require the enrollment of large numbers of
patients, and suitable patients may be difficult to identify and recruit.
Patient enrollment in clinical trials and completion of patient participation
and follow-up depends on many factors, including: the size of the patient
population; the number of patients to be enrolled; the nature of the trial
protocol; the attractiveness of, or the discomforts and risks associated with,
the treatments received by enrolled subjects; the availability of appropriate
clinical trial investigators, support staff, and proximity of patients to
clinical sites; and the patients’ ability to meet the eligibility and exclusion
criteria for participation in the clinical trial and patient compliance. For
example, patients may be discouraged from enrolling in our clinical trials if
the trial protocol requires them to undergo extensive post-treatment procedures
or follow-up to assess the safety and effectiveness of our products or if they
determine that the treatments received under the trial protocols are not
attractive or involve unacceptable risks or discomforts. In addition, patients
participating in clinical trials may die before completion of the trial or
suffer adverse medical events unrelated to investigational
products.


17




Development
of sufficient and appropriate clinical protocols to demonstrate safety and
efficacy are required, and we may not adequately develop such protocols to
support clearance and approval. Significant risk trials will require the
submission and approval of an investigational device exemption (“IDE”) from the
FDA. There is no guarantee that the FDA will approve our future IDE submissions.
Further, the FDA may require us to submit data on a greater number of patients
than we originally anticipated and/or for a longer follow-up period or change
the data collection requirements or data analysis applicable to our clinical
trials. Delays in patient enrollment or failure of patients to continue to
participate in a clinical trial may cause an increase in costs and delays in the
approval and attempted commercialization of our products or result in the
failure of the clinical trial. In addition, despite considerable time and
expense invested in our clinical trials, the FDA may not consider our data
adequate to demonstrate safety and efficacy. Such increased costs and delays or
failures could adversely affect our business, operating results and
prospects.




We
have no manufacturing experience, and will rely on third parties to manufacture
the ProUroScan System in an efficient manner. If design specification changes
are needed to develop an efficient manufacturing process, those changes may
require FDA clearance of a new 510(k) or approval of a PMA, which we may not be
able to obtain in a timely manner, if at all.




To be
successful, the ProUroScan System will need to be manufactured in sufficient
quantities, in compliance with regulatory requirements and at an acceptable
cost. We have no manufacturing experience. We have identified a third-party
manufacturer to produce commercial units of the ProUroScan System for
distribution after 510(k) clearance or PMA approval is obtained. This
third-party manufacturer is in the process of developing and optimizing the
manufacturing process to produce commercial ProUroScan Systems. If device design
changes are required to implement an efficient manufacturing process, these
design changes will need to be evaluated and implemented in accordance with
applicable Quality Systems Regulation (“QSR”) requirements. If we implement
design changes after the FDA has cleared the ProUroScan System 510(k), we will
need to assess whether those design changes could significantly affect the
safety or effectiveness of the device, and require the submission and clearance
of a new 510(k), or even require the submission of a PMA. If we determine that
these modifications require a new 510(k) clearance or PMA approval, we may not
be able to obtain this additional clearance in a timely manner, or at all. In
general, obtaining additional clearances can be a time consuming process, and
delays in obtaining required future clearances would adversely affect our
ability to market the ProUroScan System in a timely manner, which in turn would
harm our potential for future growth.




If
we or our third-party manufacturers or suppliers fail to comply with ongoing FDA
or other foreign regulatory authority requirements, or if we experience
unanticipated problems with our products, these products could be subject to
restrictions or withdrawal from the market.




Any
product for which we obtain FDA clearance or approval, and the manufacturing
processes, reporting requirements, post-approval clinical data and promotional
activities for such product, will be subject to continued regulatory review,
oversight and periodic inspections by the FDA and other domestic and foreign
regulatory bodies. In particular, we and our third-party manufacturers and
certain of our suppliers will be required to comply with the FDA’s QSR,
regulations for the manufacture of our products and other regulations which
cover the methods and documentation of the design, testing, production, control,
quality assurance, labeling, packaging, storage and shipping of any product for
which we obtain clearance or approval. Regulatory bodies, such as the FDA,
enforce the QSR and other regulations through periodic inspections. The failure
by us or one of our third-party manufacturers or suppliers to comply with
applicable statutes and regulations administered by the FDA and other regulatory
bodies, or the failure to timely and adequately respond to any adverse
inspectional observations or product safety issues, could result in, among other
things, any of the following enforcement actions:




•
            warning
      letters or untitled letters;




•
            fines
      and civil penalties;




•
            unanticipated
      expenditures to address or defend such
actions;




•
            delays
      in clearing or approving, or refusal to clear or approve, our
      products;




•
            withdrawal
      or suspension of approval of our products or those of our third-party
      suppliers by the FDA or other regulatory
bodies;


18




• 
    product recall or seizure;




• 
    orders for physician notification or device repair, replacement or
refund;




• 
    interruption of production;




• 
    operating restrictions;




• 
    injunctions; and




• 
    criminal prosecution.




If any of
these actions were to occur it would harm our reputation and cause our product
sales and profitability to suffer and may prevent us from generating revenue.
Furthermore, our third-party manufacturers and suppliers may not be in
compliance with all applicable regulatory requirements which could result in
failure to supply our products in required quantities, if at all.




Even if
regulatory clearance or approval of a product is granted, such clearance or
approval may be subject to limitations on the intended uses for which the
product may be marketed and reduce our potential to successfully commercialize
the product and generate revenue from the product. If the FDA determines that
our promotional materials, labeling, training or other marketing or educational
activities constitute promotion of an unapproved use, it could request that we
cease or modify our training or promotional materials or subject us to serious
regulatory enforcement actions, including some of those listed above. It is also
possible that other federal, state or foreign enforcement authorities might take
action if they consider our training or other promotional materials to
constitute promotion of an unapproved use, which could result in significant
fines or penalties under other statutory authorities, such as laws prohibiting
false claims for reimbursement.




In
addition, we may be required to conduct costly post-market testing and
surveillance to monitor the safety or effectiveness of our products, and we must
comply with medical device reporting requirements, including the reporting of
adverse events and malfunctions related to our products. Later discovery of
previously unknown problems with our products, including unanticipated adverse
events or adverse events of unanticipated severity or frequency, manufacturing
problems or failure to comply with regulatory requirements such as QSR, may
result in changes to labeling, restrictions on such products or manufacturing
processes, withdrawal of the products from the market or regulatory enforcement
actions.




Our
products may in the future be subject to product recalls that could harm our
reputation, business and financial results.




The FDA
and similar foreign governmental authorities have the authority to require the
recall of commercialized products in the event of material deficiencies or
defects in design or manufacture. In the case of the FDA, the authority to
require a mandatory recall must be based on an FDA finding that there is a
reasonable probability that the device would cause serious adverse health
consequences or death. In addition, foreign governmental bodies have the
authority to require the recall of our products in the event of material
deficiencies or defects in design or manufacture. Manufacturers may, under their
own initiative, initiate a field correction or removal, known as a recall, for a
product if any material deficiency in a device is found. A government mandated
or voluntary recall by us or one of our third-party manufacturers or suppliers
could occur as a result of component failures, manufacturing errors, design or
labeling defects or other deficiencies and issues. Recalls of any of our
products would divert managerial and financial resources and have an adverse
effect on our financial condition and results of operations. The FDA requires
that certain classifications of recalls be reported to the FDA within 10 working
days after the recall is initiated. Companies are required to maintain certain
records of recalls, even if they are not reportable to the FDA. We may initiate
voluntary recalls involving our products in the future that we determine do not
require notification of the FDA. If the FDA disagrees with our determinations,
they could require us to report those actions as recalls. A future recall
announcement could harm our reputation with customers and negatively affect our
sales. In addition, the FDA could take enforcement action for failing to report
the recalls when they were conducted.




If
our marketed products cause or contribute to a death or a serious injury, or
malfunction in certain ways, we will be subject to medical device reporting
regulations, which can result in voluntary corrective actions or agency
enforcement actions.




Under the
FDA medical device reporting regulation, medical device manufacturers are
required to report to the FDA information that a device has or may have caused
or contributed to a death or serious injury or has malfunctioned in a way that
would likely cause or contribute to death or serious injury if the malfunction
of the device or one of our similar devices were to recur. If we fail to report
these events to the FDA within the required timeframes, or at all, the FDA could
take enforcement action against us. Any such adverse event involving our
products also could result in future voluntary corrective actions, such as
recalls or customer notifications, or agency action, such as inspection or
enforcement action. Any corrective action, whether voluntary or involuntary, as
well as defending ourselves in a lawsuit, will require the dedication of our
time and capital, distract management from operating our business, and may harm
our reputation and financial results.


19




We
will depend upon others for the manufacturing of our products, which will
subject our business to the risk that we will be unable to fully control the
supply of our products to the market.




Our
ability to develop, manufacture and successfully commercialize our future
products depends upon our ability to enter into and maintain contractual and
collaborative arrangements with others. We do not intend to establish any of our
own manufacturing facilities for the ProUroScan System or any of our future
products. Instead, we intend to retain QSR compliant and FDA registered contract
manufacturers. We may also have to rely on a sole supplier for certain
components of our ProUroScan System. There can be no assurance that such
manufacturers will be able to supply our products in the required quantities, at
appropriate quality levels or at acceptable costs. We may be adversely affected
by any difficulties encountered by such third-party manufacturers that result in
product defects, production delays or the inability to fulfill orders on a
timely basis. If a manufacturer cannot meet our quality standards and delivery
requirements in a cost-efficient manner, we could suffer interruptions of
delivery while we arrange for alternative manufacturing sources. Any extended
disruption in the delivery of our products could result in our inability to
satisfy customer demand for our products. Consequently, our inability to obtain
alternative sources on a timely basis may have a material adverse effect on our
business.




We
may incur significant liability if it is determined that we are promoting
off-label use of our products in violation of federal and state regulations in
the United States or elsewhere.




Artann
initially intends to seek clearance of the ProUroScan System from the FDA solely
for a basic mapping and data maintenance claim. We believe that seeking 510(k)
clearance for this limited indication is the least burdensome path to initial
regulatory clearance. Our business and future growth, however, will depend
primarily on the use or enhancement of the ProUroScan System to identify the
specific three-dimensional location(s) of lesion(s) in the prostate and allow
the physician to rotate the image to assist in identifying the actual
position(s) of the lesion(s) in the prostate gland in order to provide a
diagnosis of the patient’s condition. Once 510(k) clearance is obtained and the
ProUroScan System 510(k) is transferred to us from Artann, we intend to
subsequently seek regulatory clearance or PMA approval for use of the ProUroScan
System for a variety of other prostate related indications. Unless and until we
receive regulatory clearance or approval for use of the ProUroScan System in
these procedures, uses in procedures other than basic mapping and data
maintenance will be considered off-label uses of the ProUroScan System. Under
the Federal Food, Drug and Cosmetic Act (the “FDCA”) and other similar laws, we
are prohibited from labeling or promoting our products, or training physicians,
for such off-label uses. This prohibition means that the FDA could deem it
unlawful for us to make claims about the safety or effectiveness of the
ProUroScan System in the diagnosis of lesions or proactively discuss or provide
information or training on the use of the ProUroScan System for the diagnosis of
prostate lesions, with very limited exceptions. However, although manufacturers
are not permitted to promote for off-label uses, in their practice of medicine,
physicians may lawfully choose to use medical devices for off-label uses. Even
if the FDA grants 510(k) clearance for the ProUroScan System for use in a basic
mapping and data maintenance claim, a physician could use the ProUroScan System
for uses not covered by the cleared labeling. This would constitute an off-label
use. We expect that hospitals and physicians will use the ProUroScan System for
a variety of uses beyond mapping prostate anatomy.




The FDA
and other regulatory agencies actively enforce regulations prohibiting promotion
of off-label uses and the promotion of products for which marketing clearance
has not been obtained. A company that is found to have improperly promoted
off-label uses may be subject to significant liability, including civil and
administrative remedies as well as criminal sanctions. Due to these legal
constraints, our sales and marketing efforts will focus only on the general
technical attributes and benefits of the ProUroScan System and the FDA cleared
or approved indications for use.




Federal
regulatory reforms may adversely affect our ability to sell our products
profitably.




From time
to time, legislation is drafted and introduced in Congress that could
significantly change the statutory provisions governing the clearance or
approval, manufacture and marketing of a medical device. In addition, FDA
regulations and guidance are often revised or reinterpreted by the agency in
ways that may significantly affect our business and our products. It is
impossible to predict whether legislative changes will be enacted or FDA
regulations, guidance or interpretations changed, and what the impact of such
changes, if any, may be.


20


Without
limiting the generality of the foregoing, last year, the Food and Drug
Administration Amendments Act of 2007 (the “FDA Amendments Act”) were enacted.
The FDA Amendments Act requires, among other things, that the FDA propose, and
ultimately implement, regulations that will require manufacturers to label
medical devices with unique identifiers unless a waiver is received from the
FDA. Once implemented, compliance with those regulations may require us to take
additional steps in the manufacture of our products and labeling. These steps
may require additional resources and could be costly. In addition, the FDA
Amendments Act will require us to, among other things, comply with clinical
trial registration requirements once our clinical trials are
initiated.




A
failure to successfully implement a “patient pay” sales model prior to
establishing third-party reimbursement could have a material adverse effect on
our product sales and financial results.




Until
third-party reimbursement coverage for the ProUroScan System procedure is
established, if at all, we anticipate using a “patient pay model” for physicians
to receive payment. Under a patient pay model, in the absence of coverage from
their health insurance, patients pay for the scan out of their own funds. Any
failure to successfully establish a patient pay model could have a material
adverse effect on our product sales and financial results.




The
financial success of the ProUroScan System and other future medical device
products will materially depend on our ability to obtain coverage and
reimbursement for them.




The
financial success of the ProUroScan System and other medical device products
will materially depend on the scope of coverage for each device and the ability
of medical service providers to obtain third-party reimbursement from private
and public insurance sources, such as Medicare, Medicaid and private payors. It
is difficult to predict the timing and outcome of coverage and reimbursement
decisions. There can be no assurance that coverage and reimbursement will be
obtained or will be obtained at a level that will provide a suitable return to
providers of services using our technology.




Because
the incidence of prostate cancer increases with age, we expect that a
significant percentage of our patients will be Medicare beneficiaries. Obtaining
Medicare coverage and reimbursement will be critical to our success. Ensuring
adequate Medicare coverage and reimbursement, however, can be a lengthy and
expensive endeavor and we cannot provide assurances that we will be
successful.




Significantly,
the U.S. Congress may pass laws that impact coverage and reimbursement for
healthcare services, including Medicare reimbursement to physicians and
hospitals. Furthermore, many private payors look to Medicare’s coverage and
reimbursement policies in setting their coverage policies and reimbursement
amounts. If the Centers for Medicare and Medicaid Services (“CMS”), the federal
agency that administers the Medicare program, or Medicare contractors limit
coverage or payments to physicians for the ProUroScan System, private payors may
similarly limit coverage or payments. In addition, state legislatures may enact
laws limiting or otherwise affecting the level of Medicaid reimbursement for
procedures using the ProUroScan System. As a result, physicians may not purchase
our ProUroScan System, and, consequently, our business and financial results
would be adversely affected.




We do not
currently receive coverage and reimbursement from any party for the use of our
products because we have no products fully developed and currently available for
sale in the marketplace. As a result, we have not taken any steps to obtain
approval for coverage and reimbursement for the use of the ProUroScan
System.




Our
failure to receive the third-party coverage for our products could result in
diminished marketability of our products.




Generally,
Medicare does not cover and pay for items and services that are not reasonable
or necessary for the diagnosis or treatment of illness or injury or to improve
the functioning of a malformed body member. This means that Medicare does not
usually cover and pay for preventative services, including routine screening
tests for patients who do not present with any signs or symptoms of disease,
unless the law specifically provides for such preventative coverage. Such
statutory coverage currently exists for prostate cancer screening tests.
Specifically, the law states that Medicare will cover a prostate screening test
that consists of a DRE and/or a PSA test provided for the purpose of early
detection of prostate cancer to a man over 50 years of age who has not had
such test during the preceding year. In addition, the law provides the Secretary
of Health and Human Services (the “Secretary”) the authority to cover other
prostate screening tests based upon changes in technology and standards of
medical practice, availability, effectiveness, costs and other factors deemed
appropriate by the Secretary. Thus, for the ProUroScan System to receive
Medicare coverage as a prostate screening test, the Secretary would need to add
the scan to the list of appropriate procedures for prostate cancer screening.
This could be a significant hurdle for the ProUroScan System to receive Medicare
coverage as a prostate screening test. Additionally, Congress recently created
an alternative pathway for Medicare to cover preventative services. Preventative
services that receive a grade “A” or “B” by the United States Preventive
Services Task Force (“USPSTF”) are eligible for Medicare coverage. The USPSTF
does not currently recommend prostate cancer screening with either
grade.


21




We
anticipate, however, that the ProUroScan System may be covered by Medicare as a
diagnostic test for patients who have clinical signs or symptoms of disease.
Obtaining Medicare coverage as a diagnostic test is more straightforward as long
as the test is reasonable and necessary. For example, the PSA test is covered as
a diagnostic test when used to differentiate benign from malignant disease in
men with lower urinary tract signs and symptoms (e.g., hematuria, slow
urine stream, hesitancy, urgency, frequency, nocturia and incontinence) as well
as with patients with palpably abnormal prostate glands on physician exam, and
in patients with other laboratory or imaging studies that suggest the
possibility of a malignant prostate disorder. We anticipate that the first
generation of the ProUroScan System will be used to map the prostate and to
maintain historical records for future tracking for men who have an abnormal DRE
or other signs or symptoms of disease. Thus, providers who perform prostate
mapping using the first generation ProUroScan System likely will seek Medicare
coverage and payment as a diagnostic, rather than a screening test. Even as a
diagnostic test, however, CMS or its contractors could determine that procedures
using the ProUroScan System are not medically necessary and therefore decide not
to cover them.




Even
if covered, our failure to receive appropriate reimbursement from third-party
payors could slow market uptake of our products.




Regardless
of whether the ProUroScan System is covered as a screening tool or a diagnostic
test, there is a risk that Medicare and other payors will bundle payment for it
into the payment for a covered office visit furnished to the patient on the same
day. For example, Medicare currently bundles billing and payment for a DRE into
payment for a covered evaluation and management office visit when the two
services are furnished to a Medicare beneficiary on the same day. If the DRE is
the only service or is provided as part of an otherwise non-covered service, it
may be separately paid if other coverage requirements are met. On the other
hand, the PSA typically is separately paid as a clinical diagnostic laboratory
service. Specifically, CMS could determine that due to the ease and short amount
of time needed to perform the ProUroScan System procedure, separate
reimbursement is not warranted if the physician already is billing an office
visit.




In order
for physicians and providers who perform procedures using the ProUroScan System
to receive separate reimbursement, they must bill a Current Procedure
Terminology (“CPT”) code that appropriately describes the service performed.
Although initially physicians and providers will be able to bill a miscellaneous
code to submit claims for ProUroScan System procedures, eventually we will want
to apply for a unique CPT code. The CPT application process is lengthy, and
there is no guarantee that we will receive a unique CPT code or that we will
receive a unique CPT code in a timely manner. Should we receive a unique CPT
code, the code is then valued for purposes of receiving reimbursement by the
American Medical Association’s Relative Value Scale Update Committee. The
valuation process depends on the amount of time the procedure takes and
difficulty of work involved, the practice expense and the malpractice expense
associated with using the ProUroScan System. CMS then takes the recommendation
of this committee into account when establishing the reimbursement amount. The
amount of reimbursement the physician will receive generally depends on the
values assigned to the various components of the procedure multiplied by a
conversion factor. This value is updated annually as part of the Medicare
Physician Fee Schedule. There is no guarantee that this process will result in
an appropriate level of reimbursement or an amount that supports the price and
revenues we have projected.




Even
if a unique CPT code is obtained for the test, the level of reimbursement
established may not provide adequate economic incentive to physicians, which
could deter them from using our products and limit our sales
growth.




At this
time, we do not know the extent to which physicians or providers would consider
third-party reimbursement levels adequate to cover the cost of our products.
Failure by physicians or providers to receive an amount that they consider to be
adequate reimbursement could deter them from using our products and limit our
sales growth. In addition, Medicare physician fee schedule payments may decline
over time, which could deter physicians from using the ProUroScan System. If
physicians or providers are unable to justify the costs of the ProUroScan System
or they are not adequately compensated for using our product, they may
experience an economic disincentive to purchase or use them, which would
significantly harm our business.




Notwithstanding
current or future FDA clearances, if granted, third-party payors may deny
reimbursement if the payor determines that the ProUroScan System is unnecessary,
inappropriate, not cost-effective or experimental, or is used for a non-approved
indication. Further, all third-party payors, whether governmental or private,
whether domestic or international, are developing increasingly sophisticated
methods of controlling healthcare costs. These cost control methods include
prospective payment systems, capitated rates, benefit redesigns, or
pre-authorization requirements. Increased scrutiny particularly is being placed
on medical imaging. Additionally, payors are emphasizing and covering wellness
and healthier lifestyle interventions and other cost-effective methods of
delivering healthcare in exchange for covering more procedures. These cost
control methods also potentially limit the amount that healthcare providers may
be willing to pay for medical technology which could, as a result, adversely
affect our business and financial results. In addition, in the U.S., no uniform
policy of coverage and reimbursement for medical technology exists among all
third-party payors. Therefore, coverage and reimbursement for medical technology
can differ significantly from payor to payor. There also can be no assurance
that current levels of reimbursement will not be decreased or eliminated in the
future, or that future legislation, regulation or reimbursement policies of
third-party payors will not otherwise adversely affect the demand for the
ProUroScan System or our ability to sell the ProUroScan System on a profitable
basis.


22




If
we commercialize the ProUroScan System, we will be subject, directly or
indirectly, to federal and state healthcare fraud and abuse laws and regulations
and could face substantial penalties if we are unable to fully comply with such
laws.




Although
we do not control referrals of healthcare services or directly bill Medicare,
Medicaid or other third-party payors, many healthcare laws and regulations will
apply to our business. For example, we could be subject to healthcare fraud and
abuse and patient privacy regulation and enforcement by both the federal
government and the states in which we conduct our business. The healthcare laws
and regulations that may affect our ability to operate include:




• 
    the federal healthcare programs’ Anti-Kickback Law, which
prohibits, among other things, persons or entities from soliciting, receiving,
offering or providing remuneration, directly or indirectly, in return for or to
induce either the referral of an individual for, or the purchase order or
recommendation of, any item or service for which payment may be made under a
federal healthcare program such as the Medicare and Medicaid
programs;




• 
    federal false claims laws which prohibit, among other things,
individuals or entities from knowingly presenting, or causing to be presented,
claims for payment from Medicare, Medicaid or other third-party payors that are
false or fraudulent, or are for items or services not provided as claimed, and
which may apply to entities like us to the extent that our interactions with
customers may affect their billing or coding practices;




• 
    the federal Health Insurance Portability and Accountability Act of
1996, or HIPAA, which established new federal crimes for knowingly and willfully
executing a scheme to defraud any healthcare benefit program or making false
statements in connection with the delivery of or payment for healthcare
benefits, items or services, as well as leading to regulations imposing certain
requirements relating to the privacy, security and transmission of individually
identifiable health information; and




• 
    state law equivalents of each of the above federal laws, such as
anti-kickback and false claims laws which may apply to items or services
reimbursed by any third-party payor, including commercial insurers, and state
laws governing the privacy of health information in certain circumstances, many
of which differ from each other in significant ways and often are not preempted
by HIPAA, thus complicating compliance efforts.




The
healthcare sector is, and in recent years has been, under heightened scrutiny as
the subject of government investigations and enforcement actions involving
manufacturers who allegedly offered unlawful inducements to potential or
existing customers in an attempt to procure their business, including
specifically arrangements with physician consultants. We may have arrangements
with physicians and other entities which may be subject to scrutiny. For
example, we may lease the ProUroScan System to physicians or others through
consulting agreements. Payment for these consulting services sometimes may be in
the form of cash, stock options or royalties. If our operations are found to be
in violation of any of the laws described above or any other governmental
regulations that apply to us, we may be subject to penalties, including civil
and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid
programs, and the curtailment or restructuring of our operations. Any penalties,
damages, fines, exclusions, curtailment or restructuring of our operations could
adversely affect our ability to operate our business and our financial results.
The risk of our being found in violation of these laws is increased by the fact
that many of these laws are broad and their provisions are open to a variety of
interpretations. Any action against us for violation of these laws, even if we
successfully defend against it, could cause us to incur significant legal
expenses and divert our management’s attention from the operation of our
business. If the physicians or other providers or entities with whom we do
business are found to be non-compliant with applicable laws, they may be subject
to sanctions, which could also have a negative impact on our
business.




Any
failure in our efforts or our contractor’s efforts to train physicians or other
medical staff could result in lower than expected product sales.




A
critical component of our sales and marketing efforts is the training of a
sufficient number of physicians and other medical staff to properly use the
ProUroScan System. We rely on physicians and other medical staff to devote
adequate time to learn to use our products. Convincing physicians and other
medical staff to dedicate the time and energy for adequate training in the use
of our system may be challenging, and we cannot guarantee that this will occur.
If physicians and other medical staff are not properly trained, they may misuse
or ineffectively use our products. Insufficient training may result in
unsatisfactory patient outcomes, patient injury and related liability or
negative publicity, which could have an adverse effect on our product sales or
create substantial potential liabilities.


23




Rapid
technological change in our competitive marketplace may render the ProUroScan
System obsolete or may diminish our ability to compete in the
marketplace.




The
prostate cancer detection, imaging and medical device markets are extremely
competitive, dominated by large and well financed competition and are subject to
rapid technological advances and changes. The discovery of new technologies and
advances in the application of such technologies to the medical marketplace in
general, and the market for urology-based imaging products in particular, may
render our products obsolete or non-competitive. Any such changes and advances
could force us to abandon our currently proposed products, which would have a
material adverse effect on our business.




We
may not be able to enter into manufacturing agreements or other collaborative
agreements on terms acceptable to us, if at all, which could have a material
adverse effect on our business.




We cannot
be sure that we will be able to enter into manufacturing or other collaborative
arrangements with third parties on terms acceptable to us, if at all. If we fail
to establish such arrangements when, and as necessary, we could be required to
undertake these activities at our own expense, which would significantly
increase our capital requirements and may delay the development, manufacturing
and commercialization of our products. If we are unable to address these capital
requirements, it may have a material adverse effect on our
business.




We
expect to rely materially on Artann and other consultants and contractors, some
of whom may be partially or wholly paid through issuances of common stock
dilutive to our shareholders.




We
materially rely on consultants and contractors to perform a significant amount
of research and development, pre-manufacturing, clinical, regulatory and
marketing activities. Specifically, we issued 769,231 shares of our common stock
to Artann on March 15, 2010 related to the FDA 510(k) filing milestone, and upon
receipt of FDA clearance from the FDA we expect to issue additional equity
securities to Artann valued at $1.0 million. We expect that certain other
consultants and contractors will also accept payment of a portion of their
compensation in the form of our equity securities. Any such issuances would be
dilutive to shareholders.




We
are highly dependent on the services provided by certain key
personnel.




We are
highly dependent upon the services of our executive officers, Richard Carlson
and Richard Thon. We have not obtained “key-man” life insurance policies
insuring the lives of either of these persons. If the services of either of
these persons become unavailable to us, for any reason, our business could be
adversely affected.




If
we lose our right to license and use from Artann certain critical intellectual
property for any reason, our entire business would be in jeopardy.




If we
breach or fail to perform the material conditions including payment obligations
of, or fail to extend the term of, the agreement with Artann that licenses
critical intellectual property, we may lose all or some of our rights to such
critical intellectual property and our license may terminate. If we should lose
our right to license and use technology covered by such license that is critical
to our business, such loss would have a materially adverse effect on our
business. In such a case, the viability of the Company would be in question. Our
only alternatives would be to find existing and non-infringing technology to
replace that lost, if any exists, or develop new technology ourselves. The
pursuit of any such alternative would likely cause significant delay in the
development and introduction of our proposed products.




The
protections for our key intellectual property may be successfully challenged by
third parties.




We own
various key intellectual properties. No assurance can be given that any
intellectual property claims will not be successfully challenged by third
parties. Any challenge to our intellectual property, regardless of merit, would
likely involve costly litigation which could have a material adverse effect on
our business. If a successful challenge were made to intellectual property that
is critical to our proposed products, the pursuit of any such alternative would
likely cause significant delay in the development and introduction of such
products. Moreover, a successful challenge could call into question the validity
of our business.


24




As
we lose patent protection on our critical technologies, it may have a material
adverse effect on our business.




We rely
on certain patents to provide us with exclusive rights for our technology. The
first of our primary patents on our core technology will expire in December
2012. As we begin to lose certain patent protections on our prostate imaging
systems and related critical patented technologies, we may face strong
competition as a result, which could have a material adverse effect our
business.




The
government has rights to certain of our patents.




Certain
of our patents emanated from work performed by Artann under grants from the
National Institutes of Health (“NIH”). As a result, certain standard NIH grant
obligations apply, which are designed to ensure that the U.S. investment is used
in the interest of U.S. industry and labor and that inventions are reported to
NIH. Additionally, the U.S. government retains a non-exclusive license to these
patents. As a non-exclusive licensee of certain of these patents, the U.S.
government, in addition to utilizing the inventions itself, could in certain
limited circumstances, request additional licenses to the patents be granted to
other parties and, if such license request is refused, grant the licenses
itself. Any actions by the U.S. government to require the grant of additional
licenses could materially and adversely affect our business.




We
may not be able to successfully compete against companies in our industry with
greater resources, or with any competition.




If our
development plan is successful, we expect to experience significant competition
in the medical device market. Although we believe that we may currently have a
niche in the prostate imaging marketplace, many factors beyond our control will
likely encourage new competitors. In particular, there are several large
companies that have indicated an interest in the prostate imaging business.
Therefore, no assurance can be given that we will be able to successfully
compete with these, or any other companies in the marketplace, if at
all.




Our
ability to use operating loss carryforwards to offset income in future years may
be limited.




As of
December 31, 2009, the Company had generated net operating loss
carryforwards of approximately $6.7 million which, if not used, will begin
to expire in 2021. Federal and state tax laws impose significant restrictions on
the utilization of net operating loss carryforwards in the event of a change in
ownership of the Company that constitutes an “ownership change,” as defined by
Section 382 of the Internal Revenue Code of 1986, as amended. The Company
has analyzed its equity ownership changes and believes that such an ownership
change has occurred.  The Company’s use of its net operating loss
carryforwards and built-in loss will be limited as a result of this change;
however, the amount of limitation will not be known until a full Section 382
study can be completed.




Our
business and products subject us to the risk of product liability
claims.




The
manufacture and sale of medical products and the conduct of clinical trials
using new technology involve customary risks of product liability claims. There
can be no assurance that our insurance coverage limits will be adequate to
protect us from any liabilities which we might incur in connection with the
clinical trials or the commercialization of any of our products. Product
liability insurance is expensive and in the future may not be available on
acceptable terms, if at all. A successful product liability claim or series of
claims brought against us in excess of our insurance coverage would have a
material adverse effect on our business. In addition, any claims, even if not
ultimately successful, could have a material adverse effect on the marketplace’s
acceptance of our products.




ITEM
1B:  UNRESOLVED STAFF COMMENTS




Not
applicable.




ITEM
2:PROPERTIES




Our
executive offices are located at 6440 Flying Cloud Drive, Eden Prairie,
Minnesota, where we rent approximately 1,000 square feet of office space on a
month-to-month basis.  Additional space sufficient for our foreseeable
needs is available to us on similar terms on an as-needed basis.  Our
rental cost for this office space is approximately $1,000 per month, which we
believe is at market for similar office space in Minneapolis, Minnesota. 
We do not own any real property.


25




ITEM
3:  LEGAL PROCEEDINGS




Although
we are subject to litigation or other legal proceedings from time to time in the
ordinary course of our business, we are not a party to any pending legal
proceedings and are not aware of any threatened legal proceeding.




On July
15, 2009, Rensselaer Polytechnic Institute (“RPI”) filed a lawsuit against the
Company seeking payment of $202,716 plus interest, penalties, costs and
disbursements, including attorneys’ fees. In the complaint, RPI alleged that the
Company breached obligations to pay RPI an aggregate of $202,716 under the terms
of a license agreement dated July 13, 2001 between RPI and the Company and a
sponsored research agreement dated as of December 9, 2005 between RPI and the
Company. On December 7, 2009, the Company entered into a settlement agreement
with RPI concerning litigation originally filed by RPI against the Company on
July 15, 2009.  In the settlement agreement, the Company agreed to pay to
RPI a total of $117,000 in installments as follows: $10,000 upon signing, $6,000
per month from December 2009 through October 2010, and $41,000 in November
2010.  The Company executed an affidavit for judgment by confession to
secure the above payments.  The Company has 20 days to cure any failure to
make the required payments.  As the full amount due to RPI was recorded in
prior years, no additional provision was recorded and previously recorded
minimum royalty expenses of $20,000 were reversed during the year ended December
31, 2009.




ITEM
4:  (RESERVED)




PART II





ITEM
5: MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES





General




We
currently have four equity securities quoted on the OTC Bulletin Board: common
stock, Units, and two warrant issues. Our common stock is quoted under the
symbol “PUMD.” The Units, consisting of one share of common stock and one
five-year warrant to purchase a share of common stock at $1.30 per share, are
quoted under the symbol “PUMDU.” Upon their separation from the Units, the
warrants are separately quoted under the symbol “PUMDW” (the “Public Warrants”).
Finally, three-year warrants issued as an incentive to existing warrant holders
for their early exercise of five-year warrants pursuant to our 2009 replacement
warrant offering (the “Replacement Warrants”) are quoted under the symbol
“PUMWW.”





The
following table lists the high and low bid information for our common stock and
Units as quoted on the OTC Bulletin Board by quarter from January 1, 2008
through December 31, 2009 (as adjusted for the February 2008 one-for-ten reverse
stock split).  Our common stock began trading in December 2003.  Price
quotes for the Public Warrants represent the high and low selling prices as
quoted on the OTC Bulletin Board.  No quotes are available for the
Replacement Warrants to date.





Common Stock
                                    (PUMD)
                                  
                                  
                                  Units
                                    (PUMDU)
                                  
                                  
                                  Public Warrants
                                    (PUMDW)High
                                  
                                  
                                  Low
                                  
                                  
                                  High
                                  
                                  
                                  Low
                                  
                                  
                                  High
                                  
                                  
                                  Low2008First
      Quarter
                                  
                                  $
                                  0.95
                                  
                                  
                                  $
                                  0.30
                                  
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *Second
      Quarter
                                  
                                  $
                                  2.01
                                  
                                  
                                  $
                                  0.30
                                  
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *Third
      Quarter
                                  
                                  $
                                  3.05
                                  
                                  
                                  $
                                  0.30
                                  
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *Fourth
      Quarter
                                  
                                  $
                                  1.85
                                  
                                  
                                  $
                                  0.41
                                  
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *
                                  
                                  $
                                  
                                  *2009First
      Quarter
                                  
                                  $
                                  1.21
                                  
                                  
                                  $
                                  0.20
                                  
                                  
                                  $
                                  0.80
                                  
                                  
                                  $
                                  0.70
                                  
                                  
                                  $
                                  0.20
                                  
                                  
                                  $
                                  0.15Second
      Quarter
                                  
                                  $
                                  0.70
                                  
                                  
                                  $
                                  0.50
                                  
                                  
                                  $
                                  1.10
                                  
                                  
                                  $
                                  0.70
                                  
                                  
                                  $
                                  0.20
                                  
                                  
                                  $
                                  0.15Third
      Quarter
                                  
                                  $
                                  1.45
                                  
                                  
                                  $
                                  0.55
                                  
                                  
                                  $
                                  1.55
                                  
                                  
                                  $
                                  1.10
                                  
                                  
                                  $
                                  0.51
                                  
                                  
                                  $
                                  0.15Fourth
      Quarter
                                  
                                  $
                                  4.00
                                  
                                  
                                  $
                                  1.10
                                  
                                  
                                  $
                                  2.20
                                  
                                  
                                  $
                                  1.01
                                  
                                  
                                  $
                                  1.70
                                  
                                  
                                  $
                                  0.20
 * 
  Not
traded.


26




Dividend
Policy




We have
never declared or paid any cash dividends on our capital stock and do not expect
to pay any dividends for the foreseeable future. We intend to use future
earnings, if any, in the operation and expansion of our business. Any future
determination relating to our dividend policy will be made at the discretion of
our board of directors, based on our financial condition, results of operations,
contractual restrictions, capital requirements, business properties,
restrictions imposed by applicable law and other factors our board of directors
may deem relevant. Future debt covenants may prohibit payment of
dividends.




Recent
Sales of Unregistered Securities




None.




ITEM
      6:
            SELECTED
      FINANCIAL DATA




Not
      applicable.




ITEM
      7:
            MANAGEMENT’S
      DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
      OPERATIONS




The
following discussion of our financial condition and results of operations should
be read in conjunction with our consolidated financial statements, and notes
thereto, included in this Annual Report on Form 10-K. This discussion should not
be construed to imply that the results discussed herein will necessarily
continue into the future, or that any conclusion reached herein will necessarily
be indicative of actual operating results in the future.




Overview




ProUroCare
Medical Inc. (“ProUroCare,” the “Company,” “we” or “us”) is an emerging medical
device company that is in the process of obtaining FDA clearance for its first
product, an innovative prostate imaging system known as the ProUroScanTM
System.  The ProUroScan System incorporates our new proprietary elasticity
imaging technology to create a “map” of the prostate to be used as an aid in
visualizing and documenting abnormalities of the prostate detected/monitored by
digital rectal examination.  We own and exclusively license intellectual
property related to the creation in real-time of two- and three-dimensional
images of soft tissue using special software to process data acquired by probes
that incorporate arrays of sensitive mechanical force sensors.  The
ProUroScan System is our first embodiment of this technology, to be used to
image the prostate.  We believe that this technology can be applied to
other soft organ tissue in the future.




The
ProUroScan System was developed over the past several years under agreements
with our development partner, Artann Laboratories Inc. (“Artann”), a scientific
technology company that is focused on early-stage technology
development.  During 2008 and 2009, our research and development
activities conducted through Artann have been primarily directed toward
completion of the final configuration of the ProUroScan System and conducting
clinical trials.  This work culminated in the preparation and
submission to the FDA of a 510(k) application for market clearance in November
2009.  On March 29, 2010, Artann received a letter from the FDA
regarding the pending 510(k) for the ProUroScan System. The letter notified
Artann that the FDA could not determine whether the device is substantially
equivalent to the listed predicates in the 510(k) application. The FDA
specifically noted the lack of a comparable predicate device for use as an aid
in documenting abnormalities of the prostate detected by DRE.  If the
ProUroScan System is not found to be substantially equivalent because a suitable
predicate cannot be identified, the FDA may indicate that the product may be
appropriate for Evaluation of Automatic Class III Designation because it is
deemed to be a low risk device.  This provision which is also known as
a “de novo” or a “risk based” classification is intended to allow low risk
devices to be marketed under a 510(k) when there is no adequate
predicate.  Information supporting the de novo application as a low
risk device would then be combined with the previously submitted 510(k) and
submitted to FDA for review.  If the FDA does not deem the device to
be low risk, a PMA could be required.  Such an application may take
more time to prepare and review and be more comprehensive than the 510(k) or de
novo clearance process.




For
further information concerning our agreement and commitments to Artann, see
“ProUroScan System Development Partner” in Part I, Item 1,
“Business.”




During
this pre-revenue stage, in addition to work performed by Artann, we have
conducted our development and clinical activities primarily through the use of
contracted resources that specialize in managing the clinical trial process,
developing regulatory strategies and in counseling on FDA matters.  We have
found that using consultants and contractors to perform these functions during
our development stages has allowed us to engage specialized talent and
capabilities as needed by the business while providing the flexibility to engage
them as our financial resources have permitted.  During 2009, we identified
a highly qualified contract manufacturer, Logic (Minneapolis, MN), to produce
the first commercial ProUroScan Systems.  Logic is currently working with
Artann to transfer the technology into production.


27




We expect
to market the system in cooperation with a yet-to-be-determined medical device
company that has an established worldwide presence in the urology market. We are
actively engaged in discussions with several such companies, and intend to
identify the final marketing partner during 2010. Prior to entering the market
through a commercialization partner, we plan to produce eight to ten systems and
place them with highly-regarded urologists across the United States. These key
opinion leaders will expand our base of clinical reference while evaluating
physician training and in-service programs. We also intend to place a limited
number of systems in Europe during this period. During the course of 2010, as we
move into production and begin marketing our products, we expect to add internal
resources in the areas of marketing, regulatory affairs, operations and
support.




In
addition to the research and development work, we incur ongoing expenses that
are directly related to being a publicly traded company, including professional
audit and legal fees, public and investor relations, financial printing, press
releases and transfer agent fees.  We also incur costs associated with the
prosecution and maintenance of our intellectual property.  We currently
rent approximately 1,000 square feet of office space on a month-to-month basis
at a cost of approximately $1,000 per month. Other expenses incurred include
executive officer compensation, travel, insurance, telephone, supplies and other
miscellaneous expenses.




Recent
Financings




We have
been funded to date by a combination of public and private financings, and by
bank loans that have been guaranteed by certain investors.  Since December
2007, we have raised over $7.5 million to fund our product development, clinical
trials and early preparations for market entry.




Between
December 2007 and July 2008, we raised a total of $2.0 million (including
conversion of $175,000 of existing debt) from the sale of convertible promissory
notes and warrants in four private placements.




On April
3, 2008, we purchased certain previously licensed patents, patent applications,
and know-how (the “Profile Assets”) from Profile, LLC (“Profile”). $150,000 of
the purchase price was financed under a secured promissory note with Profile
(the “Profile Note”) that was subsequently repaid. In addition, we borrowed an
aggregate of $112,500 pursuant to three convertible promissory notes each in the
amount of $37,500 to finance the purchase. In January 2009, following the
closing of the 2009 Public Offering (as defined below), we repaid $45,500 of the
notes, and $29,500 of the notes were converted into common stock at $0.70 per
share (based on 70 percent of the 2009 Public Offering price as discussed
below). On March 19, 2009, the remaining $37,500 promissory note and accrued
interest thereon, due to Mr. James Davis, a greater than 10 percent shareholder
of the Company, was refinanced along with another $150,000 promissory note due
to Mr. Davis (discussed below).




On
September 16, 2008, we received funding commitments to purchase $325,000 of
units in accordance with the terms of a unit put agreement (such funding
commitments, the “Unit Put Arrangement”).  Between September 2008 and
December 2008, we raised $315,000 from the sale of convertible promissory notes
and warrants pursuant to the Unit Put Arrangement.




On
September 25, 2008, we borrowed $150,000 pursuant to a promissory note
issued in favor of Mr. Davis. The proceeds of the loan were used to retire the
$150,000 principal amount of the Profile Note.  On March 19, 2009, Mr.
Davis agreed to refinance the $150,000 debt along with a $37,500 note, accrued
interest and other advances from Mr. Davis to us.  Pursuant to the
refinancing, we issued a $281,000 unsecured convertible promissory note to Mr.
Davis.  On May 26, 2009, Mr. Davis exercised his conversion rights under
the promissory note, and the note was converted into 510,909 shares of the
Company’s common stock.




On
January 12, 2009, we closed a public offering of 3,050,000 units at $1.00 per
unit (the “2009 Public Offering”) resulting in net cash received of $1,790,472
after offering costs of $1,259,528.Each unit sold consisted
of one share of common stock and one redeemable warrant to purchase one share of
common stock at an exercise price of $1.30 per share (the “Public
Warrants”).




The
closing of the 2009 Public Offering triggered the automatic conversion of
certain debt instruments into equity, as follows:




·
            $733,334
      convertible debentures, together with $143,815 of interest accrued
      thereon, converted into 292,384 shares of our common
  stock;


28




·
            $1.9
      million of convertible notes issued in the 2007 and 2008 private
      placements, together with $177,882 of interest accrued thereon, converted
      into 3,058,381 Units.  Each unit sold consisted of one share of
      common stock and one redeemable warrant to purchase one share of common
      stock at an exercise price of $1.30 per share (the “Private Warrants”);
      and




·
            $299,250
      of convertible notes issued pursuant to the Unit Put Arrangement, together
      with $9,563 of interest accrued thereon, converted into 441,165 shares of
      our common stock.




On March
19, 2009, we renewed our $1.2 million Crown Bank promissory note.  The
renewed note matures on April 28, 2010 and remains collateralized by all Company
assets and guaranteed by two individual guarantors.




Between
May 1, 2009 and September 16, 2009, Mr. Davis made various payments for the
benefit of the Company and provided us with certain cash advances to help fund
specific Company activities related to product development, clinical studies and
FDA related activities totaling approximately $243,000.   On September
21, 2009, Mr. Davis and the Company executed a promissory note in the principal
amount of $243,000 to formalize our obligation to Mr. Davis for these
amounts.   The note matures on March 28, 2011, and provides Mr. Davis
with a subordinated security interest in the Company’s assets.




On June
16, 2009, we borrowed $100,000 from Crown Bank pursuant to a promissory note
that is collateralized by Company assets and guaranteed by an individual
guarantor.  The note matures on April 28, 2010.




On
September 23, 2009, we borrowed $100,025 from Central Bank pursuant to a
promissory note.  The promissory note matures on January 17, 2011. The
promissory note was guaranteed by an individual guarantor.




On
September 23, 2009, we borrowed $300,000 from an individual lender pursuant to a
secured promissory note.  The promissory note matures on March 28, 2011 and
provides the lender with a subordinated security interest in the Company’s
assets.




On
September 25, 2009, we commenced our “Replacement Warrant Offering.” 
Pursuant to the offer, we temporarily modified the terms of the Public Warrants
and the Private Warrants so that each holder who tendered their warrants for
early exercise on or before November 6, 2009 received, in addition to the shares
of common stock purchased upon exercise, new three-year warrants to purchase the
same number of shares of ProUroCare common stock at an exercise price of $1.30
per share (the “Replacement Warrants”).  On November 6, 2009, warrants to
purchase 1,244,829 shares of common stock were tendered resulting in proceeds to
the Company of $1,618,278.  Net proceeds were $1,446,413 after $171,865 of
offering expenses.




On March
26, 2010, we converted a $600,000 loan along with $97,546 of accrued interest
thereon into 381,173 shares of common stock and 381,173 three-year, immediately
exercisable warrants to acquire common stock at an exercise price of $1.83 per
share.




Results
of Operations




The
following presents an analysis of the Company’s financial results for the fiscal
years ended December 31, 2009 and 2008.




Net
Loss




Our net loss for fiscal 2009 increased
49 percent to $6,944,000 compared to $4,658,000 for fiscal 2008.  Operating
expenses comprised of research and development expenses and general and
administrative expenses, as described below, increased by 51 percent to
$3,951,000 in 2009 compared to $2,624,000 in 2008.  Also contributing to
the increased net loss was a $1,357,000 incentive, in the form of Replacement
Warrants, given to warrant holders for the early exercise of their existing
warrants.




Research
and development




Research
and development expense for fiscal 2009 increased 275 percent to $2,240,000
compared to $598,000 for fiscal 2008. The majority of our research and
development expense was conducted under contracts with Artann.  The
November 18, 2009 submission of the FDA 510(k) application triggered a cash
milestone payment of $250,000, and an accrual of the issuance of 769,231 shares
of common stock valued on the submission date at approximately $1,565,000. 
In addition, we expensed $235,000 for Artann’s development retainer. 
During 2009 we also incurred approximately $137,000 of regulatory and clinical
consulting fees and contracted engineering fees of approximately $34,000. In
2008, research and development expense consisted primarily of a $250,000
milestone payment due to Artann upon the initiation of FDA clinical studies and
the expensing of the $300,000 purchase price of the Profile
Assets.


29




General
and administrative expenses




General
and administrative expenses for 2009 decreased by 16 percent, or $316,000, to
$1,711,000 compared to $2,027,000 for 2008.




Our only
employees are our two executive officers, whose base salaries have not increased
since 2006.  Cash-based compensation expenses (salary, bonus, benefits and
related payroll taxes) totaled $359,000 in 2009, including a total of $40,000 in
bonuses.  In 2008, we incurred $331,000 of compensation expense, which
included no bonus expense. Stock options granted to our directors, officers and
consultants in 2009 were valued at $481,000.  Stock-based compensation
expense in 2008 was $59,000.




We incur
costs related to being a public reporting company, including fees for securities
attorneys and our independent registered public accounting firm, proxy services,
transfer agent services, investor relations and directors and officer’s
(“D&O”) insurance costs. In 2009, we increased our investor relations
activity and expanded our D&O insurance coverage following our 2009 Public
Offering.  Consequently, public reporting company costs totaled $325,000 in
2009, representing an increase of $141,000 over 2008.




In 2009,
as we worked to complete clinical trials, submit the FDA 510(k) application and
began preparations for market entry, we incurred new fees for reimbursement
consulting, marketing, public relations and financial consulting services
totaling $212,000.




In 2008
we incurred a $600,000 up-front cash license fee and a $500,000 license fee paid
in our common stock pursuant to our license agreement with Artann, which were
expensed as general and administrative expense.




Interest
and other expense




Interest
expense for 2009 was $1,221,000, a decrease of $689,000, or 36 percent, compared
to $1,910,000 in 2008.  Our interest expense consists of the interest
charged by lenders on amounts we have borrowed plus the amortization of the cost
of consideration we have provided to lenders and loan guarantors.  Interest
charged by lenders totaled $193,000 in 2009, a 57 percent reduction from the
$453,000 n 2008.  The majority of the decrease was due to the automatic
conversion of $2,933,000 of convertible debt in January 2009 upon the completion
of our 2009 Public Offering.  The cost of consideration provided to lenders
and loan guarantors, in the form of stock, warrants or beneficial conversion
features of convertible debt, is generally recorded as original issue discount
and amortized over the term of the associated debt.  In 2009, $1,028,000 of
such consideration was amortized, a decrease of $430,000, or 29 percent from the
$1,458,000 recorded in 2008.




Debt
extinguishment expense for 2009 was $416,000, an increase of $292,000, or 236
percent, compared to $124,000 in 2008.  Debt extinguishment expense is
incurred when the cost to refinance existing loans, including changes in
interest rates and the cost of consideration provided to lenders and loan
guarantors, in the form of stock, warrants or beneficial conversion features of
convertible debt, is significant enough that we deem it to be a retirement of
existing debt and creation of a new loan.  The debt extinguishment expense
recognized in 2009 related to the refinancing of our Crown Bank loan and loans
from Mr. Davis.  The debt extinguishment expense recognized in 2008 related
to the refinancing of several loans with individual investors.




Pursuant
to our Replacement Warrant Offering (see “Recent Financings,” above), we issued
1,244,829 Replacement Warrants.  The $1,357,000 fair market value of the
Replacement Warrants, determined using the Black-Scholes pricing model, was
expensed as an incentive for early warrant exercise in 2009.




Liquidity
and Capital Resources




Assets;
Property Acquisitions and Dispositions




Our
primary assets are our intellectual property rights, including patents, patent
applications and our license agreement with Artann, which are the foundation for
our proposed product offerings. These assets secure $1.3 million of senior
bank notes and, as a result, are not available to secure other senior debt
financing.


30


We
anticipate purchasing approximately $230,000 of tooling, molds and other capital
for production, computer equipment, software and general office furniture and
equipment during the remainder of 2010. We do not anticipate selling any
significant assets in the near term.
  On
April 3, 2008, we purchased the Profile Assets pursuant to an asset
purchase agreement. The purchase price of the Profile Assets was
$300,000.  See “Recent Financings,”
above.
  Sources
and Uses of Cash
  Net cash
used in operating activities was $3.1 million in 2009 compared to $1.1 million
in 2008.  The increase in cash used was primarily the result of
payments to Artann of $600,000 for licensing fees and a total of $500,000 for
milestone achievements pursuant to our licensing and development agreements. We
also paid $205,000 to Artann for development work performed under the
development agreement.  In addition to increased operating expenses,
other uses of cash included payments for accounts payable, accrued compensation
and other accrued expenses.
  Net cash
provided by financing activities was $4.1 million in 2009 compared to $700,000
in 2008.  Proceeds from the 2009 Public Offering less underwriter’s
commissions and other payments for expenses of the offering were $2.3 million,
while net proceeds from warrant exercises was $1.7 million.  In
addition, we borrowed a total of $200,025 pursuant to two bank loans and
$543,000 pursuant to two loans from investors.  Offsetting this was
our retirement of a $400,000 bank debt in March 2009.  During 2008, we
received net proceeds from our private convertible debt placements with
individual investors of $1,197,000.  These debt proceeds were offset
by repayments of notes payable and loans from directors totaling $410,000 and
payments made for debt issuance and deferred offering costs totaling
$88,000.
  Cash
Requirements
  We expect
that our cash needs for our operating expenses (including payments due to Artann
explained below) will be approximately $4.2 million through the remainder of
2010.  Of this amount, we anticipate that on-going general and
administrative expenses, including the cost of existing personnel, rent, patent,
legal, audit and other costs of being a public company, will be approximately
$1,150,000.  We estimate that our cost of contracting for certain
product engineering and development work to reduce the size of the ProUroScan
System and make certain enhancements will cost approximately
$700,000.  We expect to add personnel in the areas of sales and
marketing, engineering, and quality during the remainder of 2010 estimated to
cost approximately $600,000.  We expect to initiate sales and
marketing programs in advance of obtaining a corporate distribution partner that
will cost approximately $450,000.  Placing systems and performing
additional patient studies at certain key institutions will cost approximately
$350,000.
  Pursuant
to the terms of the Artann development agreement, upon receipt of
FDA 510(k) clearance we are required to make a cash payment of $750,000 and
provide a $1.0 million equity payment to Artann.
  We are in
negotiations with Crown Bank to renew our existing $1.3 million of
loans.  We expect that the final agreement will include provisions
that we retire $300,000 or more of this debt over the next 12
months.  We also have other short term liabilities, consisting of
accounts payable, accrued expenses and a bank loan totaling approximately $1.4
million.
  In total,
assuming financing permits, we expect our cash requirements for operating costs,
capital expenditures, and debt retirement during the remainder of 2010 to be
approximately $5.3 million.  Of this, at least $2 million is
discretionary and subject to reduction or postponement based on
availability of funding. If FDA clearance of the ProUroScan System is delayed,
such as may happen if we need to file for de novo or PMA approval (See "Overview," above), or if additional clinical
information is requested, our cash requirements could increase and we would
likely reduce certain planned marketing and development activities.
  Current
Financing Plans
  Our plan
to meet these cash requirements consists of several elements:
  As of
March 26, 2010, we have 5,760,436 outstanding redeemable
warrants.  These warrants have an exercise price of $1.30 per
share.  Of these, we currently have the right to redeem 4,515,607
Public and Private Warrants.  We may redeem 1,244,829 Replacement
Warrants once the last sale price of our common stock equals or exceeds $4.00
per share for a period of 10 consecutive trading days.  Upon our
exercise of our right to redeem the warrants, holders of the warrants will have
a period of 30 days to exercise their warrants.  If all holders of the
Public and Private Warrants exercise their warrants, we could realize up to
approximately $5.9 million, depending on the number of shares actually exercised
pursuant to such a redemption.  If all holders of the Replacement
Warrants exercise their warrants, we could realize up to an additional $1.6
million, depending on the number of shares actually exercised pursuant to such
redemption.  There can be no assurance that we will be able to redeem
the warrants, or how much would be realized if such redemption were
made.
  31
  We plan
to identify a distribution partner to market our products (see “Marketing and
Distribution” under Part I, Item 1, “Business”) during 2010.  We
expect such a distribution partner to provide significant financial support in
the form of licensing fees, loans, equity investment or a combination of
these.  In addition to financial support, a successful collaboration
with such a partner would allow us to gain access to downstream marketing,
manufacturing and sales support.  There can be no assurance that a
distribution partner can be successfully identified and engaged during 2010, if
at all.
  If an
insufficient number of warrants are exercised, or if we do not receive adequate
financial support from a distribution partner, we will likely pursue one or more
additional rounds of funding in 2010. If additional funds are raised by the
issuance of convertible debt or equity securities, or by the exercise of
outstanding warrants, then existing shareholders will experience dilution in
their ownership interest. If additional funds are raised by the issuance of debt
or certain equity instruments, we may become subject to certain operational
limitations, and such securities may have rights senior to those of our existing
holders of common stock.
  If
adequate funds are not available through these initiatives on a timely basis, or
are not available on acceptable terms, we may be unable to fund expansion and
may be forced to delay our market entry.  Ultimately, if no additional
financing is obtained beyond what has been secured to date, we likely would be
forced to cease operations. There can be no assurance we will be successful in
raising such funds.
  Off-Balance
Sheet Arrangements
  None.
  Going
Concern
  We have
incurred operating losses, accumulated deficit and negative cash flows from
operations since inception. As of December 31, 2009, we had an accumulated
deficit of approximately $27.9 million. These factors, among others, raise
substantial doubt about our ability to continue as a going concern. Our
consolidated financial statements included in this Annual Report on Form 10-K do
not include any adjustments related to recoverability and classification of
asset carrying amounts or the amount and classification of liabilities that
might result should we be unable to continue as a going concern.
  Critical
Accounting Policies
  Our
critical accounting policies are policies which have a high impact on the
reporting of our financial condition and results, and require significant
judgments and estimates. Our critical accounting policies relate to (a) the
valuation of stock-based compensation awarded to employees, directors, loan
guarantors and consultants and (b) the accounting for debt with beneficial
conversion features.
  Valuation
of Stock-Based Compensation
  Since
inception, we have measured and recognized compensation expense for all
share-based payment awards made to employees and directors including employee
stock options based on fair value. Our determination of fair value of
share-based payment awards is based on the date of grant using an option-pricing
model which incorporates a number of highly complex and subjective variables.
These variables include, but are not limited to, the expected volatility of our
stock price and estimates regarding projected employee stock option exercise
behaviors and forfeitures. We recognize the expense related to the fair value of
the award straight-line over the vesting period.
  Debt
with Beneficial Conversion Features
  The
beneficial conversion features of the promissory notes were valued using the
Black-Scholes pricing model. The resulting original issue discount is amortized
over the life of the promissory notes using the straight-line method, which
approximates the interest method.
  32
  ITEM
7A: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
 Not
applicable.
  33
  ITEM
8:  FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
 
 The
      following financial statements are included:Report
      of Independent Registered Public Accounting Firm
                    
                    F-2Audited
      Financial Statements:Consolidated
      Balance Sheets
                    
                    F-3Consolidated
      Statements of Operations
                    
                    F-4Consolidated
      Statement of Shareholders’ Equity (Deficit)
                    
                    F-5Consolidated
      Statements of Cash Flows
                    
                    F-13Notes
      to Consolidated Financial Statements
                    
                    F-16
  F-1
  REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
 To the
Shareholders, Audit Committee and Board of Directors
 ProUroCare
Medical Inc.
 Eden
Prairie, MN
 
 We have
audited the accompanying consolidated balance sheets of ProUroCare Medical Inc.
(a development stage company) as of December 31, 2009 and 2008, and the related
consolidated statements of operations, shareholders' equity (deficit) and cash
flows for the years then ended and the period from August 17, 1999 (inception)
to December 31, 2009.  These consolidated financial statements are the
responsibility of the Company's management.  Our responsibility is to
express an opinion on these consolidated financial statements based on our
audits.
 
 We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States).  Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the consolidated financial statements are free of material
misstatement.  The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial
reporting.  Our audits included consideration of its internal control
over financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control over financial
reporting.  Accordingly, we express no such opinion.  An
audit includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements.  An audit also includes
assessing the accounting principles used and significant estimates made by
management as well as evaluating the overall consolidated financial statement
presentation.  We believe that our audits provide a reasonable basis
for our opinion.
 
 In our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of ProUroCare Medical Inc. as
of December 31, 2009 and 2008 and the results of their operations and their cash
flows for the years then ended and the period from August 17, 1999 (inception)
to December 31, 2009, in conformity with U.S. generally accepted accounting
principles.
 
 The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern.  As discussed in Note 3
to the consolidated financial statements, the Company has recurring operating
losses, negative cash flows from operations and requires additional working
capital to support future operations, which raises substantial doubt about its
ability to continue as a going concern.  Management's plans in regards
to these matters are also described in Note 3.  The consolidated
financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
 
 /s/ Baker
Tilly Virchow Krause, LLP
 
 Minneapolis,
Minnesota
 March 31,
2010
  F-2
  ProUroCare
Medical Inc.
 (A
Development Stage Company)
 Consolidated
Balance Sheets
 
 December 31,
                                  2009
                                
                                
                                December 31,
                                  2008AssetsCurrent
      assets:Cash
                                
                                $
                                1,000,874
                                
                                
                                $
                                3,900Restricted
      cash
                                
                                
                                —
                                
                                
                                
                                44,214Other
      current assets
                                
                                
                                58,200
                                
                                
                                
                                31,634Total
      current assets
                                
                                
                                1,059,074
                                
                                
                                
                                79,748Equipment
      and furniture, net
                                
                                
                                1,470
                                
                                
                                
                                —Deferred
      offering expenses
                                
                                
                                —
                                
                                
                                
                                729,924Debt
      issuance costs, net
                                
                                
                                27,383
                                
                                
                                
                                266,882$
                                1,087,927
                                
                                
                                $
                                1,076,554Liabilities
      and Shareholders’ DeficitCurrent
      liabilities:Notes
      payable, bank
                                
                                
                                1,300,000
                                
                                
                                
                                1,600,000Notes
      payable
                                
                                
                                624,865
                                
                                
                                
                                668,425Convertible
      debt, net of original issue discount
                                
                                
                                —
                                
                                
                                
                                1,386,963Convertible
      debt related parties, net of original issue discount
                                
                                
                                —
                                
                                
                                
                                826,434Accounts
      payable
                                
                                
                                985,560
                                
                                
                                
                                1,203,549Accrued
      license and development fees
                                
                                
                                1,595,385
                                
                                
                                
                                1,327,835Accrued
      expenses
                                
                                
                                269,230
                                
                                
                                
                                937,253Total
      current liabilities
                                
                                
                                4,775,040
                                
                                
                                
                                7,950,459Commitments
      and contingencies (Note 8):Long-term
      note payable, bank
                                
                                
                                100,025
                                
                                
                                
                                —Long-term
      note payable
                                
                                
                                300,000
                                
                                
                                
                                —Long-term
      note payable - related party
                                
                                
                                243,000
                                
                                
                                
                                —Long-term
      convertible debt, net of original issue discount
                                
                                
                                —
                                
                                
                                
                                221,199Long-term
      convertible debt - related parties, net of original issue
      discount
                                
                                
                                —
                                
                                
                                
                                162,759Total
      liabilities
                                
                                
                                5,418,065
                                
                                
                                
                                8,334,417Shareholders’
      deficit:Common
      stock, $0.00001 par.  Authorized 50,000,000 shares; issued and
      outstanding 11,326,283 and 1,811,429 shares on December 31, 2009and 2008,
      respectively
                                
                                
                                113
                                
                                
                                
                                18Additional
      paid-in capital
                                
                                
                                23,549,626
                                
                                
                                
                                13,677,932Deficit
      accumulated during development stage
                                
                                
                                (27,879,877
                                )
                                
                                
                                (20,935,813
                                )Total
      shareholders’ deficit
                                
                                
                                (4,330,138
                                )
                                
                                
                                (7,257,863
                                )$
                                1,087,927
                                
                                
                                $
                                1,076,554
 
 See
accompanying notes to consolidated financial statements.
  F-3
  ProUroCare
Medical Inc.
 (A
Development Stage Company)
 Consolidated
Statements of Operations
 
 Period fromAugust 17,1999Year ended
                            
                            
                            Year ended
                            
                            
                            (inception) toDecember 31,
                            
                            
                            December 31,
                            
                            
                            December 31,2009
                            
                            
                            2008
                            
                            
                            2009Operating expenses:Research
      and development
                            
                            $
                            2,239,590
                            
                            
                            $
                            597,755
                            
                            
                            $
                            7,694,897General
      and administrative
                            
                            
                            1,711,075
                            
                            
                            
                            2,026,677
                            
                            
                            
                            11,542,248Total
      operating expenses
                            
                            
                            3,950,665
                            
                            
                            
                            2,624,432
                            
                            
                            
                            19,237,145Operating
      loss
                            
                            
                            (3,950,665
                            )
                            
                            
                            (2,624,432
                            )
                            
                            
                            (19,237,145
                            )Incentive
      for early warrant exercise
                            
                            
                            (1,313,309
                            )
                            
                            
                            —
                            
                            
                            
                            (1,313,309
                            )Incentive
      for early warrant exercise - related parties
                            
                            
                            (43,555
                            )
                            
                            
                            —
                            
                            
                            
                            (43,555
                            )Interest
      income
                            
                            
                            158
                            
                            
                            
                            537
                            
                            
                            
                            18,453Interest
      expense
                            
                            
                            (909,481
                            )
                            
                            
                            (1,001,551
                            )
                            
                            
                            (4,723,955
                            )Interest
      expense - related parties
                            
                            
                            (311,230
                            )
                            
                            
                            (908,486
                            )
                            
                            
                            (1,659,223
                            )Debt
      extinguishment expense
                            
                            
                            (68,162
                            )
                            
                            
                            (75,571
                            )
                            
                            
                            (498,281
                            )Debt
      extinguishment expense - related parties
                            
                            
                            (347,820
                            )
                            
                            
                            (48,214
                            )
                            
                            
                            (422,862
                            )Net
      loss
                            
                            $
                            (6,944,064
                            )
                            
                            $
                            (4,657,717
                            )
                            
                            $
                            (27,879,877
                            )Net
      loss per common share:Basic
      and diluted
                            
                            $
                            (0.73
                            )
                            
                            $
                            (2.65
                            )
                            
                            $
                            (14.93
                            )Weighted
      average number of shares outstanding:Basic
      and diluted
                            
                            
                            9,574,914
                            
                            
                            
                            1,759,607
                            
                            
                            
                            1,867,169
 
 See
accompanying notes to consolidated financial statements.
  F-4
 
 ProUroCare
Medical Inc.
 (A
Development Stage Company)
 Consolidated
Statements of Shareholders’ Equity (Deficit)
 
 DeficitaccumulatedAdditional
                          
                          
                          during the
                          
                          
                          TotalCommon stock
                          
                          
                          paid-in
                          
                          
                          development
                          
                          
                          shareholders’Shares
                          
                          
                          Amount
                          
                          
                          capital
                          
                          
                          stage
                          
                          
                          equity (deficit)Balance at inception, August 17, 1999Net
      loss for the period from inception to December 31, 1999
                          
                          
                          —
                          
                          
                          $
                          —
                          
                          
                          $
                          —
                          
                          
                          $
                          —
                          
                          
                          $
                          —Balance,
      December 31, 1999
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          —Net
      loss for the year ended December 31, 2000
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          —Balance,
      December 31, 2000
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          —Issuance
      of common stock to founders at $33.33 per share on March 1,
      2001
                          
                          
                          1.0
                          
                          
                          
                          —
                          
                          
                          
                          20
                          
                          
                          
                          —
                          
                          
                          
                          20Cancellation
      of founders’ shares, March 6, 2001
                          
                          
                          (1.0
                          )
                          
                          
                          —
                          
                          
                          
                          (20
                          )
                          
                          
                          —
                          
                          
                          
                          (20
                          )Recapitalization
      and transfer of common stock to Clinical Network, Inc. July 6,
      2001
                          
                          
                          300,000
                          
                          
                          
                          3
                          
                          
                          
                          (3
                          )
                          
                          
                          —
                          
                          
                          
                          —Issuance
      of common stock to CS Medical Technologies, LLC as consideration for
      technology license agreement on July 6, 2001, valued at $1.58
      per share
                          
                          
                          300,000
                          
                          
                          
                          3
                          
                          
                          
                          474,997
                          
                          
                          
                          —
                          
                          
                          
                          475,000Net
      loss for the year ended December 31, 2001
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          (612,533
                          )
                          
                          
                          (612,533
                          )Balance,
      December 31, 2001
                          
                          
                          600,000
                          
                          
                          
                          6
                          
                          
                          
                          474,994
                          
                          
                          
                          (612,533
                          )
                          
                          
                          (137,533
                          )Issuance
      of common stock valued at $4.29 per share to Profile LLC for technology
      license, January 14, 2002
                          
                          
                          400,000
                          
                          
                          
                          4
                          
                          
                          
                          1,713,596
                          
                          
                          
                          —
                          
                          
                          
                          1,713,600Issuance
      of common stock at $23.33 per share for services rendered, November 14,
      2002
                          
                          
                          4,421
                          
                          
                          
                          —
                          
                          
                          
                          103,166
                          
                          
                          
                          —
                          
                          
                          
                          103,166Issuance
      of common stock for cash at $23.33 per share on November 22, 2002, net of
      costs of $193,386
                          
                          
                          45,335
                          
                          
                          
                          1
                          
                          
                          
                          864,418
                          
                          
                          
                          —
                          
                          
                          
                          864,419Options
      to purchase 90,000 shares issued to officers and directors, valued at
      $4.60 per share, granted March 19, 2002; portion vested in
      2002
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          124,583
                          
                          
                          
                          —
                          
                          
                          
                          124,583Options
      to purchase 6,000 shares issued to consultants for services rendered,
      valued at $4.60 per share, granted March 19, 2002; portion vested in
      2002
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          18,400
                          
                          
                          
                          —
                          
                          
                          
                          18,400Warrant
      for 3,000 shares valued at $4.60 per share, issued to a director on April
      19, 2002; portion vested in 2002
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          4,025
                          
                          
                          
                          —
                          
                          
                          
                          4,025Warrant
      for 150 shares valued at $3.33 per share issued for services rendered,
      November 11, 2002
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          490
                          
                          
                          
                          —
                          
                          
                          
                          490Net
      loss for the year ended December 31, 2002
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          (3,613,003
                          )
                          
                          
                          (3,613,003
                          )Balance,
      December 31, 2002
                          
                          
                          1,049,756
                          
                          
                          
                          11
                          
                          
                          
                          3,303,672
                          
                          
                          
                          (4,225,536
                          )
                          
                          
                          (921,853
                          )Stock
      issued in lieu of cash for accounts payable, valued at $23.33 per share,
      February 25, 2003
                          
                          
                          545
                          
                          
                          
                          —
                          
                          
                          
                          12,705
                          
                          
                          
                          —
                          
                          
                          
                          12,705Warrants
      for 19,286 shares valued at $3.00 per share, issued to bank line of credit
      guarantors, March 1, 2003
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          57,858
                          
                          
                          
                          —
                          
                          
                          
                          57,858Warrant
      for 2,143 shares valued at $3.00 per share, issued to director as a bank
      line of credit guarantor, March 1, 2003
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          6,429
                          
                          
                          
                          —
                          
                          
                          
                          6,429Warrant
      for 9,215 shares issued for services rendered, valued at $20.30 per share,
      June 30, 2003
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          187,060
                          
                          
                          
                          —
                          
                          
                          
                          187,060Warrants
      for 22,501 shares valued at $3.60 per share, issued to bank line of credit
      guarantors, August 5, 2003
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          81,003
                          
                          
                          
                          —
                          
                          
                          
                          81,003Warrant
      for 2,143 shares valued at $3.60 per share, issued to director as a bank
      line of credit guarantor, August 5, 2003
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          7,714
                          
                          
                          
                          —
                          
                          
                          
                          7,714Warrants
      for 6,429 shares valued at $3.40 per share, issued to bank line of credit
      guarantors, September 11, 2003
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          21,858
                          
                          
                          
                          —
                          
                          
                          
                          21,858Warrant
      for 11,789 shares valued at $3.50 per share, issued to bank line of credit
      guarantor, December 22, 2003
                          
                          
                          —
                          
                          
                          
                          —
                          
                          
                          
                          41,250
                          
                          
                          
                          —
                          
                          
                          
                          41,250
  F-5


ProUroCare
Medical Inc.
 (A
Development Stage Company)
 Consolidated
Statements of Shareholders’ Equity (Deficit) (Continued)




DeficitaccumulatedAdditional
                        
                        
                        during the
                        
                        
                        TotalCommon stock
                        
                        
                        paid-in
                        
                        
                        development
                        
                        
                        shareholders’Shares
                        
                        
                        Amount
                        
                        
                        capital
                        
                        
                        stage
                        
                        
                        equity (deficit)Options
      to purchase 90,000 shares issued to officers and directors, valued at
      $4.60 per share, granted March 19, 2002; portion vested in
      2003
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        133,400
                        
                        
                        
                        —
                        
                        
                        
                        133,400Options
      to purchase 6,000 shares issued to consultants for services rendered,
      valued at $4.60 per share, granted March 19, 2002; portion vested in
      2003
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        6,900
                        
                        
                        
                        —
                        
                        
                        
                        6,900Warrant
      for 3,000 shares valued at $4.60 per share, issued to a director on April
      19, 2002; portion vested in 2003
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        6,900
                        
                        
                        
                        —
                        
                        
                        
                        6,900Net
      loss for the year ended December 31, 2003
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        (1,632,457
                        )
                        
                        
                        (1,632,457
                        )Balance,
      December 31, 2003
                        
                        
                        1,050,301
                        
                        
                        
                        11
                        
                        
                        
                        3,866,749
                        
                        
                        
                        (5,857,993
                        )
                        
                        
                        (1,991,233
                        )Options
      to purchase 3,000 shares issued to a consultant valued at $6.70 per share,
      granted February 1, 2004, portion vested in 2004
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        10,100
                        
                        
                        
                        —
                        
                        
                        
                        10,100Options
      to purchase 45,000 shares issued to officer valued at $6.70 per share,
      granted February 1, 2004; portion vested in 2004
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        84,173
                        
                        
                        
                        —
                        
                        
                        
                        84,173Repurchase
      of 90,000 shares pursuant to the exercise of dissenters' rights at time of
      merger, April 5, 2004 in connection with $750,000 note
    payable
                        
                        
                        (90,000
                        )
                        
                        
                        (1
                        )
                        
                        
                        (749,999
                        )
                        
                        
                        —
                        
                        
                        
                        (750,000
                        )Issuance
      of shares to shareholders of Global Internet Communications, Inc. pursuant
      to merger April 5, 2004
                        
                        
                        209,700
                        
                        
                        
                        2
                        
                        
                        
                        (2
                        )
                        
                        
                        —
                        
                        
                        
                        —Issuance
      of common stock for cash at $20.00 per share during 2004, net of costs of
      $139,493
                        
                        
                        220,500
                        
                        
                        
                        2
                        
                        
                        
                        4,270,505
                        
                        
                        
                        —
                        
                        
                        
                        4,270,507Cost
      associated with Global Internet Communications, Inc. reverse merger
      effective April 5, 2004
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        (162,556
                        )
                        
                        
                        —
                        
                        
                        
                        (162,556
                        )Effect
      of anti-dilution and price-protection provisions of warrants issued to
      loan guarantors in 2003, triggered by April 5, 2004 closing ofprivate
      placement; shares subject to warrants increased by 37,501; exercise price
      reduced from $23.33 to $16.67 per share (see Note 14(g))
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        320,974
                        
                        
                        
                        —
                        
                        
                        
                        320,974Issuance
      of common stock valued at $20.00 per share for accrued expenses in lieu of
      cash, May 21, 2004
                        
                        
                        3,861
                        
                        
                        
                        —
                        
                        
                        
                        77,225
                        
                        
                        
                        —
                        
                        
                        
                        77,225Warrants
      for 10,000 shares issued for services rendered valued at $11.50 per share
      on July 19, 2004
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        114,914
                        
                        
                        
                        —
                        
                        
                        
                        114,914Options
      to purchase 20,000 shares issued to officer valued at $15.00 per share,
      granted July 21, 2004; portion vested in 2004
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        41,670
                        
                        
                        
                        —
                        
                        
                        
                        41,670Issuance
      of common stock valued at $20.00 per share for accrued interest in lieu of
      cash, October 12, 2004
                        
                        
                        4,444
                        
                        
                        
                        —
                        
                        
                        
                        88,882
                        
                        
                        
                        —
                        
                        
                        
                        88,882Warrants
      for 20,000 shares issued for services rendered valued at $8.30 per share
      on December 2, 2004
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        166,172
                        
                        
                        
                        —
                        
                        
                        
                        166,172Options
      to purchase 90,000 shares issued to officers and directors, valued at
      $4.60 per share, granted March 19, 2002; portion vested in
      2004
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        82,452
                        
                        
                        
                        —
                        
                        
                        
                        82,452Warrant
      for 3,000 shares valued at $4.60 per share, issued to a director on April
      19, 2002; portion vested in 2004
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        1,150
                        
                        
                        
                        —
                        
                        
                        
                        1,150Net
      loss for the year ended December 31, 2004
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        —
                        
                        
                        
                        (2,318,896
                        )
                        
                        
                        (2,318,896
                        )Balance,
      December 31, 2004
                        
                        
                        1,398,806
                        
                        
                        
                        14
                        
                        
                        
                        8,212,409
                        
                        
                        
                        (8,176,889
                        )
                        
                        
                        35,534




F-6




ProUroCare
Medical Inc.


(A
Development Stage Company)


Consolidated
Statements of Shareholders’ Equity (Deficit) (Continued)





DeficitaccumulatedAdditional
                                    
                                    
                                    during the
                                    
                                    
                                    TotalCommon stock
                                    
                                    
                                    paid-in
                                    
                                    
                                    development
                                    
                                    
                                    shareholders’Shares
                                    
                                    
                                    Amount
                                    
                                    
                                    capital
                                    
                                    
                                    stage
                                    
                                    
                                    equity (deficit)Options
      to purchase 90,000 shares issued to officers and directors, valued at
      $4.60 per share, granted March 19, 2002; portion vested in
      2005
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    5,734
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    5,734Options
      to purchase 45,000 shares issued to officer valued at $6.70 per share,
      granted February 1, 2004; portion vested in 2005
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    111,108
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    111,108Options
      to purchase 20,000 shares issued to officer valued at $15.00 per share,
      granted July 21, 2004; portion vested in 2005
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    100,008
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    100,008Options
      to purchase 15,000 shares issued to officer valued at $16.20 per share,
      granted January 3, 2005; portion vested in 2005
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    74,256
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    74,256Options
      to purchase 15,000 shares issued to officer valued at $6.70 per share,
      granted September 6, 2005; portion vested in 2005
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    6,625
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    6,625Issuance
      of common stock for services rendered at $10.20 per share on May 13,
      2005
                                    
                                    
                                    5,000
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    51,000
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    51,000Issuance
      of common stock for cash at $7.60 per share on June 15,
    2005
                                    
                                    
                                    6,579
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    50,001
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    50,001Issuance
      of common stock for deferred offering costs at $7.10 per share on
      September 1, 2005
                                    
                                    
                                    2,500
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    17,750
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    17,750Issuance
      of common stock in lieu of cash for accrued expenses at $8.90 per share on
      December 31, 2005
                                    
                                    
                                    4,541
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    40,418
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    40,418Warrants
      for 2,500 shares valued at $6.30 per share, issued to bank loan guarantor,
      September 14, 2005
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    15,750
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    15,750Warrants
      for 2,500 shares valued at $5.30 per share, issued in connection with
      notes payable on September 21, 2005
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    13,250
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    13,250Warrants
      for 20,000 shares valued at $4.80 per share, issued to bank loan
      guarantors, October 19, 2005
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    106,000
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    106,000Net
      loss for the year ended December 31, 2005
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    (2,028,056
                                    )
                                    
                                    
                                    (2,028,056
                                    )Balance,
      December 31, 2005
                                    
                                    
                                    1,417,426
                                    
                                    
                                    
                                    14
                                    
                                    
                                    
                                    8,804,309
                                    
                                    
                                    
                                    (10,204,945
                                    )
                                    
                                    
                                    (1,400,622
                                    )Options
      to purchase 45,000 shares issued to officer valued at $6.70 per share,
      granted February 1, 2004; portion vested in 2006
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    101,008
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    101,008Options
      to purchase 20,000 shares issued to officer valued at $15.00 per share,
      granted July 21, 2004; portion vested in 2006
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    100,008
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    100,008Options
      to purchase 15,000 shares issued to officer valued at $16.20 per share,
      granted January 3, 2005; portion vested in 2006
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    81,006
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    81,006Options
      to purchase 15,000 shares issued to officer valued at $6.70 per share,
      granted September 6, 2005; portion vested in 2006
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    8,834
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    8,834Options
      to purchase 17,500 shares issued to officers and an employee valued at
      $5.60 per share, granted March 1, 2006; portion vested in
    2006
                                    
                                    
                                    —
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    48,215
                                    
                                    
                                    
                                    —
                                    
                                    
                                    
                                    48,215


F-7


ProUroCare
Medical Inc.


(A
Development Stage Company)


Consolidated
Statements of Shareholders’ Equity (Deficit) (Continued)





DeficitaccumulatedAdditional
                                              
                                              
                                              during the
                                              
                                              
                                              TotalCommon stock
                                              
                                              
                                              paid-in
                                              
                                              
                                              development
                                              
                                              
                                              shareholders’Shares
                                              
                                              
                                              Amount
                                              
                                              
                                              capital
                                              
                                              
                                              stage
                                              
                                              
                                              equity (deficit)Options
      to purchase 3,000 shares issued to a director valued at $5.90 per share,
      granted May 30, 2006; portion vested in 2006
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              5,163
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              5,163Original
      issue discount on convertible debt issued on February 16,
    2006
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              400,000
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              400,000Warrants
      for 5,000 shares valued at $4.60 per share, issued in connection with
      notes payable on January 25, 2006
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              23,000
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              23,000Issuance
      of common stock for deferred offering costs at $9.10 per share on February
      22, 2006
                                              
                                              
                                              2,500
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              22,750
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              22,750Original
      issue discount on convertible debt issued on February 29,
    2006
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              333,334
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              333,334Issuance
      of common stock for services rendered at $6.40 per share on April 21,
      2006
                                              
                                              
                                              7,000
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              44,800
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              44,800Warrants
      for 3,750 shares valued at $6.80 per share, issued in connection with
      notes payable on June 1, 2006
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              25,500
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              25,500Warrants
      for 375 shares valued at $5.40 per share, issued in connection with notes
      payable on July 21, 2006
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              2,025
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              2,025Warrants
      for 500 shares valued at $4.60 per share, issued in connection with notes
      payable on August 30, 2006
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              2,300
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              2,300Issuance
      of common stock for cash at $4.30 per share on September 7,
      2006
                                              
                                              
                                              11,628
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              50,000
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              50,000Issuance
      of common stock for services rendered at $6.30 per share on September 8,
      2006
                                              
                                              
                                              1,415
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              8,938
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              8,938Warrants
      for 5,000 shares valued at $4.50 per share, issued in connection with
      notes payable on November 30, 2006
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              22,500
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              22,500Warrants
      for 5,171 shares valued at $5.40 per share, accrued for issuance in
      connection with a note payable as of December 31, 2006
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              27,922
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              27,922Net
      loss for the year ended December 31, 2006
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              (2,959,853
                                              )
                                              
                                              
                                              (2,959,853
                                              )Balance,
      December 31, 2006
                                              
                                              
                                              1,439,969
                                              
                                              
                                              
                                              14
                                              
                                              
                                              
                                              10,111,612
                                              
                                              
                                              
                                              (13,164,798
                                              )
                                              
                                              
                                              (3,053,172
                                              )Options
      to purchase 45,000 shares issued to officer valued at $6.70 per share,
      granted February 1, 2004; portion vested in 2007
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              16,811
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              16,811Options
      to purchase 20,000 shares issued to officer valued at $15.00 per share,
      granted July 21, 2004; portion vested in 2007
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              58,314
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              58,314Warrants
      for 5,000 shares valued at $4.50 per share, issued in connection with debt
      extinguishment on January 3, 2007
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              22,500
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              22,500Options
      to purchase 15,000 shares issued to officer valued at $16.20 per share,
      granted January 3, 2005; portion vested in 2007
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              81,007
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              81,007Options
      to purchase 17,500 shares issued to officers and an employee valued at
      $5.60 per share, granted March 1, 2006; portion vested in
    2007
                                              
                                              
                                              —
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              33,245
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              33,245Issuance
      of investment units consisting of common stock and warrants for 62,500
      shares issued for cash at $4.00 per share on January 18, January 23,
      February 28 and May 1, 2007, net of costs of $52,388
                                              
                                              
                                              125,000
                                              
                                              
                                              
                                              2
                                              
                                              
                                              
                                              447,610
                                              
                                              
                                              
                                              —
                                              
                                              
                                              
                                              447,612


F-8


ProUroCare
Medical Inc.


(A
Development Stage Company)


Consolidated
Statements of Shareholders’ Equity (Deficit) (Continued)





DeficitaccumulatedAdditional
                    
                    
                    during the
                    
                    
                    TotalCommon stock
                    
                    
                    paid-in
                    
                    
                    development
                    
                    
                    shareholders’Shares
                    
                    
                    Amount
                    
                    
                    capital
                    
                    
                    stage
                    
                    
                    equity (deficit)Options
      to purchase 20,000 shares issued to officer valued at $3.40 per share,
      granted February 1, 2007; portion vested in 2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    32,857
                    
                    
                    
                    —
                    
                    
                    
                    32,857Warrants
      for 5,000 shares valued at $3.60 per share, issued in connection with debt
      extinguishment on February 1, 2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    18,000
                    
                    
                    
                    —
                    
                    
                    
                    18,000Issuance
      of common stock in lieu of cash for a loan from a director at $4.10 per
      share on February 9, 2007
                    
                    
                    1,707
                    
                    
                    
                    —
                    
                    
                    
                    7,000
                    
                    
                    
                    —
                    
                    
                    
                    7,000Modification
      of warrant term of warrant to purchase 30,000 shares pursuant to
      separation agreement of employee dated March 15, 2007, valued at $3.20 per
      share
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    96,000
                    
                    
                    
                    —
                    
                    
                    
                    96,000Issuance
      of common stock in lieu of cash for accrued expenses at $4.00 per share on
      March 21, 2007
                    
                    
                    12,478
                    
                    
                    
                    —
                    
                    
                    
                    49,911
                    
                    
                    
                    —
                    
                    
                    
                    49,911Warrants
      for 6,240 shares issued pursuant to amendment of convertible debt valued
      at $4.30 per share on March 21, 2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    26,829
                    
                    
                    
                    —
                    
                    
                    
                    26,829Issuance
      of common stock for accounts payable $5.00 per share on April 2,
      2007
                    
                    
                    4,141
                    
                    
                    
                    —
                    
                    
                    
                    20,704
                    
                    
                    
                    —
                    
                    
                    
                    20,704Warrants
      for 20,000 shares issued for services rendered valued at $3.60 per share
      on April 16, 2007
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    72,000
                    
                    
                    
                    —
                    
                    
                    
                    72,000Modification
      of option term to purchase 45,000 shares pursuant to separation agreement
      of officer dated May 11, 2007, valued at $2.30 per share
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    103,500
                    
                    
                    
                    —
                    
                    
                    
                    103,500Modification
      of option term to purchase 45,000 shares pursuant to separation agreement
      of officer dated May 11, 2007, valued at $2.60 per share
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    117,000
                    
                    
                    
                    —
                    
                    
                    
                    117,000Options
      to purchase 3,000 shares issued to a director valued at $5.90 per share,
      granted May 30, 2006; portion vested in 2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    8,850
                    
                    
                    
                    —
                    
                    
                    
                    8,850Options
      to purchase 3,000 shares issued to a director valued at $2.40 per share,
      granted June 14, 2007; portion vested in 2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    1,800
                    
                    
                    
                    —
                    
                    
                    
                    1,800Issuance
      of common stock in lieu of cash for director's fees at $3.00 per share on
      September 10, 2007
                    
                    
                    20,694
                    
                    
                    
                    —
                    
                    
                    
                    62,082
                    
                    
                    
                    —
                    
                    
                    
                    62,082Issuance
      of common stock in lieu of cash for loans from directors at $3.00 per
      share on September 10, 2007
                    
                    
                    1,100
                    
                    
                    
                    —
                    
                    
                    
                    3,300
                    
                    
                    
                    —
                    
                    
                    
                    3,300Issuance
      of common stock as debt issuance cost at $2.00 per share on November 7,
      2007
                    
                    
                    33,333
                    
                    
                    
                    —
                    
                    
                    
                    66,666
                    
                    
                    
                    —
                    
                    
                    
                    66,666Warrants
      for 6,050 shares valued at $2.80 per share, issued in connection with
      notes payable on December 27, 2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    16,940
                    
                    
                    
                    —
                    
                    
                    
                    16,940Warrants
      for 5,800 shares valued at $1.70 per share, issued in connection with
      notes payable on December 27, 2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    9,860
                    
                    
                    
                    —
                    
                    
                    
                    9,860Warrants
      for 700 shares valued at $2.20 per share, issued in connection with notes
      payable on December 27, 2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    1,540
                    
                    
                    
                    —
                    
                    
                    
                    1,540Original
      issue discount on convertible debt issued on December 27,
    2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    595,666
                    
                    
                    
                    —
                    
                    
                    
                    595,666Original
      issue discount attributable to warrants for 240,000 shares issued on
      December 27, 2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    88,576
                    
                    
                    
                    —
                    
                    
                    
                    88,576Issuance
      of common stock as compensation for loan guarantees at $1.00 per share on
      December 28, 2007
                    
                    
                    88,889
                    
                    
                    
                    1
                    
                    
                    
                    88,888
                    
                    
                    
                    —
                    
                    
                    
                    88,889Warrants
      for 15,400 shares valued at $4.00 per share, accrued for issuance in
      addition to interest on a note payable as of December 31,
    2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    61,600
                    
                    
                    
                    —
                    
                    
                    
                    61,600Warrants
      for 51,010 shares valued at $3.60 per share, accrued for issuance in
      connection with debt extinguishment as of December 31,
2007
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    183,637
                    
                    
                    
                    —
                    
                    
                    
                    183,637


F-9




ProUroCare
Medical Inc.


(A
Development Stage Company)


Consolidated
Statements of Shareholders’ Equity (Deficit) (Continued)





DeficitaccumulatedAdditional
                                            
                                            
                                            during the
                                            
                                            
                                            TotalCommon stock
                                            
                                            
                                            paid-in
                                            
                                            
                                            development
                                            
                                            
                                            shareholders’Shares
                                            
                                            
                                            Amount
                                            
                                            
                                            capital
                                            
                                            
                                            stage
                                            
                                            
                                            equity (deficit)Warrants
      for 15,221 shares valued at $5.40 per share, accrued for issuance in
      connection with debt extinguishment as of December 31,
2007
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            82,191
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            82,191Net
      loss for the year ended December 31,
      2007
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            (3,113,298
                                            )
                                            
                                            
                                            (3,113,298
                                            )Balance,
      December 31, 2007
                                            
                                            
                                            1,727,311
                                            
                                            
                                            
                                            17
                                            
                                            
                                            
                                            12,586,496
                                            
                                            
                                            
                                            (16,278,096
                                            )
                                            
                                            
                                            (3,691,583
                                            )Original
      issue discount on convertible debt issued between Jan 4, 2008 and July 30,
      2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            350,873
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            350,873Warrants
      for 160,000 shares valued at $0.47 to $1.10 per share issued in connection
      with convertible debt between Jan 4, 2008 and July 30,
2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            65,160
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            65,160Warrants
      for 14,500 shares valued at $1.00 per share issued to former employee
      pursuant to a termination agreement on January 4, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            14,500
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            14,500Warrants
      for 52,357 shares valued at $3.60 per share, connection with debt
      extinguishment on January 16, 2008; portion expensed in
    2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            4,848
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            4,848Rounding
      of common stock due to reverse stock split on February 14,
      2008
                                            
                                            
                                            39
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —Warrants
      for 75,000 shares valued at $0.92 per share, issued in connection with
      notes payable on April 3, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            42,768
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            42,768Options
      to purchase 20,000 shares issued to officers valued at $0.79 per share,
      granted July 11, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            15,800
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            15,800Cancellation
      of an officer's options to purchase 20,000 shares valued at $0.27 per
      share on July 11, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            (5,400
                                            )
                                            
                                            
                                            —
                                            
                                            
                                            
                                            (5,400
                                            )Cancellation
      of an officer's options to purchase 15,000 shares valued at $0.31 per
      share on July 11, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            (4,650
                                            )
                                            
                                            
                                            —
                                            
                                            
                                            
                                            (4,650
                                            )Options
      to purchase 3,000 shares issued to directors valued at $0.71 per share,
      granted July 11, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            2,130
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            2,130Issuance
      of common stock valued at $1.00 per share in lieu of cash for directors'
      fees on July 11, 2008
                                            
                                            
                                            59,634
                                            
                                            
                                            
                                            1
                                            
                                            
                                            
                                            59,633
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            59,634Extension
      of note payable modified with a conversion feature added and recorded as
      debt extinguishment on September 12, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            48,214
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            48,214Original
      issue discount on convertible debt issued between September 16, 2008 and
      December 11, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            145,743
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            145,743Warrants
      for 95,500 shares valued at $0.89 to $1.31 per share issued in connection
      with convertible debt between September 16, 2008 and December 11,
      2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            75,819
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            75,819Original
      issue discount attributable to warrants for 100,000 shares valued at $0.47
      per share, issued on September 25, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            46,604
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            46,604Warrants
      for 31,817 shares valued at $5.40 per share, issued on September 30, 2008
      in connection with debt extinguishment expensed and accrued from previous
      years; portion expensed in 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            61,700
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            61,700Warrants
      for 3,000 shares valued at $1.32 per share, issued in connection with debt
      extinguishment on October 24, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            3,960
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            3,960Issuance
      of common stock as compensation for loan guarantees at $1.00 per share on
      October 31, 2008
                                            
                                            
                                            17,778
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            17,778
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            17,778Warrants
      for 44,445 shares valued at $0.77 per share issued as compensation for
      loan guarantees on October 31, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            34,223
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            34,223Issuance
      of common stock valued at $1.00 per share for debt
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            —issuance
      cost on October 31, 2008
                                            
                                            
                                            6,667
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            6,667
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            6,667Warrants
      for 16,667 shares valued at $0.77 per share issued as
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            —debt
      issuance costs on October 31, 2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            12,834
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            12,834Warrants
      for 3,836 shares valued at $1.32 per share, accrued for issuance in
      connection with debt extinguishment as of December 31,
2006
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            5,063
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            5,063Options
      to purchase 17,500 shares issued to officers and an employee valued at
      $5.60 per share, granted March 1, 2006; portion vested in
    2008
                                            
                                            
                                            —
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            9,663
                                            
                                            
                                            
                                            —
                                            
                                            
                                            
                                            9,663


F-10




ProUroCare
      Medical Inc.(A
      Development Stage Company)Consolidated
      Statements of Shareholders’ Equity (Deficit)
  (Continued)





DeficitaccumulatedAdditional
                                        
                                        
                                        during the
                                        
                                        
                                        TotalCommonstock
                                        
                                        
                                        paid-in
                                        
                                        
                                        development
                                        
                                        
                                        shareholders’Shares
                                        
                                        
                                        Amount
                                        
                                        
                                        capital
                                        
                                        
                                        stage
                                        
                                        
                                        equity(deficit)Options
      to purchase 3,000 shares issued to a director valued at $5.90 per share,
      granted May 30, 2006; portion vested in 2008
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        3,687
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        3,687Options
      to purchase 3,000 shares issued to a director valued at $2.40 per share,
      granted June 14, 2007; portion vested in 2008
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        3,600
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        3,600Options
      to purchase 5,000 shares issued to officer valued at $3.40 per share,
      granted February 1, 2007; portion vested in 2008
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        8,869
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        8,869Options
      to purchase 15,000 shares issued to officer valued at $16.20 per share,
      granted January 3, 2005; portion vested in 2008
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        6,731
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        6,731Options
      to purchase 85,000 shares issued to officers valued at $0.85 per share,
      granted July 11, 2008; portion expensed in 2008
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        12,042
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        12,042Reversal
      of expense associated with performance-based option of an officer that did
      not vest
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        (7,727
                                        )
                                        
                                        
                                        —
                                        
                                        
                                        
                                        (7,727
                                        )Warrants
      for 12,576 shares valued at $4.00 per share, accrued for issuance in
      addition to interest on a note payable; portion expensed in
      2008
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        50,304
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        50,304Net
      loss for the year ended December 31, 2008
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        (4,657,717
                                        )
                                        
                                        
                                        (4,657,717
                                        )Balance,
      December 31, 2008
                                        
                                        
                                        1,811,429
                                        
                                        
                                        
                                        18
                                        
                                        
                                        
                                        13,677,932
                                        
                                        
                                        
                                        (20,935,813
                                        )
                                        
                                        
                                        (7,257,863
                                        )Issuance
      of common stock in conversion of convertible debt at $0.70 per share upon
      the January 7, 2009 effective date of the 2009 Public
    Offering
                                        
                                        
                                        2,743,535
                                        
                                        
                                        
                                        28
                                        
                                        
                                        
                                        1,920,446
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        1,920,474Issuance
      of common stock in conversion of convertible debt at $0.50 per share upon
      the January 7, 2009 effective date of the 2009 Public
    Offering
                                        
                                        
                                        314,846
                                        
                                        
                                        
                                        3
                                        
                                        
                                        
                                        157,405
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        157,408Adjustment
      to original issue discount on 2007 and 2008 prive placement debt offerings
      based on final 2009 Public Offering closing price
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        47,046
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        47,046Issuance
      of common stock pursuant to the January 12, 2009 closing of the 2009
      Public Offering at $1.00 per share net of closing costs of
      $1,259,558
                                        
                                        
                                        3,050,000
                                        
                                        
                                        
                                        31
                                        
                                        
                                        
                                        1,790,441
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        1,790,472Underwriter's
      warrants to acquire 305,000 Units issued upon close of 2009 Public
      Offering
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        50
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        50Issuance
      of common stock in conversion of convertible debt at $3.00 per share upon
      the January 12, 2009 closing date of the 2009 Public
    Offering
                                        
                                        
                                        292,384
                                        
                                        
                                        
                                        3
                                        
                                        
                                        
                                        877,146
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        877,149Warrants
      for 459 shares valued at $1.32 per share, issued on January 13, 2009 in
      addition to interest on a note payable
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        607
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        607Issuance
      of common stock valued at $1.10 per share for contracted development costs
      on January 15, 2009
                                        
                                        
                                        454,546
                                        
                                        
                                        
                                        5
                                        
                                        
                                        
                                        499,995
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        500,000Issuance
      of common stock in conversion of convertible
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        —debt
      at $0.70 per share on January 20, 2009
                                        
                                        
                                        42,143
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        29,500
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        29,500Warrants
      for 680 shares valued at $4.00 per share, issued on January 20, 2009 in
      addition to interest on a note payable
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        2,720
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        2,720Issuance
      of common stock in conversion of convertible debt at $0.70 per share on
      February 6, 2009
                                        
                                        
                                        441,165
                                        
                                        
                                        
                                        4
                                        
                                        
                                        
                                        308,809
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        308,813Adjustment
      to original issue discount on convertible debt issued in put offering
      based on final conversion price
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        81,059
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        81,059Issuance
      of common stock to guarantors of bank debt and a lender on March 19, 2009,
      valued at $0.50 per share
                                        
                                        
                                        200,001
                                        
                                        
                                        
                                        2
                                        
                                        
                                        
                                        99,998
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        100,000To
      record original issue discount on debt upon retirement of related note
      payable
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        103,396
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        103,396Original
      issue discount on convertible debt issued March 19, 2009
                                        
                                        
                                        —
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        123,000
                                        
                                        
                                        
                                        —
                                        
                                        
                                        
                                        123,000


F-11




ProUroCare
Medical Inc.
 (A
Development Stage Company)
 Consolidated
Statements of Shareholders’ Equity (Deficit) (Continued)
 
 DeficitaccumulatedAdditional
                            
                            
                            during the
                            
                            
                            TotalCommonstock
                            
                            
                            paid-in
                            
                            
                            development
                            
                            
                            shareholders’Shares
                            
                            
                            Amount
                            
                            
                            capital
                            
                            
                            stage
                            
                            
                            equity(deficit)Issuance
      of common stock valued at $0.74 per share in lieu of cash for directors'
      fees on April 3, 2009
                            
                            
                            27,366
                            
                            
                            
                            —
                            
                            
                            
                            20,251
                            
                            
                            
                            —
                            
                            
                            
                            20,251Issuance
      of common stock in conversion of convertible debt at $0.55 per share on
      May 26, 2009
                            
                            
                            510,909
                            
                            
                            
                            5
                            
                            
                            
                            280,995
                            
                            
                            
                            —
                            
                            
                            
                            281,000Issuance
      of common stock to guarantor of bank debt on June 16, 2009, valued at
      $0.82 per share
                            
                            
                            6,667
                            
                            
                            
                            —
                            
                            
                            
                            5,467
                            
                            
                            
                            —
                            
                            
                            
                            5,467Issuance
      of common stock as consideration to lender on September 21, 2009, valued
      at $1.43 per share
                            
                            
                            19,833
                            
                            
                            
                            —
                            
                            
                            
                            28,262
                            
                            
                            
                            —
                            
                            
                            
                            28,262Issuance
      of common stock as consideration to lender on September 23, 2009, valued
      at $1.35 per share
                            
                            
                            20,000
                            
                            
                            
                            —
                            
                            
                            
                            27,000
                            
                            
                            
                            —
                            
                            
                            
                            27,000Issuance
      of common stock to guarantor of bank debt on September 23, 2009, valued at
      $1.35 per share
                            
                            
                            6,667
                            
                            
                            
                            —
                            
                            
                            
                            9,000
                            
                            
                            
                            —
                            
                            
                            
                            9,000Issuance
      of common stock valued at $1.50 per share in lieu of cash for directors'
      fees on September 29, 2009
                            
                            
                            4,834
                            
                            
                            
                            —
                            
                            
                            
                            7,250
                            
                            
                            
                            —
                            
                            
                            
                            7,250Warrants
      for 30,000 shares valued at $0.88 per share, issued on September 30, 2009
      for services rendered
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            26,400
                            
                            
                            
                            —
                            
                            
                            
                            26,400Issuance
      of common stock pursuant to closing of early warrant exercise offering on
      November 6, 2009, net of offering expenses of $171,865; $1.30 per share
      exercise price
                            
                            
                            1,244,829
                            
                            
                            
                            13
                            
                            
                            
                            1,446,400
                            
                            
                            
                            —
                            
                            
                            
                            1,446,413Issuance
      of replacement warrants pursuant to closing of early warrant exercise
      offering
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            1,356,864
                            
                            
                            
                            —
                            
                            
                            
                            1,356,864Issuance
      of common stock valued at $1.43 per share for interest on note payableon
      November 6, 2009
                            
                            
                            925
                            
                            
                            
                            —
                            
                            
                            
                            1,322
                            
                            
                            
                            —
                            
                            
                            
                            1,322Issuance
      of common stock pursuant to options exercised during November,
      2009
                            
                            
                            22,229
                            
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            —Issuance
      of common stock pursuant to warrants exercised during December,
      2009
                            
                            
                            101,975
                            
                            
                            
                            1
                            
                            
                            
                            132,567
                            
                            
                            
                            —
                            
                            
                            
                            132,568Issuance
      of common stock valued at $0.74 per share on December 3, 2009 for services
      rendered
                            
                            
                            10,000
                            
                            
                            
                            —
                            
                            
                            
                            7,425
                            
                            
                            
                            —
                            
                            
                            
                            7,425Options
      to purchase 3,000 shares issued to a director valued at $2.40 per share,
      granted June 14, 2007; portion vested in 2009
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            1,800
                            
                            
                            
                            —
                            
                            
                            
                            1,800Options
      to purchase 17,500 shares issued to officers and an employee valued at
      $5.60 per share, granted March 1, 2006; portion vested in
    2009
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            2,823
                            
                            
                            
                            —
                            
                            
                            
                            2,823Options
      to purchase 85,000 shares issued to officers valued at $0.85 per share,
      granted July 11, 2008; portion expensed in 2009
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            24,083
                            
                            
                            
                            —
                            
                            
                            
                            24,083Options
      to purchase 215,000 shares issued to officers and directors, valued at
      $0.68 per share, granted March 3, 2009
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            146,400
                            
                            
                            
                            —
                            
                            
                            
                            146,400Options
      to purchase 6,500 shares issued to a consultant valued at $0.87 per share,
      granted July 23, 2009
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            5,655
                            
                            
                            
                            —
                            
                            
                            
                            5,655Options
      to purchase 100,000 shares issued to a consultant granted July 23, 2009;
      50,000 shares valued at $0.97 per share, 50,000 shares valued at $2.14 per
      share in 2009
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            64,792
                            
                            
                            
                            —
                            
                            
                            
                            64,792Options
      to purchase 3,000 shares issued to directors valued at $1.00 per share,
      granted August 11, 2009
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            3,000
                            
                            
                            
                            —
                            
                            
                            
                            3,000Options
      to purchase 320,000 shares issued to officers and directors, valued at
      $1.21 per share, granted September 29, 2009; portion vested in
      2009
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            232,320
                            
                            
                            
                            —
                            
                            
                            
                            232,320Net
      loss for the year ended December 31, 2009
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            —
                            
                            
                            
                            (6,944,064
                            )
                            
                            
                            (6,944,064
                            )Balance,
      December 31, 2009
                            
                            
                            11,326,283
                            
                            
                            $
                            113
                            
                            
                            $
                            23,549,626
                            
                            
                            $
                            (27,879,877
                            )
                            
                            $
                            (4,330,138
                            )
  F-12
  ProUroCare
Medical Inc.
 (A
Development Stage Company)
 Consolidated
Statements of Cash Flows
 
 Year Ended
                      December 31,
                    
                    
                    Year Ended
                      December 31,
                    
                    
                    Period from August
                      17, 1999 (inception) to2009
                    
                    
                    2008
                    
                    
                    December31,2009Cash
      flows from operating activities:Net
      loss
                    
                    $
                    (6,944,064
                    )
                    
                    $
                    (4,657,717
                    )
                    
                    $
                    (27,879,877
                    )Adjustments
      to reconcile net loss to net cash used in operating
      activities:Depreciation
      and amortization
                    
                    
                    186
                    
                    
                    
                    605
                    
                    
                    
                    20,983Gain
      on sale of furniture and equipment
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    (2,200
                    )Stock-based
      compensation
                    
                    
                    480,873
                    
                    
                    
                    59,245
                    
                    
                    
                    2,245,220Common
      stock issued for services rendered
                    
                    
                    14,675
                    
                    
                    
                    50,467
                    
                    
                    
                    222,046Common
      stock issued to related parties for interest
                    
                    
                    1,322
                    
                    
                    
                    —
                    
                    
                    
                    1,322Common
      stock issued for debt guarantees
                    
                    
                    —
                    
                    
                    
                    17,778
                    
                    
                    
                    106,667Common
      stock issued for debt issuance cost
                    
                    
                    —
                    
                    
                    
                    6,667
                    
                    
                    
                    6,667Common
      stock issued for debt extinguishment
                    
                    
                    33,333
                    
                    
                    
                    —
                    
                    
                    
                    33,333Notes
      payable issued for intangibles expensed as research and
      development
                    
                    
                    —
                    
                    
                    
                    150,000
                    
                    
                    
                    150,000Warrants
      issued for services
                    
                    
                    26,400
                    
                    
                    
                    —
                    
                    
                    
                    567,036Warrants
      issued for debt guarantees
                    
                    
                    —
                    
                    
                    
                    34,223
                    
                    
                    
                    355,197Warrants
      issued for debt extinguishment
                    
                    
                    607
                    
                    
                    
                    75,571
                    
                    
                    
                    360,007Warrants
      issued for debt extinguishment-related parties
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    26,828Warrants
      issued for debt issuance cost
                    
                    
                    —
                    
                    
                    
                    12,834
                    
                    
                    
                    12,834Warrants
      issued for early warrant exercise incentive
                    
                    
                    1,356,864
                    
                    
                    
                    —
                    
                    
                    
                    1,356,864Amortization
      of note payable-original issue discount
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    152,247Amortization
      of note payable-related parties original issue discount
                    
                    
                    2,720
                    
                    
                    
                    50,304
                    
                    
                    
                    142,964Amortization
      of convertible debt-original issue discount
                    
                    
                    507,902
                    
                    
                    
                    428,430
                    
                    
                    
                    1,146,587Amortization
      of convertible debt-related parties original issue
discount
                    
                    
                    444,328
                    
                    
                    
                    505,217
                    
                    
                    
                    1,194,132Amortization
      of debt issuance costs
                    
                    
                    443,161
                    
                    
                    
                    421,564
                    
                    
                    
                    2,148,894Bargain
      conversion option added to note payable- related parties for debt
      extinguishment
                    
                    
                    —
                    
                    
                    
                    48,214
                    
                    
                    
                    48,214Write-off
      debt issuance cost for debt extinguishment
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    42,797Write-off
      of deferred offering cost
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    59,696License
      rights expensed as research and development, paid by issuance of common
      stock to CS Medical Technologies, LLC
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    475,000License
      rights expensed as research and development, paid by issuance of common
      stock to Profile, LLC
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    1,713,600Changes
      in operating assets and liabilities:Other
      current assets
                    
                    
                    54,779
                    
                    
                    
                    44,603
                    
                    
                    
                    (883
                    )Accounts
      payable
                    
                    
                    (52,009
                    )
                    
                    
                    199,379
                    
                    
                    
                    877,825Accrued
      development expense
                    
                    
                    767,550
                    
                    
                    
                    1,327,835
                    
                    
                    
                    2,095,385Accrued
      expenses
                    
                    
                    (288,359
                    )
                    
                    
                    129,808
                    
                    
                    
                    851,437Net
      cash used in operating activities
                    
                    
                    (3,149,732
                    )
                    
                    
                    (1,094,973
                    )
                    
                    
                    (11,469,178
                    )Cash
      flows from investing activities:Purchases
      of equipment and furniture
                    
                    
                    (1,656
                    )
                    
                    
                    —
                    
                    
                    
                    (22,453
                    )Deposit
      into a restricted cash account
                    
                    
                    —
                    
                    
                    
                    (214
                    )
                    
                    
                    (44,214
                    )Withdrawal
      from a restricted cash account
                    
                    
                    44,214
                    
                    
                    
                    —
                    
                    
                    
                    44,214Net
      cash provided by (used in) investing activities
                    
                    
                    42,558
                    
                    
                    
                    (214
                    )
                    
                    
                    (22,453
                    )
  F-13
  ProUroCare
Medical Inc.
 (A
Development Stage Company)
 Consolidated
Statements of Cash Flows (Continued)
 
 Year Ended
                      December 31,
                    
                    
                    Year Ended
                      December 31,
                    
                    
                    Period from August
                      17, 1999 (inception) to2009
                    
                    
                    2008
                    
                    
                    December31,2009Cash
      flows from financing activities:Proceeds
      of note payable, bank
                    
                    
                    100,000
                    
                    
                    
                    —
                    
                    
                    
                    600,000Payments
      of note payable, bank
                    
                    
                    (400,000
                    )
                    
                    
                    —
                    
                    
                    
                    (900,000
                    )Proceeds
      of notes payable
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    340,500Payment
      of notes payable
                    
                    
                    (90,905
                    )
                    
                    
                    (333,222
                    )
                    
                    
                    (1,461,423
                    )Proceeds
      of notes payable - related parties
                    
                    
                    93,638
                    
                    
                    
                    112,500
                    
                    
                    
                    653,738Payments
      of notes payable - related parties
                    
                    
                    (79,500
                    )
                    
                    
                    (76,450
                    )
                    
                    
                    (282,800
                    )Proceeds
      from long-term notes payable and bank debt
                    
                    
                    400,025
                    
                    
                    
                    923,337
                    
                    
                    
                    4,207,362Proceeds
      from long-term notes payable, related parties
                    
                    
                    243,000
                    
                    
                    
                    254,500
                    
                    
                    
                    1,363,500Payments
      on long-term bank debt
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    (600,000
                    )Proceeds
      from warrants
                    
                    
                    —
                    
                    
                    
                    54,500
                    
                    
                    
                    104,500Proceeds
      from exercise of warrants
                    
                    
                    1,713,596
                    
                    
                    
                    —
                    
                    
                    
                    1,713,596Payments
      for debt issuance costs
                    
                    
                    (92,790
                    )
                    
                    
                    (148,211
                    )
                    
                    
                    (766,227
                    )Payment
      for rescission of common stock
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    (100,000
                    )Payments
      for offering expenses
                    
                    
                    (396,516
                    )
                    
                    
                    (88,480
                    )
                    
                    
                    (513,823
                    )Cost
      of reverse merger
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    (162,556
                    )Net
      proceeds from issuance of common stock
                    
                    
                    2,613,600
                    
                    
                    
                    —
                    
                    
                    
                    8,296,138Net
      cash provided by financing activities
                    
                    
                    4,104,148
                    
                    
                    
                    698,474
                    
                    
                    
                    12,492,505Net
      increase (decrease) in cash
                    
                    
                    996,974
                    
                    
                    
                    (396,713
                    )
                    
                    
                    1,000,874Cash,
      beginning of the period
                    
                    
                    3,900
                    
                    
                    
                    400,613
                    
                    
                    
                    —Cash,
      end of the period
                    
                    $
                    1,000,874
                    
                    
                    $
                    3,900
                    
                    
                    $
                    1,000,874Supplemental
      cash flow information:Cash
      paid for interest
                    
                    $
                    122,643
                    
                    
                    $
                    123,073
                    
                    
                    $
                    839,052Non-cash
      investing and financing activities:Deferred
      offering costs included in accounts payable
                    
                    
                    (61,497
                    )
                    
                    
                    461,456
                    
                    
                    
                    509,947Deferred
      offering costs included in accrued expenses
                    
                    
                    (70,000
                    )
                    
                    
                    47,350
                    
                    
                    
                    —Debt
      issuance costs included in accounts payable
                    
                    
                    —
                    
                    
                    
                    58,339
                    
                    
                    
                    114,156Warrants
      issued pursuant to notes payable
                    
                    
                    3,327
                    
                    
                    
                    139,677
                    
                    
                    
                    467,191Warrants
      issued for debt issuance costs
                    
                    
                    —
                    
                    
                    
                    55,409
                    
                    
                    
                    298,021Prepaid
      expenses financed by note payable
                    
                    
                    81,345
                    
                    
                    
                    54,504
                    
                    
                    
                    246,871Convertible
      debt issued in lieu of cash for accrued expenses
                    
                    
                    —
                    
                    
                    
                    31,413
                    
                    
                    
                    31,413Common
      stock issued in lieu of cash for accrued expenses
                    
                    
                    20,250
                    
                    
                    
                    9,167
                    
                    
                    
                    259,053Common
      stock issued in lieu of cash for accrued development cost
                    
                    
                    500,000
                    
                    
                    
                    —
                    
                    
                    
                    500,000Common
      stock issued for debt issuance cost
                    
                    
                    136,396
                    
                    
                    
                    6,667
                    
                    
                    
                    301,230Warrants
      issued in lieu of cash for accrued expenses
                    
                    
                    —
                    
                    
                    
                    1,250
                    
                    
                    
                    1,250Conversion
      of notes payable, related parties into convertible
    debentures
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    200,000
  F-14
 
 ProUroCare
Medical Inc.
 (A
Development Stage Company)
 Consolidated
Statements of Cash Flows (Continued)
 
 Year Ended
                      December 31,
                    
                    
                    Year Ended
                      December 31,
                    
                    
                    Period from August
                      17, 1999 (inception) to2009
                    
                    
                    2008
                    
                    
                    December31,2009Common
      stock issued in lieu of cash for accounts payable
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    122,291Common
      stock issued in lieu of cash for notes payable-related
    parties
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    10,300Convertible
      debt issued as debt issuance costs related to guarantee of long-term debt
      (recorded as a beneficial conversion in additional paid-in capital)
      applied to accounts payable
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    733,334Issuance
      of note payable for redemption of common stock
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    650,000Conversion
      of accounts payable to note payable
                    
                    
                    12,293
                    
                    
                    
                    —
                    
                    
                    
                    253,906Conversion
      of accrued expenses to note payable
                    
                    
                    13,569
                    
                    
                    
                    —
                    
                    
                    
                    13,569Deposits
      applied to note payable and accrued interest
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    142,696Deposits
      applied to accounts payable
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    45,782Assumption
      of liabilities in the Profile, LLC transaction
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    25,000Proceeds
      from sale of furniture and equipment
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    2,200Deposits
      applied to accrued expenses
                    
                    
                    —
                    
                    
                    
                    —
                    
                    
                    
                    1,076Deferred
      offering costs offset against gross proceeds of offering
                    
                    
                    823,078
                    
                    
                    
                    —
                    
                    
                    
                    823,078Conversion
      of convertible debt to units (see Note 2)
                    
                    
                    1,638,750
                    
                    
                    
                    —
                    
                    
                    
                    1,638,750Conversion
      of convertible debt-related parties to units (see Note 2)
                    
                    
                    1,323,334
                    
                    
                    
                    —
                    
                    
                    
                    1,323,334Conversion
      of convertible debt-related parties to common stock
                    
                    
                    281,000
                    
                    
                    
                    —
                    
                    
                    
                    281,000Conversion
      of accrued expenses to units (see Note 2)
                    
                    
                    331,261
                    
                    
                    
                    —
                    
                    
                    
                    331,261Note
      payable-related party tendered for warrant exercise
                    
                    
                    26,000
                    
                    
                    
                    —
                    
                    
                    
                    26,000Warrant
      exercise cost paid in lieu of cash for services rendered-related
      party
                    
                    
                    11,250
                    
                    
                    
                    —
                    
                    
                    
                    11,250
 
 See
accompanying notes to consolidated financial statements.
  F-15


ProUroCare
Medical Inc.




A
Development Stage Company




Notes
to Consolidated Financial Statements




December
31, 2009 and 2008 and the period from


August
17, 1999 (inception) to December 31, 2009





(1)  Description
of Business and Summary of Significant Accounting Policies




(a)
              Description
      of Business, Development Stage Activities and Basis of
      Presentation




ProUroCare
Medical Inc. (“ProUroCare,” the “Company,” “we” or “us”) is engaged in the
business of developing for market innovative products for the detection and
characterization of male urological prostate disease.  The primary
focus of the Company is currently the ProUroScanTM
prostate imaging system, designed for use as an aid to the physician in
visualizing and documenting tissue abnormalities in the prostate that have been
previously detected by a digital rectal exam.  The Company’s
developmental activities, conducted by its wholly owned operating subsidiary
ProUroCare Inc. (“PUC”), have included the acquisition of several technology
licenses, the purchase of intellectual property, the development of a strategic
business plan and a senior management team, product development and fund raising
activities.




PUC had
no activities from its incorporation in August 1999 until July 2001, when it
acquired a license to certain microwave technology from CS Medical Technologies,
LLC (“CS Medical”).  In January 2002, PUC acquired a license to
certain prostate imaging technology from Profile, LLC (“Profile”).




Pursuant
to a merger agreement effective April 5, 2004 (the “Merger”), PUC became a
wholly owned operating subsidiary of Global Internet Communications, Inc.
(“Global”), which changed its name to ProUroCare Medical Inc. on April 26,
2004.  In connection with the Merger, the Company completed a private
placement of 220,500 shares, as adjusted for the Reverse Split (as defined
below), of common stock (the “2004 Private Placement”) pursuant to Rule 506
under the Securities Act of 1933, as amended (the “Securities
Act”).




On
December 27, 2007, the Company’s shareholders approved a one-for-ten reverse
split of the Company’s common stock without a corresponding reduction in the
number of authorized shares of the Company capital stock (the “Reverse
Split”).  The Reverse Split became effective on February 14,
2008.  The exercise price and the number of shares of common stock
issuable under the Company's outstanding convertible debentures, options and
warrants were proportionately adjusted to reflect the Reverse Split for all
periods presented.




Between
December 27, 2007 and December 11, 2008, the Company closed on a total of $2.0
million of private placements of investment units (the “2007 and 2008 Private
Placements”) and $315,000 of private placements of convertible debentures in a
unit put arrangement (the “2008 Unit Put Arrangement”) each consisting of
convertible debentures and warrants (see Notes 2 and 14(e)).  Upon the
closing of the Company’s 2009 Public Offering (as defined below), the
convertible debentures issued in these private placements were automatically
converted into equity (see Note 2).




On
January 12, 2009, the Company closed a public offering of 3,050,000 units at
$1.00 per unit (the “2009 Public Offering”).  Each unit sold (the
“2009 Units”) consisted of one share of common stock and one redeemable warrant
to purchase one share of common stock at an exercise price of $1.30 per
share.  Upon the January 7, 2009 effective date of the 2009 Public
Offering, $1.9 million of  convertible promissory notes issued in
private placements during 2007 and 2008 along with $177,882 of interest accrued
thereon automatically converted into 3,058,381 units identical to the 2009 Units
(see Note 14(e)).




The
accompanying consolidated financial statements include the accounts of the
Company and its wholly owned subsidiary, PUC.  Significant
inter-company accounts and transactions have been eliminated in
consolidation.




F-16




(b)
            Restatement
      of Share Data




All share
data has been restated to give effect to the Reverse Split.




At the
effective time of the Merger, all 350,100 shares of common stock of PUC that
were outstanding immediately prior to the Merger and held by PUC shareholders
were cancelled, with one share of ProUroCare common stock issued to
Global.  Simultaneously, the non-dissenting shareholders of PUC
received an aggregate of 960,300 shares of common stock of Global in exchange
for their aggregate of 320,100 shares of PUC.  The share data in this
paragraph has been restated to give effect to the Reverse Split, as noted
above.




All share
data has been restated to give effect to the Merger under which each PUC share
was converted into three shares of Global.




(c)
            Accounting
      Estimates




The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of expenses during the
reporting periods. The Company’s significant estimates include the determination
of the fair value of its common stock and stock-based compensation awarded to
employees, directors, loan guarantors and consultants and the accounting for
debt with beneficial conversion features. Actual results could differ from those
estimates.




Valuation of Stock-Based
Compensation.Since inception, the Company has measured and recognized
compensation expense for all share-based payment awards made to employees and
directors including employee stock options based on fair values. The Company’s
determination of fair value of share-based payment awards is based on the date
of grant using an option-pricing model which incorporates a number of highly
complex and subjective variables. These variables include, but are not limited
to, the Company’s expected stock price volatility and estimates regarding
projected employee stock option exercise behaviors and forfeitures. The Company
recognizes the expense related to the fair value of the award straight-line over
the vesting period.




Debt with Beneficial Conversion
Features.  The beneficial conversion features of convertible
promissory notes were valued using the Black-Scholes pricing model, which is
considered the Company’s equivalent to the fair value of the conversion. The
resulting original issue discount is amortized over the life of the promissory
notes (generally no more that 24 months) using the straight-line method, which
approximates the interest method.




(d)
            Net
      Loss Per Common Share




Basic and
diluted loss per common share is computed by dividing net loss by the
weighted-average number of common shares outstanding for the reporting period.
These calculations reflect the effects of the Reverse Split (see Note 1(a)).
Dilutive common-equivalent shares have not been included in the computation of
diluted net loss per share because their inclusion would be antidilutive.
Antidilutive common equivalent shares issuable based on future exercise of stock
options or warrants could potentially dilute basic loss per common share in
subsequent years. All options and warrants outstanding were antidilutive for the
years ended December 31, 2009 and 2008 and the period from August 17, 1999
(inception) to December 31, 2009 due to the Company’s net losses. 8,532,058 and
1,603,994 shares of common stock issuable under our stock options, warrants,
convertible debt and contingent shares and warrants issuable under agreements
with loan guarantors were excluded from the computation of diluted net loss per
common share for the years ended December 31, 2009 and 2008, respectively. Also
excluded were the undetermined number of shares issuable pursuant to the
convertible notes and warrants issued in connection with our 2007 and 2008
Private Placements, the 2008 Unit Put Arrangement and certain convertible notes,
whose terms of conversion were based on the price of the equity securities
offered in the 2009 Public Offering, as described and defined in Note 2. The
number of such shares was determined on the January 7, 2009 effective date of
the 2009 Public Offering to be 6,937,177 shares as of December 31,
2008.




F-17




(e)
            Comparative
      Figures




Due to
common stock issuances during 2009, certain persons who were beneficial owners
of greater than five percent of the Company’s outstanding common stock and
therefore deemed to be related parties as of December 31, 2008 ceased to be
related as of December 31, 2009.  Certain comparative figures have
been reclassified to conform to the financial statement presentation adopted in
the current year, including the reclassification of transactions with former
related parties.




(f)
            Cash




The
Company maintains its cash in financial institutions.  The balances,
at times, may exceed federally insured limits.




(g)
            Equipment
      and Furniture




Equipment
and furniture are stated at cost and depreciated using the straight-line method
over the estimated useful lives ranging from three to seven years. Maintenance,
repairs, and minor renewals are expensed as incurred.




(h)
            License
      Agreements




The costs
associated with acquisition of licenses for technology are recognized at the
fair value of stock and cash used as consideration.  Costs of
acquiring technology which has no alternative future uses are expensed
immediately as research and development expense.




(i)
            Stock-Based
      Compensation




The
Company’s policy is to grant stock options at fair value at the date of grant
and to record the expense at fair value as determined using the Black-Scholes
pricing model. Stock-based employee and non-employee compensation cost related
to stock options was $480,873, $44,745 and $2,122,645 for the years ended
December 31, 2009 and 2008, and the period from August 17, 1999 (inception) to
December 31, 2009, respectively. The Company estimates the amount of future
stock-based compensation expense related to currently outstanding options to be
approximately $270,000 and $12,000 for the years ending December 31, 2010 and
2011, respectively. Shares issued upon the exercise of stock options are newly
issued from the Company’s authorized shares.




The
Black-Scholes option-pricing model was developed for use in estimating the fair
value of traded options that have no vesting restrictions and are fully
transferable. In addition, option pricing models require the input of highly
subjective assumptions. Because the Company’s employee and consultant stock
options have characteristics significantly different from those of traded
options, and because changes in the subjective input assumptions can materially
affect the fair value estimate, the existing models may not necessarily provide
a reliable single measure of the fair value of the Company’s employee stock
options.




In
determining the compensation cost of the options granted for the years ended
December 31, 2009 and 2008, the fair value of each option grant has been
estimated on the date of grant using the Black-Scholes pricing model and the
weighted-average assumptions used in these calculations are summarized as
follows:




For the years ended December 31,2009
                  
                  
                  2008Risk-free
      Interest Rate
                  
                  
                  1.73
                  %
                  
                  
                  3.13
                  %Expected
      Life of Options Granted
                  
                  3.6
      years
                  
                  
                  4.3
      yearsExpected
      Volatility
                  
                  
                  134.6
                  %
                  
                  
                  131.2
                  %Expected
      Dividend Yield
                  
                  
                  0
                  
                  
                  
                  0


F-18




The
expected life of the options is determined using a simplified method, computed
as the average of the option vesting periods and the contractual term of the
option. For performance based options that vest upon the occurrence of an event,
the Company uses an estimate of when the event will occur as the vesting period
used in the Black-Scholes calculation for each option grant. Expected volatility
is based on a simple average of weekly price data since the date of the Merger.
Based on the lack of history to calculate a forfeiture rate, the Company has not
adjusted the calculated value of the options. The risk-free rates for the
expected terms of the stock options and awards are based on the U.S. Treasury
yield curve in effect at the time of grant.




(j)
            Warrants




The
Company has elected to utilize the fair-value method of accounting for warrants
issued to non-employees as consideration for goods or services received,
including warrants issued to lenders and guarantors of Company debt (see Notes
14(f) and 14(g)). Stock-based employee and non-employee compensation cost
related to stock warrants was $0, $14,500 and $122,575 for the years ended
December 31, 2009 and 2008, and the period from August 17, 1999 (inception) to
December 31, 2009, respectively. The weighted-average fair value of the warrants
granted during the years ended December 31, 2009 and 2008 was $0.95 and $1.37,
respectively, and such warrants are immediately vested and exercisable on the
date of grant.




The fair
value of stock warrants is the estimated present value at grant date using the
Black-Scholes pricing model with the following weighted average
assumptions:




For the years ended December 31,2009
                        
                        
                        2008Risk-free
      Interest Rate
                        
                        
                        1.18
                        %
                        
                        
                        3.23
                        %Expected Life of
      Warrants Issued1
                        
                        2.1
      years
                        
                        
                        5.0
      yearsExpected
      Volatility
                        
                        135.2
                        %
                        
                        129.5
                        %Expected
      Dividend Yield
                        
                        
                        0
                        
                        
                        
                        01The
      contractual term of the warrants.




The
expected volatility is based on weekly price data since the date of the Merger
on April 5, 2004. Based on the lack of history to calculate a forfeiture rate,
the Company has not adjusted the calculated value of the warrants. The risk-free
rates for the expected terms of the stock warrants are based on the U.S.
Treasury yield curve in effect at the time of grant.




(k)
            Financial
      Instruments




The
carrying amount for all financial instruments approximates fair value. The
carrying amounts for cash, notes payable, accounts payable and accrued
liabilities approximate fair value because of the short maturity of these
instruments. The carrying amounts for long-term debt, and other obligations
approximates fair value as the interest rates and terms are substantially
similar to rates and terms which could be obtained currently for similar
instruments.




(l)
            Research
      and Development




Expenditures
for research and product development costs, including certain upfront license
fees for technologies under development, are expensed as incurred.




(m)
            Debt
      Issuance Costs




The
Company has issued common stock and warrants as consideration to various
individual lenders and loan guarantors of its bank debt (see Note
14(g)).  The fair value of the equity consideration along with loan
initiation fees is recorded on the balance sheet as debt issuance
cost.  Debt issuance costs are amortized over the term of the related
debt as interest expense using the straight-line method, which approximates the
interest method.




(n)
            Deferred
      Offering Costs




The
legal, accounting, printing and certain other expenses directly related to the
2009 Public Offering that became effective on January 7, 2009 were recorded as a
deferred offering cost asset as of December 31, 2008. The deferred offering
costs were recorded as a cost of the offering and a reduction of additional
paid-in capital upon its closing on January 12, 2009.




F-19




(o)
            Restricted
      Cash




Pursuant
to the October 15, 2007 renewal of its promissory notes with Crown Bank, the
Company agreed to deposit with Crown Bank four months worth of future interest
payments due under the notes.    The funds on deposit were
not available to the Company for any purpose other than for debt service on the
Crown Bank promissory notes.  On March 19, 2009, pursuant to a further
renewal of a Crown Bank promissory note, this restriction was
removed.




(p)
            Income
      Taxes




The
Company utilizes the liability method of accounting for income taxes. Under this
method, deferred tax assets and liabilities are recognized for the expected
future tax consequences attributable to temporary differences between the
financial statement and income tax reporting bases of assets and liabilities.
Deferred tax assets are reduced by a valuation allowance to the extent that
realization is not assured.




(q)
            Purchased
      Intangible Assets




On April
3, 2008, the Company purchased certain patents, patent applications and know-how
from Profile (the “Profile Assets”) pursuant to an asset purchase agreement. The
purchase of the Profile Assets effectively terminated the license agreement. The
technology encompassed by the Profile Assets provides the basis for the
ProUroScan System, the Company’s initial product currently in the final stages
of development. The purchase price of the Profile Assets was $300,000, of which
$150,000 was paid in cash and $150,000 was financed under a promissory note from
Profile. The promissory note was fully paid in 2008. As this intangible asset
was purchased for a particular research and development project and has no
alternative future uses, the entire $300,000 purchase price was expensed as
research and development expense for the year ended December 31,
2008.




(r)
            Subsequent
      Events




The
Company evaluates events occurring after the date of the financial statements
for events requiring recording or disclosure in the financial statements. 
Any required events have been disclosed in Note 16.




(2)
            2009
      Public Offering; Automatic Conversion of Convertible
  Debt.




On
January 7, 2009, the 2009 Public Offering was declared effective by the SEC, and
on January 12, 2009 the 2009 Public Offering was closed.  In the
offering, the Company sold 3,050,000 of 2009 Units at $1.00 per unit resulting
in net cash received of $1,790,472, after offering costs of
$1,259,528.




The
completion of the 2009 Public Offering triggered automatic conversion provisions
of several outstanding convertible debt instruments:




·
            Upon
      the January 7, 2009 effective dateof the 2009 Public
      Offering, $733,334 of convertible debentures originally issued as
      consideration to guarantors of its bank debt, along with $143,815 interest
      accrued thereon, converted into 292,384 shares of the Company’s common
      stock.  Unamortized original issue discount relating to the
      convertible debentures totaling $33,796 was expensed as interest expense
      upon the conversion.




·
            Upon
      the January 12, 2009 closing of the 2009 Public Offering, the $1,757,500
      aggregate amount of promissory notes issued in the 2007 and 2008 Private
      Placement, along with $162,959 of interest accrued thereon, automatically
      converted into 2,743,535 units identical to the 2009 Units (based on 70
      percent of the offering price, or $0.70 per share). In addition, a
      $142,500 promissory note issued as part of the 2007 Private placement to
      James Davis, a greater than ten percent shareholder of the Company, on
      December 27, 2007, along with $14,923 of interest accrued thereon,
      automatically converted into 314,846 units identical to the 2009 Units
      (based on 50 percent of the offering price, or $0.50 per share). The
      closing of the 2009 Public Offering resolved a contingent conversion
      feature of the promissory notes. Consequently, the valuation of the
      beneficial conversion feature of the promissory notes was recalculated,
      resulting in the recording of a $47,046 increase in the original issue
      discount. Unamortized original issue discount relating to the warrants and
      the beneficial conversion feature of these notes (including the adjustment
      resulting from the new valuation) totaling $434,215 and unamortized debt
      issuance cost of $207,575 was expensed as interest expense upon the
      conversion.




F-20




·
            On
      February 6, 2009 (30 days after the effective date of the 2009 Public
      Offering), the $299,250 outstanding promissory notes issued pursuant to
      the Company’s 2008 Unit Put Arrangement, along with the $9,563 interest
      accrued thereon, automatically converted into 441,165 shares of the
      Company’s common stock. The notes and accrued interest converted at 70
      percent of the 2009 Public Offering price, or $0.70 per share. The closing
      of the 2009 Public Offering resolved a contingent conversion feature of
      the promissory notes. Consequently, the valuation of the beneficial
      conversion feature of the promissory notes was recalculated, resulting in
      the recording of an $81,059 increase in the original issue discount.
      Unamortized original issue discount relating to the warrants and the
      beneficial conversion feature of the notes (including the adjustment
      resulting from the new valuation) totaling $209,879 and unamortized debt
      issuance cost of $44,686 was expensed as interest expense upon the
      conversion.




(3)
              Going
      Concern; Management’s Plan to Fund Working Capital
  Needs




The
Company incurred net losses of $6,944,064, $4,657,717 and $27,879,877 and
negative cash flows from operating activities of $3,149,732, $1,094,973, and
$11,469,178 for the years ended December 31, 2009 and 2008 and for the period
from August 17, 1999 (inception) to December 31, 2009, respectively. The Company
has completed the development of its first product and recently submitted a
510(k) premarket notification application to the FDA for a basic mapping and
data maintenance labeling claim. Assuming that FDA clearance is obtained on a
timely basis, the Company expects to increase its expenditures as it establishes
the production and marketing capabilities through both contracted and internal
resources. The Company’s business plan is dependent upon its ability to obtain
sufficient capital to fund its transition from product development to production
and marketing its products.




As of
March 26, 2010, the Company had approximately $575,000 cash on hand and current
liabilities of approximately $2.9 million, including $1.3 million of secured
debt due on April 28, 2010. However, the Company does not currently have
sufficient funds to make a significant commercial launch into the urology
market. Management believes that during the remainder of 2010 the Company will
need approximately $4 million of working capital to fund planned
operations.




As of
March 26, 2010, we have 5,760,436 outstanding redeemable warrants. These
warrants have an exercise price of $1.30 per share. Of these, we currently have
the right to redeem 4,515,607 Public and Private Warrants. We may redeem
1,244,829 Replacement Warrants once the last sale price of our common stock
equals or exceeds $4.00 per share for a period of 10 consecutive trading days.
Upon our exercise of our right to redeem the warrants, holders of the warrants
will have a period of 30 days to exercise their warrants. If all holders of the
Public and Private Warrants exercise their warrants, we could realize up to
approximately $5.9 million, depending on the number of shares actually exercised
pursuant to such a redemption. If all holders of the Replacement Warrants
exercise their warrants, we could realize up to an additional $1.6 million,
depending on the number of shares actually exercised pursuant to such
redemption. There can be no assurance that we will be able to redeem the
warrants, or how much would be realized if such redemption were
made.




The
Company also plans to identify a distribution partner to market our products
during 2010. The Company expects such a distribution partner to provide
significant financial support in the form of licensing fees, loans, equity
investment or a combination of these. In addition to financial support, a
successful collaboration with such a partner would allow us to gain access to
downstream marketing, manufacturing, and sales support. There can be no
assurance that a distribution partner can be successfully identified and engaged
during 2010, or at all.




The
Company intends to negotiate with the lenders and loan guarantors and expects to
extend the majority of the loans that come due in 2010. Amounts that are not
able to be refinanced would be repaid from the proceeds of warrant exercises.
The Company continues to work with other short term creditors and expect to make
satisfactory arrangements to pay amounts due from the proceeds of the warrant
exercises.




F-21




If an
insufficient number of warrants are exercised, or if adequate financial support
from a distribution partner is not received, the Company will likely pursue one
or more additional rounds of funding in 2010. If additional funds are raised by
the issuance of convertible debt or equity securities, or by the exercise of
outstanding warrants, then existing shareholders will experience dilution in
their ownership interest. If additional funds are raised by the issuance of debt
or certain equity instruments, the Company may become subject to certain
operational limitations, and such securities may have rights senior to those of
our existing holders of common stock.




If
adequate funds are not available through these initiatives on a timely basis, or
are not available on acceptable terms, The Company may be unable to fund
expansion and may be forced to delay market entry.  Ultimately, if no
additional financing is obtained beyond what has been secured to date, the
Company likely would be forced to cease operations. There can be no assurance
the Company will be successful in raising such funds.




(4)
              Equipment
      and Furniture




Equipment
and furniture consisted of the following at December 31:




2009
                      
                      
                      2008Computer
      equipment
                      
                      $
                      4,473
                      
                      
                      $
                      11,563Furniture
                      
                      
                      4,279
                      
                      
                      
                      4,2798,752
                      
                      
                      
                      15,842Less
      accumulated depreciation
                      
                      
                      (7,282
                      )
                      
                      
                      (15,842
                      )$
                      1,470
                      
                      
                      $
                      0




Depreciation
expense was $186, $605 and $20,983 for the years ended December 31, 2009 and
2008 and the period from August 17, 1999 (inception) to December 31, 2009,
respectively.




(5)
            Debt
      Issuance Cost




The costs
related to the Company’s $2.2 million Crown Bank promissory notes issued in
January and February 2006 were recorded as debt issuance cost, and were
amortized over the approximately two-year term of the notes using the
straight-line method until October 14, 2007. At that time, $600,000 of the notes
was retired, and approximately $42,800 of debt issuance cost related to that
portion of the notes was expensed as debt extinguishment expense. The debt
issuance cost associated with the remaining Crown Bank notes were amortized as
interest expense until December 28, 2007, when the notes were modified to extend
the maturity date of the notes to February 28, 2009. It was determined that the
modification was not a substantial modification of the terms of the notes, as
the present value of the cash flows under the new convertible promissory note
was less than 10 percent different from the present value of the cash flows
under the original note. Accordingly, the debt issuance cost from the old debt
was carried forward. The remaining $36,370 of unamortized debt issuance cost,
together with $12,000 of bank fees associated with the extension, was amortized
over the new term of the notes as interest expense.




On
October 15, 2007, the Company borrowed $600,000 pursuant to a promissory note
issued an individual investor that matured on February 28, 2009. In
consideration for this loan, on November 7, 2007 the Company agreed to issue
33,333 shares of its common stock to the lender. The $66,666 value of this
consideration was recorded as debt issuance cost and was amortized over the term
of the loan. On March 19, 2009, the note was renewed to mature on March 28,
2010. As consideration to the lender for renewing the loan, the Company issued
66,667 shares of its common stock, representing the first six months
compensation, and will accrue for issuance 11,111 shares per month for each
additional month the note remains outstanding after December 31, 2009. It was
determined that a substantial modification of the terms of the note was made as
the present value of the cash flows under the new convertible promissory note
was greater than 10 percent different from the present value of the cash flows
under the original note. Accordingly, the $33,333 value of the initial 66,667
shares issued was recorded as debt issuance cost and expensed as debt
extinguishment expense. Additional accruals of stock to be issued if the
promissory notes remain outstanding after August 31, 2009 were expensed each
month as debt extinguishment expense. During the year ended December 31, 2009,
44,444 shares were accrued for issuance pursuant to this loan guarantee
compensation arrangement, resulting in additional debt extinguishment expense of
$22,222.




Direct
costs of the 2007 and 2008 Private Placements and 2008 Unit Put Arrangement
offerings totaling $586,201, including underwriting fees, legal and accounting
expenses and printing costs, were recorded as a debt issuance cost
asset.  Also included in this debt issuance cost was the issuance of
warrants to acquire 32,500 shares of our common stock valued at $42,575 related
to the origination of the unit put financing facility.  The debt
issuance costs were amortized over the term of the related
debt.  Unamortized debt issuance cost was expensed upon the automatic
conversion of the convertible debt following the closing of the 2009 Public
Offering.




F-22




On March
19, 2009, pursuant to guaranties received relating to the Company’s renewal of
its $1.2 million Crown Bank promissory note, the Company issued an aggregate of
133,334 shares of its common stock to the guarantors representing the first six
months’ consideration for providing their guarantee (see Note 11). The $66,667
value of the shares on the issuance date was recorded as debt issuance cost and
was amortized on a straight-line basis through August 31, 2009. For each month
the promissory note remains outstanding after August 31, 2009, the Company is
accruing for issuance to the guarantors 22,222 shares of its common stock. A
total of 88,888 shares valued at $44,444 were accrued for issuance and recorded
as interest expense during the year ended December 31, 2009.




On June
16, 2009, pursuant to a guarantee received relating to a $100,000 Crown Bank
promissory note, the Company issued 6,667 shares of its common stock to the
guarantor representing the first six months’ consideration for providing his
guarantee (see Note 11).  The $5,467 value of the shares on the
issuance date along with $600 of loan origination fees was recorded on the
balance sheet as debt issuance cost and was amortized on a straight-line basis
over a six month period ending December 31, 2009.




On
September 21, 2009, the Company issued 19,833 shares to James Davis representing
six months’ consideration for providing a $243,000 loan (see Note
10).  The $28,262 value of the shares was recorded as debt issuance
cost and is being amortized as interest expense over a six-month
period.




On
September 23, 2009, the Company issued 6,667 shares to a guarantor as
consideration for providing a guarantee of a $100,025 bank loan (see Note
11).  The $9,000 value of the shares was recorded as debt issuance
cost and is being amortized as interest expense over a six-month
period.




On
September 23, 2009, the Company issued 20,000 shares to an individual lender as
consideration for providing a $300,000 loan (see Note 10).  The
$27,000 value of the shares was recorded as debt issuance cost and is being
amortized as interest expense over a six-month period.




Debt
issuance costs are summarized as follows:




For the years ended December 31,2009
                          
                          
                          2008Debt
      issuance costs, gross
                          
                          $
                          203,662
                          
                          
                          $
                          701,238Less
      amortization
                          
                          
                          (176,279
                          )
                          
                          
                          (434,356
                          )Debt
      issuance costs, net
                          
                          $
                          27,383
                          
                          
                          $
                          266,882




Amortization
      expense related to debt issuance costs was $443,161, $421,564, and
      $2,148,894 for the years ended December 31, 2009 and 2008 and the period
      from August 17, 1999 (inception) to December 31, 2009,
      respectively.




F-23




(6)
              Accrued
      Expenses




Accrued
expenses consisted of the following at December 31:




2009
                    
                    
                    2008Accrued
      interest
                    
                    $
                    148,129
                    
                    
                    $
                    169,985Accrued
      stock to be issued for loan guarantees – related parties
                    
                    
                    44,444
                    
                    
                    
                    –Accrued
      stock to be issued for loan consideration
                    
                    
                    22,222
                    
                    
                    
                    –Consulting
      fees
                    
                    
                    11,500
                    
                    
                    
                    15,000Legal
      fees
                    
                    
                    19,710
                    
                    
                    
                    –Audit
      fees
                    
                    
                    14,000
                    
                    
                    
                    47,000Accrued
      interest-related party
                    
                    
                    9,225
                    
                    
                    
                    263,522Accrued
      compensation, benefits, and  related taxes
                    
                    
                    –
                    
                    
                    
                    350,836Public
      offering costs
                    
                    
                    –
                    
                    
                    
                    70,000Directors’
      fees
                    
                    
                    –
                    
                    
                    
                    20,249Other
                    
                    
                    –
                    
                    
                    
                    661$
                    269,230
                    
                    
                    $
                    937,253




(7)
              Agreements
      with Artann Laboratories Inc.




The
Company has developed its ProUroScan System under contracts with Artann
Laboratories, Inc. (“Artann”), a scientific technology company based in
Trenton, New Jersey, that is focused on early stage technology
development.




Artann
2008 License Agreement




On July
25, 2008, the Company entered into two agreements with Artann. Under the first
agreement, the “License Agreement,” Artann granted to the Company an exclusive,
worldwide, sublicensable license to certain patent applications, trade secrets
and technology to make, use and market certain mechanical imaging products in
the diagnosis or treatment of urologic disorders of the prostate, kidney or
liver field of use. Artann also agreed to transfer possession of five fully
functional prostate imaging systems to the Company and grant the Company full
access to all relevant documentation thereto. The License Agreement became
effective on December 23, 2008. As consideration, the Company agreed to pay, on
the effective date of the agreement, an upfront cash license fee of $600,000 and
shares of the Company’s common stock valued at $500,000. The total $1,100,000
license fee was recorded as a general and administrative expense in the year
ended December 31, 2008. In addition, the Company agreed to pay Artann a royalty
equal to four percent of the first $30 million of net cumulative sales of
licensed products, three percent of the next $70 million of net cumulative sales
and two percent of net cumulative sales over $100 million. Further, the Company
will pay Artann a technology royalty of one percent of net sales on prostate
imaging system products through December 31, 2016. The combined royalties are
subject to a minimum annual royalty equal to $50,000 per year for each of the
first two years after clearance from the Food and Drug Administration (“FDA”)
for commercial sale and $100,000 per year for each year thereafter until
termination or expiration of the License Agreement. The Company also agreed to
grant Artann a non-exclusive fully paid up, sublicensable, royalty-free and
worldwide license for Artann to make, use or sell any mechanical imaging system
for the diagnosis or treatment of disorders of the female human breast. The
License Agreement will terminate upon the expiration of all royalty obligations,
by failure of either party to cure a breach of the agreement within a 60-day
cure period, if the Company fails to make a payment to Artann and such failure
is not cured within a 30-day cure period or should one of the parties become
insolvent, go into liquidation or receivership or otherwise lose legal control
of its business.




F-24




Artann
2008 Development Agreement




Under the
second Artann agreement, the “Development and Commercialization Agreement,” the
parties are collaborating to develop, commercialize and market prostate
mechanical imaging systems. During 2008 and 2009, Artann completed all
pre-clinical activities and testing on the prostate imaging system, conducted
clinical trials and filed an FDA 510(k) submission. In the future, Artann will
provide hardware and software development, refinement and debugging services.
For the services provided, the Company made cash milestone payments to Artann of
$250,000 upon initiation of an FDA approved clinical study and $250,000 upon
Artann’s November 18, 2009 completion of the FDA study and submission of the
510(k) approval application on the prostate imaging system. The Company also
accrued for issuance to Artann 769,231 shares of common stock of the Company
valued at $1,565,385 following the 510(k) submission, which was recorded as
research and development expense in the year ended December 31, 2009. Further,
as a success bonus, the Company will make a $750,000 cash payment and issue to
Artann shares of its common stock having a value of $1 million upon receiving
FDA clearance allowing the prostate imaging system to be commercially sold in
the United States. The success bonus will be reduced by ten percent for each
month that FDA clearance is delayed beyond March 23, 2009. The Company also
agreed to pay a monthly retainer fee for technical advice and training by Artann
personnel of $30,000 per month for each of the first six months following the
effective date of the Development and Commercialization Agreement and $15,000
per month for the next 12 months. During the years ended December 31, 2009 and
2008, retainer fees of $235,000 and $50,000 were recorded as research and
development expense, respectively. On March 15, 2010, the Company issued the
769,231 shares of common stock that had been accrued for issuance as of December
31, 2009 (see Note 16).




Additionally,
Artann will facilitate the transfer of commercial production to a third
party.  Qualified Artann personnel shall provide manufacture and
scale-up services to the Company or a third party manufacturer designated by the
Company to facilitate the commercial manufacture of the prostate imaging systems
at a cost of $1,200 per day per individual for such services.




The
initial term of the Development and Commercialization Agreement is for three
years and may thereafter be renewed for additional one year terms upon mutual
agreement of the parties. The Development and Commercialization Agreement may
also terminate if the Company fails to make a payment to Artann and such failure
is not cured within a 60-day cure period or should one of the parties become
insolvent, go into liquidation or receivership or otherwise lose legal control
of its business.




Accrued
License and Development Fees




Accrued
license and development fees consisted of the following amounts due to Artann
under the License Agreement and the Development and Commercialization Agreement
as of December 31:




2009
                    
                    
                    2008Accrued
      stock payment for development milestone
                    
                    $
                    1,565,385
                    
                    
                    $
                    -Contracted
      development fees
                    
                    
                    30,000
                    
                    
                    
                    -Upfront
      license fee payable in cash
                    
                    
                    -
                    
                    
                    $
                    600,000Upfront
      license fee payable in equity
                    
                    
                    -
                    
                    
                    
                    500,000First
      milestone cash payment due under the Development and Commercialization
      Agreement
                    
                    
                    -
                    
                    
                    
                    250,000Less:
      Advances
                    
                    
                    -
                    
                    
                    
                    (22,165
                    )Accrued
      license and development fees
                    
                    $
                    1,595,385
                    
                    
                    $
                    1,327,835




(8)
            Commitments
      and Contingencies




(a)
            Lease




The
Company rents a small amount of office space on a month-to-month basis at a cost
of approximately $1,100 per month, which is the market price for similar office
space in Minneapolis, Minnesota. Rent expense for the years ended December 31,
2009 and 2008, and the period from August 17, 1999 (inception) to December 31,
2009 was $10,668, $23,062 and $266,874, respectively.




F-25




(b)
            Legal
      proceedings




On July
15, 2009, Rensselaer Polytechnic Institute (“RPI”) filed a lawsuit against the
Company seeking payment of $202,716 plus interest, penalties, costs and
disbursements, including attorneys’ fees. In the complaint, RPI alleged that the
Company breached obligations to pay RPI an aggregate of $202,716 under the terms
of a license agreement dated July 13, 2001 between RPI and the Company and a
sponsored research agreement dated as of December 9, 2005 between RPI and the
Company. On December 7, 2009, the Company entered into a settlement agreement
with RPI concerning litigation originally filed by RPI against the Company on
July 15, 2009. In the settlement agreement, the Company agreed to pay to RPI a
total of $117,000 in installments as follows: $10,000 upon signing, $6,000 per
month from December 2009 through October 2010, and $41,000 in November 2010. The
Company executed an affidavit for judgment by confession to secure the above
payments. The Company has 20 days to cure any failure to make the required
payments. As the full amount due to RPI was recorded in prior years, no
additional provision was recorded and previously recorded minimum royalty
expenses of $20,000 were reversed during the year ended December 31,
2009.




(9)
            Income
    Taxes




The
Company has generated net operating loss carryforwards of approximately $6.7
million which, if not used, will begin to expire in 2021.  Federal and
state tax laws impose significant restrictions on the utilization of net
operating loss carryforwards in the event of a change in ownership of the
Company that constitutes an “ownership change,” as defined by Section 382 of the
Code.  The Company has analyzed its equity ownership changes and
believes that such an ownership change has occurred.  The Company’s
use of its net operating loss carryforwards and built-in loss will be limited as
a result of this change; however, the amount of limitation will not be known
until a full Section 382 study can be completed.




The
Company has recorded a full valuation allowance against its deferred tax assets
and deferred tax liability due to the uncertainty of realizing the related
benefits and costs as follows:




2009
                  
                  
                  2008Deferred
      tax assetsNet
      operating loss carryforwards
                  
                  $
                  2,559,000
                  
                  
                  $
                  1,916,000Capitalized
      start up costs
                  
                  
                  3,570,000
                  
                  
                  
                  2,921,000Expenses
      paid with options and warrants
                  
                  
                  722,000
                  
                  
                  
                  724,000Capitalized
      licenses
                  
                  
                  804,000
                  
                  
                  
                  893,000Accrued
      expenses to be paid in stock
                  
                  
                  625,000
                  
                  
                  
                  0Other
                  
                  
                  0
                  
                  
                  
                  164,000Deferred
      tax liabilityBeneficial
      conversion feature of convertible debentures
                  
                  
                  0
                  
                  
                  
                  (212,000
                  )Less:
      valuation allowance
                  
                  
                  (8,280,000
                  )
                  
                  
                  (6,406,000
                  )Net
      deferred tax assets
                  
                  $
                  0
                  
                  
                  $
                  0





The
change in the valuation allowance was $1,874,000, $1,336,000 and $8,280,000 for
the years ended December 31, 2009 and 2008 and the period from August 17, 1999
(inception) to December 31, 2009, respectively.  The Company has
reviewed its issuances of convertible debt, and has recognized a deferred tax
liability for the temporary difference between the book basis and tax basis
resulting from beneficial conversion features of the debt
instruments.  The effect of recognizing the deferred tax liability was
charged to equity.  During the year ended December 31, 2009, all of
the Company’s convertible debt was retired or converted, and the deferred tax
liability was reversed.   The remaining deferred tax liability at
December 31, 2008 was $212,000, which was offset against the deferred tax
valuation.




F-26




Reconciliation
between the federal statutory rate and the effective tax rates for the years
ended December 31, 2009 and 2008 and the period from August 17, 1999 (inception)
to December 31, 2009 is as follows:




2009
                      
                      
                      2008
                      
                      
                      Period from
                        August 17,
                        1999
                        (inception) to
                        December 31,
                        2009Federal
      statutory tax rate
                      
                      
                      (34.0
                      )
      %
                      
                      
                      (34.0
                      )
      %
                      
                      
                      (34.0
                      )
      %State
      taxes, net of federal benefit
                      
                      
                      (4.5
                      )
                      
                      
                      (4.5
                      )
                      
                      
                      (4.5
                      )Employee
      incentive stock options
                      
                      
                      1.0
                      
                      
                      
                      0.3
                      
                      
                      
                      1.7Expired
      warrants and options
                      
                      
                      1.3
                      
                      
                      
                      4.5
                      
                      
                      
                      1.4Replacement
      warrants issued as an incentive to early exercise warrants
                      
                      
                      7.5
                      
                      
                      
                      –
                      
                      
                      
                      1.9Capitalized
      license fees
                      
                      
                      –
                      
                      
                      
                      –
                      
                      
                      
                      0.7Beneficial
      conversion feature of convertible debt
                      
                      
                      5.1
                      
                      
                      
                      7.0
                      
                      
                      
                      3.1Change
      in valuation allowance
                      
                      
                      23.6
                      
                      
                      
                      26.7
                      
                      
                      
                      29.7Effective
      tax rate
                      
                      
                      0.0
                      %
                      
                      
                      0.0
                      %
                      
                      
                      0.0
                      %





The
Company has adopted the policy of classifying interest in interest expense and
penalties in general and administrative expense.




The
Company had no significant unrecognized tax benefits as of December 31, 2009 or
December 31, 2008 and, likewise, no significant unrecognized tax benefits that,
if recognized, would affect the effective tax rate.




The
Company had no positions for which it deemed that it is reasonably possible that
the total amounts of the unrecognized tax benefit will significantly increase or
decrease.




The tax
years that remain subject to examination by major tax jurisdictions currently
are:




Federal
2006 - 2008


State of
Minnesota 2006 - 2008




(10)
            Notes
      Payable




On
October 31, 2007, the Company issued a promissory note for $600,000 in favor of
an individual lender effective as of October 15, 2007.  On March 11,
2008, the promissory note was amended to make the interest accrued pursuant to
the promissory note payable on the maturity date, rather than payable
monthly.  On March 19, 2009, the Company again amended the promissory
note with the lender.  Under the terms of the amendment, the note’s
maturity date was extended to March 28, 2010 and the interest rate was changed
to 1.0 percent over the prime rate, but never less than 6.00 percent (6.00
percent and 6.50 percent at December 31, 2009 and 2008, respectively), and has a
subordinated security interest in all of the Company’s assets.  As
consideration to the lender for making this loan and amendments thereto, the
Company issued shares of its common stock and warrants to acquire shares of its
common stock (see Note 14(g)).  On March 26, 2010, the note was
retired pursuant to an equity conversion (see Note 16).




Between
May 1, 2009 and September 16, 2009, James Davis made various payments for the
benefit of the Company and provided the Company with certain cash advances
totaling approximately $243,000. The purpose of these payments and advances was
to help fund specific Company activities related to product development,
clinical studies and Food and Drug Administration (“FDA”) related activities. On
September 21, 2009, Mr. Davis and the Company executed a promissory note in the
principal amount of $243,000 (the “Davis Note”) to formalize the Company’s
obligation to Mr. Davis for these amounts. In lieu of cash interest the Company
is accruing 1,618 shares of its common stock for issuance to Mr. Davis for each
month or portion thereof that the principal amount of the Davis Note is
outstanding. As of December 31, 2009, 6,474 shares of common stock were accrued
for issuance and $9,225 of interest expense was recorded. All of the accrued
shares will be issued upon repayment of the Davis Note. The Davis Note matures
on March 28, 2011, and provides Mr. Davis with a subordinated security interest
in the Company’s assets.




F-27




On June
1, 2009, the Company borrowed $81,345 pursuant to an unsecured insurance policy
financing agreement. The financing agreement is payable in 10 monthly
installments of $8,058 per month and bear interest at 6.48 percent.




On
September 1, 2009, the Company received an advance of $26,000 from a
director.  On November 6, 2009, the advance was applied to the
director’s exercise of warrants.  In lieu of cash interest, the
Company issued 925 shares of its common stock to the director and recorded
$1,323 of interest expense.




On
September 23, 2009, the Company borrowed $300,000 from an individual lender
pursuant to a secured promissory note.  In lieu of cash, the Company
is accruing 1,998 shares of its common stock for issuance to the investor for
each month or portion thereof that the principal amount of the loan remains
outstanding.  As of December 31, 2009, 7,992 shares of common stock
were accrued for issuance and $10,789 of interest expense was
recorded.  All accrued shares will be issued upon repayment of the
loan.  The promissory note matures on March 28, 2011 and provides the
lender with a subordinated security interest in the Company’s
assets.




The
Company has provided equity consideration to the individual
lenders.  See Note 14(g) for more information regarding the equity
consideration issued.  See Note 15 for information regarding related
party transactions and loans.




The
following summarizes notes payable balances at December 31, 2009 and 2008, and
the related activity during the year ended December 31, 2009:




Year Ended December 31,2009
                            
                            
                            2008
                            
                            2009 ActivityShort
      term notes payable:Note
      payable dated October 15, 2007
                            
                            $
                            600,000
                            
                            
                            $
                            600,000
                            
                            Amended
      to extend maturity date to March 28, 2010Note
      payable dated July 31, 2007
                            
                            
                            —
                            
                            
                            
                            34,000
                            
                            Paid
      in fullNote
      payable dated June 1, 2006
                            
                            
                            —
                            
                            
                            
                            9,350
                            
                            Paid
      in fullInsurance
      policy financing
                            
                            
                            24,865
                            
                            
                            
                            25,075
                            
                            2008
      balance paid in full; 2009 balance per description
aboveTotal
      notes payable-short term
                            
                            $
                            624,865
                            
                            
                            $
                            668,425Long
      term notes payable:Long
      term note payableNote
      payable dated September 23, 2009
                            
                            $
                            300,000
                            
                            
                            $
                            —
                            
                            2009
      balance per description aboveLong-term
      note payable – related partyNote
      payable dated September 21, 2009
                            
                            $
                            243,000
                            
                            
                            $
                            —
                            
                            2009
      balance per description
above





(11)
            Notes Payable -
      Bank




On March
19, 2009, the Company renewed its $1.2 million Crown Bank promissory
note.  The renewed note matures on March 28, 2010 and bears interest
at the prime rate plus one percent,but never less than 6.00
percent (6.0 percent and 6.5 percent at December 31, 2009 and 2008,
respectively).  No other note terms were changed.  The note
remains collateralized by all Company assets and guaranteed by two individual
guarantors.  On March 26, 2010, the maturity date of the promissory
note was extended to mature on April 28, 2010.




On June
16, 2009, the Company borrowed $100,000 from Crown Bank pursuant to a promissory
note that is collateralized by all Company assets and guaranteed by an
individual guarantor. The note matures on March 28, 2010 and bears interest at
the prime rate plus one percent,but never less than 6.00
percent (6.0 percent at December 31, 2009).




F-28


On
September 23, 2009, the Company borrowed $100,025 from Central Bank pursuant to
an unsecured promissory note. The promissory note matures on January 17, 2011,
and bears interest at the prime rate plus one percent, with a minimum rate of
6.0 percent (6.0 percent at December 31, 2009). The promissory note was
guaranteed by an individual guarantor, whose guaranty was collateralized by
Company assets. On March 26, 2010, the maturity date of the promissory note was
extended to mature on April 28, 2010.




The
Company has provided shares of its common stock as consideration to the
guarantors of its bank debt (see Note 14(g).




The
following summarizes bank notes payable balances at December 31, 2009 and 2008,
and the related activity during the year ended December 31, 2009:




Year Ended December 31,2009
                
                
                2008
                
                2009 ActivityShort
      term note payable – bank:Crown
      Bank note
                
                $
                1,200,000
                
                
                $
                1,200,000
                
                Amended
      to extend maturity date to March 28, 2010Crown
      Bank note
                
                
                —
                
                
                
                400,000
                
                Paid
      in fullCrown
      Bank note
                
                
                100,000
                
                
                
                —
                
                2009
      balance per description aboveTotal
      notes payable bank-short term
                
                $
                1,300,000
                
                
                $
                1,600,000Long
      term note payable – bank:Central
      Bank note
                
                $
                100,025
                
                
                $
                —
                
                2009
      balance per description
above





(12)
            Convertible
      Debt




On April
3, 2008, the Company borrowed $37,500 pursuant to a convertible promissory note
issued in favor of James Davis. On September 25, 2008, the Company borrowed an
additional $150,000 pursuant to another convertible promissory note issued in
favor of Mr. Davis. As Mr. Davis’s ability to exercise the conversion feature of
the $150,000 note was contingent upon an event outside of his control, the
note’s bargain conversion feature valued at $103,396 was not recorded until the
January 12, 2009 closing of the 2009 Public Offering when the contingency was
removed. On March 19, 2009, Mr. Davis agreed to refinance both the $150,000 debt
(and $7,291 of interest accrued thereon) and the $37,500 note (and $3,646 of
accrued interest thereon), along with another $2,632 payable to Mr. Davis and
$12,293 of expenses paid by Mr. Davis on behalf of the Company. Mr. Davis also
agreed to loan to the Company an additional $67,638 to pay for the exhibition of
the prostate mechanical imaging system at the annual American Urology
Association meeting, the retention of an investor relations firm and the
initiation of a clinical advisory board. He also agreed to have certain website
maintenance services performed for the Company. Pursuant to the refinancing and
the other arrangements, the Company issued a $281,000 unsecured convertible
promissory note to Mr. Davis. The promissory note was to mature on March 19,
2010, bore no interest and was convertible into our common stock at $0.55 per
share at the option of Mr. Davis. It was determined that a substantial
modification of the terms of the note was made as the present value of the cash
flows under the new convertible promissory note was greater than 10 percent
different from the present value of the cash flows under the original note.
Accordingly, $113,709 of unamortized original issue discount related to the
original $150,000 note was expensed as debt extinguishment expense and the
bargain conversion option of the new note, valued at $123,000 using the
Black-Sholes pricing model, was recorded as original issue discount and
amortized as debt extinguishment expense over the term of the note. On May 26,
2009, Mr. Davis exercised his conversion rights under the promissory note, and
the note was converted into 510,909 shares of the Company’s common
stock.




F-29


The
following summarizes convertible notes payable balances at December 31, 2009 and
2008, and the related activity during the year ended December 31,
2009:




Year Ended December 31,2009
                                              
                                              
                                              2008
                                              
                                              2009 ActivityShort-term
      convertible debt:10%
      unsecured convertible debentures
                                              
                                              $
                                              —
                                              
                                              
                                              $
                                              333,334
                                              
                                              Fully
      converted (see Note 2)10%
      convertible promissory notes issued pursuant to 2007 and 2008 Private
      Placements
                                              
                                              
                                              —
                                              
                                              
                                              
                                              1,268,250
                                              
                                              Fully
      converted (see Note 2)Convertible
      promissory note dated April 3, 2008
                                              
                                              $
                                              —
                                              
                                              
                                              $
                                              37,500
                                              
                                              Repaid
      $8,000 in cash, fully converted  the remaining
      $29,500Less:
      original issue discount
                                              
                                              
                                              —
                                              
                                              
                                              
                                              (252,121
                                              )
                                              Remaining
      original issue discount expensed upon debt conversionTotal
      notes payable bank-short term
                                              
                                              $
                                              —
                                              
                                              
                                              $
                                              1,386,963Short-term
      convertible debt – related party:10%
      unsecured convertible debentures
                                              
                                              $
                                              —
                                              
                                              
                                              $
                                              400,000
                                              
                                              Fully
      converted (see Note 2)10%
      convertible promissory notes issued pursuant to 2007 and 2008 Private
      Placements
                                              
                                              
                                              —
                                              
                                              
                                              
                                              465,500
                                              
                                              Fully
      converted (see Note 2)Convertible
      promissory note dated April 3, 2008
                                              
                                              
                                              —
                                              
                                              
                                              
                                              37,500
                                              
                                              Fully
      convertedConvertible
      promissory note dated April 3, 2008
                                              
                                              
                                              —
                                              
                                              
                                              
                                              37,500
                                              
                                              Refinanced
      on March 19, 2009 (see above)Less:
      original issue discount
                                              
                                              
                                              —
                                              
                                              
                                              
                                              (114,066
                                              )
                                              Remaining
      original issue discount expensed upon debt conversionTotal
      notes payable bank-short term
                                              
                                              $
                                              —
                                              
                                              
                                              $
                                              826,434Long-term
      convertible debt:10%
      convertible promissory notes issued pursuant to the 2008 Unit Put
      arrangement
                                              
                                              $
                                              —
                                              
                                              
                                              $
                                              204,250
                                              
                                              Fully
      converted (see Note 2)10%
      convertible promissory notes issued pursuant to 2008 Private
      Placements
                                              
                                              
                                              —
                                              
                                              
                                              
                                              166,250
                                              
                                              Fully
      converted (see Note 2)Less:
      original issue discount
                                              
                                              
                                              —
                                              
                                              
                                              
                                              (149,301
                                              )
                                              Remaining
      original issue discount expensed upon debt conversion$
                                              —
                                              
                                              
                                              $
                                              221,199Long-term
      convertible debt – related parties:10%
      convertible promissory notes issued pursuant to the 2008 Unit Put
      arrangement
                                              
                                              $
                                              —
                                              
                                              
                                              $
                                              95,000
                                              
                                              Fully
      converted (see Note 2)Promissory
      note dated September 25, 2008
                                              
                                              
                                              —
                                              
                                              
                                              
                                              150,000
                                              
                                              Refinanced
      on March 19, 2009 (see above)Less:
      original issue discount
                                              
                                              
                                              —
                                              
                                              
                                              
                                              (82,241
                                              )
                                              Remaining
      original issue discount expensed upon debt conversion$
                                              —
                                              
                                              
                                              $
                                              162,759




F-30




(13)
            Future
      Maturities of Long term Debt




Future
maturities of long-term notes for the years succeeding December 31, 2009 are as
follows:




Year
                    
                    Notes
                      Payable
                    
                    
                    Notes
                      Payable-
                      Bank
                    
                    
                    Total2010
                    
                    $
                    –
                    
                    
                    $
                    –
                    
                    
                    $
                    –2011
                    
                    
                    543,000
                    
                    
                    
                    100,025
                    
                    
                    
                    643,025Total
                    
                    $
                    543,000
                    
                    
                    $
                    100,025
                    
                    
                    $
                    643,025





(14)
            Shareholders’
      Equity (Deficit)




(a)
            Common
      stock issued related to formation and licensing
  activities




The
Company issued 300,000 shares to Clinical Network Inc. in July 2001. In
connection with the Company’s license agreements with CS Medical and Profile,
the Company issued 300,000 and 400,000 shares of common stock in 2001 and 2002,
respectively.




(b)
            Common
      Stock and Warrants issued related to 2002 Private
  Placement




In
connection with a private placement to accredited investors, the Company issued
45,335 shares of common stock in 2002.  In addition, the Company
issued warrants to purchase 4,535 shares of common stock to three individuals
related to services rendered in connection with the private
placement.  These warrants expired unexercised.




(c)
            Common
      Stock and Warrants issued related to Merger and 2004 Private
      Placement




Merger
Agreement




Prior to
the April 5, 2004 Merger (see Note 1(a)), Profile had notified the Company of a
possible breach of its license agreement with the Company, and had also
dissented from the Merger proposal as the registered holder of securities
beneficially owned by certain shareholders holding, in the aggregate, 30,847
(pre-merger) shares of PUC’s common stock. Effective on April 4, 2004, the
parties reached an agreement pursuant to which Profile waived any existing
defaults under the Profile license agreement, and the Company agreed to purchase
30,000 of the 30,847 (pre-conversion) shares with respect to which dissenters’
rights were exercised for an aggregate purchase of $750,000. Of that amount,
$100,000 was paid upon the initial closing of the private placement (described
below) and the balance of $650,000 was paid pursuant to the delivery of a
promissory note, which was paid in full in October 2004. The remaining 847
(pre-conversion) shares with respect to which dissenters’ rights were originally
exercised withdrew their dissents and participated in the Merger.




At the
effective time of the Merger all 350,100 (pre-conversion) shares of common stock
of PUC that were outstanding immediately prior to the Merger and held by PUC
shareholders were cancelled, with one share of PUC common stock issued to
Global.  Simultaneously, the former shareholders of PUC common stock
received an aggregate of 960,300 shares of common stock of Global, representing
approximately 82.1 percent of Global’s common stock outstanding immediately
after the Merger.




Global
was a non-operating public shell company at the time of the Merger. Accordingly,
the Merger transaction was recorded as a recapitalization rather than a business
combination. The assets and liabilities resulting from the reverse acquisition
were the former PUC assets and liabilities (at historical cost) plus a $13,500
accrued Global liability (assumed at historical cost). There were no other
assets or liabilities on Global’s books at the time of the Merger. The Company
recorded costs associated with the Merger totaling $162,556 during
2004.




F-31




2004 Private Placement of
Common Stock.




In
connection with the Merger, the Company completed a private placement offering
of 220,500 shares of common stock pursuant to Rule 506 promulgated under the
Securities Act. The initial closing occurred on April 5, 2004, at which time the
Company issued 198,000 shares at $20.00 per share, aggregating to gross proceeds
of $3.96 million.  Subsequent to April 5, 2004, the Company issued an
additional 22,500 shares at $20.00 per share, aggregating to gross proceeds of
$450,000.  Costs associated with the private placement (including the
subsequent registration costs) were $139,493.




As part
of the private placement, the Company engaged a consultant to provide
financial-advisory services. Under terms of the arrangement, the consultant was
paid $27,000 and was issued a warrant for 30,000 shares of common stock upon the
first closing of the private placement. The warrant had a three-year term and
was exercisable at $20.00 per share.




(d)
            Private
      sales of Common Stock




·
            On
      June 15, 2005, the Company sold 6,579 shares of its common stock to an
      accredited investor in a non-public offering.  The per share
      selling price of $7.60 was based on the last selling price prior to this
      sale as reported on the Over-the-Counter Bulletin Board.  Net
      proceeds received from this placement were
  $50,000.




·
            On
      September 7, 2006, the Company sold 5,814 shares of its common stock to
      Scott Smith, a director of the Company, and 5,814 shares of our common
      stock to an investor.  The per share selling price of $4.30 was
      based on the last selling price prior to this sale as reported on the
      Over-the-Counter Bulletin Board.  Net proceeds received from
      these investments were $50,000.




·
            During
      the year ended December 31, 2007, the Company sold 125,000 of the
      Company’s Investment Units at a price of $4.00 per unit, with total gross
      proceeds of $500,000. The Investment Units were sold in tranches of 31,250
      Units each to four investors on January 18, January 23, February 28 and
      May 1, 2007. Each Investment Unit consists of one share of the Company’s
      common stock and a 3-year warrant (immediately exercisable) to acquire 0.5
      shares of the Company’s common stock for $2.50 ($5.00 per share). Costs of
      this sale totaled $52,388.




·
            On
      February 12, 2007, the Company sold 1,707 shares of its common stock to
      Scott Smith, a director of the Company.  The per share selling
      price of $4.10 was based on the last selling price prior to this sale as
      reported on the Over-the-Counter Bulletin Board.  The
      subscription price was paid by the conversion of a $7,000 loan to the
      Company from Mr. Smith.




·
            On
      March 21, 2007, the Company and the four guarantors of the Company’s Crown
      Bank promissory notes (see Note 11) agreed to amend the related debenture
      agreements.  Pursuant to the revised debenture agreements, among
      other things, the Company issued a total of 12,478 shares of its
      Investment Units to the four guarantors in lieu of $49,911 of accrued
      interest.  The 6,240 warrants were valued at $26,829 using the
      Black-Scholes method and were recorded as debt extinguishment
      expense.




·
            On
      September 10, 2007, the Company sold a total of 1,100 shares of its common
      stock to Mr. Carlson and Mr. Smith.  The per share selling price
      of $3.00 was based on the last selling price prior to this sale as
      reported on the Over-the-Counter Bulletin Board.  The
      subscription price was paid by the conversion of a $3,300 of loans to the
      Company from Mr. Carlson and Mr.
Smith.




(e)
            Common
      stock and warrants issued pursuant to the 2007 and 2008 Private
      Placements, the 2008 Unit Put Arrangement and the 2009 Public
      Offering




·
            Between
      December 27, 2007 and July 30, 2008, the Company closed on the sale of an
      aggregate $1,850,000 of units under its 2007 and 2008 Private Placements
      (see Note 1(a)), and converted $150,000 of existing loans from James Davis
      into similar units.  At the closings, the Company issued
      warrants to purchase a total of 400,000 shares of common stock to the
      investors.  The exercise price of the warrants was set upon the
      January 7, 2009 effective date of the 2009 Public Offering at $0.50 per
      share (based on 50 percent of the offering price).  All of these
      warrants became exercisable upon the January 12, 2009 closing of the 2009
      Public Offering and will remain exercisable until December 31,
      2012.


F-32




The
$153,735 relative fair value of the aggregate 400,000 warrants issued were
recorded as an original issue discount as defined in Financial Accounting
Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 470
against the convertible debt liability, and were amortized as interest expense
over the term of the convertible debentures.  The unamortized original
issue discount relating to the warrants was expensed as interest expense upon
the January 12, 2009 closing of the 2009 Public Offering.




·
            On
      September 16, 2008, pursuant to the Company’s 2008 Unit Put
      Arrangement (see Note 1(a)), the Company issued warrants, exercisable
      until December 31, 2012 at an exercise price of $1.00 per share, to
      purchase an aggregate 32,500 shares of our common stock (the “Origination
      Warrants”).  Of these, 31,500 Origination Warrants became
      exercisable when the Company exercised its put options and closed on
      $315,000 of the 2008 Unit Put Arrangement, while 1,000 Origination
      Warrants were forfeited when an investor failed to meet a $10,000 unit put
      obligation.  The Origination Warrants, valued at $42,575 using
      the Black-Scholes pricing model, were recorded as a debt issuance cost
      asset and amortized as interest expense over the term of the 2008 Unit Put
      Arrangement (see Note 5).




Each unit
issued in the 2008 Unit Put Arrangement included a warrant that will remain
exercisable until December 31, 2012 at an exercise price of $1.00 per share (a
“Unit Put Warrant”). The purchase price of the warrant portion of each unit was
$500.




Between
September 16, 2008 and December 11, 2008, the Company exercised $315,000 of its
put options under the Unit Purchase Agreement and issued 63,000 Unit Put
Warrants.  The $17,493 relative fair value of the Unit Put Warrants
was recorded as an original issue discount as defined in ASC Topic 470 against
the convertible debt liability, and was amortized as interest expense over the
term of the convertible debentures.  On February 6, 2009, the $299,250
outstanding promissory notes issued pursuant to the Company’s 2008 Unit Put
Arrangement, along with the $9,563 interest accrued thereon, automatically
converted into 441,165 shares of the Company’s common stock.  The
unamortized original issue discount was expensed as interest cost upon this
conversion.




·
            On
      January 7, 2009, the 2009 Public Offering was declared effective by the
      United States Securities and Exchange Commission, and January 12, 2009 the
      2009 Public Offering was closed.  In the offering, the Company
      sold 3,050,000 units at $1.00 per unit, with each unit consisting of one
      share of common stock and one redeemable warrant to purchase one share of
      common stock at an exercise price of $1.30 per share resulting in net cash
      of $1,790,472, after costs of
$1,259,528.




·
            As
      additional compensation pursuant to the 2009 Public Offering, the Company
      sold to the underwriter, Feltl & Company, for nominal consideration, a
      warrant (the “Underwriter’s Warrant”) to purchase up to
      305,000 units. The Underwriter’s Warrant is not exercisable until
      January 7, 2010 and thereafter is exercisable at $1.20 per unit for a
      period of four years.




·
            On
      the January 7, 2009 effective date of the 2009 Public Offering, the
      $1,757,500 aggregate amount of notes from the 2007 and 2008 Private
      Placements, along with $162,974 of interest accrued thereon, automatically
      converted into 2,743,535 units identical to those sold in the 2009 Public
      Offering (based on 70 percent of the offering price, or $0.70 per
      share).  On the same date, the $142,500 of Davis Note, along
      with $14,908 of interest accrued thereon, automatically converted into
      314,846 units identical to those sold in the 2009 Public Offering (based
      on 50 percent of the offering price, or $0.50 per
  share).




·
            The
      exercise price of the Davis Warrants and the warrants from the 2007 and
      2008 Private Placements was set upon the January 7, 2009 effective date of
      the 2009 Public Offering at $0.50 per share (based on 50 percent of the
      offering price.  All of these warrants became exercisable upon
      the January 12, 2009 closing of the 2009 Public Offering and will remain
      exercisable until December 31, 2012  Unamortized original issue
      discount relating to the warrants and the beneficial conversion feature of
      the notes totaling $387,169 and unamortized debt issuance cost of $207,575
      was expensed as interest expense upon the
  conversion.


F-33




(f)
            Common
      Stock and Warrants issued for services and
  liabilities




·
            In
      March 2002, the Company granted a warrant to purchase 3,000 shares of
      common stock to a former director that was exercisable at $11.33 per
      share. This warrant expired unexercised.  An aggregate of
      $12,075 of stock-based compensation expense related to this warrant was
      recognized in the period from August 17, 1999 (inception) to December 31,
      2009.




·
            In
      November 2002, the Company granted a warrant to purchase 150 shares of
      common stock at an exercise price of $23.33 per share to a consultant, for
      services rendered.  This warrant expired
      unexercised.  An aggregate of $490 of stock-based compensation
      expense related to this warrant was recognized in the period from August
      17, 1999 (inception) to December 31,
2009.




·
            In
      February 2003, the Company issued 545 common shares to a consultant, in
      lieu of $12,705 cash for accounts
payable.




·
            In
      June 2003, under the terms of an agreement with a supplier, the Company
      issued a warrant to purchase 9,215 shares of common stock at an exercise
      price of $3.33 per share.  This warrant expired
      unexercised.  The value of $187,060 related to this warrant was
      recognized as research and development expense in the year ended December
      31, 2003.




·
            In
      May 2004, a vendor was issued 3,861 shares of the Company’s common stock
      as payment for product development work valued at
  $77,225.




·
            In
      July 2004, the Company entered into a research and development agreement
      for the development of the ProUroScan System.  Under this
      agreement, warrants for the purchase of 10,000 shares of the Company’s
      common stock upon the execution of the agreement and warrants for the
      purchase of 20,000 shares of the Company’s common stock in December 2004.
      The warrants were fully vested, five-year warrants at a per share exercise
      price of $20.00 per share value.  The total value of these
      warrants computed using the Black-Scholes pricing model was
      $281,086.  The value of the warrants was recorded as research
      and development expense in the year ended December 31,
    2004.




·
            In
      October 2004, another vendor was issued 4,444 shares of the Company’s
      common stock in lieu of $88,882 cash for accounts
  payable.




·
            On
      April 11, 2005, the Company entered into a placement agency agreement with
      an investment firm to raise working capital for the
      Company.  Pursuant to the agreement, on May 13, 2005 the Company
      issued 5,000 shares of the Company’s common stock to the placement
      agent.  The 5,000 shares were valued at $51,000 using the stock
      price on the date of grant and were recorded as general and administrative
      expense during the year ended December 31,
2005.




·
            On
      December 30, 2005, the Company issued 4,541 shares of common stock to our
      current and former directors in satisfaction of accrued director’s fees in
      the amount of $40,418.




·
            On
      April 21, 2006, the Company issued 7,000 shares of its common stock to its
      former Vice-President of Engineering, upon his resignation, pursuant to
      his employment agreement.  The shares were valued at $44,800
      based on the average closing share price during the five days before and
      after the issuance date, and were recorded as compensation expense during
      the year ended December 31, 2006.




·
            On
      September 8, 2006, the Company issued 1,415 shares of its common stock to
      a vendor, as payment for product development work valued at
      $8,938.




·
            On
      April 2, 2007, the Company issued 4,141 shares of its common stock to a
      vendor, as payment for product development work valued at
      $20,704.




·
            On
      April 16, 2007, the Company issued to Artann five-year warrants
      (immediately exercisable) to acquire 20,000 shares of its common stock at
      $4.10 per share pursuant to an agreement with Artann.  The
      warrants were valued at $72,000 by the Black-Scholes pricing model and
      recorded as research and development expense during the year ended
      December 31, 2007.


F-34




·
            On
      September 10, 2007, the Company issued a total of 20,694 shares of its
      common stock to its directors and former directors as payment for $62,082
      of accrued directors’ fees.




·
            On
      January 4, 2008, pursuant to a final separation agreement with a former
      employee of the Company, the Company issued to the former employee
      five-year warrants (immediately exercisable) to acquire up to 14,500
      shares of the Company’s common stock at an exercise price of $5.00 per
      share, and amended a previously issued warrant to acquire up to 30,000
      shares of the Company’s common stock to provide for cashless exercise
      thereof.  The warrants, valued at $14,500 using the
      Black-Scholes pricing model, were recorded as compensation expense during
      the year ended December 31, 2008.




·
            On
      July 11, 2008, the Company’s directors received 21,667 of shares of the
      Company’s common stock in lieu of cash for $21,667 of unpaid director’s
      fees accrued through June 30, 2008.  The shares were valued at
      $1.00 per share and expensed during the period of
  service.




·
            On
      July 11, 2008, the Company issued a total of 37,967 shares of the
      Company’s common stock to its directors in recognition of extraordinary
      amount of time and effort they spent on the Company’s restructuring and
      refocusing efforts since January 2007.  The shares were valued
      at $1.00 per share and expensed on the date of
  issuance.




·
            On
      January 15, 2009, the Company issued 454,546 shares of common stock to
      Artann in satisfaction of a $500,000 liability pursuant to its license
      agreement with Artann.




·
            On
      April 13, 2009, the Company issued an aggregate of 27,366 shares to its
      independent directors as payment of $20,250 directors’ fees accrued
      through December 31, 2008, in lieu of
cash.




·
            On
      July 23, 2009, the Company issued a two-year warrant to purchase 30,000
      shares of our common stock at an exercise price of $1.25 per share to its
      public relations firm as consideration for services provided to the
      Company.  The warrant, valued at $26,400 using the Black-Scholes
      pricing model, was recorded as general and administrative
      expense.




·
            On
      September 29, 2009, the Company issued 4,834 shares to a director as
      payment of $7,250 directors’ fees, in lieu of
  cash.




·
            On
      December 3, 2009, the Company issued 10,000 shares of its common stock to
      a web-site designer for services provided valued at
  $7,425.




(g)
            Common
      Stock and Warrants issued pursuant to loans and loan
      guarantees




Each
warrant listed below was valued using the Black-Scholes pricing model; however,
the recorded value of warrants issued to lenders and guarantors of Company debt
is limited to the corresponding amount loaned or guaranteed.




·
            During
      the year ended December 31, 2003, the Company issued warrants to purchase
      a total of 64,287 shares of common stock at $23.33 per share to nine
      individuals, including 4,286 shares to a Company director in exchange for
      their guaranteeing a bank line of credit.  An aggregate of
      $216,112 of debt issuance cost related to these warrants was recorded and
      amortized over the life of the bank line of credit.  Upon the
      closing of the Company’s 2004 private placement and Merger on April 5,
      2004, certain exercise price protections and anti-dilution provisions of
      these warrants became effective.  Under the terms of these
      provisions, the holders of these warrants became eligible to purchase a
      total of 101,788 shares at $16.67 per share.  The additional
      warrants and revaluation of the existing warrants were valued at $320,974
      using the Black Scholes pricing model, and were recorded as interest
      expense at the time of issuance.  The warrants expired
      unexercised.


F-35


·
            In
      September 2005, the Company engaged a consultant to assist with the
      introduction of strategic investors to the Company.  Under this
      agreement, on September 1, 2005 and February 22, 2006, the Company issued
      a total of 5,000 shares of common stock valued at $40,500 on the grant
      dates to the consultant.  Upon the closing of the Company’s
      Crown Bank notes on February 16, 2006, the $43,000 aggregate value of the
      shares and initial retainer were recorded as debt issuance cost and were
      amortized over the term of the
notes.




·
            On
      September 14, 2005, in connection with a commercial guaranty of a $100,000
      bank loan, the Company issued two five-year warrants (immediately
      exercisable) to an individual investor to acquire a total of 5,000 shares
      of the Company’s common stock at $5.00 per share.  The warrants,
      valued at $29,000 using the Black-Scholes pricing model, were recorded as
      debt issuance costs and expensed over the term of the loan as interest
      expense.  The Company recorded $29,000 of expense related to the
      value of the warrants during the period from August 17, 1999 (inception)
      to December 31, 2009.




·
            On
      September 21, 2005, in connection with $100,000 loan from an individual
      investor, the Company issued two five-year warrants (immediately
      exercisable) to the lender to acquire a total of 5,000 shares of the
      Company’s common stock at $5.00 per share.  The gross proceeds
      of $100,000 were allocated between the promissory note and the common
      stock warrants based on the relative fair values of the securities at the
      time of issuance. The warrants, valued at $26,500 using the Black-Scholes
      pricing model, were recorded as original issue discount as defined in ASC
      Topic 470 expensed on a straight-line basis over the term of the
      promissory note as interest expense.  The Company recorded
      $26,500 of expense related to the value of the warrants during the period
      from August 17, 1999 (inception) to December 31,
  2009.




·
            On
      October 19, 2005, in connection with commercial guaranties of a $300,000
      loan from a bank, the Company issued five-year warrants (immediately
      exercisable) to two investors to acquire up to 7,500 shares (15,000 shares
      in total) of the Company’s common stock at $5.00 per share.  The
      warrants, valued at $79,500 using the Black-Scholes pricing model, were
      recorded as debt issuance costs and expensed over the term of the loan as
      interest expense.  The Company recorded $79,500 of expense
      related to the value of the warrants during the period from August 17,
      1999 (inception) to December 31,
2009.




·
            On
      January 25, 2006, in connection with a $23,000 loan, the Company issued a
      five-year warrant (immediately exercisable) to a partnership to acquire
      5,000 shares of Company common stock at $5.00 per
      share.    The gross proceeds of $23,000 were allocated
      between the promissory note and the common stock warrant based on the
      relative fair values of the securities at the time of
      issuance.  The fair value of the warrant estimated at grant date
      using the Black-Scholes pricing model exceeded the amount of the
      loan.  Accordingly, the warrant was valued at $23,000 and
      recorded as original issue discount as defined in ASC Topic 470 and
      expensed as interest expense over the term of the
  loan.




·
            On
      June 1, 2006, the Company borrowed $75,000 from an individual investor,
      and in connection therewith issued to the investor a promissory note to
      mature on August 30, 2006.  Under the terms of the loan
      agreement, the Company issued a five-year warrant (immediately
      exercisable)to the investor
      to acquire 3,750 shares of Company common stock at $5.00 per
      share.  The fair value of the warrant at the grant date was
      estimated using the Black-Scholes pricing model to be $25,500 and was
      recorded as original issue discount as defined in ASC Topic 470 and
      subsequently expensed as interest expense over the 90-day term of the
      loan.




On August
24, 2006 the promissory note was amended to mature on October 29, 2006 and the
Company agreed to issue a five-year warrant to the investor to acquire 41.7
shares of the Company’s common stock at $5.00 per share for each day the
promissory note was outstanding after August 30, 2006 upon repayment of the
promissory note.  These warrants were valued at $5.40 per share using
the Black-Scholes pricing model.  In connection with amendments to the
promissory note, the Company issued to the investor 31,817 warrants accrued
between August 30, 2006 and October 1, 2008 along with a warrant to acquire
3,000 shares of its common stock and agreed to continue to accrue 41.7 warrants
per day to be issued upon the Company’s repayment of the promissory
note.  The warrants issued and accrued on and after October 1,
2008 were five-year warrants with an exercise price of $1.50 per share, and were
valued at $1.32 per share using the Black-Scholes pricing
model.


F-36


The
present value of the cash flows under both amendments was greater than 10
percent different from the present value of the cash flows under the original
agreement, indicating that a substantial modification of debt terms had
occurred.  Accordingly, the warrants issued and the accrual of
warrants to be issued pursuant to the amended note were recorded as debt
extinguishment expense.  The total debt extinguishment expense
recorded for the 459, 15,262 and 36,112 warrants accrued for issuance during the
years ended December 31, 2009 and 2008, and the period from August 17, 1999
(inception) to December 31, 2009 was $607, $70,723 and $181,443,
respectively.  On January 12, 2009, the Company repaid the promissory
note and issued 4,295 warrants related to this note.




·
            On
      July 21, 2006, in connection with a $7,500 loan from an individual
      investor, the Company issued a five-year warrant (immediately
      exercisable)to the investor
      to acquire 375 shares of Company common stock at $5.00 per
      share.  The gross proceeds of $7,500 were allocated between the
      promissory note and the common stock warrant based on the relative fair
      values of the securities at the time of issuance.  The warrant,
      valued at $2,025 using the Black-Scholes pricing model, was recorded as
      original issue discount as defined in ASC Topic 470 and was expensed as
      interest expense during the year ended December 31,
  2006.




·
            On
      August 30, 2006, in connection with a $10,000 loan from an individual
      investor, the Company issued a five-year warrant (immediately exercisable)
      to the investor to acquire 500 shares of Company common stock at $5.00 per
      share. The gross proceeds of $10,000 were allocated between the promissory
      note and the common stock warrant based on the relative fair values of the
      securities at the time of issuance.  The warrant, valued at
      $2,300 using the Black-Scholes pricing model, was recorded as original
      issue discount as defined in ASC Topic 470 and was expensed as interest
      expense during the year ended December 31,
2006.




·
            On
      November 30, 2006, the Company borrowed $100,000 from a partnership, and
      in connection therewith issued to the partners a promissory note to mature
      on January 2, 2007.  Pursuant to the terms of the promissory
      note, the Company issued five-year warrants (immediately exercisable) to
      the partners to acquire 5,000 shares of Company common stock at $5.00 per
      share.  In addition, pursuant to the terms of the promissory
      note, the Company issued an additional five-year warrant (immediately
      exercisable) to the partners to acquire 5,000 shares of Company common
      stock at $5.00 per share, when the loan was not repaid on January 2,
      2007.  The first warrant, valued at $22,500 using the
      Black-Scholes pricing model, was recorded as original issue discount as
      defined in ASC Topic 470 and was expensed as interest expense over the
      term of the promissory note.  The second warrant, also valued at
      $22,500, was expensed immediately as interest expense.  The
      Company recorded interest expense of $45,000 related to the warrants
      issued pursuant to the original agreement during the period from August
      17, 1999 (inception) to December 31,
2009.




On each
of March 20, 2007 and August 8, 2007, the Company amended the promissory note
with the partnership, resulting in an extension of its due dates, the issuance
of a third warrant to acquire 5,000 shares of Company common stock at $5.00 per
share on February 1, 2007 and an agreement to issue to the partners five-year
warrants to acquire 167 shares at $5.00 per share for each day the principal
remained unpaid on and after March 1, 2007.  The present value of the
cash flows under the modifications was greater than 10 percent different from
the present value of the cash flows under the existing agreement, indicating
that a substantial modification of debt terms had
occurred.  Accordingly, the accrual of warrants to be issued and the
warrants issued on February 1, 2007 pursuant to the promissory note were
recorded as debt extinguishment expense.  The Company expensed as debt
extinguishment cost $0, $4,848 and $206,485 related to the accrual of 0,1,347
and 52,357 warrants to be issued of warrants pursuant to the amended terms of
the promissory note during the years ended December 31, 2009 and 2008, and the
period from August 17, 1999 (inception) to December 31, 2009,
respectively.  On January 16, 2008, the Company repaid the outstanding
principal amount of the note and issued the 52,357 accrued
warrants.




·
            On
      March 14, 2007, upon the termination of employment of an employee, and in
      consideration for an agreement to defer payment of accrued salaries until
      the Company is able to make such payments, the Company agreed to extend by
      three years the expiration date of 30,000 warrants beneficially held by
      the employee.  The modification of the warrant resulted in the
      recording of an immediate incremental compensation expense totaling
      $96,000, computed as the increase in the fair value of the warrant as
      determined using the Black-Scholes pricing model over the fair value so
      determined immediately before the
modification.


F-37


·
            On
      July 31, 2007, the Company borrowed $100,000 for short-term working
      capital needs pursuant to a promissory note issued to an individual
      investor.  During the years ended December 31, 2009 and 2008,
      and the period from August 17, 1999 (inception) to December 31, 2009, the
      Company accrued for issuance warrants to acquire 680, 12,576 and 28,656
      shares of the Company’s common stock, respectively, and recorded interest
      expense of $2,720, $50,304 and $114,624, respectively, related
      thereto.  On January 20, 2009, the Company repaid the promissory
      note and issued 28,656 warrants related to this
  note.




·
            On
      August 29, October 31, and November 30, 2007, the Company borrowed for
      working capital needs $50,000, $100,000 and $25,000, respectively, from
      James Davis.  On December 27, 2007 these notes were converted
      into the units sold by the Company in its 2007 Private Placement (see Note
      14(e)). Pursuant to the terms of the promissory note the Company issued to
      Mr. Davis 12,550 warrants that were valued at $28,340 using the
      Black-Scholes pricing model, which were expensed as interest expense
      during the period from August 17, 1999 (inception) to December 31,
      2009.




·
            On
      October 15, 2007, the Company borrowed $600,000 pursuant to a promissory
      note issued to an individual investor.  In consideration for
      this loan, on November 7, 2007 the Company agreed to issue 33,333 shares
      of its common stock to the investor.  The $66,666 value of this
      consideration was recorded as debt issuance cost and was amortized over
      the term of the loan using the straight-line method, which approximates
      the interest method.  The Company recorded $7,836, $48,473 and
      $66,667 of interest expense related to the amortization of this debt
      issuance cost during the years ended December 31, 2009 and 2008, and the
      period from August 17, 1999 (inception) to December 31, 2009,
      respectively.  On October 31, 2008, pursuant to the terms of the
      loan when the loan remained unpaid on that date, the Company issued to the
      investor 6,667 shares of its common stock and a five-year immediately
      exercisable warrant to acquire 16,667 shares of its common stock at an
      exercise price of $2.00.  The $6,667 value of the shares issued
      and the $12,834 value of the warrants was recorded as interest expense
      during the year ended December 31,
2008.




On March
19, 2009, the note was renewed to mature on March 28, 2010.  As
consideration to the lender for renewing the loan, the Company issued 66,667
shares of its common stock, representing the first six months compensation, and
is accruing for issuance 11,111 shares per month for each additional month the
note remains outstanding after August 31, 2009.  It was determined
that a substantial modification of the terms of the note was made as the present
value of the cash flows under the new convertible promissory note was greater
than 10 percent different from the present value of the cash flows under the
original note.  Accordingly, the $33,333 value of the initial 66,667
shares issued was recorded as debt extinguishment expense.  Additional
accruals of stock to be issued if the promissory notes remain outstanding after
August 31, 2009 were expensed each month as debt extinguishment
expense.  During the year ended December 31, 2009, 44,444 shares were
accrued for issuance pursuant to this loan guarantee compensation arrangement,
resulting in additional debt extinguishment expense of $22,222.




·
            On
      January 7, 2009, upon the effective date of the 2009 Public Offering, the
      Company issued 292,384 shares of common stock to holders of $733,334 of
      convertible debentures pursuant to the automatic conversion of the
      debentures and $143,815 interest accrued
  thereon.




·
            On
      December 28, 2007, pursuant to the terms of guarantees of its $1.2 million
      Crown Bank promissory note, the Company issued to the three guarantors an
      aggregate of 88,889 shares of the Company’s common stock.  The
      $88,889 value of the shares was immediately expensed as
      interest.  On October 31, 2008, pursuant to the terms of the
      guarantees when the Crown bank loan remained unpaid, the Company issued to
      the three guarantors an aggregate amount of 17,778 shares of our common
      stock and five-year immediately exercisable warrants to acquire an
      aggregate of 44,445 shares of our common stock at an exercise price of
      $2.00 per share.  The $17,778 value of the shares issued and the
      $34,223 value of the warrants was recorded as interest expense during the
      year ended December 31, 2008.




On March
19, 2009, pursuant to guaranties received relating to the Company’s renewal of
the Crown Bank promissory note, the Company issued an aggregate of 133,334
shares of its common stock to the guarantors representing the first six months’
consideration for providing their guarantee (see Note 11).  The
$66,667 value of the shares on the issuance date was recorded as debt issuance
cost and was amortized on a straight-line basis through August 31,
2009.  For each month the promissory note remains outstanding after
August 31, 2009, the Company is accruing for issuance to the guarantors 22,222
shares of its common stock.  A total of 88,888 shares were accrued for
issuance as of December 31, 2009.  The $44,444 value of the shares was
recorded as interest expense.


F-38




·
            On
      April 3, 2008, as consideration to James Davis, William Reiling and
      another investor for providing certain loans to the Company, the Company
      issued five-year warrants (immediately exercisable) to purchase a total of
      75,000 shares of the Company’s common stock at $1.50 per
      share.  The gross proceeds were allocated between the note and
      the warrants based on the relative fair value at the time of
      issuance.  The relative fair value of warrants was recorded as
      original issue discount on the related convertible promissory notes and
      was expensed as interest expense over the term of the
      notes.  During the year ended December 31, 2008, original issue
      discounts of $42,768 were expensed as interest expense.  On
      January 22, 2009, $29,500 of the convertible promissory notes was
      converted into 42,143 shares of the Company’s common
  stock.




·
            On
      September 25, 2008, the Company borrowed $150,000 pursuant to a
      convertible promissory note issued in favor of James Davis.  As
      consideration for providing the loan, the Company issued an immediately
      exercisable, five-year warrant to purchase 100,000 shares of the Company’s
      common stock at $1.50 per share to Mr. Davis.  The $46,604
      relative fair value of the warrant was recorded as original issue discount
      and expensed as interest expense over the term of the promissory
      note.  During the year ended December 31, 2008, original issue
      discount of $8,280 was expensed as interest expense.  On March
      19, 2009, Mr. Davis agreed to refinance the $150,000 debt interest and a
      $37,500 note along with accrued interest and additional amounts loaned to
      the Company. Pursuant to the refinancing and the other arrangements, the
      Company issued a $281,000 unsecured convertible promissory note to Mr.
      Davis.  On May 26, 2009, Mr. Davis exercised his conversion
      rights under the promissory note, and the note was converted into 510,909
      shares of the Company’s common stock (see Notes 12 and
  15).




·
            On
      June 16, 2009, the Company issued 6,667 shares valued at $5,467 to a
      guarantor as consideration for providing a guarantee of a $100,000 bank
      loan (see Note 11). The Company will accrue for issuance 1,111 shares of
      its common stock as further consideration for each month or portion
      thereof that the principal amount of the loan remains outstanding
      beginning January 1, 2010. All accrued shares will be issued upon
      repayment of the loan.  The value of the shares was recorded as
      debt issuance cost.




·
            On
      September 21, 2009, the Company issued 19,833 shares valued at $28,262 to
      Mr. Davis as six months worth of consideration for providing a $243,000
      loan (see Notes 10 and 15).  The value of the shares was
      recorded as debt issuance cost and is being amortized over six
      months.  The Company will accrue for issuance 2,700 shares of
      its common stock as further consideration for each month or portion
      thereof that the principal amount of the loan remains outstanding
      beginning March 23, 2010. All accrued shares will be issued upon repayment
      of the loan.  The value of the shares was recorded as debt
      issuance cost.




·
            On
      September 23, 2009, the Company issued 6,667 shares valued at $9,000 to a
      guarantor as six months worth of consideration for providing a guarantee
      of a $100,025 bank loan (see Note 11).  The value of the shares
      was recorded as debt issuance cost and is being amortized over six
      months.  The Company will accrue for issuance 1,111 shares of
      its common stock as further consideration for each month or portion
      thereof that the principal amount of the loan remains outstanding
      beginning March 23, 2010. All accrued shares will be issued upon repayment
      of the loan.  The value of the shares was recorded as debt
      issuance cost.




·
            On
      September 23, 2009, the Company issued 20,000 shares valued at $27,000 to
      an individual lender as six months worth of consideration for providing a
      $300,000 loan (see Note 10).  The value of the shares was
      recorded as debt issuance cost and is being amortized over six
      months.  The Company will accrue for issuance 3,333 shares of
      its common stock as further consideration for each month or portion
      thereof that the principal amount of the loan remains outstanding
      beginning March 23, 2010. All accrued shares will be issued upon repayment
      of the loan.  The value of the shares was recorded as debt
      issuance cost.




·
            On
      November 6, 2009, the Company issued 925 shares of its common stock valued
      at $1,322 to Scott Smith, a director, as consideration for providing a
      $26,000 loan.


F-39




(h)
            Warrant
      exercises




On
      September 25, 2009, the Company commenced its Replacement Warrant
      Offering.  The warrants subject to the offer were: (a) 3,050,000
      publicly traded warrants to purchase common stock that were issued on
      January 12, 2009; and (b) 3,058,381 unregistered warrants to purchase
      common stock which were also issued on January 12, 2009 (together, the
      “Warrants”).  Pursuant to the offer, the Company temporarily
      modified the terms of the Warrants so that each holder who tendered
      Warrants for early exercise on or before November 6, 2009 received, in
      addition to the shares of common stock purchased upon exercise, new
      three-year warrants to purchase the same number of shares of ProUroCare
      common stock at an exercise price of $1.30 per share (the “Replacement
      Warrants”).  On November 6, 2009, Warrants to purchase 1,244,829
      shares of common stock were tendered resulting in gross proceeds to the
      Company of $1,618,278, including the cancellation of a $26,000 loan from a
      director and $11,250 of directors’ fees owed to another director in lieu
      of cash payments for the exercise of a portion the Warrants they
      exercised.




The
      $1,356,864 fair value of the Replacement Warrants as determined using the
      Black-Scholes pricing model was expensed with an offsetting entry to
      additional paid-in capital.  The $1,618,278 purchase price of
      the stock issued pursuant to the Warrant exercise, less the $171,865
      expenses of the offering was recorded as capital stock and additional
      paid-in capital.




In
      December 2009, the Company issued 101,975 shares of common stock to
      certain warrant holders upon their exercise of warrants.  The
      Company realized proceeds of $132,568 from these warrant
      exercises.




(i)
            Warrants
      summary




Warrant
activity was as follows for the years ended December 31:




Warrants
                    
                    
                    Weighted-Average Exercise
                      Price2009
                    
                    
                    2008
                    
                    
                    2009
                    
                    
                    2008Outstanding,
      January 1
                    
                    
                    1,074,014
                    
                    
                    
                    639,504
                    
                    
                    $
                    3.05
                    
                    
                    $
                    6.61Granted
                    
                    
                    7,689,349
                    
                    
                    
                    538,297
                    
                    
                    
                    1.30
                    
                    
                    
                    1.38Exercised
                    
                    
                    (1,346,804
                    )
                    
                    
                    -
                    
                    
                    
                    1.30
                    
                    
                    
                    -Expired
                    
                    
                    (30,000
                    )
                    
                    
                    (103,787
                    )
                    
                    
                    20.00
                    
                    
                    
                    16.37Outstanding,
      December 31
                    
                    
                    7,386,559
                    
                    
                    
                    1,074,014
                    
                    
                    $
                    1.47
                    
                    
                    $
                    3.05




The fair
value of stock warrants is the estimated present value at grant date using the
Black-Scholes pricing model (see Note 1(j)).  The weighted-average
fair value of the warrants granted during the years ended December 31, 2009 and
2008 was $1.30 and $1.37, respectively. The expense related to warrants issued
to lenders and debt guarantors was $3,327, $262,305 and $1,100,511 for the years
ended December 31, 2009 and 2008, and the period from August 17, 1999
(inception) to December 31, 2009, respectively (excluding warrants issued in
connection with the 2007 and 2008 Private Placements and the 2008 Unit Put
Arrangement).  Stock-based compensation cost related to warrants
issued to the Company’s consultants and suppliers was $26,400, $14,500 and
$677,536 for the years ended December 31, 2009 and 2008, and the period from
August 17, 1999 (inception) to December 31, 2009,
respectively.  Stock-based compensation cost related to warrants
issued to directors (in lieu of stock options) was $0, $0 and $12,075 for the
years ended December 31, 2009 and 2008, and the period from August 17, 1999
(inception) to December 31, 2009, respectively.




(j)
            Stock
      Options




Stock
Option Plans




In April
2002, the Company’s Board passed a resolution adopting the ProUroCare Medical
Inc. 2002 Stock Plan (the “2002 Plan”), reserving 150,000 shares of the
Company’s common stock for issuance.




In July
2004, the Board passed a resolution adopting the ProUroCare Medical Inc. 2004
Stock Option Plan (the “2004 Plan”), which was approved by the Company’s
shareholders in July 2005.  The Company has reserved 150,000 shares of
common stock for issuance under the 2004 Plan.


F-40




In
February 2009, the Board passed a resolution adopting the ProUroCare Medical
Inc. 2009 Stock Option Plan (the “2009 Plan”), which was approved by the
Company’s shareholders in August 2009.  The Company has reserved
1,200,000 shares of common stock for issuance under the 2009 Plan.




The plans
permit the Company to grant incentive and nonqualified options, stock
appreciation rights, stock awards, restricted stock awards, performance shares
and cash awards to Company employees and independent contractors.  The
exercise price for all options granted under the plans shall be determined by
the Board. The term of each stock option and period of exercisability will also
be set by the Board, but will not exceed a period of ten years and one day from
grant date. The agreements also include provisions for anti-dilution of
options.




Stock
Option Grants




Each of
the options granted below were valued using the Black-Scholes pricing model (see
Note 1(i)) and are being expensed over the vesting period as general and
administrative expense.




·
            In
      March 2002, the Company granted an aggregate of 90,000 employee stock
      options to officers and directors that were exercisable at $11.33 per
      share.  The officers’ options vested ratably over a 36-month
      period through December 2004, while the directors’ options vested ratably
      over a 24-month period through April 2004.  An aggregate
      $342,782 of stock-based compensation expense related to these options was
      recognized in the period from August 17, 1999 (inception) to December 31,
      2009.




In
October 2003, an officer resigned from the Company and 15,000 of his unvested
options were forfeited and in October 2004 his remaining 21,000 options
expired.  In February 2004, a director resigned from the Board, and
375 of his unvested options were forfeited, and in October 2005 his remaining
2,625 options expired.  Effective May 1, 2007, Maurice Taylor, the
Company’s former Chairman and Chief Executive Officer, retired from the
Company.  Pursuant to a May 11, 2007 agreement to defer payment of his
unpaid salary, the Company extended the date through which Mr. Taylor may
exercise 45,000 options (including options gifted to his children) following his
separation to April 1, 2012.  The Company recorded stock-based
compensation expense of $103,500 related to the extension of the exercise date
in the year ended December 31, 2007.




·
            In
      April 2002, the Company issued a nonqualified stock option to a consultant
      to acquire 3,000 shares of common stock at $11.33 per share. This option
      expired unexercised.  At the same time, the Company also issued
      a nonqualified stock option to another consultant to acquire 3,000 shares
      of common stock at $11.33 per share. This option vested ratably over a
      two-year period through April 2004.  An aggregate of $27,600 of
      stock-based compensation expense related to these options was recognized
      in the period from August 17, 1999 (inception) to December 31,
      2009.




·
            In
      February 2004, the Company issued 45,000 employee stock options to Michael
      Grossman, our former President and Chief Operating
      Officer.  These options were valued at $6.70 per share, vested
      ratably over a three-year period and are exercisable at $20.00 per
      share.  The Company expensed, $16,811 and $303,000 related to
      these options during the year ended December 31, 2007 and the period from
      August 17, 1999 (inception) to December 31, 2009,
      respectively.  Pursuant to a May 11, 2007 separation agreement,
      the Company extended the date through which Mr. Grossman may exercise
      45,000 options (including options gifted to his children) following his
      separation until February 1, 2012.  The Company recorded
      stock-based compensation expense of $117,000 related to the extension of
      the exercise date in the year ended December 31,
  2007.




·
            In
      February 2004, the Company issued 3,000 nonqualified stock options to a
      consultant in consideration of services rendered.  The options
      were valued at $6.70 per share, and vested as to 1,500 shares upon
      issuance and as to the remaining 1,500 shares on January 1,
      2005.  These options are exercisable at $20.00 per share through
      February 2014.  The Company expensed $20,200 related to these
      options during the period from August 17, 1999 (inception) to December 31,
      2009.




·
            In
      July 2004, the Company issued 20,000 employee stock options to Mr. Thon in
      connection with his employment agreement.  These options were
      valued at $15.00 per share, vested ratably over a three-year period, and
      are exercisable at $25.00 per share through July 2014.  The
      Company expensed $58,314 and $300,000 related to these options during the
      year ended December 31, 2007 and the period from August 17, 1999
      (inception) to December 31, 2009, respectively.  On July 11,
      2008, in connection with the issuance of new options to Mr. Thon (see
      below), these options were
cancelled.


F-41




·
            In
      January 2005, the Company issued 15,000 stock options to Mr. Carlson, who
      at the time was the Company’s Vice President of Marketing and
      Sales.  The options were valued at $16.20 per share, vest
      ratably over a three-year period, and are exercisable at $23.50 per share
      through January 2015.  The Company expensed $0, $6,729, and
      $243,000 related to these options during the years ended December 31, 2009
      and 2008 and the period from August 17, 1999 (inception) to December 31,
      2009, respectively.  On July 11, 2008, in connection with the
      issuance of new options to Mr. Carlson (see below), these options were
      cancelled.




·
            In
      September 2005, the Company issued 15,000 stock options exercisable at
      $6.00 per share to an employee.  The options were valued at
      $5.30 per share and expired unexercised.  The Company expensed
      $15,460 related to these options during the period from August 17, 1999
      (inception) to December 31, 2009.




·
            On
      March 1, 2006, the Company issued to five of its employees five-year stock
      options to acquire a total of up to 20,000 shares of common stock at $7.50
      per share.  The options, valued at $5.60 per share, vest upon
      the Company securing FDA approval of its ProUroScanTM
      system.  10,000 of these options were awarded to employees who
      subsequently left the Company and have been forfeited.  The
      remaining options are being expensed over the vesting period (estimated by
      the Company as forty-one months) as general and administrative
      expense.  The Company expensed $2,823, $9,663 and $94,007
      related to these options during the years ended December 31, 2009 and
      2008, and the period from August 17, 1999 (inception) to December 31,
      2009, respectively.




·
            On
      May 30, 2006, the Company issued 3,000 nonqualified stock options to Mr.
      Smith, a director, upon his appointment to the Board.  The
      options were valued at $5.90 per share, and vested over a two year
      period.  These options are exercisable at $7.00 per share
      through May 2013.  The Company expensed $0, $3,688 and $17,700
      related to these options during the years ended December 31, 2009 and
      2008, and the period from August 17, 1999 (inception) to December 31,
      2009, respectively.




·
            On
      February 1, 2007, the Company granted to Mr. Carlson, a seven-year option
      to acquire up to 20,000 shares of the Company’s common stock at a price of
      $5.00 per share.  The options were valued at $3.40 per share
      using the Black-Scholes pricing model and will be expensed over the
      vesting period as general and administrative expense. The options vested
      as follows:




(a)
            5,000
      shares vested immediately.




(b)
            5,000
      shares vest upon the Company’s closing on new equity financing
      arrangements aggregating to $3,000,000 or more after February 1, 2007 and
      prior to December 31, 2007.  This objective was not met, and
      these options did not vest and were
forfeited.




(c)
            5,000
      shares vest if the Company records gross product revenues of $1,000,000 or
      more in the Company’s 2008 fiscal year.  This objective was not
      met, and these options did not vest and were
  forfeited.




(d)
            5,000
      shares vested on December 31, 2008.




The
Company expensed $0, $1,143, and $34,000 related to these options during the
year ended December 31, 2009 and 2008, and the period from August 17, 1999
(inception) to December 31, 2009, respectively.




·
            On
      June 14, 2007, the Company issued 3,000 nonqualified stock options to Mr.
      Rudelius, upon his appointment to the Board.  The options were
      valued at $2.40 per share, and vest ratably over a 24-month period through
      June 14, 2009.  These options are exercisable at $2.90 per share
      through May 2014.  The Company expensed $1,800, $3,600 and
      $7,200 related to these options during the year ended December 31, 2009
      and 2008,and the
      period from August 17, 1999 (inception) to December 31, 2009,
      respectively.


F-42


·
            On
      July 11, 2008, the Company issued incentive stock options to acquire
      70,000 shares of its common stock to Mr. Carlson.  The options
      are exercisable for a period of seven years at an exercise price of $1.00
      per share.  Of the options, 10,000 shares vest immediately and
      20,000 shares will vest on July 1 of each of 2009, 2010 and
      2011.  At the same time, Mr. Carlson agreed to cancel existing,
      fully-vested stock options to acquire 15,000 shares of common stock at an
      exercise price of $23.50 per share.  The Company accounts for
      options that are cancelled and reissued simultaneously as a modification
      of the terms of the original option.  Accordingly, the
      incremental compensation cost of the fully vested portion of the newly
      issued options, valued at $0.79 per share using the Black-Scholes pricing
      model, over the $0.31 per share value of the cancelled options on the
      cancellation date were expensed immediately as general and administrative
      expense.  The value of the unvested portion will be recorded as
      general and administrative expense over the three-year vesting
      period.  The Company expensed $17,000, $11,750 and $28,750
      related to these options during the year ended December 31, 2009 and 2008,
      and the period from August 31, 1999 (inception) to December 31, 2009,
      respectively.




·
            On
      July 11, 2008, the Company issued incentive stock options to acquire
      35,000 shares of its common stock to Mr. Thon.  The options are
      exercisable for a period of seven years at an exercise price of $1.00 per
      share.  Of the options, 10,000 shares vest immediately and 8,333
      shares will vest on July 1 of each of 2009, 2010 and 2011.  At
      the same time, Mr. Thon agreed to cancel existing, fully-vested stock
      options to acquire 20,000 shares of common stock at an exercise price of
      $25.00 per share.  The Company accounts for options that are
      cancelled and reissued simultaneously as a modification of the terms of
      the original option.  Accordingly, the incremental compensation
      cost of the fully vested portion of the newly issued options, valued at
      $0.79 per share using the Black-Scholes pricing model, over the $0.27 per
      share value of the cancelled options on the cancellation date were
      expensed immediately as general and administrative expense.  The
      value of the unvested portion will be recorded as general and
      administrative expense over the three-year vesting period.  The
      Company expensed $7,083, $6,042 and $13,125 related to these options
      during the year ended December 31, 2009 and 2008, and the period from
      August 31, 1999 (inception) to December 31, 2009,
      respectively.




·
            On
      August 11, 2008, the Company issued 1,000 non-qualified stock options
      (immediately exercisable) to each of its three outside directors, Mr.
      Koenig, Mr. Smith and Mr. Rudelius, pursuant to its standard annual option
      award program, upon their re-election to the Company’s
      Board.  The options are exercisable for a period of seven years
      at an exercise price of $0.90 per share, and were valued at $0.71 per
      share.  The Company expensed $2,130 related to these option
      during the year ended December 31,
2008.




·
            On
      March 3, 2009, the Company granted non-qualified stock options to acquire
      an aggregate of 70,000 shares of its common stock to its non-employee
      directors, and incentive options to acquire 45,000 shares of its common
      stock to Richard Thon, our Chief Financial Officer (the
      “CFO”).  The options are fully vested and are exercisable for a
      period of seven years at an exercise price of $0.85 per
      share.  The 115,000 options were valued at $0.68 per share using
      the Black-Scholes pricing model and $78,200 was immediately expensed as
      general and administrative expense.




Also on
March 3, 2009, the Company granted an incentive stock option to acquire an
aggregate of 100,000 shares of its common stock to Richard Carlson, our Chief
Executive Officer (the “CEO”).  Of the options, 90,000 shares vest
immediately and 10,000 shares will vest on January 2, 2010.  At the
same time, Mr. Carlson agreed to cancel existing, unvested stock options to
acquire 5,000 shares of common stock at an exercise price of $7.50 per
share.  The options that were cancelled and simultaneously reissued
were treated as a modification of the terms of the original
option.  Accordingly, the incremental compensation cost of the fully
vested portion of the newly issued options valued at $0.68 per share using the
Black-Scholes pricing model over the $0.07 per share value of the cancelled
options on the cancellation date was expensed immediately as general and
administrative expense.  A total of $68,200 was recorded as
compensation expense related to this option grant during the year ended December
31, 2009




·
            On
      July 23, 2009, the Company granted a non-qualified stock option to acquire
      an aggregate of 6,500 shares of its common stock to a consultant pursuant
      to a consulting arrangement.  The options are fully vested and
      are exercisable for a period of five years at an exercise price of $1.21
      per share.  The options were valued at $0.87 per share using the
      Black-Scholes pricing model and $5,655 was immediately expensed as general
      and administrative expense.


F-43


·
            On
      July 23, 2009, the Company granted a non-qualified stock option to acquire
      an aggregate of 100,000 shares of its common stock to a consultant
      pursuant to a consulting arrangement.  The options expire seven
      years from the date of issuance and have an exercise price of $1.21 per
      share.  Options to purchase 50,000 shares vested immediately,
      and were valued at $0.97 per share using the Black-Scholes pricing
      model.  Options to purchase the remaining 50,000 shares vest on
      July 23, 2010 if the consultant remains a consultant to the Company at
      that time.  The cost of these options will ultimately be
      measured on the date that the consultant’s performance is complete, which
      is the vesting date.  For purposes of measuring the cost during
      interim periods, the options are measured at their then-current fair value
      at each interim reporting date.  The fair value of the unvested
      options as of December 31, 2009 as determined using the Black Scholes
      pricing model was $2.14 per share.  The value of the options to
      purchase all 100,000 shares is being recognized as general and
      administrative expense over the 12 month consulting period.  The
      Company expensed $64,792 during the year ended December 31,
      2009.




·
            On
      August 11, 2009, the Company issued 1,000 non-qualified stock options
      (immediately exercisable) to each of its non-employee directors pursuant
      to its standard annual option award program, upon their re-election to the
      Board.  The options are fully vested and exercisable for a
      period of seven years at an exercise price of $1.25 per
      share.  The options were valued at $1.00 per share using the
      Black-Scholes pricing model and $3,000 was immediately expensed as general
      and administrative expense.




·
            On
      September 29, 2009, the Company issued non-qualified stock options to each
      of its non-employee directors, Mr. Koenig (50,000 options), Mr. Smith
      (30,000 options) and Mr. Rudelius (30,000 options).  On the same
      date, the Company issued incentive stock options to its executive
      officers, Mr. Carlson (150,000 options) and Mr. Thon (60,000
      options).  The options expire seven years from the date of
      issuance, are exercisable at $1.50 per share and vest upon the latter of
      the date that the Company is cleared by the FDA to sell its ProUroScan
      System in the United States or the date that the Company closes on an
      aggregate of $2 million or more of incremental financing after the date of
      grant, including financing received upon the exercise of existing
      warrants.  The options were valued at $1.21 per share using the
      Black-Scholes pricing model and are being expensed over the estimated
      vesting period as general and administrative expense.  The
      Company expensed $232,320 during the year ended December 31, 2009 related
      to these options.




·
            On
      November 23, 2009, Mr. Koenig exercised 32,000 of his non-qualified
      options in a cashless exercise that resulted in a net issuance of 22,229
      shares of common stock.




(k)
            Stock
      options summary




Stock
option activity was as follows for the years ended December 31:





Options
                  
                  
                  Weighted-Average Exercise
                    Price2009
                  
                  
                  2008
                  
                  
                  2009
                  
                  
                  2008Outstanding,
      January 1
                  
                  
                  233,000
                  
                  
                  
                  175,500
                  
                  
                  $
                  7.73
                  
                  
                  $
                  15.16Granted
                  
                  
                  644,500
                  
                  
                  
                  108,000
                  
                  
                  
                  1.23
                  
                  
                  
                  1.00Exercised
                  
                  
                  (32,000
                  )
                  
                  
                  –
                  
                  
                  
                  0.86
                  
                  
                  
                  –Forfeited/Expired
                  
                  
                  (5,000
                  )
                  
                  
                  (50,500
                  )
                  
                  
                  7.50
                  
                  
                  
                  19.16Outstanding,
      December 31
                  
                  
                  840,500
                  
                  
                  
                  233,000
                  
                  
                  $
                  3.01
                  
                  
                  $
                  7.73Exercisable,
      December 31
                  
                  
                  398,833
                  
                  
                  
                  132,250
                  
                  
                  $
                  4.73
                  
                  
                  $
                  12.20


F-44




The
following table summarizes information about stock options outstanding as of
December 31, 2009:




OptionsVestedorExpectedtoVest
                  
                  
                  OptionsExercisableRangeofExercisePrices
                  
                  Numberof
                    Options
                  
                  
                  Weighted
                    Average
                    Exercise
                    Price
                  
                  
                  Weighted
                    Average
                    Remaining
                    Contractual
                    Life
                  
                  
                  Numberof
                    Options
                  
                  
                  Weighted
                    Average
                    Exercise
                    Price$0.85-$1.25
                  
                  
                  400,500
                  
                  
                  $
                  0.99
                  
                  
                  
                  6.08
                  
                  
                  
                  283,833
                  
                  
                  
                  0.95$1.50
                  
                  
                  320,000
                  
                  
                  $
                  1.50
                  
                  
                  
                  6.75
                  
                  
                  
                  -
                  
                  
                  
                  -$2.90
                  
                  
                  3,000
                  
                  
                  $
                  2.90
                  
                  
                  
                  4.45
                  
                  
                  
                  3,000
                  
                  
                  
                  2.90$5.00-$7.50
                  
                  
                  18,000
                  
                  
                  $
                  6.03
                  
                  
                  
                  5.04
                  
                  
                  
                  13,000
                  
                  
                  
                  5.46$11.33
                  
                  
                  51,000
                  
                  
                  $
                  11.33
                  
                  
                  
                  2.26
                  
                  
                  
                  51,000
                  
                  
                  $
                  11.33$20.00
                  
                  
                  48,000
                  
                  
                  $
                  20.00
                  
                  
                  
                  2.21
                  
                  
                  
                  48,000
                  
                  
                  $
                  20.00840,500
                  
                  
                  $
                  3.01
                  
                  
                  
                  5.85
                  
                  
                  
                  398,833
                  
                  
                  $
                  4.73





The
aggregate intrinsic value of the options outstanding and exercisable at December
31, 2009 was $925,835 and $439,835, respectively.  The average fair
value of each option granted during the years ended December 31, 2009 and 2008,
and the period from August 17, 1999 (inception) to December 31, 2009, as
determined using the Black-Scholes pricing model (see Note 1(i)) was $0.99,
$0.84 and $2.34, respectively.  The stock-based employee and
non-employee compensation cost related to stock options was $480,873, $44,745
and $2,122,645, or $0.05, $0.03 and $1.14 per share, for the years ended
December 31, 2009 and 2008, and the period from August 17, 1999 (inception) to
December 31, 2009, respectively.  The total intrinsic value of the
32,000 options exercised during the year ended December 31, 2009 was
$62,910.  The options were exercised pursuant to cashless exercise
provisions of the options and no cash was received by the Company.




(15)
            Related
      Parties




The
Company considers its directors, executives and beneficial shareholders of more
than five percent of its common stock to be related parties.  During
the years ended December 31, 2009 and 2008, the following significant
transactions were made between the Company and those parties that were related
parties at the time of each transaction:




From
March 1, 2007 to January 31, 2009, the Company rented executive offices within
the offices of a former Company director, Mr. Alex Nazarenko.  Our
rental cost for these offices was approximately $2,129 per month, which is the
market price for similar office space in Minneapolis, Minnesota.




On
February 28, 2008, director Robert Rudelius acquired $10,000 of the units sold
in the 2008 Private Placement.




On
April 3, 2008, in connection with the Company’s purchase of the Profile
Assets, the Company borrowed an aggregate of $112,500 pursuant to three
promissory notes each in the amount of $37,500. The promissory notes were issued
in favor of James Davis, William Reiling and the Phillips W. Smith Family Trust
(the “Smith Trust”), then each greater than five percent
shareholders.  On September 12, 2008, these three promissory
notes were amended to extend their due dates to the earlier of seven days
following the close of an underwritten public offering or December 31,
2008, and to give the holders an option to convert their notes into shares of
our common stock at a conversion price equal to 70 percent of the price of the
Units sold in such offering.




On
September 16, 2008, Mr. Davis agreed to purchase $100,000 of the puts
pursuant to the 2008 Unit Put Arrangement.  On September 24,
2008, the Company closed on $50,000 of Mr. Davis’ put commitment, and
issued a $47,500 convertible note and a warrant to acquire 10,000 shares of our
common stock at an exercise price of $1.00 per share. On October 28, 2008,
the Company closed on the remaining $50,000 of Mr. Davis’ put commitment,
and issued a $47,500 convertible note and a warrant to acquire 10,000 shares of
our common stock at an exercise price of $1.00 per share.




On
September 25, 2008, the Company borrowed $150,000 pursuant to a promissory
note issued in favor of Mr. Davis and used the proceeds to retire the $150,000
principal amount of the Profile Note (see Note 12(d)). As consideration for
providing the loan, the Company issued an immediately exercisable, five-year
warrant to purchase 100,000 shares of our common stock at $1.50 per share to
Mr. Davis.


F-45




On
January 15, 2009, the Company repaid an outstanding $37,500 loan along with
accrued interest thereon to Mr. Reiling.




On March
19, 2009, pursuant to the guaranties received relating to the Company’s renewal
of its $1,200,000 Crown Bank promissory note, the Company issued an aggregate
133,334 shares of its common stock as consideration to Mr. Davis and Mr.
Reiling, and will issue a further 11,111 shares to each per month for each month
the notes remain outstanding after August 31, 2009.




On March
19, 2009, a $37,500 convertible promissory note and a $150,000 convertible
promissory note due to Mr. Davis were refinanced and combined with other loans
and advances on behalf of the Company from Mr. Davis into a $281,000 convertible
promissory note.  On May 26, 2009, Mr. Davis exercised his conversion
rights under the promissory note and the note was converted into 510,909 shares
of the Company’s common stock (see Note 12).




On April
13, 2009, the Company issued an aggregate of 27,366 shares of its common stock
to its non-employee directors as payment of $20,250 directors’ fees accrued
through December 31, 2008, in lieu of cash.




On
September 1, 2009, the Company borrowed $26,000 from Mr. Smith for working
capital purposes.  On November 6, 2009, the entire amount due to Mr.
Smith was applied toward his exercise of warrants tendered in the Replacement
Warrant Offering.  Although no promissory note was issued, on November
6, 2009, the Company issued 925 shares of its common stock valued at $1,322 to
Mr. Smith as consideration for making the loan and in lieu of cash
interest.




Between
May 1, 2009 and September 16, 2009, Mr. Davis made various payments for the
benefit of the Company and provided the Company with certain cash advances
totaling approximately $243,000.  On September 21, 2009, Mr. Davis and
the Company executed the Davis Note.  Upon execution of the Davis
Note, the Company agreed, as consideration for making the payments and advances
represented by the Davis Note, to issue to Mr. Davis 19,833 shares of its common
stock and to accrue for future issuance to Mr. Davis 2,700 shares of common
stock for each month (or portion thereof) that the Davis Note is outstanding
after March 21, 2010.  In addition, under the terms of the Davis Note,
the Company will accrue for issuance to Mr. Davis in lieu of cash interest,
1,618 shares of its common stock for each month (or portion thereof) that the
principal amount of the Davis Note is outstanding.  All of the shares
accrued for issuance to Mr. Davis will be issued upon repayment of the Davis
Note.  The Davis Note matures on March 28, 2011. The promissory note
provides Mr. Davis with a subordinated security interest in the Company’s
assets.




In total,
amounts expensed for related party interest and related party debt
extinguishment costs were $311,230 and $347,820,  respectively, during
the year ended December 31, 2009, $908,486 and $48,214,  respectively,
during the year ended December 31, 2008, and $1,659,223 and
$422,862,  respectively, during the period from August 17, 1999
(inception) to December 31, 2009.




(16)
            Subsequent
      Events




Between
      February 3, 2010 and March 2, 2010, holders of 249,970 warrants to
      purchase the Company’s common stock exercised their warrants resulting in
      proceeds to the Company of
$321,761.




On March
15, 2010, the Company issued 769,231 shares of common stock to Artann pursuant
to the Development and Commercialization Agreement (see Note 7).  The
$1,565,230 value of the shares was recorded as research and development expense
during the year ended December 31, 2009.




On March
26, 2010, the Company converted its $600,000 loan from an individual lender and
$97,546 of accrued interest thereon into 381,173 shares of the Company’s common
stock and 381,173 warrants to purchase the Company’s common
stock.  The immediately exercisable warrants had a three-year term, an
exercise price of $1.83 per share and a cashless exercise
provision.  The lender immediately elected to exercise the warrants,
and the Company issued 102,154 shares of stock to the lender pursuant to the
cashless exercise. The Company will recognize debt extinguishment expense of
$870,981 in March 2010, representing the excess fair value of the securities
issued over the carrying value of the debt and interest. Upon the termination of
the loan upon conversion to equity, the company issued to the individual lender
66,666 shares of common stock as consideration pursuant to the original terms of
the loan (see Notes 10 and 14(g)).


F-46





On March
26, 2010, the maturity dates of the Company’s $1.3 million of Crown Bank
promissory notes were extended to April 28, 2010 with no changes to other
existing note terms (see Note 11).


F-47


ITEM
      9:
            CHANGES
      IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
      DISCLOSURE





None.





ITEM
      9A(T):
            CONTROLS
      AND PROCEDURES





Disclosure
Controls and Procedures





We
maintain disclosure controls and procedures designed to ensure that information
required to be disclosed in our reports filed or submitted under the Exchange
Act is recorded, processed, summarized and reported within the time periods
specified in the rules and forms of the Securities and Exchange Commission. As
of December 31, 2009, the end of the period covered by this Annual Report on
Form 10-K, we carried out an evaluation, under the supervision and with the
participation of management, including our Chief Executive Officer and Chief
Financial Officer, of the effectiveness of the design and operation of our
disclosure controls and procedures pursuant to Exchange Act Rule 13a-15. Based
upon that evaluation, our Chief Executive Officer and Chief Financial Officer
concluded that our disclosure controls and procedures were
effective.




Management’s
Annual Report on Internal Control Over Financial Reporting




The
financial statements, financial analyses and all other information included in
this Annual Report on Form 10-K were prepared by the Company’s management, which
is responsible for establishing and maintaining adequate internal control over
financial reporting.




The
Company’s internal control over financial reporting is designed to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles. The Company’s internal control over
financial reporting includes those policies and procedures that:




·
            pertain
      to the maintenance of records that, in reasonable detail, accurately and
      fairly reflect the transactions and dispositions of the assets of the
      Company;




·
            provide
      reasonable assurance that transactions are recorded as necessary to permit
      preparation of financial statements in accordance with generally accepted
      accounting principles, and that receipts and expenditures of the Company
      are being made only in accordance with authorizations of management and
      directors of the Company; and




·
            provide
      reasonable assurance regarding prevention or timely detection of
      unauthorized acquisition and use or disposition of the Company’s assets
      that could have a material effect on the financial
    statements.




There are
inherent limitations in the effectiveness of any internal control, including the
possibility of human error and the circumvention or overriding of controls.
Accordingly, even effective internal controls can provide only reasonable
assurances with respect to financial statement preparation. Further, because of
changes in conditions, the effectiveness of internal controls may vary over
time.




Management
assessed the design and effectiveness of the Company’s internal control over
financial reporting as of December 31, 2009. In making this assessment,
management used the criteria set forth by the Committee of Sponsoring
Organizations of the Treadway Commission inInternal Control—Integrated
Framework. Based on management’s assessment using this framework, it
believes that, as of December 31, 2009, the Company’s internal control over
financial reporting is effective.




This
Annual Report on Form 10-K does not include an attestation report of the
Company’s independent registered public accounting firm regarding internal
control over financial reporting.  Management’s report was not subject
to attestation by the Company’s independent registered public accounting firm
pursuant to temporary rules of the Securities and Exchange Commission that
permit the Company to provide only management’s report in this Annual Report on
Form 10-K.




Changes
in Internal Control Over Financial Reporting




During
the quarter ended December 31, 2009, there has been no change in the Company’s
internal control over financial reporting (as defined in Rule 13a-15(f) under
the Exchange Act) that has materially affected, or is reasonably likely to
materially affect, the Company’s internal control over financial
reporting.


34





ITEM
      9B:
            OTHER
      INFORMATION





None.







PART III





ITEM
      10:
              DIRECTORS,
      EXECUTIVE OFFICERS AND CORPORATE
GOVERNANCE




Directors
and Executive Officers




The
following information sets forth the names of our executive officers and
directors, their ages and their present positions with the Company as of March
1, 2010. The directors serve for a term of one year or until the next annual
meeting of the shareholders. Each officer serves at the discretion of the Board
of Directors.




Name
                          
                          Age
                          
                          PositionRichard
      C. Carlson
                          
                          58
                          
                          Chief
      Executive Officer and Acting Chairman of the BoardMichael
      Chambers
                          
                          55
                          
                          DirectorJames
      L. Davis
                          
                          65
                          
                          DirectorDavid
      F. Koenig
                          
                          69
                          
                          DirectorRobert
      J. Rudelius
                          
                          54
                          
                          DirectorScott
      E Smith
                          
                          54
                          
                          DirectorRichard
      B. Thon
                          
                          54
                          
                          Chief
      Financial
Officer





Richard C. Carlson, Chief
Executive Officer, Director since 2006 and Acting Chairman of the Board since
2007.  Mr. Carlson was hired as our Vice President of Marketing and
Sales in January 2005, and was promoted to Chief Executive Officer in November
2006.  Prior to joining the Company, Mr. Carlson held several
positions with SurModics, Inc., a company that provides surface modification
solutions for medical device and biomedical applications, from 1998 to 2004,
including Vice President of Marketing and Sales and Vice President of Strategic
Planning.




Mr.
Carlson’s extensive experience marketing urology products with American Medical
Systems and Boston Scientific is invaluable in developing market strategies for
the Company’s products.




Michael Chambers, JD, Ph.D.
Elected Director on March 1, 2010.  Dr. Chambers currently serves as
President and CEO of Swift Biotechnology, a company he co-founded in January
2010. Swift is commercializing early diagnostics for gynecological cancers
through technology invented at the Mitchell Cancer Institute.  From
1999 through 2005, Dr. Chambers served as President and CEO of InnoRx
Pharmaceuticals, a privately-held company specializing in drugs and drug
delivery systems for ophthalmic diseases that he helped establish. He is also
"of Counsel" to the law firm of Cabaniss Johnston, based in Birmingham,
Alabama.  Dr. Chambers is a member of the Nominating and Governance
Committee.




Dr.
Chambers experience as an attorney, angel investor and medical products
entrepreneur helps the Board address key issues it faces in intellectual
property matters and global expansion opportunities.




James L. Davis. Elected
Director on March 1, 2010.  Mr. Davis is the President of Davis &
Associates, Inc. which he founded more than 30 years ago. Davis & Associates
represents the leading edge lighting and controls manufacturers, providing
lighting and controls solutions for customers in the upper
Midwest.  Mr. Davis is a member of the Compensation
Committee.


35




Mr. Davis
brings to the Board extensive experience as a successful independent business
owner and an active investor in entrepreneurial companies. He has served as
Director on both private and public company Boards over the last 20
years.




David F. Koenig, Director
since 2004.   Mr. Koenig served as a director of our predecessor
company, ProUroCare Inc. (“PUC”), from 1999 until April 2004, when he became a
director of the Company upon the merger of PUC with an acquisition subsidiary of
the Company (the “Merger”).  From 1996 to 2005, Mr. Koenig was the
Executive Vice President and Chief Operating Officer of Solar Plastics, Inc., a
manufacturer of custom rotationally molded plastic parts.  Mr. Koenig
is Chairman of the Compensation Committee.




Mr.
Koenig has valuable experience in raising funds with both private and
institutional investors, in commercial banking relationships and deal
structuring and in strategic business planning. All of these functions are of
particular importance to the Company at its current stage.




Robert J. Rudelius, Director
since 2007.  Since 2003, Mr. Rudelius has been the Managing Director
and CEO of Noble Ventures, LLC, a company he founded, providing advising and
consulting services to early-stage companies in the information technology,
renewable energy and loyalty marketing fields.  Mr. Rudelius is also
the Managing Director and CEO of Noble Logistics, LLC, a holding company he
founded in 2002 to create, acquire and grow a variety of businesses in the
freight management, logistics and information technology
industries.  Mr. Rudelius is the Chairman of the Nominating and
Governance Committee and is a member of the Audit Committee.




Mr.
Rudelius' experience launching several new ventures combined with 25 years of
experience leading information technology companies and consulting
on IT/systems matters for global companies provides a valued
perspective to the Board.




Scott E Smith, Director since
2006. Mr. Smith currently provides consulting to best-in-class companies to help
them grow rapidly and profitably. He was previously employed by F-2 Intelligence
Group (“F2”), a company engaged in providing critical insights to multinational
corporations and private equity clients on a broad range of strategic issues.
From 2004 to 2008, Mr. Smith served as F2’s Regional Director of Sales for
Private Equity, where he advised private equity firms on market and competitive
intelligence issues. Prior to joining F2, Mr. Smith was employed by Arthur
Andersen for 23 years and served the last 10 years as an audit
partner.  Mr. Smith also serves on the board of directors and chairs
the audit committee of Table Trac, Inc.  Mr. Smith is a Certified
Public Accountant and a Certified Management Accountant. Mr. Smith is Chairman
of the Audit Committee and a member of the Compensation Committee.




Mr.
Smith’s expertise gained through 23 years of experience in public accounting
(including 10 years as an audit partner at Arthur Andersen) is invaluable to the
Company.  Mr. Smith provides leadership and guidance on the Company’s
accounting and financial reporting issues.




Richard B. Thon, Chief
Financial Officer.  Mr. Thon has been our Chief Financial Officer
since 2004.




There are
no family relationships among our executive officers or directors.




Audit
Committee




Our Board
of Directors has established a two-member Audit Committee that currently
consists of Messrs. Smith, the Chairman, and Rudelius.  Mr. Koenig was
a member of the Audit committee during all of 2009 and through March 1, 2010.
The Board of Directors has adopted a written charter for the Audit Committee,
which is available on our website www. prourocare.com.




The board
of directors has determined that Mr. Smith is an “audit committee financial
expert” as that term is defined in Item 407(d)(5) of Regulation S-K promulgated
under the Exchange Act.  Mr. Smith was an Audit Partner for Arthur
Andersen and is a Certified Public Accountant and a Certified Management
Accountant.  Both members of the Audit Committee qualify as
“independent directors,” as such term is defined in Section 5000(a)(19) of the
NASDAQ listing standards.  Moreover, the board of directors has
determined that each of the Audit Committee members is able to read and
understand fundamental financial statements.


36







Code of Ethics Disclosure
Compliance




On
February 15, 2005, our Board of Directors adopted a Code of Ethics for Financial
Executives, which includes our Company’s principal executive officer, principal
financial officer, principal accounting officer or controller, or persons
performing similar functions, as required by Sections 406 and 407 of the
Sarbanes-Oxley Act of 2002.  Our Code of Ethics is available on our
website www.prourocare.com, and we will provide a copy, without charge, to any
shareholder upon written request to Dick Thon, ProUroCare Medical Inc., 6440
Flying Cloud Drive, Suite 101, Eden Prairie, MN  55344.





Section 16(a) Beneficial
Ownership Reporting Compliance




The rules
of the Securities and Exchange Commission require our directors, executive
officers and holders of more than 10 percent of our common stock to file reports
of stock ownership and changes in ownership with the Securities and Exchange
Commission.  Based on the Section 16 reports filed by our directors,
executive officers and greater than 10 percent beneficial owners and written
representations of our directors and executive officers, we believe there were
no late or inaccurate filings for transactions occurring during fiscal 2009,
except as follows:




Name
                            
                            NumberofLateReports
                            
                            NumberofTransactions
                              ReportedLateDavid
      Koenig
                            
                            1
                            
                            1Robert
      Rudelius
                            
                            1
                            
                            1Scott
      Smith
                            
                            1
                            
                            1James
      Davis
                            
                            1
                            
                            1





ITEM
11:  EXECUTIVE COMPENSATION





Summary
Compensation Table




The
following table sets forth the compensation earned for services rendered in all
capacities by our Chief Executive Officer and Chief Financial Officer. There
were no other executive officers or other individuals who earned more than
$100,000 during 2009. The individuals named in the table will be hereinafter
referred to as the “Named Executive Officers.”




Summary
Compensation Table




Name and
                              Position
                            
                            Year
                            
                            Salary
                                ($)
                            
                            
                            Bonus
                                ($)
                            
                            
                            Option
                                Awards
                                ($)(3)
                            
                            
                            All Other
                                Compensa-
                                tion
                                ($)(4)
                            
                            
                            Total
                                ($)Richard
      Carlson(1)
                            
                            2009
                            
                            $
                            150,000
                            
                            
                            $
                            20,000
                            
                            
                            $
                            249,700
                            
                            
                            $
                            2,107
                            
                            
                            $
                            421,807Chief
      Executive Officer
                            
                            2008
                            
                            $
                            150,000
                            
                            
                            $
                            —
                            
                            
                            $
                            58,900
                            
                            
                            $
                            2,103
                            
                            
                            $
                            231,003and
      Acting Chairman of the BoardRichard
      Thon(2)
                            
                            2009
                            
                            $
                            133,015
                            
                            
                            $
                            20,000
                            
                            
                            $
                            103,200
                            
                            
                            $
                            8,185
                            
                            
                            $
                            264,400Chief
      Financial Officer
                            
                            2008
                            
                            $
                            136,375
                            
                            
                            $
                            —
                            
                            
                            $
                            29,150
                            
                            
                            $
                            4,825
                            
                            
                            $
                            170,350





(1)
            All
      compensation Mr. Carlson earned is related to his duties as an
      officer.  See “Executive Compensation—Employment Agreements” for
      the terms of Mr. Carlson’s current employment arrangements with
      us.




(2)
            See
      “Executive Compensation—Employment Agreements” for the terms of Mr. Thon’s
      current employment arrangements with
us.




(3)
            The
      amount in the Option Awards column represents the aggregate grant date
      fair value computed in accordance with Financial Accounting Standards
      Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718 for
      stock options granted during the fiscal years ended December 31, 2009 and
      2008, as determined using the Black-Scholes pricing model. See
      Notes 1(f) and 7(b) to the Consolidated Financial Statements for the
      fiscal year ended December 31, 2008 included in Part II, Item 8 of
      our Annual Report on Form 10-K for the fiscal year ended December 31, 2008
      and Notes 1(i) and 15(j) to the Consolidated Financial Statements for the
      fiscal year ended December 31, 2009 included in Part II, Item 8 of this
      Annual Report on Form 10-K for the material terms of stock option
      grants.


37




(4)
            Other
      compensation represents insurance premiums paid by us with respect to term
      life insurance and long-term care polices for the benefit of the
      executive. There is no cash surrender value associated with the
      policies.




Outstanding
Equity Awards at December 31, 2009




No stock
options or stock-appreciation rights were exercised by our Named Executive
Officers during fiscal 2009, and no stock appreciation rights were outstanding
at the end of fiscal 2009. The table below sets forth outstanding but
unexercised options of our Named Executive Officers as of December 31,
2009.




Name
                                  
                                  Number of
                                      Securities
                                      Underlying
                                      Unexercised
                                      Options
                                      (#)
                                      Exercisable(1)
                                  
                                  
                                  Number of
                                      Securities
                                      Underlying
                                      Unexercised
                                      Options
                                      (#)
                                      Unexercisable(1)
                                  
                                  
                                  Equity Incentive
                                      Plan Awards:
                                      Number of
                                      Securities
                                      Underlying
                                      Unexercised
                                      Unearned
                                      Options
                                      (#)
                                  
                                  
                                  Option
                                      Exercise
                                      Price
                                  
                                  Option Expiration
                                      DateRichard
      Carlson
                                  
                                  
                                  10,000
                                  
                                  
                                  
                                  —
                                  
                                  
                                  
                                  —
                                  
                                  
                                  $
                                  5.00
                                  
                                  February
      1, 201730,000
                                  
                                  
                                  
                                  40,000
                                  (2)
                                  
                                  
                                  —
                                  
                                  
                                  $
                                  1.00
                                  
                                  July
      11, 201590,000
                                  
                                  
                                  
                                  10,000
                                  (3)
                                  
                                  
                                  —
                                  
                                  
                                  $
                                  0.85
                                  
                                  March
      3, 2016—
                                  
                                  
                                  
                                  —
                                  
                                  
                                  
                                  150,000
                                  (4)
                                  
                                  $
                                  1.50
                                  
                                  September
      29, 2016Richard
      Thon
                                  
                                  
                                  —
                                  
                                  
                                  
                                  —
                                  
                                  
                                  
                                  5,000
                                  (5)
                                  
                                  $
                                  7.50
                                  
                                  March 1,
      20113,000
                                  
                                  
                                  
                                  —
                                  
                                  
                                  
                                  —
                                  
                                  
                                  $
                                  11.33
                                  
                                  April 18,
      201218,333
                                  
                                  
                                  
                                  16,667
                                  (6)
                                  
                                  
                                  —
                                  
                                  
                                  $
                                  1.00
                                  
                                  July
      11, 201545,000
                                  
                                  
                                  
                                  —
                                  
                                  
                                  
                                  —
                                  
                                  
                                  $
                                  0.85
                                  
                                  March
      3, 2016—
                                  
                                  
                                  
                                  —
                                  
                                  
                                  
                                  60,000
                                  (4)
                                  
                                  $
                                  1.50
                                  
                                  September
      29,
2016





(1)
            See
      Notes 1(i) and 14(j) to the Consolidated Financial Statements for the
      fiscal year ended December 31, 2009 included in Part II, Item 8 in
      this Annual Report on Form 10-K for the material terms of stock option
      grants.




(2)
            20,000
      shares will vest on July 1 of each of 2010 and
  2011.




(3)
            Vested
      January 1, 2010.




(4)
            Equity
      Incentive Plan awards will vest upon the latter of (i) the Company
      securing FDA market clearance of its ProUroScan System and (ii) the date
      that the Company closes on an aggregate of $2.0 million or more of
      incremental equity financing after the date of
  grant.




(5)
            Equity
      Incentive Plan Award that will vest upon the Company securing FDA market
      clearance of its ProUroScan System.




(6)
            8,333
      shares will vest on July 1, 2010 and 8,334 shares on July 1,
      2011.




Director
Compensation




During
2009, each of our non-employee directors received an annual payment of $10,000
for services to the Company. The chairpersons of our Compensation, Audit and
Nominating and Governance committees received an additional annual payment of
$2,500 and each committee member received an annual payment of $1,000 per
committee. In addition, we granted to all non-employee directors a one-time
non-qualified stock option upon election or appointment to the Board of
Directors to purchase 3,000 shares of our common stock at fair market value that
vested ratably over two years of service.  We also granted immediately
vesting options to purchase 1,000 shares of our common stock at fair market
value to each director upon their annual re-election to the
Board.


38




Effective
January 1, 2010, in addition to the annual payment of $10,000 for services to
each of our non-employee directors, the chairpersons of our Compensation and
Nominating and Governance Committees will receive $750 per committee meeting up
to a maximum of $3,000 per year.  Non-chair committee members of those
committees will receive $500 per meeting, up to an annual maximum of
$2,000.  The chairperson of the Audit Committee will receive $750 per
committee meeting, up to a maximum of $6,000 per year, while other members of
the Audit Committee will receive $500 per meeting up to a maximum of $4,000 per
year.  In addition, non-employee directors will receive non-qualified
stock options upon election or appointment to the Board of Directors, and
annually thereafter, to purchase a number of shares equal to $25,000 divided by
the then current stock price.  The initial grant will vest ratably
over two years of service, while subsequent annual grants will vest
immediately.




On March
3, 2009, the Company granted non-qualified stock options to Mr. Koenig (30,000
options), Mr. Smith (20,000 options) and Mr. Rudelius (20,000
options).  The options are fully vested and are exercisable for a
period of seven years at an exercise price of $0.85 per share.  On
September 29, 2009, the Company issued non-qualified stock options to Mr. Koenig
(50,000 options), Mr. Smith (30,000 options) and Mr. Rudelius (30,000
options).  The options expire seven years from the date of issuance,
are exercisable at $1.50 per share and vest upon the latter of the date that the
Company is cleared by the FDA to sell its ProUroScan System in the United States
or the date that the Company closes on an aggregate of $2.0 million or more of
incremental financing after the date of grant, including financing received upon
the exercise of existing warrants.




Directors
are reimbursed for travel and other out-of-pocket expenses incurred in
connection with attendance at meetings of the Board of Directors and its
committees.




The table
below sets forth director compensation earned during 2009:




Name
                    
                    Fees Earned
                        or Paid in
                        Cash
                        ($)
                    
                    
                    Stock
                        Awards(4)
                        ($)
                    
                    
                    Option
                        Awards(5)
                        ($)
                    
                    
                    Total
                        ($)David
      Koenig(1)
                    
                    $
                    7,250
                    
                    
                    $
                    7,250
                    
                    
                    $
                    81,900
                    
                    
                    $
                    96,400Scott
      Smith(2)
                    
                    $
                    12,500
                    
                    
                    $
                    0
                    
                    
                    $
                    50,900
                    
                    
                    $
                    63,400Robert
      Rudelius(3)
                    
                    $
                    13,500
                    
                    
                    $
                    0
                    
                    
                    $
                    50,900
                    
                    
                    $
                    64,400





(1)
            Chairman
      of the Compensation Committee.




(2)
            Chairman
      of the Audit Committee.




(3)
            Chairman
      of the Nominating and Governance
Committee.




(4)
            On
      September 29, 2009, we issued a total of 4,834 shares of our common stock
      to Mr. Koenig in lieu of $7,250 cash as payment of directors’ fees earned
      in 2009, based on the average of the closing bid and asked price on that
      date as quoted by the OTCBB.  Not included in the 2009
      compensation are 27,366 shares of common stock issued to our directors in
      lieu of cash as payment for $20,251 of directors’ fees earned in
      2008.




(5)
            The
      amount in the Option Awards column represents the aggregate grant date
      fair value computed in accordance with FASB ASC Topic 718 for stock
      options granted during the fiscal years ended December 31, 2009 as
      determined using the Black-Scholes pricing model. See Notes 1(i) and
      14(j) to the Consolidated Financial Statements for the fiscal year ended
      December 31, 2009 included in Part II, Item 8 of this Annual Report
      on Form 10-K for the material terms of stock option grants.  As
      of December 31, 2009, Mr. Koenig held 53,000 stock options and Mr. Smith
      and Mr. Rudelius each held 55,000
options.




Employment
Agreements




On
July 16, 2008, we entered into an employment agreement with
Mr. Carlson, our Chief Executive Officer. The agreement provided for a
minimum annual salary of $150,000, a cash incentive bonus potential of up to
40 percent of Mr. Carlson’s base pay, and eligibility to participate
in an annual grant of options to purchase shares of common stock, as determined
by our board of directors. Mr. Carlson’s agreement expired on December 31,
2009.


39




On
July 21, 2007, we entered into an employment agreement with our Chief
Financial Officer, Richard Thon. The agreement provided for a minimum annual
salary of $140,000, a cash incentive bonus potential of up to 30 percent of
Mr. Thon’s base pay and eligibility to participate in an annual grant of
options to purchase shares of common stock, as determined by our Board of
Directors. Mr. Thon’s agreement  expired on June 30,
2009.




ITEM
      12:
            SECURITY
      OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
      STOCKHOLDER MATTERS





The
following table sets forth certain information regarding beneficial ownership of
our common stock as of March 26, 2010, by (i) each person known by us to be the
beneficial owner of more than five percent of the outstanding common stock, (ii)
each director of the Company, (iii) each executive officer of the Company and
(iv) all executive officers and directors as a group.





The
number of shares beneficially owned is determined under rules promulgated by the
SEC and the information is not necessarily indicative of beneficial ownership
for any other purpose.  The definition of beneficial ownership for
proxy statement purposes includes shares over which a person has sole or shared
voting power or dispositive power, whether or not a person has any economic
interest in the shares. The definition also includes shares that a person has a
right to acquire currently or within 60 days of March 26,
2010.  Including those shares in the tables does not, however,
constitute an admission that the named stockholder is a direct or indirect
beneficial owner of those shares.  Unless otherwise indicated, each
person or entity named in the table has sole voting power and investment power
(or shares that power with that person’s spouse) with respect to all shares of
common stock listed as owned by that person or entity.  Unless
otherwise indicated, the address of each of the following persons is 6440 Flying
Cloud Drive, Suite 101, Eden Prairie, MN 55344.





Name
                    
                    Shares
                      Beneficially Owned
                    
                    
                    Percent of ClassRichard
      C. Carlson(1)
                    
                    
                    130,850
                    
                    
                    
                    1.0Michael
      Chambers(2)
                    
                    
                    197,642
                    
                    
                    
                    1.5James
      L. Davis (3)
                    
                    
                    3,042,914
                    
                    
                    
                    21.6David
      F. Koenig(4)
                    
                    
                    107,363
                    
                    
                    
                    *Robert
      J. Rudelius(5)
                    
                    
                    164,815
                    
                    
                    
                    1.3Scott
      E Smith(6)
                    
                    
                    211,067
                    
                    
                    
                    1.6Richard
      B. Thon(7)
                    
                    
                    66,333
                    
                    
                    
                    *All
      directors and officers as a group (7 total)(8)
                    
                    
                    3,920,984
                    
                    
                    
                    27.0Armen
      Sarvazyan(9)(10)
                    
                    
                    1,077,485
                    
                    
                    
                    8.3Phillips
      W. Smith Family Trust(11)(12)
                    
                    
                    683,522
                    
                    
                    
                    5.3





*Less
than one percent.




(1)
            Includes
      direct holdings of 850 shares of common stock and currently exercisable
      options to purchase 130,000 shares of common
  stock.




(2)
            Includes
      direct holdings of 113,000 shares of common stock, currently exercisable
      options to purchase 866 shares of common stock and currently exercisable
      warrants to purchase 83,776 shares of common
  stock.




(3)
            Includes
      the following directly held shares and immediately exercisable warrants
      and convertible notes: 1,739,210 shares of common stock, 66,666 shares of
      stock issuable pursuant to loan guarantees within 60 days, currently
      exercisable options to purchase 866 shares of common stock and warrants to
      purchase 989,530 shares of common stock.  Shares beneficially
      owned also include the following shares and immediately exercisable
      warrants held by Davis & Associates Inc., 401K PSP, of which
      Mr. Davis has sole voting power: 74,964 shares of common stock and
      warrants to purchase 91,014 shares of common stock.  Shares
      beneficially owned also include the following shares and immediately
      exercisable warrants held by Davis & Associates Inc., of which
      Mr. Davis has sole voting power: 37,482 shares of common stock and
      warrants to purchase 43,182 shares of common
  stock.




(4)
            Includes
      direct holdings of 75,916 shares of common stock held directly and
      currently exercisable options to purchase 3,000 shares of common stock.
      Also includes 1,875 shares held by Clinical Network Management Corp. and
      26,572 shares held by Clinical Network, Inc. with respect to each of which
      Mr. Koenig is an officer and minority
owner.


40




(5)
            Includes
      direct holdings of 64,317 shares of common stock, warrants to purchase
      33,986 shares of common stock and currently exercisable options to
      purchase 25,000 shares of common stock.  Also includes 24,756
      shares of common stock and currently exercisable warrants to purchase
      16,756 share of common stock held by Nobel Ventures, of which Mr. Rudelius
      is an officer and the managing
director.




(6)
            Includes
      direct holdings of 126,592 shares of common stock, warrants to purchase
      59,475 shares of common stock and currently exercisable options to
      purchase 25,000 shares of common
stock.




(7)
            Includes
      currently exercisable directly held options to purchase 66,333 shares of
      common stock.




(8)
            Includes
      Messrs. Carlson, Chambers, Davis, Koenig, Rudelius, Smith and
      Thon.




(9)
            The
      address of Dr. Sarvazyan is 1753 Linvale Harbourton Rd., Lambertville, NJ
      08530.




(10)
            Includes
      direct holdings of 937,099 shares of common stock.  Also
      includes 122,386 shares of common stock and currently exercisable warrants
      to purchase 18,000 shares of common stock held by Artann Laboratories
      Inc., of which Dr. Sarvazyan is an officer and minority
    owner.




(11)
            The
      address of the Phillips W. Smith Family Trust is 5636 E. Mockingbird Lane,
      Paradise Valley, AZ 85253.




(12)
            Shares
      beneficially owned include 613,199 directly held shares and immediately
      exercisable warrants to purchase 70,323
shares.




Securities Authorized for
Issuance under Equity Compensation Plans


as of Last Fiscal Year
(December 31, 2009)





Number of Securities to
                        be Issued Upon Exercise
                        of Outstanding Options,
                        Warrants and Rights
                      
                      
                      Weighted-Average
                        Exercise Price of
                        Outstanding Options,
                        Warrants and Rights
                      
                      
                      Number of Securities
                        Remaining Available
                        for Issuance Under
                        Equity Compensation
                        Plans (excluding
                        securities reflected in
                        column (a))(a)
                      
                      
                      (b)
                      
                      
                      (c)Equity
      compensation plans approved by stockholders (1)
                      
                      
                      840,500
                      
                      
                      $
                      3.01
                      
                      
                      
                      617,500Equity
      compensation plans not approved by stockholders (2)
                      
                      
                      1,763,982
                      
                      
                      $
                      2.07
                      
                      
                      
                      —Total
                      
                      
                      2,604,482
                      
                      
                      $
                      2.37
                      
                      
                      
                      617,500








(1)
            Includes
      shares of our common stock issuable pursuant to options granted under our
      2002, 2004 and 2009 Plans (as defined
below).


(2)
            Consists
      of warrants issued to vendors, consultants, lenders and loan
      guarantors.




The Board
of Directors adopted the ProUroCare Inc. 2002 Stock Plan (the “2002 Plan”), the
ProUroCare Inc. 2004 Stock Option Plan (and the “2004 Plan”) and the ProUroCare
Inc. 2009 Stock Plan (the “2009 Plan”) to provide a means by which our
employees, directors, officers and consultants may be given an opportunity to
purchase our stock, to assist in retaining the services of such persons, to
secure and retain the services of persons capable of filling such positions and
to provide incentives for such persons to exert maximum efforts for our
success.  Under the three Plans, we are able to grant incentive and
non-qualified options, stock appreciation rights, stock awards, restricted stock
awards and performance shares.  Incentive stock options granted under
the Plans are intended to qualify as “incentive stock options” within the
meaning of Section 422 of the Internal Revenue Code of 1986, as amended (the
“Code”).  Non-qualified stock options granted under the Plans will not
qualify as incentive stock options under the Code.  The Compensation
Committee of the board of directors determines the vesting provisions of
stock-based awards under the Plans on a case-by-case basis.  We
utilize the fair-value method of accounting for these options.  An
aggregate of $480,873, $44,745 and $2,122,645 of stock-based compensation
related to these options was recognized in the years ended December 31, 2009,
2008 and the period from August 17, 1999 to December 31, 2009,
respectively.


41




ITEM
      13:
            CERTAIN
      RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
      INDEPENDENCE




Upon the
January 7, 2009 effective date of the Company’s 2009 Public Offering,
convertible debentures and accrued interest in the amount of $239,222 were
automatically converted into 79,741 shares of our common stock for each of James
Davis and William Reiling.




Upon the
January 12, 2009 closing of the 2009 Public Offering, the following convertible
notes held by related parties were automatically converted into Units, each
consisting of one share of our common stock and one five-year warrant to
purchase common stock at $1.30 per share:




Related Party
                    
                    Amount of Convertible Debt and
                      Accrued Interest Converted
                    
                    
                    Units Received upon
                      ConversionJames
      Davis
                    
                    $
                    393,557
                    
                    
                    
                    652,182William
      Reiling
                    
                    $
                    52,474
                    
                    
                    
                    74,964Robert
      Rudelius
                    
                    $
                    31,318
                    
                    
                    
                    44,742Scott
      Smith
                    
                    $
                    36,732
                    
                    
                    
                    52,475




On
January 15, 2009, the Company repaid an outstanding $37,500 loan along with
accrued interest thereon to Mr. Reiling.




On
February 6, 2009, convertible debentures (and the accrued interest thereon) in
the amount of $98,114 held by Mr. Davis automatically converted into 140,163
shares of our common stock.




On March
19, 2009, pursuant to the guaranties received relating to the Company’s renewal
of its $1,200,000 Crown Bank promissory note, the Company issued an aggregate
66,667 shares of its common stock as consideration to each of Mr. Davis and Mr.
Reiling, and will issue a further 11,111 shares to each per month for each month
the notes remain outstanding after August 31, 2009.




On March
19, 2009, a $37,500 convertible promissory note and a $150,000 convertible
promissory note due to Mr. Davis were refinanced and combined with other loans
and advances on behalf of the Company from Mr. Davis in a $281,000 convertible
promissory note.  On May 26, 2009, Mr. Davis exercised his conversion
rights under the promissory note and the note was converted into 510,909 shares
of the Company’s common stock.




On April
13, 2009, the Company issued an aggregate of 27,366 shares of its common stock
to Mr. Koenig, Mr. Rudelius and Mr. Smith as payment of $20,251 directors’ fees
accrued through December 31, 2008, in lieu of cash.




On
September 1, 2009, the Company borrowed $26,000 from Mr. Smith for working
capital purposes.  On November 6, 2009, the entire amount due to Mr.
Smith was applied toward his exercise of warrants tendered in the Replacement
Warrant Offering.  On November 6, 2009, the Company issued 925 shares
of its common stock valued at $1,322 to Mr. Smith as consideration for making
the loan and in lieu of cash interest.




Between
May 1, 2009 and September 16, 2009, Mr. Davis made various payments for the
benefit of the Company and provided the Company with certain cash advances
totaling approximately $243,000.  On September 21, 2009, Mr. Davis and
the Company executed the Davis Note.  Upon execution of the Davis
Note, the Company agreed, as consideration for making the payments and advances
represented by the Davis Note, to issue to Mr. Davis 19,833 shares of its common
stock and to accrue for future issuance to Mr. Davis 2,700 shares of common
stock for each month (or portion thereof) that the Davis Note is outstanding
after March 21, 2010.  In addition, under the terms of the Davis Note,
the Company will accrue for issuance to Mr. Davis in lieu of cash interest,
1,618 shares of its common stock for each month (or portion thereof) that the
principal amount of the Davis Note is outstanding.  All of the shares
accrued for issuance to Mr. Davis will be issued upon repayment of the Davis
Note.  The Davis Note matures on March 28, 2011. The promissory note
provides Mr. Davis with a subordinated security interest in the Company’s
assets




Director
Independence




Each of
Messrs. Chambers, Koenig, Rudelius and Smith qualifies as an “independent
director,” as such term is defined in Section 5000(a)(19) of the NASDAQ listing
rules.  As an executive officer of the Company, Mr. Carlson does not
qualify as an “independent director.”  Our Board has determined that
due to his beneficial ownership of our securities, Mr. Davis does not qualify as
independent.


42





ITEM
14: PRINCIPAL ACCOUNTANT FEES AND SERVICES





Principal Accountant Fees
and Services




The
following is a summary of the fees billed to the Company by Baker Tilly Virchow
Krause, LLP (“Baker Tilly Virchow Krause”) for professional services rendered
for the fiscal years ended December 31, 2009 and 2008,
respectively:




Fee Category
                        
                        Fiscal 2009 Fees
                        
                        
                        Fiscal 2008 FeesAudit
      Fees
                        
                        $
                        77,041
                        
                        
                        $
                        91,021Tax
      Fees
                        
                        
                        2,060
                        
                        
                        
                        1,300All
      Other Fees
                        
                        
                        20,955
                        
                        
                        
                        44,790Total
      Fees
                        
                        $
                        100,056
                        
                        
                        $
                        137,111




Audit Fees. These consist of
fees billed by our auditors for professional services rendered for the audit of
our consolidated financial statements and review of the interim consolidated
financial statements included in quarterly reports.




Tax Fees. These consist of
fees billed by our auditors for professional services for tax compliance, tax
advice and tax planning.




All Other Fees. There consist
of fees billed by our auditors for professional services rendered for the review
of private placement memorandums and registration statement filings on Form S-1,
Form S-3 and Form S-8.





Preapproval
Policies





The
policy of our Audit Committee is to review and preapprove both audit and
non-audit services to be provided by the independent auditors (other than with
de minimus exceptions permitted by the Sarbanes-Oxley Act of
2002).  This duty may be delegated to one or more designated members
of the Audit Committee with any such approval reported to the committee at its
next regularly scheduled meeting.  Approval of non-audit services
shall be disclosed to investors in periodic reports required by Section 13(a) of
the Exchange Act.  100 percent of the fees paid to Baker Tilly Virchow
Krause were pre-approved as aforesaid.





No
services in connection with appraisal or valuation services, fairness opinions
or contribution-in-kind reports were rendered by Baker Tilly Virchow
Krause.  Furthermore, no work of Baker Tilly Virchow Krause with
respect to its services rendered to the Company was performed by anyone other
than Baker Tilly Virchow Krause.


43


PART
IV





ITEM
15:  EXHIBITS, FINANCIAL STATEMENT SCHEDULES





Exhibit No.
            
            Description2.1
            
            Agreement
      of Merger and Reorganization by and among Global Internet Communications,
      Inc., GIC Acquisition Co., and ProUroCare Inc. dated April 5, 2004
      (incorporated by reference to Exhibit 2.1 to our Current Report on Form
      8-K filed April 20, 2004).2.2
            
            Articles
      of Merger relating to the merger of GIC Acquisition Co., then a wholly
      owned subsidiary of the registrant with and into ProUroCare Inc., as filed
      with the Minnesota Secretary of State on April 5, 2004 (incorporated by
      reference to Exhibit 2.2 to our Current Report on Form 8-K filed April 20,
      2004).3.1
            
            Amended
      and Restated Articles of Incorporation of ProUroCare Medical Inc.
      (incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K
      filed August 17, 2009).3.2
            
            Amended
      and Restated Bylaws of ProUroCare Medical Inc. (incorporated by reference
      to Exhibit 3.2 to Annual Report on Form 10-KSB filed March 31,
      2005).4.1
            
            Warrant
      to acquire 300,000 shares of common stock of ProUroCare Medical Inc.,
      issued in favor of BINA Enterprises on April 5, 2004 (incorporated by
      reference to Exhibit 4.2 to Registration Statement on Form SB-2 filed
      August 3, 2004).4.2
            
            Form
      of Warrants issued to promissory note guarantors and a lender between
      September 14 and October 19, 2005 (incorporated by reference to Exhibit
      4.9 to Annual Report on Form 10-KSB filed March 31,
  2006).4.3
            
            Warrant
      to acquire 25,000 shares of common stock of ProUroCare Medical Inc. issued
      in favor of Adron Holdings, LLC, dated January 25, 2006 (incorporated by
      reference to Exhibit 10.7 to Current Report on Form 8-K filed January 31,
      2006).4.4
            
            Form
      of Warrant to acquire shares of common stock of ProUroCare Medical Inc.
      issued in favor of Roman Pauly and Maryjo Pauly (37,500 shares), Andrew
      Write (3,750 shares), Leslie Pearson (5,000 shares) and Roman Pauly
      (31,817 shares), dated between June 1, 2006 and October 24, 2008
      (incorporated by reference to Exhibit 10.7 to Current Report on Form 8-K
      filed June 6, 2006).4.5
            
            Form
      of Warrants to acquire an aggregate of 67,657 shares of common stock of
      ProUroCare Medical Inc. issued to the partners of Adron Holdings, LLC in
      connection with a $100,000 promissory note dated November 29, 2006,
      January 3, 2007, February 1, 2007, and January 16, 2008 (incorporated by
      reference to Exhibit 4.17 to Annual Report on Form 10-KSB filed March 30,
      2007).4.6
            
            Form
      of Warrants to acquire an aggregate of 68,740 shares of common stock of
      ProUroCare Medical Inc. issued in favor of subscribers of the Company’s
      $500,000 Investment Unit offering dated January 18, 2007, January 23,
      2007, February 28, 2007, and May 1, 2007 (incorporated by reference to
      Exhibit 4.18 to Annual Report on Form 10-KSB filed March 30,
      2007).4.7
            
            Amendment
      No. 1 to Warrant to acquire 300,000 shares of common stock of ProUroCare
      Medical Inc., originally issued in favor of BINA Enterprises on April 5,
      2004, dated April 5, 2007 (incorporated by reference to Exhibit 4.14 to
      Annual Report on Form 10-KSB filed March 31, 2008).4.8
            
            Form
      of Warrant issued pursuant to the Company’s 2007 Private Placement dated
      December 27, 2007 (incorporated by reference to Exhibit 4.16 to Annual
      Report on Form 10-KSB filed March 31, 2008).4.9
            
            Warrant
      issued to James Davis dated December 27, 2007 (incorporated by reference
      to Exhibit 4.17 to Annual Report on Form 10-KSB filed March 31,
      2008).4.10
            
            Form
      of Warrant issued pursuant to the Company’s 2008 Private Placement dated
      February 13, 2008 (incorporated by reference to Exhibit 4.18 to Annual
      Report on Form 10-KSB filed March 31, 2008).4.11
            
            Form
      of Warrants issued to William Reiling, James Davis, and the Phillips W.
      Smith Family Trust dated April 3, 2008 (incorporated by reference to
      Exhibit 4.1 to Quarterly Report on Form 10-Q filed May 8,
      2008).4.12
            
            Form
      of Origination Warrant issued pursuant to the Company’s Unit Put Agreement
      dated September 16, 2008 (incorporated by reference to Exhibit 4.22 to
      Registration Statement on Form S-1 filed September 19,
    2008).4.13
            
            Form
      of Put Warrant issued pursuant to the Company’s exercise of its put right
      pursuant to the Unit Put Agreement dated September 16, 2008 (incorporated
      by reference to Exhibit 4.23 to Registration Statement on Form S-1 filed
      September 19, 2008).4.14
            
            Warrant
      issued to James Davis dated September 25, 2008 (incorporated by reference
      to Exhibit 4.1 to Quarterly Report on Form 10-Q filed October 23,
      2008).4.15
            
            Form
      of Warrant issued to James Davis, Bruce Culver, William S. Reiling, and
      the Smith Family Trust, dated October 31, 2008 (incorporated by reference
      to Exhibit 4.25 to Amendment No. 1 to Registration Statement on Form S-1
      filed November 10, 2008).


44





Exhibit No.
            
            Description4.16
            
            Form of
      Underwriters Warrant Agreement (incorporated by reference to
      Exhibit 4.26 to Amendment No. 3 to Registration Statement on
      Form S-1 filed December 18, 2008).4.17
            
            Form
      of Warrants to acquire an aggregate of 20,000 shares of common stock of
      ProUroCare Medical Inc. issued in favor of Artann Laboratories and
      Vladimir Drits on April 16, 2007 (incorporated by reference to Exhibit
      4.18 to Registration Statement Form S-4/A filed October 16,
      2009).4.18
            
            Form
      of Warrants to purchase an aggregate of 7,295 shares of ProUroCare Medical
      Inc. common stock issued to Roman Pauly on October 24, 2008 and January
      12, 2009(incorporated by reference to Exhibit 4.19 to Registration
      Statement Form S-4/A filed October 16, 2009).4.19
            
            Warrant
      to purchase 28,656 shares of ProUroCare Medical Inc. common stock issued
      to the Phillips W. Smith Family Trust on January 20, 2009 (incorporated by
      reference to Exhibit 4.20 to Registration Statement Form S-4/A filed
      October 16, 2009).4.20
            
            Warrant
      to purchase 30,000 shares of ProUroCare Medical Inc. common stock issued
      to Kohnstamm Communications on August 6, 2009 (incorporated by reference
      to Exhibit 4.21 to Registration Statement Form S-4/A filed October 16,
      2009).4.21
            
            Form
      of Warrant Agreement between ProUroCare Medical Inc. and Interwest
      Transfer (incorporated by reference to Exhibit 4.27 to Amendment
      No. 3 to Registration Statement on Form S-1 filed
      December 18, 2008).4.22
            
            Specimen
      Warrant (incorporated by reference to Exhibit 4.28 to Amendment
      No. 3 to Registration Statement on Form S-1 filed
      December 18, 2008).4.23
            
            Form of
      Unit Certificate (incorporated by reference to Exhibit 4.29 to
      Amendment No. 3 to Registration Statement on Form S-1 filed
      December 18, 2008).4.24
            
            Form of
      Unit Agreement between ProUroCare Medical Inc. and Interwest Transfer
      (incorporated by reference to Exhibit 4.30 to Amendment No. 3 to
      Registration Statement on Form S-1 filed December 18,
      2008).4.25
            
            Form
      of First Amendment to Warrant Agreement between ProUroCare Medical Inc.
      and Interwest Transfer Company, Inc. (incorporated by reference to Exhibit
      4.3 to Registration Statement Form S-3 filed September 25,
      2009).4.26
            
            Specimen
      Replacement Warrant (incorporated by reference to Exhibit 4.4 to
      Registration Statement Form S-3 filed September 25,
  2009).4.27
            
            Warrant
      to acquire 381,173 shares of ProUroCare Medical Inc. common stock issued
      in favor of the Phillips W. Smith Family Trust on March 26, 2010 (filed
      herewith).10.1
      *
            
            ProUroCare
      Medical Inc. Amended and Restated 2002 Stock Plan (incorporated by
      reference to Exhibit 4.1 to Registration Statement on Form S-8
      filed March 31, 2008).10.2
      *
            
            ProUroCare
      Medical Inc. Amended and Restated 2004 Stock Option Plan
      (incorporated by reference to Exhibit 4.2 to Registration Statement
      on Form S-8 filed March 31, 2008).10.3
            
            Promissory
      Note issued in favor of the Phillips W. Smith Family Trust executed
      on October 31, 2007 effective as of October 15, 2007
      (incorporated by reference to Exhibit 10.35 to Annual Report on
      Form 10-KSB filed March 31, 2008).10.4
            
            Security
      Agreement issued in favor of the Phillips W. Smith Family Trust
      executed on October 31, 2007 effective as of October 15, 2007
      (incorporated by reference to Exhibit 10.36 to Annual Report on
      Form 10-KSB filed March 31, 2008).10.5
            
            $400,000
      Promissory Note issued in favor of Crown Bank executed October 31,
      2007(incorporated by reference to Exhibit 10.37 to Annual Report on
      Form 10-KSB filed March 31, 2008).10.6
            
            $1,200,000
      Promissory Note issued in favor of Crown Bank, executed October 31
      2007 (incorporated by reference to Exhibit 10.38 to Annual Report on
      Form 10-KSB filed March 31, 2008).10.8
            
            Guaranty
      provided to Crown Bank on behalf of ProUroCare Medical Inc. by James
      Davis dated October 10, 2007 (incorporated by reference to
      Exhibit 10.41 to Annual Report on Form 10-KSB filed
      March 31, 2008).10.9
            
            Guaranty
      provided to Crown Bank on behalf of ProUroCare Medical Inc. by
      William Reiling dated October 10, 2007 (incorporated by reference to
      Exhibit 10.42 to Annual Report on Form 10-KSB filed
      March 31, 2008).10.14
            
            Form of
      Convertible Note issued pursuant to the Company’s 2008 Private Placement
      dated February 13, 2008 (incorporated by reference to
      Exhibit 10.47 to Annual Report on Form 10-KSB filed
      March 31, 2008).10.15
            
            Amendment
      No. 1 to Promissory Note dated July 31, 2007 between ProUroCare
      Medical Inc. and the Phillips W. Smith Family Trust dated
      March 11, 2008 (incorporated by reference to Exhibit 10.48 to
      Annual Report on Form 10-KSB filed March 31,
    2008).10.16
            
            Amendment
      No. 1 to $600,000 Promissory Note dated October 15, 2007 between
      ProUroCare Medical Inc. and the Phillips W. Smith Family Trust
      dated March 11, 2008 (incorporated by reference to Exhibit 10.49
      to Annual Report on Form 10-KSB filed March 31,
      2008).


45





Exhibit No.
            
            Description10.17
            
            Commercial
      Loan and Security Agreement with Crown Bank, executed October 31,
      2007 and effective as of December 28, 2007 (incorporated by reference
      to Exhibit 10.39 to Annual Report on Form 10-KSB filed
      March 31, 2008).10.18
            
            Asset
      Purchase Agreement by and between ProUroCare Medical Inc. and
      Profile, LLC dated April 3, 2008 (incorporated by reference to
      Exhibit 10.1 to Quarterly Report on Form 10-Q filed May 8,
      2008).10.19
            
            Security
      Agreement by and between ProUroCare Medical Inc. and
      Profile, LLC dated April 3, 2008 (incorporated by reference to
      Exhibit 10.2 to Quarterly Report on Form 10-Q filed May 8,
      2008).10.20
            
            Promissory
      Note by and between ProUroCare Medical Inc. and Profile, LLC
      dated April 3, 2008 (incorporated by reference to Exhibit 10.3
      to Quarterly Report on Form 10-Q filed May 8,
    2008).10.21
            
            Form of
      Promissory Notes by and between ProUroCare Medical Inc. and each of
      William Reiling, James Davis, and the Phillips W. Smith Family Trust
      dated April 3, 2008 (incorporated by reference to Exhibit 10.4
      to Quarterly Report on Form 10-Q filed May 8,
    2008).10.22
      *
            
            Employment
      Agreement by and between ProUroCare Inc. and Richard Carlson dated
      July 16, 2008 (incorporated by reference to Exhibit 10.1 to
      Quarterly Report on Form 10-Q filed August 14,
      2008).10.23
      *
            
            Form of
      Stock Option Agreement and Notice of Stock Option Grant for incentive
      stock options issued to Richard Carlson and Richard Thon on July 11,
      2008 (incorporated by reference to Exhibit 10.4 to Quarterly Report
      on Form 10-Q filed August 14, 2008).10.24
            
            License
      Agreement by and between ProUroCare Medical Inc. and Artann
      Laboratories Inc. dated July 25, 2008 (incorporated by reference
      to Exhibit 10.2 to Quarterly Report on Form 10-Q filed
      August 14, 2008).10.25
            
            Development
      and Commercialization Agreement by and between ProUroCare
      Medical Inc. and Artann Laboratories Inc. dated July 25,
      2008 (incorporated by reference to Exhibit 10.3 to Quarterly Report
      on Form 10-Q filed August 14, 2008).10.26
            
            Amendment
      Number 1 to Promissory Note by and between ProUroCare
      Medical Inc. and Profile, LLC dated April 3, 2008
      (incorporated by reference to Exhibit 10.1 to Current Report on
      Form 8-K filed September 16, 2008).10.27
            
            Form of
      Amendment Number 1 to Promissory Notes by and between ProUroCare
      Medical Inc. and each of William Reiling, James Davis and the
      Phillips W. Smith Family Trust dated April 3, 2008 (incorporated
      by reference to Exhibit 10.2 on Form 8-K filed
      September 16, 2008).10.28
            
            Unit
      Put Agreement dated September 16, 2008 (incorporated by reference to
      Exhibit 10.43 to Registration Statement on Form S-1 filed
      September 19, 2008).10.29
            
            Form of
      Unit Put Origination Warrant issued pursuant to Unit Put Agreement dated
      September 16, 2008 (incorporated by reference from Exhibit 4.23
      to Registration Statement on Form S-1 filed September 19,
      2008).10.30
            
            Form of
      Unit Put Warrant to be issued to Unit Put Agreement dated
      September 16, 2008 (incorporated by reference from Exhibit 4.22
      to Registration Statement on Form S-1 filed September 19,
      2008).10.31
            
            Form of
      Convertible Promissory Note issued pursuant to the Company’s exercise of
      its put right pursuant to the Unit Put Agreement dated September 16,
      2008 (incorporated by reference to Exhibit 10.44 to Registration
      Statement on Form S-1 filed September 19,
  2008).10.32
            
            Convertible
      Promissory Note dated September 25, 2008 issued in favor of James
      Davis (incorporated by reference to Exhibit 10.7 to Quarterly Report
      on Form 10-Q filed October 23, 2008).10.33
            
            Amendment
      of License Agreement by and between ProUroCare Medical Inc. and Artann
      Laboratories, Inc. dated December 19, 2008 (incorporated by
      reference to Exhibit 10.46 to Amendment No. 4 to Registration
      Statement on Form S-1 filed December 22,
  2008).10.34
            
            Amendment
      No.1 to Development and Commercialization Agreement by and between
      ProUroCare Medical Inc. and Artann Laboratories, Inc. dated
      December 19, 2008 (incorporated by reference to Exhibit 10.46 to
      Amendment No. 4 to Registration Statement on Form S-1 filed
      December 22, 2008).10.35
            
            Promissory
      Note dated March 19, 2009 issued in favor of Crown Bank (incorporated
      by reference to Exhibit 10.51 to Annual Report on Form 10-K
      filed March 26, 2009).10.36
            
            Financing
      Agreement by and between ProUroCare Medical Inc. and James Davis dated
      March 19, 2009 (incorporated by reference to Exhibit 10.52 to Annual
      Report on Form 10-K filed March 26, 2009).10.37
            
            Form of
      Loan Guarantor Compensation Letter Agreement dated March 19, 2009
      (incorporated by reference to Exhibit 10.53 to Annual Report on
      Form 10-K filed March 26, 2009).10.38
            
            Letter
      Agreement by and between ProUroCare Medical Inc. and the Phillips W. Smith
      Family Trust dated March 19, 2009 (incorporated by reference to
      Exhibit 10.54 to Annual Report on Form 10-K filed March 26,
      2009).


46





Exhibit No.
            
            Description10.39
            
            Amendment
      #2 to $600,000 Promissory Note dated October 15, 2007 between
      ProUroCare Medical Inc. and the Phillips W. Smith Family Trust
      dated March 19, 2009 (incorporated by reference to Exhibit 10.55
      to Annual Report on Form 10-K filed March 26,
    2009).10.40
            
            Convertible
      Promissory Note dated March 19, 2009 issued in favor of James Davis
      (incorporated by reference to Exhibit 10.56 to Annual Report on
      Form 10-K filed March 26, 2009).10.41
            
            Promissory
      Note dated June 12, 2009 issued in favor of Crown Bank (incorporated
      by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q
      filed August 14, 2009).10.42
            
            Security
      Agreement with Crown Bank dated June 12, 2009 (incorporated by
      reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed
      August 14, 2009).10.43
            
            ProUroCare
      Medical Inc. 2009 Stock Plan (incorporated by reference to
      Exhibit 10.1 to Current Report on Form 8-K filed August 17,
      2009)10.44
            
            Promissory
      Note dated September 21, 2009 issued in favor of James L. Davis
      (incorporated by reference to Exhibit 10.44 to Registration Statement on
      Form S-4/A filed October 16, 2009).10.45
            
            Promissory
      Note dated September 23, 2009 issued in favor of Jack Petersen
      (incorporated by reference to Exhibit 10.45 to Registration Statement on
      Form S-4/A filed October 16, 2009).10.46
            
            Promissory
      Note dated September 23, 2009 issued in favor of Central Bank
      (incorporated by reference to Exhibit 10.46 to Registration Statement on
      Form S-4/A filed October 16, 2009).10.47
            
            Security
      Agreement with Bruce Johnson dated September 23, 2009 (incorporated by
      reference to Exhibit 10.47 to Registration Statement on Form S-4/A filed
      October 16, 2009).10.48
            
            Amendment
      No.2 to Development and Commercialization Agreement by and between
      ProUroCare Medical Inc. and Artann Laboratories, Inc. dated November
      17, 2009 (filed herewith).10.49
            
            Settlement
      Agreement by and between ProUroCare Medical Inc. and Rensselaer
      Polytechnic Institute dated December 7, 2009 (filed
    herewith).10.50
            
            Modification/Amendment
      Agreement to Crown Bank Loans dated March 26, 2010 (filed
      herewith).21.1
            
            List
      of Subsidiaries of ProUroCare Medical Inc. (incorporated by reference
      to Exhibit 21.1 to Registration Statement on Form SB-2 filed
      August 3, 2004).23.1
            
            Consent
      of Baker Tilly Virchow Krause, LLP (filed herewith).24.1
            
            Power
      of Attorney (included on signature page hereof).31.1
            
            Certification
      of Principal Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) of the
      Sarbanes-Oxley Act of 2002 (filed herewith).31.2
            
            Certification
      of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) of the
      Sarbanes-Oxley Act of 2002 (filed herewith).32.1
            
            Certification
      of Chief Executive Officer and Chief Financial Officer pursuant to
      pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of
      the Sarbanes-Oxley Act of 2002 (filed herewith).


Note: In
order that share data agree with the underlying documents, no share data in this
list of Exhibits have been restated to reflect the effect of the Company’s
February 2008 one-for-ten reverse stock split.


47


SIGNATURES





Pursuant
to the requirements of Section 13 and 15 (d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.





ProUroCare
Medical, Inc.





By:
              /s/ Richard C. CarlsonRichard
      C. CarlsonChief
      Executive OfficerDate:
      March 31, 2010





Pursuant
to the requirements of the Securities Act of 1934, this Annual Report has been
signed as of March 29, 2010, by the following persons in the capacities
indicated.





Name
                
                Title/s/ Richard C. Carlson
                
                Chief
      Executive Officer (Principal Executive Officer)Richard
      C. Carlson/s/ Richard Thon
                
                Chief
      Financial Officer (Principal Financial and AccountingRichard
      Thon
                
                Officer)/s/ K. W. Michael Chambers
                
                DirectorK.
      W. Michael Chambers/s/ James L. Davis
                
                DirectorJames
      L. Davis/s/ David Koenig
                
                DirectorDavid
      Koenig/s/ Robert Rudelius
                
                DirectorRobert
      Rudelius/s/ Scott E. Smith
                
                DirectorScott
      E. Smith


48