UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549









FORM 10-Q




(Mark One)


|(X) |  | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
|--- |  | ---------------------------------------------------------------------------------------



For the quarterly period ended September 30,
2010




OR


|(    ) |  | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
|------ |  | ----------------------------------------------------------------------------------------



For the transition period from _________________ to
_______________




Commission File Number:001-33718









BIOHEART, INC.




(Exact name of registrant as specified in its
charter)












|Florida                                                        |  |  |  | 65-0945967                          
|-------------------------------------------------------------- |  |  |  | ------------------------------------
|(State or other
jurisdiction of incorporation or organization) |  |  |  | (I.R.S. Employer Identification No.)



13794 NW 4th Street, Suite 212, Sunrise, Florida 33325(Address of principal executive offices) (Zip Code)




(954) 835-1500(Registrants telephone
number, including area code)









Indicate by check mark whether
the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 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. Yes [X] 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(§232.045 of this chapter) 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 whether
the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See 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 [  ] (Do not check if a smaller reporting company)  Smaller reporting company [X]




Indicate by check mark whether
the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [  ]   No [X]




As of September 30, 2010 there
were 29,366,985 outstanding shares of the registrants common stock, par value $0.001 per share.


---





BIOHEART, INC.




INDEX


|PART I  FINANCIAL INFORMATION
|------------------------------
|Item
1.                       
|                              
|                              
|                              
|                              
|                              
|                              
|                              
|                              
|                              
|                              
|                              
|Item
2.                       
|                              
|Item
3.                       
|                              
|Item
4.                       
|                              
|PART II  OTHER INFORMATION   
|                              
|Item
1.                       
|                              
|Item
1A.                      
|                              
|Item
2.                       
|                              
|Item
3.                       
|                              
|Item
4.                       
|                              
|Item
5.                       
|                              
|Item
6.                       
|                              
|Signatures                    
|                              
|Index to Exhibits             



1


---





PART I  FINANCIAL INFORMATION




Item 1. Financial Statements




Bioheart, Inc. and Subsidiaries (A development stage
enterprise)




Consolidated Balance Sheets







|                                                                                                                                                                                   |  |  |  | September 30,2010 |              | December 31, 2009
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |  |  |  | ----------------- | ------------ | -----------------
|                                                                                                                                                                                   |  |  |  | (Unaudited)       |              | (Audited)        
|ASSETS                                                                                                                                                                            
|Current
assets                                                                                                                                                                     |  |  |  |                   |              |                  
|Cash and cash
equivalents                                                                                                                                                          |  |  |  | $                 | 145,296      |                  
|Receivables                                                                                                                                                                        |  |  |  |                   | 142,751      |                  
|Inventory                                                                                                                                                                          |  |  |  |                   | 77,550       |                  
|Prepaid
expenses and other current assets                                                                                                                                          |  |  |  |                   | 57,688       |                  
|Total current
assets                                                                                                                                                               |  |  |  |                   | 423,285      |                  
|Property and
equipment, net                                                                                                                                                        |  |  |  |                   | 56,443       |                  
|Deferred loan
costs, net                                                                                                                                                           |  |  |  |                   | 1,142,313    |                  
|Other
assets                                                                                                                                                                       |  |  |  |                   | 69,054       |                  
|Total
assets                                                                                                                                                                       |  |  |  | $                 | 1,691,095    |                  
|                                                                                                                                                                                  
|LIABILITIES AND SHAREHOLDERS DEFICIT                                                                                                                                             
|Current
liabilities                                                                                                                                                                |  |  |  |                   |              |                  
|Accounts
payable                                                                                                                                                                   |  |  |  | $                 | 2,052,186    |                  
|Accrued
expenses and other current liabilities                                                                                                                                     |  |  |  |                   | 4,071,825    |                  
|Deferred
revenue                                                                                                                                                                   |  |  |  |                   | 507,281      |                  
|Notes payable
 current                                                                                                                                                            |  |  |  |                   | 5,640,899    |                  
|Total current
liabilities                                                                                                                                                          |  |  |  |                   | 12,272,191   |                  
|Deferred
rent                                                                                                                                                                      |  |  |  |                   |             |                  
|Subordinated
related party loan                                                                                                                                                    |  |  |  |                   |             |                  
|Note payable
 long term                                                                                                                                                           |  |  |  |                   | 1,192,788    |                  
|Total
liabilities                                                                                                                                                                  |  |  |  |                   | 13,464,979   |                  
|                                                                                                                                                                                  
|Commitments
and contingencies                                                                                                                                                      |  |  |  |                   |              |                  
|                                                                                                                                                                                  
|Shareholders deficit                                                                                                                                                              |  |  |  |                   |              |                  
|Preferred
stock ($0.001 par value) 5,000,000 shares authorized; none issued and outstanding                                                                                        |  |  |  |                   |             |                  
|Common stock
($0.001 par value) 75,000,000 shares authorized; 29,366,985 and 20,035,684 shares issued and outstanding as of September 30, 2010 and December 31,
2009, respectively |  |  |  |                   | 28,418       |                  
|Additional
paid-in capital                                                                                                                                                         |  |  |  |                   | 93,069,304   |                  
|Deficit
accumulated during the development stage                                                                                                                                   |  |  |  |                   | (104,871,606 | )                
|Total
shareholders deficit                                                                                                                                                        |  |  |  |                   | (11,773,884  | )                
|Total
liabilities and shareholders deficit                                                                                                                                        |  |  |  | $                 | 1,691,095    |                  



The accompanying notes are an integral part of these
consolidated financial statements




2


---



Bioheart, Inc. and Subsidiaries (A development stage
enterprise)




Consolidated Statements of Operations







|                                                      |  |  |  | For the Three-Month Period Ended September 30, |            | For the Nine-Month Period Ended September 30, |  | Cumulative Period from August 12, 1999 (date
of inception) to September 30, |           
|----------------------------------------------------- |  |  |  | ---------------------------------------------- | ---------- | --------------------------------------------- |  | --------------------------------------------------------------------------- | ----------
|
|                                                      |  |  |  | (Unaudited)                                    |            |                                               |  |                                                                             |           
|Revenues                                              |  |  |  | $                                              | 6,422      |                                               |  | $                                                                           | 17,250    
|Cost of
sales                                         |  |  |  |                                                | 2,827      |                                               |  |                                                                             | 10,933    
|Gross
profit                                          |  |  |  |                                                | 3,595      |                                               |  |                                                                             | 6,317     
|Development
revenues                                  |  |  |  |                                                |           |                                               |  |                                                                             |          
|                                                     
|Expenses:                                             |  |  |  |                                                |            |                                               |  |                                                                             |           
|Research and
development                              |  |  |  |                                                | 173,797    |                                               |  |                                                                             | 1,223,978 
|Marketing,
general and administrative                 |  |  |  |                                                | 430,930    |                                               |  |                                                                             | 547,443   
|Depreciation
and amortization                         |  |  |  |                                                | 11,257     |                                               |  |                                                                             | 44,723    
|Total
expenses                                        |  |  |  |                                                | 615,984    |                                               |  |                                                                             | 1,816,144 
|Loss from
operations                                  |  |  |  |                                                | (612,389   | )                                             |  |                                                                             | (1,809,827
|Interest
income                                       |  |  |  |                                                |           |                                               |  |                                                                             | 2         
|Interest
expense                                      |  |  |  |                                                | (567,348   | )                                             |  |                                                                             | (428,796  
|Reversal of
Litigation Accrual                        |  |  |  |                                                |            |                                               |  |                                                                             |           
|Net interest
expense                                  |  |  |  |                                                | (567,348   | )                                             |  |                                                                             | (428,794  
|Loss before
income taxes                              |  |  |  |                                                | (1,179,737 | )                                             |  |                                                                             | (2,238,621
|Income
taxes                                          |  |  |  |                                                |           |                                               |  |                                                                             |          
|Net
loss                                              |  |  |  | $                                              | (1,179,737 | )                                             |  | $                                                                           | (2,238,621
|Loss per
sharebasic and diluted                      |  |  |  | $                                              | (0.04      | )                                             |  | $                                                                           | (0.13     
|                                                     
|Weighted
average shares outstandingbasic and diluted |  |  |  |                                                | 28,544,853 |                                               |  |                                                                             | 16,618,813



The accompanying notes are an integral part of these
consolidated financial statements




3


---



Bioheart, Inc. and Subsidiaries (A development stage
enterprise)




Consolidated Statement of Shareholders Deficit
(Unaudited)


|                                                                               |  |  |  | Common Stock |           
|------------------------------------------------------------------------------ |  |  |  | ------------ | ----------
|
|Balance as
of December 31, 2009                                                |  |  |  |              | 20,035,684
|                                                                              
|Stock-based
compensation                                                       |  |  |  |              |          
|Common stock
issued in settlement of accounts payable                          |  |  |  |              | 285,506   
|Issuance of
warrants in connection with notes payable                          |  |  |  |              |          
|Issuance of
common stock (net of issuance costs of $2,950)                     |  |  |  |              | 3,407,135 
|                                                                              
|Common stock
issued in exchange for services                                   |  |  |  |              | 844,230   
|Common stock
issued in connection with Bank of America loan guarantors payment |  |  |  |              | 4,794,430 
|                                                                              
|Net
loss                                                                       |  |  |  |              |          
|Balance as
of September 30, 2010                                               |  |  |  |              | 29,366,895



The accompanying notes are an integral part of these
consolidated financial statements




4


---



Bioheart, Inc. and Subsidiaries (A development stage
enterprise)




Consolidated Statements of Cash Flows







|                                                                                      |  |  |  | For the Nine-Month Period EndedSeptember 30, |            | Cumulative Period from August 12, 1999
(date of inception) to September 30, | 
|------------------------------------------------------------------------------------- |  |  |  | -------------------------------------------- | ---------- | --------------------------------------------------------------------------- | 
|
|                                                                                      |  |  |  | (Unaudited)                                  |            | (Unaudited)                                                                
|Cash flows
from operating activities                                                  |  |  |  |                                              |            |                                                                             | 
|Net
loss                                                                              |  |  |  | $                                            | (4,242,824 | )                                                                           | 
|Adjustments
to reconcile net loss to net cash used in operating activities:           |  |  |  |                                              |            |                                                                             | 
|Depreciation
and amortization                                                         |  |  |  |                                              | 47,955     |                                                                             | 
|Bad debt
expense                                                                      |  |  |  |                                              |            |                                                                             | 
|                                                                                     
|Discount on
convertible debt                                                          |  |  |  |                                              |           |                                                                             | 
|Amortization
of warrants issued in exchange for licenses and intellectual property    |  |  |  |                                              |            |                                                                             | 
|Amortization
of warrants issued in connection with notes payable                      |  |  |  |                                              | 916,797    |                                                                             | 
|Amortization
of loan costs                                                            |  |  |  |                                              | 69,208     |                                                                             | 
|Warrants
issued in exchange for services                                              |  |  |  |                                              |           |                                                                             | 
|Equity
instruments issued in connection with settlement agreement                     |  |  |  |                                              |           |                                                                             | 
|Equity
instruments issued in connection with R & D agreement                          |  |  |  |                                              | 567,820    |                                                                             | 
|Common stock
issued in exchange for services                                          |  |  |  |                                              |           |                                                                             | 
|Common stock
issued in connection with amounts due to Bank of America loan guarantors |  |  |  |                                              | 69,159     |                                                                             | 
|Common stock
issued in exchange for distribution rights and intellectual property     |  |  |  |                                              |           |                                                                             | 
|Common stock
issued in connection with accounts payable                               |  |  |  |                                              | 133,594    |                                                                             | 
|Warrants
issued in connection with accounts payable                                   |  |  |  |                                              |           |                                                                             | 
|Stock-based
compensation                                                              |  |  |  |                                              | 141,894    |                                                                             | 
|Changes in
assets and liabilities                                                     |  |  |  |                                              |            |                                                                             | 
|Receivables                                                                           |  |  |  |                                              | (472       | )                                                                           | 
|Inventory                                                                             |  |  |  |                                              | 122,364    |                                                                             | 
|Prepaid
expenses and other current assets                                             |  |  |  |                                              | (31,959    | )                                                                           | 
|Other
assets                                                                          |  |  |  |                                              | (200       | )                                                                           | 
|Accounts
payable                                                                      |  |  |  |                                              | 135,063    |                                                                             | 
|Accrued
expenses and deferred rent                                                    |  |  |  |                                              | 962,215    |                                                                             | 
|Deferred
revenue                                                                      |  |  |  |                                              |           |                                                                             | 
|Net cash used
in operating activities                                                 |  |  |  |                                              | (1,109,386 | )                                                                           | 



The accompanying notes are an integral part of these
consolidated financial statements




5


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|Cash flows
from investing activities                                      |  |  |  |   |           |   |  |   |            |   |  |   |            |  
|------------------------------------------------------------------------- |  |  |  | - | --------- | - |  | - | ---------- | - |  | - | ---------- | -
|Acquisitions
of property and equipment                                    |  |  |  |   |          |   |  |   | (2,019     | ) |  |   | (898,800   | )
|Net cash used
in investing activities                                     |  |  |  |   |          |   |  |   | (2,019     | ) |  |   | (898,800   | )
|                                                                         
|Cash flows
from financing activities                                      |  |  |  |   |           |   |  |   |            |   |  |   |            |  
|Proceeds from
(payments for) initial public offering of common stock, net |  |  |  |   |          |   |  |   |           |   |  |   | 1,447,829  |  
|Proceeds from
private placements of common stock, net                     |  |  |  |   | 1,199,651 |   |  |   | 1,325,419  |   |  |   | 60,672,026 |  
|Proceeds from
exercise of stock options                                   |  |  |  |   |          |   |  |   | 32,000     |   |  |   | 292,117    |  
|Proceeds from
notes payable                                               |  |  |  |   |          |   |  |   | 298,000    |   |  |   | 11,498,000 |  
|Proceeds from
subordinated related party loan                             |  |  |  |   |          |   |  |   | 3,000,000  |   |  |   | 3,000,000  |  
|Payment of
notes payable                                                  |  |  |  |   |          |   |  |   | (3,000,000 | ) |  |   | (3,000,000 | )
|Prepayment of
notes payable                                               |  |  |  |   |          |   |  |   |           |   |  |   | (2,256,568 | )
|Payment of
loan costs                                                     |  |  |  |   | (20,000   | ) |  |   | (137,994   | ) |  |   | (1,219,268 | )
|Net cash
provided by financing activities                                 |  |  |  |   | 1,179,651 |   |  |   | 1,517,425  |   |  |   | 70,434,136 |  
|Net
increase (decrease) in cash and cash equivalents                      |  |  |  |   | 70,265    |   |  |   | 37,427     |   |  |   | 145,296    |  
|                                                                         
|Cash and cash
equivalents, beginning of period                            |  |  |  |   | 75,031    |   |  |   | 50,091     |   |  |   |           |  
|Cash and cash
equivalents, end of period                                  |  |  |  | $ | 145,296   |   |  | $ | 87,518     |   |  | $ | 145,296    |  
|                                                                         
|Disclosures of cash flow information:                                     |  |  |  |   |           |   |  |   |            |   |  |   |            |  
|                                                                         
|Interest
paid                                                             |  |  |  | $ | 282,960   |   |  | $ | 290,096    |   |  | $ | 1,527,614  |  
|Income taxes
paid                                                         |  |  |  | $ |          |   |  | $ |           |   |  | $ |           |  



The accompanying notes are an integral part of these
consolidated financial statements




6


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|1. |  | Organization and Summary of Significant Accounting
Policies
|-- |  | -----------------------------------------------------------



Organization and Business




Bioheart, Inc. (the
Company) is committed to maintaining leading position within the cardiovascular sector of the cell technology industry delivering cell
therapies, intelligent devices and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial
infarctions and other issues. We work to prevent the worsening of heart failure conditions with devices that monitor and diagnose. Our goals are to
cause damaged tissue to be regenerated, if possible, and to improve a patients quality of life and reduce health care costs and
hospitalizations.




Specific to biotechnology, we are
focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic
and acute heart damage and peripheral vascular disease. MyoCell is a clinical muscle-derived cell therapy designed to populate regions of scar tissue
within a patients heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.




The Companys pipeline
includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived
cell treatment for acute heart damage, and MyoCell® SDF-1, a therapy utilizing autologous cells that are genetically modified to express
additional potentially therapeutic growth proteins.




The Company was incorporated in
Florida on August 12, 1999.




Development Stage




The Company has operated as a
development stage enterprise since its inception by devoting substantially all of its efforts to raising capital, research and development of products
noted above, and developing markets for its products. Accordingly, the consolidated financial statements of the Company have been prepared in
accordance with the accounting and reporting principles prescribed by Accounting Standards Codification (ASC) Topic 915, Development
Stage Entities, issued by the Financial Accounting Standards Board (FASB).




Prior to marketing its products
in the United States, the Companys products must undergo rigorous preclinical and clinical testing and an extensive regulatory approval process
implemented by the Food and Drug Administration (FDA) and other regulatory authorities. There can be no assurance that the Company will not
encounter problems in clinical trials that will cause the Company or the FDA to delay or suspend clinical trials. The Companys success will
depend in part on its ability to successfully complete clinical trials, obtain necessary regulatory approvals, obtain patents and product license
rights, maintain trade secrets, and operate without infringing on the proprietary rights of others, both in the United States and other countries.
There can be no assurance that patents issued to or licensed by the Company will not be challenged, invalidated, or circumvented, or that the rights
granted thereunder will provide proprietary protection or competitive advantages to the Company. The Company will require substantial future capital in
order to meet its objectives. The Company currently has no committed sources of capital. The Company will need to seek substantial additional financing
through public and/or private financing, and financing may not be available when the Company needs it or may not be available on acceptable
terms.




Basis of Presentation




The accompanying unaudited
consolidated interim financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the
SEC) for reporting of interim financial information. Pursuant to such rules and regulations, certain information and footnote
disclosures




7


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normally included in
financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or
omitted.




In the opinion of management, the
accompanying unaudited consolidated interim financial statements of the Company contain all adjustments (consisting of normal recurring adjustments)
necessary to present fairly the financial position of the company as of September 30, 2010, the results of its operations for the three and nine months
periods ended September 30, 2010 and 2009, and its cash flows for the nine month periods ended September 30, 2010 and 2009. The results of operations
and cash flows for the nine month periods ended September 30, 2010 are not necessarily indicative of the results of operations or cash flows which may
be reported for future periods or for the year ending December 31, 2010.




The accompanying unaudited
consolidated interim financial statements included the accounts of Bioheart, Inc. and its wholly-owned subsidiaries. All intercompany transactions are
eliminated in consolidation.




The accompanying unaudited
consolidated interim financial statements and notes thereto should be read in conjunction with Managements Discussion and Analysis of Financial
Condition and Results of Operations contained in this report and the audited financial statements for the year ended December 31, 2009 and the notes
thereto included in the Companys Annual Report on Form 10-K and Form 10-K/A for the year ended December 31, 2009.




Use of 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 the disclosure of contingent assets and liabilities as of the date of the
financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those
estimates.




Fair Value of Financial Instruments




Fair value of certain of the
Companys financial instruments including cash and cash equivalents, accounts receivable, accounts payable, accrued expenses, notes payables, and
other accrued liabilities approximate cost because of their short maturities. The Company measures and reports fair value in accordance with ASC 820,
Fair Value Measurements and Disclosure defines fair value, establishes a framework for measuring fair value in accordance with generally
accepted accounting principles and expands disclosures about fair value investments.




Fair value, as defined in ASC
820, is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the
measurement date. The fair value of an asset should reflect its highest and best use by market participants, principal (or most advantageous) markets,
and an in-use or an in-exchange valuation premise. The fair value of a liability should reflect the risk of nonperformance, which includes, among other
things, the Companys credit risk.




Valuation techniques are
generally classified into three categories: the market approach; the income approach; and the cost approach. The selection and application of one or
more of the techniques may require significant judgment and are primarily dependent upon the characteristics of the asset or liability, and the quality
and availability of inputs. Valuation techniques used to measure fair value under ASC 820 must maximize the use of observable inputs and minimize the
use of unobservable inputs. ASC 820 also provides fair value hierarchy for inputs and resulting measurement as follows:




8


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Level 1




Quoted prices (unadjusted) in
active markets that are accessible at the measurement date for identical assets or liabilities;




Level 2




Quoted prices for similar assets
or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; inputs other than quoted
prices that are observable for the asset or liability; and inputs that are derived principally from or corroborated by observable market data for
substantially the full term of the assets or liabilities; and




Level 3




Unobservable inputs for the asset
or liability that are supported by little or no market activity and that are significant to the fair values.




Fair value measurements are
required to be disclosed by the Level within the fair value hierarchy in which the fair value measurements in their entirety fall. Fair value
measurements using significant unobservable inputs (in Level 3 measurements) are subject to expanded disclosure requirements including a reconciliation
of the beginning and ending balances, separately presenting changes during the period attributable to the following: (i) total gains or losses for the
period (realized and unrealized), segregating those gains or losses included in earnings, and a description of where those gains or losses included in
earning are reported in the statement of income.




The Company has no fair value
items required to be disclosed.




Inventory




Inventory consists of raw
materials and finished product. Finished product consists primarily of finished catheters. Cost of finished product, consisting of raw materials and
contract manufacturing costs, is determined by the first-in, first-out (FIFO) method for valuing inventories. Costs of raw materials are determined
using the FIFO method. Inventory is stated at the lower of costs or market (estimated net realizable value).




Inventory consisted of the
following as of September 30, 2010 and December 31, 2009







|                 |  |  |  | September 30, |        | December 31,
|---------------- |  |  |  | ------------- | ------ | ------------
|
|Finished
product |  |  |  | $             | 20,796 |             
|Raw
materials    |  |  |  |               | 56,754 |             
|Total
inventory  |  |  |  | $             | 77,550 |             



Prepaid Expenses and Other Current
Assets




Prepaid expenses and other
current assets as of September 30, 2010 consisted principally of prepaid insurance.




Deferred Loan Costs




Deferred loan costs consist
principally of legal and loan origination fees incurred to obtain $10 million in loans in June 2007 and the fair value of warrants issued in connection
with the loans. These deferred loan costs




9


---



are being amortized to
interest expense over the terms of the respective loans using the effective interest rate method. At September 30, 2010 and December 31, 2009, the
Company had net deferred loan costs of $1,142,313 and $1,250,106, respectively. For the nine months ended September 30, 2010 and for the nine months
ended September 30, 2009, the Company recorded $986,006 and $597,781, respectively, of interest expense related to the amortization of deferred loan
costs, which included $529,145 and $448,888, respectively, related to the fair value of warrants issued in connection with the loans.




Stock Options and Warrants




On January 1, 2006, the Company
adopted the provisions of ASC Topic 718, formerly SFAS No. 123 (revised 2004), Share-Based Payment (SFAS No. 123R) using the
modified prospective transition method. ASC Topic 718, formerly SFAS No. 123R, requires the Company to measure all share-based payment awards granted
after January 1, 2006, including those with employees, at fair value. Under ASC Topic 718, formerly SFAS No. 123R, the fair value of stock options and
other equity-based compensation must be recognized as expense in the statements of operations over the requisite service period of each
award.




Share-based awards granted
subsequent to January 1, 2006 are valued using the fair value method and compensation expense is recognized on a straight-line basis over the vesting
period of the awards. Beginning January 1, 2006, the Company also began recognizing compensation expense under ASC Topic 718, formerly SFAS No. 123R
for the unvested portions of outstanding share-based awards previously granted under its stock option plans, over the periods these awards continue to
vest.




The Company accounts for certain
share-based awards, including warrants, with non-employees in accordance with ASC Topic 718, formerly SFAS No. 123R and related guidance, including ASC
Topic 505, formerly EITF Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction
with Selling Goods or Services. The Company estimates the fair value of such awards using the Black-Scholes valuation model at each reporting
period and expenses the fair value over the vesting period of the share-based award, which is generally the period in which services are
provided.




In its meeting of August 17,
2009, the Board of Directors approved the repricing of current employees stock options (other than Executive Officers). In accordance with
regulations concerning such a repricing and in conformance with generally accepted procedures, all options granted before August 12, 2008, were
repriced on the basis of the 5-day average closing price of BHRT, during the period of August 11 through August 17, 2009.




The following information applies
to the repricing which occurred as of October 8, 2009.







|Original Exercise Price |  |  |  | New Exercise Price |  | Number of shares underlying
Options
|----------------------- |  |  |  | ------------------ |  | -----------------------------------
|$1.28                   |  |  |  | $0.71              |  |                                    
|$4.11                   |  |  |  | $0.71              |  |                                    
|$5.67                   |  |  |  | $0.71              |  |                                    
|$7.69                   |  |  |  | $0.71              |  |                                    
|$8.47                   |  |  |  | $0.71              |  |                                    
|                        |  |  |  |                    |  |                                    



Of those options listed above,
61,778 expired in December 2009 without having been exercised,308,891 expired in March 2010 without having been exercised, 959 expired in August 2010
without having been exercised and 18,844 expired in September 2010 without having been exercised.




10


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On February 24, 2010, by way of a
written consent, the Companys Board of Directors amended the Directors and Consultants 1999 Stock Option Plan to extend the termination date of
the Plan to December 1, 2011.




Loss Per Share




Loss per share has been computed
based on the weighted average number of shares outstanding during each period, in accordance with ASC Topic 260, formerly SFAS No. 128, Earnings per
Share. The effect of outstanding stock options and warrants, which could result in the issuance of 2,299,313 and 9,946,944 shares of common stock
at September 30, 2010 and 2009 respectively, is antidilutive. As a result, diluted loss per share data does not include the assumed exercise of
outstanding stock options and warrants and has been presented jointly with basic loss per share.




Recent Accounting Updates




Recent accounting pronouncements
that the Company has adopted or that will be required to adopt in the future are summarized below.




On September 30, 2009, the
Company adopted updates issued by the Financial Accounting Standards Board (FASB) to the authoritative hierarchy of GAAP. These changes establish the
FASB Accounting Standards CodificationTM (ASC) as the source of authoritative accounting
principles recognized by the FASB to be applied by nongovernmental entities in the preparation of financial statements in conformity with GAAP. Rules
and interpretive releases of the Securities and Exchange Commission (SEC) under authority of federal securities laws are also sources of
authoritative GAAP for SEC registrants. The FASB will no longer issue new standards in the form of Statements, FASB Staff Positions, or Emerging Issues
Task Force Abstracts; instead the FASB will issue Accounting Standards Updates. Accounting Standards Updates will not be authoritative in their own
right as they will only serve to update the Codification. These changes and the Codification itself do not change GAAP. Other than the manner in which
new accounting guidance is referenced, the adoption of these changes had no impact on the Consolidated Financial Statements.




In August 2009, the FASB issued
ASU 2009-05, which amends ASC 820 to provide further guidance on measuring the fair value of a liability. It primarily does three things: 1) sets forth
the types of valuation techniques to be used to value a liability when a quoted price in an active market for the identical liability is not available,
2) clarifies that when estimating the fair value of a liability, a reporting entity is not required to include a separate input or adjustment to other
inputs relating to the existence of a restriction that prevents the transfer of the liability, and 3) clarifies that both a quoted price in an active
market for the identical liability at the measurement date and the quoted price for the identical liability when traded as an asset in an active
market, when no adjustments to the quoted price of the asset are required, are Level 1 fair value measurements. This standard became effective for the
Company beginning in the fourth quarter of 2009. The Companys adoption of ASU 2009-05 did not have a material impact on its financial position,
results of operations or liquidity.




In June 2009, the FASB issued
guidance now codified as ASC Topic 105, Generally Accepted Accounting Principles (ASC 105), which establishes the FASB
Accounting Standards Codification as the source of GAAP to be applied to nongovernmental agencies. ASC 105 explicitly recognizes rules and interpretive
releases of the SEC under authority of federal securities laws as authoritative GAAP for SEC registrants. ASC 105 became effective for interim or
annual periods ending after September 15, 2009. ASC 105 does not have a material impact on the Companys consolidated financial statements
presented hereby.




In May 2009, the FASB issued
guidance now codified as ASC Topic 855, Subsequent Events (ASC 855). The pronouncement modifies the definition of what
qualifies as a subsequent eventthose events or




11


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transactions that occur
following the balance sheet date, but before the financial statements are issued, or are available to be issuedand requires companies to disclose
the date through which it has evaluated subsequent events and the basis for determining that date. The Company adopted the provisions of ASC 855 in the
third quarter of 2009, in accordance with the effective date.




In January 2010, the FASB issued
Update No. 2010-6, Improving Disclosures About Fair Value Measurements (ASU 2010-6), which requires reporting entities to make
new disclosures about recurring or nonrecurring fair-value measurements including significant transfers into and out of Level 1 and Level 2 fair-value
measurements and information on purchases, sales, issuances, and settlements on a gross basis in the reconciliation of Level 3 fair-value measurements.
ASU 2010-6 is effective for annual reporting periods beginning after December 15, 2009, except for Level 3 reconciliation disclosures, which are
effective for annual periods beginning after December 15, 2010. The Company is currently evaluating the effect of this update on its financial
position, results of operations and liquidity.




In October 2009, the FASB issued
authoritative guidance on revenue recognition that will become effective for the Company beginning July 1, 2010, with earlier adoption permitted. Under
the new guidance on arrangements that include software elements, tangible products that have software components that are essential to the
functionality of the tangible product will no longer be within the scope of the software revenue recognition guidance, and software-enabled products
will now be subject to other relevant revenue recognition guidance. We believe adoption of this new guidance will not have a material impact on our
financial statements.




Other recent accounting
pronouncements issued by the FASB (including its Emerging Issues Task Force), the AICPA, and the SEC did not or are not believed by management to have
a material impact on the Companys present or future financial statements


|2. |  | Going Concern
|-- |  | -------------



The accompanying consolidated
financial statements have been prepared and are presented assuming the Companys ability to continue as a going concern. The Company has incurred
significant operating losses over the past several years and has a deficit accumulated during the development stage of approximately $104.9 million as
of September 30, 2010 In addition, as of September 30, 2010, the Companys current liabilities exceed current assets by $11.8 million. Current
liabilities include notes payable of $5.6 million. While, subsequent to September 30, 2010, the Company received cash proceeds of approximately $26,000
in a series of private placements, this will not provide sufficient cash to support the Companys operations through December 2010. The Company
will need to secure additional sources of capital by the end of November 2010 to develop its business and product candidates as planned, and continue
as a going concern.




The Company currently has no
commitments or arrangements from third parties for any additional financing to fund research and development and/or other operations, except for its
REGEN trial, discussed below. That trial is being funded by the Ascent Medical Technology Fund II, LP, and the Ascent Medical Product Development
Centre Inc., which as of September 30, 2010 was controlled by a current director and a former director of the Company. The director has since resigned
from the Companys Board of Directors. In addition, the Ascent Medical Technology Fund II, LP is funding, on a project basis, some of the
activities of the Companys Centers of Excellence, discussed below. The Company is seeking substantial additional financing through public and/or
private financing, which may include equity and/or debt financings, research grants, and through other arrangements, including collaborative
arrangements. As part of such efforts, the Company may seek loans from certain of our executive officers, directors and/or current shareholders.
However, financing may not be available to the Company or on terms acceptable to the Company. The Companys inability to obtain additional
financing would have a material adverse effect on its financial condition and ability to continue operations. Accordingly, the Company could be forced
to significantly curtail or suspend




12


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operations, default on its
debt obligations, file for bankruptcy or seek to sell some or all of its assets. As such, the Companys continuation as a going concern is
uncertain.




Due to the Companys
financial condition, the report of the Companys independent registered public accounting firm on the Companys December 31, 2009
consolidated financial statements includes an explanatory paragraph indicating that these conditions raise substantial doubt about the Companys
ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments relating to the
recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might be necessary should the Company
be unable to continue as a going concern.


|3. |  | Collaborative License and Research/Development
Agreements
|-- |  | ---------------------------------------------------------



The Company has entered into a
number of contractual relationships for technology licenses and research and development projects. The following provides a summary of the
Companys significant contractual relationships:




In February 2000, the Company
entered into a license agreement (the Original License Agreement) with Cell Transplants International, LLC (CTI). Pursuant to
the Original License Agreement, among other things, CTI granted the Company a license to certain patents related to heart muscle regeneration and
angiogenesis for the life of the patents. In July 2000, the Company and CTI, together with Dr. Peter K. Law, executed an addendum to the Original
License Agreement, which amended or superseded a number of terms of the Original License Agreement (the License Addendum).




More specifically, the License
Addendum provided, among other things:


| |  | The parties agreed that the Company would issue, and the Company
did issue, to CTI a five-year warrant exercisable for 1.2 million shares of the Companys common stock at an exercise price of $8.00 per share
instead of, as originally contemplated under the Original License Agreement, issuing to CTI or Dr. Law 600,000 shares of the Companys common
stock and options to purchase 600,000 shares of the Companys common stock at an exercise price of $1.80 per share. These share amounts and
exercise prices do not take into account any subsequent recapitalizations or reverse stock splits.
|- |  | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| |  | The parties agreed that the Companys obligation to pay CTI
a $3.0 million milestone payment would be triggered upon the Companys commencement of a bona fide U.S. Phase II human clinical trial study that
utilizes technology claimed under U.S. Patent No. 5,130,141 with FDA approval in the United States, instead of, as originally contemplated under the
Original License Agreement, upon initiation of an FDA approved human clinical trial study of such technology in the United States.
|- |  | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



In addition, if the Company
obtains FDA approval of a method of heart muscle regeneration utilizing the patented technology licensed under the Original License Agreement, the
Company will be required to pay CTI $5 million. Further, the Company would be obligated to pay CTI a royalty of 5% of gross sales of products and
services that directly read upon the claims of the licensed patents. During the course of certain litigation initiated by Dr. Law against the Company,
see Note 8, the Company learned that CTI, a Tennessee limited liability company, was administratively dissolved by the Secretary of State of Tennessee
in 2004.




In February 2006, the Company
entered into an exclusive license agreement with The Cleveland Clinic Foundation for various pending patents to be used in connection with the MyoCell
SDF-1 product candidate. Our MyoCell SDF-1 product candidate, which has recently completed preclinical testing, is intended to be an improvement to
MyoCell. Dr. Marc Penn, the Medical Director of the Cardiac Intensive Care Unit at the Cleveland Clinic and a staff cardiologist in the Departments of
Cardiovascular Medicine and Cell Biology, joined our Scientific Advisory Board. The license for SDF-1 was passed on to a Cleveland Clinic
affiliate,




13


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Juventas, in July of 2009.
Bioheart entered into a memorandum of understanding with Juventas pursuant to which the license with Bioheart would be reinstated upon completion by
Bioheart of certain financial milestones by February, 2010. In October of 2009, Cleveland Clinics patent applications were denied by the United
States Patent Office. Although Cleveland Clinic filed an appeal, Bioheart allowed the memorandum of understanding with Juventas to lapse, believing
that the current climate concerning the patenting of genetic properties would not permit the patents to be issued, even in a revised
form.




In April 2006, the Company
entered into an agreement to license from TriCardia, LLC various patents to be used in connection with the MyoCath® II product candidate. In
exchange for the license, the Company agreed to do the following: 1) pay $100,000 upon the closing of the agreement; and 2) issue a warrant exercisable
for 32,515 shares of the Companys common stock at an exercise price of $7.69 per share. The warrant vested on a straight line basis over a 12
month period and expires on February 28, 2016. The fair value of this warrant of approximately $193,000, as determined using the Black-Scholes
valuation model, was amortized to research and development expense on a straight line basis over the twelve month vesting period. The Company recorded
$144,867 of expense in 2006 and the remaining $48,289 of expense in 2007.




In December 2006, the Company
entered into an agreement with Tissue Genesis, Inc. (Tissue Genesis) for exclusive distribution rights to Tissue Genesis products and
a license for various patents to be used in connection with the Bioheart Acute Cell Therapy and TGI 1200TM product candidates. In exchange for the license, the Company agreed to do the following: 1) issue 13,006 shares of the
Companys common stock at a price of $7.69 per share; and 2) issue a warrant exercisable for 1,544,450 shares of the Companys common stock
to Tissue Genesis at an exercise price of $7.69 per share, which warrant expires on December 31, 2026. This warrant shall vest in three parts as
follows: i) 617,780 shares vesting only upon the Companys successful completion of human safety testing of the licensed technology, ii) 463,335
shares vesting only upon the Company exceeding net sales of $10 million or net profit of $2 million from the licensed technology, and iii) 463,335
shares vesting only upon the Company exceeding net sales of $100 million or net profit of $20 million from the licensed technology. Since the vesting
of this warrant is contingent upon the achievement of the specific milestones, the fair value of this warrant at the time the milestones are met will
be expensed to research and development. In the event of an acquisition (or merger) of the Company by a third party, all unvested shares of common
stock subject to the warrant shall immediately vest prior to such event. In addition, the Company will pay a 2% royalty of net sales of licensed
products. On October 26, 2010 the Company received a written notice of termination of Customer Agreement and Distribution Agreement. See, Subsequent
Events, in Note 12, Other Information, Notes to Consolidated Interim Financial Statements.




On April 13, 2007 Bioheart signed
a Research Agreement with Indiana University to sponsor pre-IND large animal research related to the use of adipose tissue derived stem cells for use
in treating acute myocardial infarction. The data from research will be used to file an IND related to this product platform. The total budget for this
study is $726,584.06, of which $506,719 has been spent to date.




Bioheart originally entered into
a Research Agreement with the University of Florida on July 1, 2004. The original purpose of this Research Agreement was to conduct small animal
research related to Biohearts SDF-1 gene modified cell therapy. The research continued into large animals and the contract has been amended six
times. The most recent budget amendment was to sponsor an additional $305,855 for large animal research which was signed on November 18, 2008, of which
$209,799 has been spent to date.




There are currently 11 executed
clinical site contracts and one open Academic Research Organization contract (ARO) associated with the ongoing Marvel Clinical Trial. Clinical site
contracts include Minneapolis Heart Institute, Scripps Hospital, Florida Hospital, Jim Moran Heart Institute, Mayo Clinic, The Lindner Center, Swedish
Medical Center, Newark Beth Israel, Arizona Heart Institute, Cardiology P. C. and Mercy Gilbert Medical Center. Bioheart is obligated for payments in
the aggregate amount of $375,773 for clinical site contracts. Bioheart also entered into a contract in support of the Marvel trial with Duke Clinical
Research




14


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Institute, an Academic
Research Organization (ARO) on March 9, 2007. The total obligation for this contract is $469,844, of which $464,844 has been spent to date. In
addition, there are various consultants and core laboratories which provide support for Marvel. Biohearts total commitment towards contracts for
all consultants and Core Laboratories is $301,651.




On February 2, 2010, Bioheart,
Inc. (the Company) and the Ascent Medical Product Development Centre Inc. (Ascent) entered into an agreement whereby Ascent
would oversee the conduct of a Phase I Clinical Trial for the Company, namely the REGEN trial. Ascent is owned by the Ascent Medical Technology Fund
II, LP, (the Fund), which will provide funding for the study. The Funds General Partner is Ascent Private Equity II, LLC, which is
controlled by Karl E. Groth, Ph.D., whom as of September 30, 2010 was a current director of the Company and Peggy A. Farley, a former director of the
Company. Dr. Groth has since resigned as a director of the Company.




On March 23, 2010, the Company
announced plans for establishing five Centers of Excellence in Latin America to provide its cell therapy procedures to patients suffering from
congestive heart failure (CHF) and peripheral arterial disease (PAD). Bioheart entered into its first agreement with a leading treatment facilitator,
Regenerative Medicine Institute of Tijuana, Mexico. Therapies for CHF and PAD patients will be made available at the Hospital Angeles Tijuana, a fully
equipped state-of-the-art private specialties hospital. This is the first of five Centers of Excellence with four additional Centers to be
announced.


|4. |  | Accrued Expenses and Other Current
Liabilities
|-- |  | ----------------------------------------------



Accrued expenses and other
current liabilities consisted of the following, as of September 30, 2010 and December 31, 2009.







|                                                                                                                    |  |  |  | September 30, |           | December 31,
|------------------------------------------------------------------------------------------------------------------- |  |  |  | ------------- | --------- | ------------
|
|License and
royalty fees                                                                                            |  |  |  | $             | 1,037,500 |             
|Amounts
payable to the Guarantors of the Companys loan agreement with Bank of America, including fees and interest |  |  |  |               | 1,183,777 |             
|Interest payable on notes payable                                                                                   |  |  |  |               | 457,889   |             
|Clinical
trial contracts                                                                                            |  |  |  |               | 527,210   |             
|Other                                                                                                               |  |  |  |               | 865,449   |             
|                                                                                                                    |  |  |  | $             | 4,071,825 |             

|5. |  | Notes Payable
|-- |  | -------------



Notes payable were comprised of
the following as of September 30, 2010 and December 31, 2009:







|                                                                                                       |  |  |  | September 30, |            | December 31,
|------------------------------------------------------------------------------------------------------ |  |  |  | ------------- | ---------- | ------------
|
|Bank of
America note payable. Terms described below.                                                   |  |  |  | $             | 1,333,400  |             
|BlueCrest
Capital Finance note payable. Monthly payments of principal and interest as described below. |  |  |  |               | 2,615,315  |             
|Subordinated
Related Party                                                                             |  |  |  |               |           |             
|Short term
note payable  Rogers Telecommunications                                                    |  |  |  |               | 1,000,000  |             
|Short-term
notes payable. Terms described below.                                                       |  |  |  |               | 1,884,972  |             
|                                                                                                       |  |  |  |               | 6,833,687  |             
|Less current
portion.                                                                                  |  |  |  |               | (5,640,899 | )           
|Notes payable
 long term.                                                                             |  |  |  | $             | 1,192,788  |             



Notes payable at September 30,
2010 mature as follows:




15


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|2010 |  |  |  | $ | 338,772   | 
|---- |  |  |  | - | --------- | 
|2011 |  |  |  |   | 1,468,716 | 
|2012 |  |  |  |   | 5,026,199 | 
|     |  |  |  | $ | 6,833,687 | 



Bank of America Note Payable




On June 1, 2007, the Company
entered into a loan agreement with Bank of America, N.A. for an eight month, $5.0 million term loan, to be used for working capital purposes. The loan
bears interest at the annual rate of the prime rate plus 1.5%. The prime rate was 3.25% and 7.25% at December 31, 2008 and 2007, respectively. As
consideration for the loan, the Company paid Bank of America a fee of $100,000. Effective as of January 31, 2008, the maturity date of the loan was
extended until June 1, 2008. As consideration for this extension of the maturity date of the loan, the Company paid Bank of America a fee of $50,000.
Effective as of June 1, 2008, Bank of America agreed to extend the maturity date of the loan until January 5, 2009. As consideration for this extension
of the maturity date of the loan, the Company paid Bank of America a fee of $75,000. Effective January 5, 2009, Bank of America agreed to extend the
maturity date of the loan until July 6, 2009. As consideration for this extension of the maturity date of the loan, the Company paid Bank of America a
fee of $50,000. Effective July 6, 2009, Bank of America agreed to extend the maturity of the loan until January 5, 2010. As consideration for this
extension of the maturity date of the loan, the Company paid Bank of America a fee of $25,000. Effective January 5, 2010, Bank of America agreed to
extend the maturity of the loan until July 6, 2010. As consideration for this extension of the maturity date of the loan, the Company agreed to pay
Bank of America a fee of $30,000. Under the terms of the loan, Bank of America is entitled to receive a semi-annual payment of interest and all
outstanding principal and accrued interest by the maturity date.




The Company has provided no
collateral for the loan. On June 1, 2007, for the Companys benefit, the Companys Chief Technology Officer and his former spouse, certain
other members of the Companys Board of Directors and one of the Companys shareholders (the Guarantors) provided collateral to
guarantee the loan. Except for a $1.1 million personal guaranty (backed by collateral) provided by the Companys Chief Technology Officer and his
former spouse, these guarantees are limited to the collateral each provided to the lender.




In June 2007, the Company and
Bank of America have agreed with BlueCrest Capital Finance, L.P., the lender of the BlueCrest Loan (defined below), that the Company will not
individually make any payments due under the Bank of America loan while the BlueCrest Loan is outstanding. For the Companys benefit, the
Guarantors agreed to provide Bank of America in the aggregate up to $5.5 million of funds and/or securities to make these payments.




In June 2007, the Company has
agreed to reimburse the Guarantors with interest at an annual rate of the prime rate plus 5.0% for any and all payments made by them under the Bank of
America loan as well as to pay them certain cash fees in connection with their provision of collateral to guarantee the loan. Upon entering into the
loan agreement, the Company issued to each Guarantor warrants to purchase 3,250 shares of common stock at an exercise price of $7.69 per share for each
$100,000 of principal amount of the loan guaranteed by such Guarantor. The warrants have a ten-year term and became exercisable one year following the
date the warrants were issued. Warrants to purchase an aggregate of 216,095 shares of common stock were issued to the Guarantors. These warrants had an
aggregate fair value of $1,437,638, which amount was accounted for as additional paid in capital and reflected as a component of deferred loan costs
and amortized as interest expense over the initial term of the loan using the effective interest method. As discussed below, certain of these
Guarantors were replaced in September 2007. The unamortized fair value of the warrants issued to the Guarantors that were replaced, which was
previously reflected as a component of deferred loan costs, was recorded as interest expense in September 2007.




16


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In September 2007, a member of
the Companys Board of Directors and two of the Companys shareholders agreed to provide collateral valued at $750,000, $600,000 and
$500,000, respectively, to secure the loan. The collateral provided by these new Guarantors fully replaced the collateral originally provided by one of
the members of the Companys Board of Directors and partially replaced the collateral originally provided by another member of the Companys
Board of Directors whose collateral now secures $400,000 of the loan. In consideration for providing the collateral, the Company issued to the new
Guarantors warrants to purchase 3,250 shares of common stock at an exercise price of $7.69 per share for each $100,000 of principal amount of the loan
guaranteed by such new Guarantor. The warrants have a ten-year term and became exercisable one year following the date the warrants were issued.
Warrants to purchase an aggregate of 60,118 shares of the Companys common stock were issued to the new Guarantors. These warrants had an
aggregate fair value of $380,482, which was accounted for as additional paid in capital and reflected as a component of deferred loan costs and
amortized as interest expense over the initial term of the loan using the effective interest method.




In accordance with the provisions
of the warrants issued to the Guarantors, the aggregate number of shares of common stock underlying such warrants increased on September 30, 2007 as
the Bank of America loan remained outstanding at that date. The additional 38,861 warrant shares had an aggregate fair value of $244,463. The portion
of this amount attributed to the Guarantors that were replaced in September 2007 was accounted for as additional paid in capital and immediately
recorded as interest expense with the remainder accounted for as additional paid in capital and reflected as a component of deferred loan costs and
amortized as interest expense over the initial term of the loan using the effective interest method.




In October 2007, the
Companys Chief Technology Officer and his former spouse agreed to provide an additional $2.2 million limited personal guarantee of the loan and
pledged securities accounts to backup this limited personal guarantee. The additional collateral provided by the Companys Chief Technology
Officer and his former spouse fully replaced the collateral provided by one of the original Guarantors. The Companys Chief Technology Officer and
his former spouse by then had personally guaranteed an aggregate of $3.3 million of the loan. The Companys agreement with the Companys
Chief Technology Officer and his former spouse with respect to the additional collateral is substantially similar to the Companys agreement with
them in connection with the $1.1 million personal guarantee they originally provided in June 2007. In consideration for providing the collateral, the
Company issued to the Companys Chief Technology Officer and his former spouse, a warrant to purchase 81,547 shares of the Companys common
stock at an exercise price of $7.69 per share. The warrant has a ten-year term and became exercisable one year following the date the warrant was
issued. The warrant had a fair value of $516,193, which was accounted for as additional paid in capital and reflected as a component of deferred loan
costs and amortized as interest expense over the initial term of the loan using the effective interest method.




As a result of this replacement
of the collateral originally provided by one of the original Guarantors in October 2007, the unamortized fair value of the warrant to purchase 81,548
shares of the Companys common stock at an exercise price of $7.69 per share issued to that Guarantor was recorded as interest expense in October
2007. In October 2007, the Company cancelled the warrant previously issued to such original Guarantor, which warrant included the adjustment provisions
discussed above, and, in exchange, issued to them a warrant to purchase 101,934 shares of the Companys common stock at an exercise price of $7.69
per share, which new warrant does not contain the adjustment provisions discussed above. The additional 20,386 warrant shares had an aggregate fair
value of $128,228, which was accounted for as additional paid in capital and immediately recorded as interest expense.




In accordance with the provisions
of the warrants issued to the Guarantors, the aggregate number of shares of common stock underlying such warrants increased on June 1, 2008 as the Bank
of America loan remained outstanding at that date. The additional 78,773 warrant shares had an aggregate fair value of $168,387. The portion of this
amount attributed to the Guarantors that were replaced in September 2007 was accounted for as additional paid in capital and immediately recorded as
interest expense with the remainder accounted for as




17


---



additional paid in capital
and reflected as a component of deferred loan costs to be amortized as interest expense over the term of the loan using the effective interest
method.




In accordance with the provisions
of the warrants issued to the Guarantors, the aggregate number of shares of common stock underlying such warrants increased on June 1, 2009 as the Bank
of America loan remained outstanding at that date and the Company had not reimbursed the Guarantors in full for payments made by them in connection
with the loan. The additional 131,281 warrant shares had an aggregate fair value of $73,516.




In accordance with the provisions
of the warrants issued to the Guarantors, the aggregate number of shares of common stock underlying such warrants increased on June 1, 2010 as the Bank
of America loan remained outstanding at that date and the Company had not reimbursed the Guarantors in full for payments made by them in connection
with the loan. The additional 239,392 warrant shares had an aggregate fair value of $111,790.




The amount of interest expense on
the principal amount of the loan for the nine months ended September 30, 2010 and 2009 totaled approximately $56,600 and $103,000, respectively. Fees
and interest earned by the Guarantors, which are recorded as interest expense, for the nine months ended September 30, 2010 and 2009 totaled
approximately $184,801 and $379,000, respectively. Interest due on the principal amount of the loan has been paid by the Guarantors. As of September
30, 2010 and December 31, 2009, that amount totaled approximately $441,269 and $693,000, respectively, and was included in accrued expenses at those
dates.




In March 2009, the Companys
Chief Technology Officer and his former spouse repaid $3.0 million of principal and a pro rata portion of accrued interest on behalf of the Company.
The Company then owed this $3.0 million to the Companys Chief Technology Officer and his former spouse. This liability was reflected on the
Companys consolidated balance sheet on a separate line titled Subordinated related party loan. This amount continued to accrue
interest at an annual rate of 4.75%.




In February 2010 the
Companys Chief Technology Officer and his spouse filed for divorce papers. Pursuant to the divorce, their jointly owned shares and their
ownership of the loan to Bioheart for which they hold as a result of their payment of $3 million of principal and related interest to Bank of America
on behalf of Bioheart, would be divided equally between them. As a result, the Chief Technology Officers common shares were then reduced to
2,513,840 and his percentage shareholding of the Company to 13.8%, with his former spouse assuming ownership of the same number of common shares and
percentage shareholding of the Company. Their commonly owned loan and related interest, as of March 29, 2010, of $4,140,201, was been equally split.
The Chief Technology Officer on March 29, 2010, elected to convert his portion of the loan and related interest to restricted common stock and
warrants. As a result, Howard Leonhardt, the Companys Chief Technology Officer, as of September 30, 2010, owns approximately 18% of the
Company.




In March of 2010, one of the
Guarantors paid directly to Bank of America the $666,600 of principal that he had been guaranteeing, and a pro rata portion of accrued interest on
behalf of the Company. That Guarantor agreed to accept from the Company the equivalent of his payment to Bank of America in restricted common stock and
warrants. With his acceptance of the restricted common stock and warrants, the former Guarantor owned, at September 30, 2010, approximately 6% of the
Company.




On July 16, 2010, the Company
received a written notice of default under the Bank of America loan documents by reason of the Companys failure to pay the loan in full at
maturity on July 5, 2010 and failure to pay the extension fee of $30,000 by June 28, 2010, as required by the loan documents, as amended. The Company
is engaged in discussions with the guarantors, who provided the loan collateral regarding a structuring of the indebtedness in the event Bank of
America seeks recourse against the collateral and those guarantors, by reason of such action, become successors to Bank of America rights and interests
under the Bank of America loan.




18


---



As of September 30, 2010, the
outstanding obligation to Bank of America was approximately $1.3 million plus interest.On October 25, 2010 the Company entered into a Loan Agreement
with Seaside National Bank and Trust for a $980,000 loan that was used to refinance the Companys loan with Bank of America. In addition, a member
of the Companys Board of Directors whom was also one of the guarantors of the Bank of America loan paid down the remaining debt of
$367,244.




BlueCrest Capital Finance Note
Payable




On June 1, 2007, the Company
closed on a $5.0 million senior loan from BlueCrest Capital Finance, L.P. with a term of 36 months which bears interest at an annual rate of 12.85%
(the BlueCrest Loan). The first three months required payment of interest only with equal principal and interest payments over the
remaining 33 months. As consideration for the loan, the Company issued to BlueCrest Capital Finance, L.P. a warrant to purchase 65,030 shares of common
stock at an exercise price of $7.69 per share. The warrant, which became exercisable one year following the date the warrant was issued, has a ten year
term. This warrant had a fair value of $432,635, which was accounted for as additional paid in capital and reflected as a component of deferred loan
costs and is being amortized as interest expense over the term of the loan using the effective interest method. The Company also paid the lender a fee
of $100,000 to cover diligence and other costs and expenses incurred in connection with the loan. On August 31, 2007, BlueCrest Capital Finance, L.P.
assigned its rights, liabilities, duties and obligations under the BlueCrest Loan and warrant to BlueCrest Venture Finance Master Fund Limited
(BlueCrest).




The loan may be prepaid in whole
but not in part. However, the Company is subject to a prepayment penalty equal to 3% of the outstanding principal if the BlueCrest Loan is prepaid
during the first year of the loan, 2% of the outstanding principal if prepaid during the second year of the loan and 1% of the outstanding principal if
prepaid during the third year of the loan. As collateral to secure its repayment obligations under the loan, the Company granted BlueCrest a first
priority security interest in all of the Companys assets, excluding intellectual property but including the proceeds from any sale of any of the
Companys intellectual property. The loan has certain restrictive terms and covenants including among others, restrictions on the Companys
ability to incur additional senior or pari-passu indebtedness or make interest or principal payments on other subordinate loans.




In the event of an uncured event
of default under the loan, all amounts owed to BlueCrest are immediately due and payable and BlueCrest has the right to enforce its security interest
in the assets securing the loan. During the continuance of an event of default, all outstanding amounts under the loan will bear interest (payable on
demand) at an annual rate of the 14.85%. In addition, any unpaid amounts are subject, until paid, to a service charge in an amount equal to two percent
(2%) of the unpaid amount. Events of default include, among others, the Companys failure to timely make payments of principal when due, the
Companys uncured failure to timely pay any other amounts owing to BlueCrest under the loan, the Companys material breach of the
representations and warranties contained in the loan agreement and the Companys default in the payment of any debt to any of its other lenders in
excess of $100,000 or any other default or breach under any agreement relating to such debt, which gives the holders of such debt the right to
accelerate the debt.




On January 2, 2009, the Company
failed to make the monthly payment of principal and interest of approximately $181,000 due on such date. On January 28, 2009, the Company received from
BlueCrest notice of this event of default (the Default Notice) under the BlueCrest Loan. By reason of the stated event, BlueCrest demanded
payment of a 2% late fee of approximately $3,600, together with the principal and interest payment of approximately $181,000. On February 2, 2009, the
Company received from BlueCrest notice of acceleration of the outstanding principal amount of the BlueCrest Loan and demanded repayment in full of all
outstanding principal and accrued interest on the loan, including late fees, in the aggregate amount of $2,947,045. (The acceleration notice, together
with the Default Notice, are referred to as the Notices).




19


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The Company and BlueCrest entered
into an amendment to the BlueCrest Loan as of April 2, 2009 (the  BlueCrest Loan Amendment), that, among other things, includes
BlueCrests agreement to forbear from exercising any of its rights or remedies regarding the defaults described in Notices (the
Forbearance) as long as there are no new defaults under the BlueCrest Loan, as amended.




The BlueCrest Loan Amendment, (a)
increases the amount of permitted unsecured indebtedness of the Company, (b) amended the amortization schedule for the Loan to provide for
interest-only payments until July 1, 2009, at which time monthly principal and interest payments of $262,692 will commence, and (c) prohibits the
Company from granting any lien against its intellectual property and grants to BlueCrest a lien against the Companys intellectual property that
will become effective in the event of a default. In addition, the Company issued BlueCrest a warrant to purchase 1,315,542 shares of the Companys
common stock at $0.53 per share.




In connection with the BlueCrest
Loan Amendment the Company paid BlueCrest accrued interest in the aggregate amount of $126,077. The Company also paid BlueCrest a fee of
$15,000.




Effective July 1, 2009, the
Company and BlueCrest agreed to enter into an amendment to the BlueCrest Loan to amend the amortization schedule for the Loan to provide for
interest-only payments until January 1, 2010, at which time monthly principal and interest payments of $139,728 will commence.




In connection with that Amendment
the Company issued BlueCrest a warrant to purchase $600,000 of the Companys common shares and paid a fee of $29,435.




Effective December 31, 2009, the
Company and BlueCrest entered into an amendment to the BlueCrest Loan to amend the amortization schedule for the Loan to provide for interest-only
payments until July 1, 2010, at which time monthly principal and interest payments of $139,728.82 will commence.




In connection with that
Amendment, the Company issued BlueCrest a warrant to purchase $600,000 of the Companys common shares and paid a fee of $20,000. The Company also
provided BlueCrest with a lien on its intellectual property.




The amount of interest expense on
the principal amount of the BlueCrest Loan for the nine months ended September 30, 2010 totaled approximately $276,671 and for the year ended December
31, 2009 the interest totaled approximately $378,231.




Short-term Note Payable




On August 20, 2008, the Company
borrowed $1.0 million from a third party pursuant to the terms of an unsecured Promissory Note and Agreement. Outstanding principal and interest on the
loan, which accrues at the rate of 13.5% per annum, is payable in one balloon payment upon the Companys repayment of the BlueCrest Loan. In the
event the Company completes a private placement of its common stock and/or securities exercisable for or convertible into its common stock which
generates at least $19.0 million of gross proceeds, the Company may prepay, without penalty, all outstanding principal and interest due under the loan
using the same type of securities issued in the subject private placement. Because repayment of the loan could occur within 12 months from the date of
the balance sheet, the Company has classified this loan as short term. Subject to certain conditions, at the end of each calendar quarter during the
time the loan is outstanding, the Company may, but is not required to, pay all or any portion of the interest accrued but unpaid as of such date with
shares of its common stock.




The amount of interest expense on
the principal amount of the loan accrued as of September 30, 2010 is $289,500. The Company has not paid any of the interest accrued to date under the
Promissory Note and Agreement.




20


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|6. |  | Related Party Transactions
|-- |  | --------------------------



The Companys Chief
Technology Officer has personally guaranteed the Companys obligations under its lease for its facilities in Sunrise, Florida and has provided a
personal guarantee for the Company credit card, which is for his use only.




In 2010, the Company entered into
a research agreement with an entity controlled as of September 30, 2010 by a current director and a former director of the Company, with funding for
the project emanating from venture capital funds controlled by the same two people. The director has since resigned from the Companys Board of
Directors. In connection with its funding of the REGEN trial, Ascent Medical Technology Fund II, LP, the Ascent Medical Technology Fund, LP, and Ascent
Medical Product Development Centre Inc. are being issued a total of 1,044,451 shares of the Companys common stock, and warrants to purchase
90,861 shares at exercise prices 20% above the price at which the related common will be issued.




In February 2010, the Company
sold to four members of the Board of Directors, in a private placement, an aggregate of 121,450 shares of the Companys common stock and warrants
to purchase 36,435 shares of the Companys common stock for aggregate gross cash proceeds of $70,441.




In February 2010 the
Companys Chief Technology Officer and his spouse filed for divorce. Pursuant to the divorce, their jointly owned shares and their ownership of
the loan to Bioheart which they hold as a result of their payment of $3 million of principal and related interest to Bank of America on behalf of
Bioheart, would be divided equally between them. As a result, the Chief Technology Officers common shares were then reduced to 2,513,840 and his
percentage shareholding of the Company to 13.8%, with his former spouse assuming ownership of the same number of common shares and percentage
shareholding of the Company. Their commonly owned loan and related interest, as of March 29, 2010, $4,140,201, was been equally split. The Chief
Technology Officer on March 29, 2010, elected to convert his portion of the loan and related interest to restricted common stock and warrants. As a
result, Howard Leonhardt, the Companys Chief Technology Officer, owns approximately 18% of the Company as of September 30, 2010.




During the nine month period
through September 2010 three Board Members and two Shareholders advanced the Company an aggregate of $776,246. As of October 22, 2010 the Company has
received notice that three of the individuals which to convert an aggregate of $426,246 to equity in the Company. The Company has executed Promissory
Notes for the remaining $350,000.


|7. |  | Shareholders Equity
|-- |  | --------------------



In September 2007, by way of a
written consent, the Companys shareholders holding a majority of its outstanding shares of common stock, the Companys shareholders approved
an amendment to Biohearts Articles of Incorporation, increasing the number of authorized shares of capital stock so that, following the reverse
stock split that was effectuated on September 27, 2007, the Company had 50 million shares of common stock authorized with a par value of $0.001 per
share and five million shares of preferred stock authorized with a par value of $0.001 per share.




As further discussed in Note 1,
on February 22, 2008 the Company completed its IPO pursuant to which it sold 1,100,000 shares of common stock at a price per share of $5.25 for net
proceeds of approximately $1.45 million after deducting underwriter discounts of approximately $400,000 and offering costs of approximately $3.92
million. The Consolidated Statement of Cash Flows for the year ended December 31, 2008 reflects the Companys receipt of approximately $4.24
million of Proceeds from (payments for) initial public offering of common stock, net. The $4.24 million cash proceeds figure is
approximately $2.79 million higher than the $1.45 million net proceeds figure identified above due to payment of $2.79 million of various offering
expenses prior to January 1, 2008.




21


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On August 6, 2008, the Company
amended its Articles of Incorporation to increase the number of authorized shares of its common stock from 50 million to 75 million shares. This
amendment was approved by the Companys shareholders at the Annual Meeting of Shareholders held on July 30, 2008.




In the nine month period ended
September 30, 2010, the Company sold in a private placement to accredited investors an aggregate of 8,731,085 shares of its common stock and warrants
to purchase 2,221,232 shares of its common stock for aggregate gross cash proceeds of approximately $1,143,065. The warrants are (i) exercisable solely
for cash at a weighted average exercise price of $ 0.69 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in
whole or in part, at any time and from time to time during the period commencing on the date that is six months and one day following the date of
issuance and ending on the third year anniversary of the date of issuance.




In December 2009, the Company
also sold in a private placement to accredited investors an aggregate of 255,830 shares of its common stock and warrants (the Warrants) to
purchase 76,749 shares of its common stock for aggregate gross cash proceeds of approximately $188,996. The Warrants are (i) exercisable solely for
cash at a weighted average exercise price of $0.89 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole
or in part, at any time and from time to time during the period commencing on the date that is six months and one day following the date of issuance
and ending on the third year anniversary of the date of issuance.




In 2009, the Company also sold in
a private placement to accredited investors, initiated in 2008, an aggregate of 2,509,480 shares of its common stock and warrants (the
Warrants) to purchase 752,844 shares of its common stock for aggregate gross cash proceeds of approximately $1,74 million. The Warrants are
(i) exercisable solely for cash at a weighted average exercise price of $0.83 per share, (ii) non-transferable for six months following issuance and
(iii) exercisable, in whole or in part, at any time and from time to time during the period commencing on the date that is six months and one day
following the date of issuance and ending on the third year anniversary of the date of issuance. In connection with the private placement, the Company
paid to a finder who introduced certain investors to the Company aggregate cash fees of $17,856 and warrants to purchase 26,592 shares of common stock
at a weighted average exercise price of $0.89 per share. The warrants issued to the finder have the same terms and conditions as the Warrants issued in
the private placement. The 2008 PIPE was closed on October 31, 2009, with total capital raised of $3,887,032.




In 2008, the Company also sold,
in a private placement to accredited investors, an aggregate of 1,230,280 shares of its common stock and warrants (the Warrants) to
purchase 369,084 shares of its common stock for aggregate gross cash proceeds of approximately $2.14 million. The Warrants are (i) exercisable solely
for cash at a weighted average exercise price of $2.09 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in
whole or in part, at any time and from time to time during the period commencing on the date that is six months and one day following the date of
issuance and ending on the third year anniversary of the date of issuance. In connection with the private placement, the Company paid to a finder who
introduced certain investors to the Company aggregate cash fees of $24,325 and warrants to purchase 24,325 shares of common stock at a weighted average
exercise price of $1.95 per share. The warrants issued to the finder have the same terms and conditions as the Warrants issued in the private
placement.




In 2007, the Company sold 529,432
shares of common stock at a price of $7.69 per share to various investors for net proceeds of approximately $3.9 million.




In 2006, the Company sold
1,069,699 shares of common stock at a price of $7.69 per share to accredited investors. The Company also issued 63,566 shares in exchange for services
at a price ranging from $5.67 to $7.69 per share.




22


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In 2005, the Company sold
1,994,556 shares of common stock at a price of $5.67 per share to accredited investors. The Company also issued 1,210 shares in exchange for services
and issued 95,807 shares in exchange for debt at a price of $5.67 per share.




In 2004, the Company sold 808,570
shares of common stock at a price of $5.67 per share to accredited investors. The Company also issued 1,854 shares to various vendors in exchange for
services valued at $10,500. The Company also issued 15,150 shares to the Companys Chief Science and Technology Officer as compensation for
services valued at $85,830.




In March 2003, the Company
effected a recapitalization. The recapitalization provided two shares of common stock for every one share issued as of that date. The Companys
Chief Technology Officer and founding shareholder, who owned 4,405,541 shares of common stock, did not participate in the recapitalization. The number
of shares and prices per share in the accompanying financial statements has been retroactively adjusted to reflect the effect of the
recapitalization.




After the 2003 recapitalization,
the Company sold 561,701 shares of common stock at a price of $5.67 per share to accredited investors. The Company issued 72,980 shares valued at
$416,383 to employees as compensation for services related to the closing of various locations. The Company also issued 4,248 shares to various vendors
in exchange for services valued at $24,066 and issued 67,073 shares to the Companys Chief Technology Officer as compensation for services
provided to the Company during 2003 and 2002.




In 2002, the Company sold
1,092,883 shares of common stock at a price of $6.47 per share to accredited investors. The Company also issued 35,137 shares to various vendors in
exchange for services valued at $227,503.




In 2001, the Company sold 985,668
shares of common stock at a price of $6.47 per share to accredited investors. The Company also issued 8,291 shares to various vendors in exchange for
services valued at $54,001 and issued 81,084 shares to the Companys Chief Technology Officer as compensation for services provided to the Company
during 2001.




In 2000, the Company sold
1,493,575 shares of common stock at a price of $6.47 per share to accredited investors. Of the 1,493,575 shares sold in 2000, payment on 77,222 of
these shares was not received until January 2001. The Company also issued 7,964 shares to various vendors in exchange for services valued at
$52,001.




In 1999, the Companys Chief
Technology Officer purchased 4,324,458 shares of common stock from the company for $400,000.


|8. |  | Stock Options and Warrants
|-- |  | --------------------------



Stock Options




In July 2008, the Board of
Directors approved, subject to shareholder approval, the establishment of the Bioheart Omnibus Equity Compensation Plan (the Omnibus Plan).
The establishment of the Omnibus Plan was approved by the Companys shareholders at the Annual Meeting of Shareholders held on July 30, 2008.
Pursuant to the Omnibus Plan, the Company may grant restricted stock, incentive stock options, non-statutory stock options, stock appreciation rights,
deferred stock, stock awards, performance shares, and other stock-based awards consisting of cash, restricted stock or unrestricted stock in various
combinations to the Companys employees, directors and consultants. 5,000,000 shares of common stock have been reserved for issuance under the
Omnibus Plan. As of December 31, 2008, no instruments had been issued under the Omnibus Plan.




23


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In December 1999, the Company
adopted two stock option plans; an employee stock option plan and a directors and consultants stock option plan (collectively referred to as the
Stock Option Plans), under which a total of 1,235,559 shares of common stock were reserved for issuance upon exercise of options granted by
the Company. In 2001, the Company amended the Stock Option Plans to increase the total shares of common stock reserved for issuance to 1,698,894. In
2003, the Company approved an increase of 308,890 shares, making the total 2,007,784 shares available for issuance under the Stock Option Plans. In
2006, the Company approved an increase of 1,081,114 shares, making the total 3,088,898 shares available for issuance under the Stock Option Plans. The
Stock Option Plans provide for the granting of incentive and non-qualified options. The terms of stock options granted under the Stock Option Plans are
determined by the Compensation Committee of the Board of Directors at the time of grant, including the exercise price, vesting provisions and
contractual term of such options. The exercise price of incentive stock options must equal at least the fair value of the common stock on the date of
grant, and the exercise price of non-qualified stock options may be no less than the per share par value. The options have terms of up to ten years
after the date of grant and become exercisable as determined upon grant, typically over either three or four year periods from the date of grant.
Certain outstanding options vested over a one-year period and some vested immediately. On February 24, 2010, by way of a written consent, the
Companys Board of Directors amended the Directors and Consultants 1999 Stock Option Plan to extend the termination date of the Plan to December
1, 2011.




A summary of options at September
30, 2010 and activity during the nine-month period then ended is presented below:







|                                          |  |  |  | Shares |           | Weighted-Average Exercise Price |  | Weighted-Average Remaining Contractual
Term (in years) |       | Aggregate Intrinsic Value
|----------------------------------------- |  |  |  | ------ | --------- | ------------------------------- |  | ------------------------------------------------------ | ----- | -------------------------
|Options
outstanding at January 1, 2010    |  |  |  |        | 2,119,431 |                                 |  | $                                                      | 3.28  |                          
|Granted                                   |  |  |  |        | 1,533,630 |                                 |  | $                                                      | 0.36  |                          
|Exercised                                 |  |  |  |        | 600,216   |                                 |  | $                                                      | 0.001 |                          
|Forfeited                                 |  |  |  |        | 753,532   |                                 |  | $                                                      | 2.41  |                          
|Options
outstanding at September 30, 2010 |  |  |  |        | 2,299,313 |                                 |  | $                                                      | 2.84  |                          
|Options
exercisable at September 30, 2010 |  |  |  |        | 1,547,990 |                                 |  | $                                                      | 3.89  |                          
|Available for
grant at September 30, 2010 |  |  |  |        | 517,376   |                                 |  |                                                        |       |                          



The aggregate intrinsic value
represents the amount by which the fair market value of the Companys common stock exceeds the exercise price of options at September 30, 2010.
The weighted average fair value of options granted in the nine-month periods ended September 30, 2010 and 2009 was $0.46 and $0.55 per share,
respectively. The total intrinsic value of options exercised in the nine month periods ended September 30, 2010 was $382,588.




For the nine month period ended
September 30, 2010, the Company recognized $141,894 in stock based compensation expense. This amount consisted of $79,965 in stock-based compensation
that was included in research and development expenses and $61,929 that was included in marketing, general and administrative
expenses.




For the three month period ended
September 30, 2010, the Company recognized $47,298 in stock based compensation expense. This amount consisted of $26,655 in stock-based compensation
that was included in research and development expenses and $20,643 that was included in marketing, general and administrative expenses. No tax benefits
were attributed to the stock-based compensation expense because a valuation allowance was maintained for all net deferred tax assets. The Company
elected to adopt the alternative method




24


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of calculating the historical
pool of windfall tax benefits as permitted by ASC Topic 718, formerly FSP No. SFAS 123R-c, Transition Election Related to Accounting for the Tax
Effects of Share-Based Payment Awards. This is a simplified method to determine the pool of windfall tax benefits that is used in determining the
tax effects of stock compensation in the results of operations and cash flow reporting for awards that were outstanding as of the adoption of ASC Topic
718, formerly SFAS No. 123R.




The following information applies
to options outstanding and exercisable at September 30, 2010:


|             |  |  |  | Options Outstanding |           | Options Exercisable | 
|------------ |  |  |  | ------------------- | --------- | ------------------- | 
|
|$0.001$0.70 |  |  |  |                     | 829,398   |                     | 
|$0.71$1.28  |  |  |  |                     | 474,666   |                     | 
|$5.25$5.67  |  |  |  |                     | 948,881   |                     | 
|$7.69        |  |  |  |                     | 39,572    |                     | 
|$8.47        |  |  |  |                     | 6,796     |                     | 
|             |  |  |  |                     | 2,299,313 |                     | 



The Company uses the
Black-Scholes valuation model to determine the fair value of options on the date of grant. This model derives the fair value of options based on
certain assumptions related to expected stock price volatility, expected option life, risk-free interest rates and dividend yield. The Companys
expected volatility is based on the historical volatility of other publicly traded development stage companies in the same industry. Prior to January
1, 2008, the Company estimated the expected term for stock option grants by review of similar data from a peer group of companies. The Company adopted
SAB 110 effective January 1, 2008 and will apply the simplified method in SAB 107 until enough historical experience is readily available to provide a
reasonable estimate of the expected term for stock option grants. The risk-free interest rate assumption is based upon the U.S. Treasury yield curve
appropriate for the term of the expected life of the options.




For the nine-month periods ended
September 30, 2010 and 2009, the fair value of each option grant was estimated on the date of grant using the following weighted-average
assumptions.







|                                  |  |  |  | For the Nine Months ended September 30, |     
|--------------------------------- |  |  |  | --------------------------------------- | ----
|
|Expected
dividend yield           |  |  |  |                                         | 0.0 
|Expected
price volatility         |  |  |  |                                         | 187 
|Risk free
interest rate           |  |  |  |                                         | 2.75
|Expected life
of options in years |  |  |  |                                         | 4   



During the nine-month period
ended September 30, 2010, the Company issued options to purchase an aggregate of 1,533,630 shares of its common stock at a weighted average exercise
price of $0.36 per share. These options consisted of the following:


| |  | stock options to purchase an aggregate of 307,692 shares of
common stock at an exercise price of $0.001 per share issued to a related party as discussed in Note 6. The options vested immediately upon issuance
and will expire on the tenth anniversary of the issuance date.
|- |  | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



25


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| |  | stock options to purchase an aggregate of 292,524 shares of
common stock at an exercise price of $0.001 per share issued to Consultants. The options vested immediately upon issuance and will expire on the tenth
anniversary of the issuance date.
|- |  | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| |  | stock options to purchase an aggregate of 250,000 shares of
common stock at an exercise price of $0.68 per share issued to certain members of the Companys Board of Directors. The options vested immediately
upon issuance and will expire on the tenth anniversary of the issuance date.
|- |  | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| |  | stock option to purchase 50,000 shares of common stock at an
exercise price of $0.92 per share issued to certain members of the Companys Board of Directors. The options vested immediately upon issuance and
will expire on the tenth anniversary of the issuance date.
|- |  | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| |  | stock options to purchase an aggregate of 133,414 shares of
common stock at an exercise price of $0.68 per share issued to employees. The options vest in 4 equal annual installments, commencing one month after
the date of grant, and will expire on the tenth anniversary of the issuance date.
|- |  | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| |  | stock options to purchase 500,000 shares of common stock at an
exercise price of $0.50 per share issued to an employee. The options vest in 4 equal annual installments, commencing one year after the date of grant,
and will expire on the tenth anniversary of the issuance date.
|- |  | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



In its meeting of August 17,
2009, the Board of Directors approved the repricing of current employees stock options (other than Executive Officers). In accordance with
regulations concerning such a repricing and in conformance with generally accepted procedures, all options granted before August 12, 2008, were
repriced on the basis of the 5-day average closing price of BHRT, during the period of August 11 through August 17, 2009.




The following information applies
to the repricing which occurred as of October 8, 2009.







|Original Exercise Price |  |  |  | New Exercise Price |  | Number of shares underlying
Options
|----------------------- |  |  |  | ------------------ |  | -----------------------------------
|$1.28                   |  |  |  | $0.71              |  |                                    
|$4.11                   |  |  |  | $0.71              |  |                                    
|$5.67                   |  |  |  | $0.71              |  |                                    
|$7.69                   |  |  |  | $0.71              |  |                                    
|$8.47                   |  |  |  | $0.71              |  |                                    
|                        |  |  |  |                    |  |                                    



Of those options listed above,
61,778 expired in December 2009 without having been exercised, 308,891 expired in March 2010 without having been exercised, 959 expired in August 2010
without having been exercised and 18,844 expired in September 2010 without having been exercised.




Warrants to Purchase Common Stock




The Company does not have a
formal plan in place for the issuance of common stock purchase warrants. However, at times, the Company will issue warrants to non-employees or in
connection with financing transactions. The exercise price, vesting period, and term of these warrants is determined by the Companys Board of
Directors at the time of issuance. A summary of warrants at September 30, 2010 and activity during the nine-month period then ended is presented
below:




26


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|                                  |  |  |  | Shares |           | Weighted-Average Exercise Price |  | Weighted-Average Remaining Contractual
Term (in years) |      | Aggregate Intrinsic Value
|--------------------------------- |  |  |  | ------ | --------- | ------------------------------- |  | ------------------------------------------------------ | ---- | -------------------------
|Outstanding
at January 1, 2010    |  |  |  |        | 7,355,057 |                                 |  | $                                                      | 3.06 |                          
|Issued                            |  |  |  |        | 2,719,927 |                                 |  | $                                                      | 1.65 |                          
|Exercised                         |  |  |  |        | 0         |                                 |  | $                                                      | 0.00 |                          
|Forfeited                         |  |  |  |        | 128,040   |                                 |  | $                                                      | 0.74 |                          
|Outstanding
at September 30, 2010 |  |  |  |        | 9,946,944 |                                 |  | $                                                      | 2.70 |                          
|Exercisable
at September 30, 2010 |  |  |  |        | 7,008,715 |                                 |  | $                                                      | 2.01 |                          



The Company uses the
Black-Scholes valuation model to determine the fair value of warrants on the date of issuance. The Companys expected volatility is based on the
historical volatility of other publicly traded development stage companies in the same industry. The expected life of the warrants is based primarily
on the contractual life of the warrants. The risk-free interest rate assumption is based upon the U.S. Treasury yield curve appropriate for the term of
the expected life of the warrants.




The Company did not issue any
warrants that require Fair Value Calculation during the quarter ended September 30, 2010. For the period ended September 30, 2009, the fair value of
warrants issued in transactions that resulted in the recognition of expense, was estimated on the date of issuance using the following weighted-average
assumptions.







|                                  |  |  |  | For the Nine Month Period ended September 30, |    
|--------------------------------- |  |  |  | --------------------------------------------- | ---
|
|Expected
dividend yield           |  |  |  |                                               | n/a
|Expected
price volatility         |  |  |  |                                               | n/a
|Risk free
interest rate           |  |  |  |                                               | n/a
|Expected life
of options in years |  |  |  |                                               | n/a



The following information applies
to warrants outstanding and exercisable at September 30, 2010:







|            |  |  |  | Warrants Outstanding |           | Warrants Exercisable | 
|----------- |  |  |  | -------------------- | --------- | -------------------- | 
|
|$0.01$0.50 |  |  |  |                      | 170,180   |                      | 
|$0.52$0.68 |  |  |  |                      | 3,776,909 |                      | 
|$0.70$1.62 |  |  |  |                      | 2,649,454 |                      | 
|$1.81$2.61 |  |  |  |                      | 427,119   |                      | 
|$3.60$4.93 |  |  |  |                      | 105,000   |                      | 
|$5.67$7.69 |  |  |  |                      | 2,818,282 |                      | 
|            |  |  |  |                      | 9,946,944 |                      | 



27


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| |  | During the nine month period ended September 30, 2010, the
Company issued warrants to purchase an aggregate of 2,349,254 shares of its common stock at a weighted average exercise price of $0.69 per share. These
warrants were issued in connection with a private placement. The warrant vests six months following issuance and expires on the third year anniversary
of the date of issuance.
|- |  | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| |  | During the nine month period ended September 30, 2010 the
Company recognized issuance of warrants to purchase an aggregate of 370,673 shares of its common stock at a weighted average exercise price of $7.69
per share. These warrants were issued in connection with the guarantee of the Bank of America Loan  See, Bank of America Note Payable, in
Note 5, Notes Payable, Notes to Consolidated Interim Financial Statements
|- |  | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

|9. |  | Legal Proceedings
|-- |  | -----------------



The Company is not subject to any
legal proceedings.


|10. |  | Contingency
|--- |  | -----------



The Company believes that it may
have issued options to purchase common stock to certain of its employees, directors and consultants in California in violation of the registration or
qualification provisions of applicable California securities laws. As a result, the Company intends to make a rescission offer to these persons. The
Company will make this offer to all persons who have a continuing right to rescission, which it believes to include two persons. In the rescission
offer, in accordance with California law, the Company will offer to repurchase all unexercised options issued to these persons at 77% of the option
exercise price multiplied by the number of option shares, plus interest at the rate of 7% from the date the options were granted. Based upon the number
of options that were subject to rescission as of December 31, 2009, assuming that all such options are tendered in the rescission offer, the Company
estimated that its total rescission liability would be up to approximately $371,000. However, as the Company believes there is only a remote likelihood
the rescission offer will be accepted by any of these persons in an amount that would result in a material expenditure by the Company, no liability was
recorded as of September 30, 2010 or December 31, 2009.


|11. |  | Supplemental Disclosure of Cash Flow
Information
|--- |  | ------------------------------------------------



During the nine months ended
September 30, 2010 and December 31, 2009, the Company issued warrants in connection with the renewal of the BlueCrest loan with an aggregate fair value
of $687,677 and $1,580,575, respectively.




During the nine month period
ended September 30, 2010 the Company recognized issuance of warrants in connection with the guarantee of the Bank of America Loan with an aggregate
fair value of $185,306.




For the nine months ended
September 30, 2010 the Company issued Common Stock in connection with the settlement of Accounts Payable with an aggregate value of
$133,594.




For the nine months ended
September 30, 2010 the Company issued Common Stock in connection with amount due to loan guarantor for payment of $666,600 to Bank of
America.




For the nine months ended
September 30, 2010 the Company issued Common Stock in connection with payment of the subordinated related party loan for $1,500,000.




For the nine months ended
September 30, 2010 the Company issued Common Stock in connection with the payment of accrued interest and loans fees due to Bank of America loan
guarantors for $798,770.




28


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12. Subsequent
Events




Private Placement  Common Stock and
Warrants




During the nine month period
ended September 30, 2010, the Company sold, an aggregate of 8,731,085 shares of the Companys common stock and warrants to purchase 2,221,232
shares of the Companys common stock for aggregate gross cash proceeds of $1,199,651. The warrants are (i) exercisable solely for cash at an
exercise price of $0.18 to $0.84 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any
time during the period commencing on the date that is six months and one day following the date of issuance and ending on the third year anniversary of
the date of issuance.




During October 2010, the Company
sold, an aggregate of 520,620 shares of the Companys common stock and warrants to purchase 260,310 shares of the Companys common stock for
aggregate gross cash proceeds of $78,093. The warrants are (i) exercisable solely for cash at an exercise price of $0.18 per share, (ii)
non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time during the period commencing on the date
that is six months and one day following the date of issuance and ending on the third year anniversary of the date of issuance.




Defaults Upon Senior Securities




On July 16, 2010, the Company
received a written notice of default under the Bank of America loan documents by reason of the Companys failure to pay the loan in full at
maturity on July 5, 2010 and failure to pay the extension fee of $30,000 by June 28, 2010, as required by the loan documents, as amended. On October
25, 2010 the Company entered into a Loan Agreement with Seaside National Bank and Trust for a $980,000 loan that was used to refinance the
Companys loan with Bank of America. In addition, a member of the Companys Board of Directors whom was also one of the guarantors of the
Bank of America loan paid down the remaining debt of $367,244. See, Bank of America Note Payable, in Note 5, Notes Payable, Notes to
Consolidated Interim Financial Statements.




Other Information




On October 26, 2010, Bioheart,
Inc. (the Company) received a written notice of termination of Customer Agreement and Distribution Agreement, dated as of March 15, 2007
and December 12, 2006 respectively (as amended from time to time, the TGI Agreements), between Tissue Genesis Incorporated and the Company.
The notice stated that it is being given as a result of breach of the payment obligations under the agreement. The letter also indicated that Tissue
Genesis Incorporated was open to discussing collaborations with the Company in the future.




On October 28, 2010, the Company
received a letter from Karl E. Groth, Ph.D. resigning as a Director and as the Chairman of the Board of Directors. His resignation did not indicate as
a reason any dispute with the Board of Directors, or the management of the Company and a copy of this current report on Form 8-K was furnished to the
director for review prior to its filing.




On November 2, 2010, the Board of
Directors of Bioheart, Inc. (the Company) appointed William P. Murphy, Jr., M.D. as the Companys Chairman of the Board. Dr. Murphy
has served as a member of the Companys Board of Directors since June 2003. Dr. Murphys experience in the healthcare industry and medical
background together with his experience serving on the Companys Board of Directors makes him well-qualified to serve as Chairman of the Board of
Directors.




29


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|Item
2. |  | Managements Discussion and Analysis of Financial
Condition and Results of Operations
|------- |  | -------------------------------------------------------------------------------------



Unless otherwise indicated,
references in this Quarterly Report on Form 10-Q to we, us, and our are to the Company. The following discussion
and analysis by our management of our financial condition and results of operations should be read in conjunction with our unaudited consolidated
interim financial statements and the accompanying related notes included in this quarterly report and our audited consolidated financial statements and
related notes and Managements Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K
and on Form 10-K/A for the year ended December 31, 2009 filed with the Securities and Exchange Commission.




Cautionary Statement Regarding Forward-Looking
Statements




This report may contain
forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we intend that
such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements are based on our managements
beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in
Managements Discussion and Analysis of Financial Condition and Results of Operations and Risk Factors. Forward-looking
statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive
position, industry environment, potential growth opportunities and the effects of regulation. Forward-looking statements include all statements that
are not historical facts and can be identified by terms such as anticipates, believes, could,
estimates, expects, hopes, intends, may, plans, potential,
predicts, projects, should, will, would or similar expressions.




Forward-looking statements
involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed or implied by the forward-looking statements. We discuss many of these risks
in greater detail in Risk Factors. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
Also, forward-looking statements represent our managements beliefs and assumptions only as of the date of this report. You should read this
report and the documents that we reference in this report and have filed as exhibits to the report completely and with the understanding that our
actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update these
forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking
statements, even if new information becomes available in the future.




Additional information concerning
these and other risks and uncertainties is contained in our filings with the Securities and Exchange Commission, including the section entitled
Risk Factors in our Annual Report on Form 10-K and on Form 10-K/A for the year ended December 31, 2009.




Our Ability To Continue as a Going
Concern




Our independent registered public
accounting firm has issued its report dated, March 31, 2010, in connection with the audit of our financial statements as of December 31, 2009, that
included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern.
Our consolidated financial statements as of September 30, 2010 have been prepared under the assumption that we will continue as a going concern. If we
are not able to continue as a going concern, it is likely that holders of our common stock will lose all of their investment. Our financial statements
do not include any adjustments that might result from the outcome of this uncertainty.




30


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Overview




We are committed to maintaining a
leading position within the cardiovascular sector of the cell technology industry, delivering cell therapies, intelligent devices and biologics that
help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. We work to prevent
the worsening of heart failure conditions with devices that monitor and diagnose. Our goals are to cause damaged tissue to be regenerated, if possible,
and to improve a patients quality of life and reduce health care costs and hospitalizations.




Biotechnology Product Candidates




Specific to biotechnology, we are
focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic
and acute heart damage and peripheral vascular disease. MyoCell is a clinical muscle-derived cell therapy designed to populate regions of scar tissue
within a patients heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. Our most recent
clinical trials of MyoCell include the MARVEL trial, a phase II/III US trial, the SEISMIC Trial, a completed 40-patient, randomized, multicenter,
controlled, Phase II-a study conducted in Europe and the MYOHEART Trial, a completed 20-patient, multicenter, Phase I dose-escalation trial conducted
in the United States. We were approved by the U.S. Food and Drug Administration (the FDA) to proceed with a 330 patient, multicenter Phase
II/III trial of MyoCell in North America and Europe (the MARVEL Trial). We completed the MyoCell implantation procedure on the first
patient in the MARVEL Trial on October 24, 2007. Thus far, 20 patients, including 6 control patients, have been treated. Initial results for the 20
patients were released at the Heart Failure Society of American meeting in October, 2009, showing a dramatic (35%) improvement in 6 minute walk
distance for those patients who were treated, and less distance from baseline for those who received a placebo. We are planning, on the basis of these
results, to ask the FDA to consider the MARVEL Trial a pivotal trial (pivotal from Phase II to Phase III) and to reduce the number of patients in the
trial to 150 from 330. The SEISMIC, MYOHEART and MARVEL Trials have been designed to test the safety and efficacy of MyoCell in treating patients with
severe, chronic damage to the heart. Upon regulatory approval of MyoCell or MyoCell SDF-1, our second generation therapy, discussed below, we intend to
generate revenue in the United States from the sale of cell-culturing services for treatment of patients by qualified physicians. Abroad, we are
identifying centers where it is acceptable to use the MyoCell and MyoCell SDF-1 treatments so that patients with this problem can have access to
treatment.




We received approval from the FDA
in July of 2009 to conduct a Phase I safety study on 15 patients of a combined therapy (Myocell with SDF-1), the first approval of a study combining
gene and cell therapies. Work commenced on this study, called the REGEN trial, during the first quarter of 2010. Based on the results of the trial, we
intend to either incorporate the combination treatment into the MARVEL trial, or continue with the MARVEL trial based on the use of MyoCell
alone.




In our pipeline, we have multiple
product candidates for the treatment of heart damage, including an autologous, adipose cell treatment for heart damage and MyoCell® SDF-1. Tissue
Genesis, Inc., the entity from whom we have obtained the worldwide right to sell or lease the TGI 1200TM adipose tissue processing system announced on November 13, 2008 that the TGI 1200TM had been certified with a CE Marking, thus making the system available throughout the European marketplace. We understand that
Tissue Genesis is in the process of evaluating the regulatory pathway that should be pursued for the TGI 1200TM device. We hope to demonstrate that our various product candidates are safe and effective complements to existing
therapies for chronic and acute heart damage as well as peripheral arterial disease.




MyoCath




The MyoCath was developed by
Bioheart co-founder Robert Lashinski specifically for delivering new cells to damaged tissue. It is a deflecting tip needle injection catheter that has
a larger needle which is 25




31


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gauge for better flow rates
and less leakage than systems that are 27 gauge. This larger needle allows for thicker compositions to be injected which helps with cell retention in
the heart. Also, the MyoCath needle has more fluoroscopic brightness than the normally used nitinol needle, enabling superior visualization during the
procedure. Seeing the needle well during injections enables the physician who is operating the catheter to pinpoint targeted areas more precisely, thus
improving safety. The MyoCath competes well with other biological delivery systems on price and efficiency and allows the physician to utilize standard
fluoroscopy and echo equipment found in every cath lab. The MyoCath is used to inject cells into cardiac tissue in therapeutic procedures to treat
chronic heart ischemic and congestive heart failure. As of September 30, 2010 all finished goods inventory of MyoCath had expired. The Company is
considering several contract manufacturers to produce additional inventory.




Center of Excellence Program




On March 23, 2010, the Company
announced plans for establishing five Centers of Excellence in Latin America to provide its cell therapy procedures to patients suffering from
congestive heart failure (CHF) and peripheral arterial disease (PAD). Bioheart entered into its first agreement with a leading treatment facilitator,
Regenerative Medicine Institute of Tijuana, Mexico. Therapies for CHF and PAD patients will be made available at the Hospital Angeles Tijuana, a fully
equipped state-of-the-art private specialties hospital. This is the first of five Centers of Excellence with four additional Centers to be announced in
the coming months




On April 14, 2010, the Company
announced that treatment with stem cell therapy on two congestive heart failure (CHF) patients was performed successfully at the Hospital Angeles
Tijuana, Mexico, through Biohearts Center of Excellence program with Regenerative Medicine Institute.




In August of 2010, the Company
announced that stem cell treatments and 3 month follow up on the first two congestive heart failure patients have been performed successfully. To date,
four patients have been treated utilizing an autologous, adipose tissue-derived cell treatment. Two of the patients have completed the 3-month
follow-up testing. Significant improvements were seen in both the 6-minute walk as well as the left ventricular ejection fraction (LVEF). The first
patient improved his walking distance from 315 to 420 meters and LVEF from 32% to 38%. The second patient improved his walking distance from 450 to 492
meters and LVEF from 40% to 55%.




Intelligent Devices  Distribution
Agreements




Effective as of April 3, 2008, we
entered into a distribution agreement with RTX Healthcare A/S (Denmark) (RTX) pursuant to which we secured worldwide, non-exclusive
distribution rights to the Bioheart 3370 Heart Failure Monitor, an interactive and simple-to-use at-home intelligent device designed specifically to
improve available healthcare to patients outside hospitals who are suffering from heart failure. The device, manufactured by RTX, has 510(k) market
clearance from the U.S. Food and Drug Administration for marketing in the United States and CE mark approval for marketing in Europe and other
countries that follow this mark. The compact Bioheart 3370 Heart Failure Monitor engages patients through personalized daily interactions and
questions, while collecting vital signs and transmitting the information directly into a database. The data are regularly monitored by a remotely
located medical professional, who watches for any abnormal readings that may signal a change in the patients health status. These changes are
reported back to the treating physician. We do not have any minimum purchase commitment under the agreement. However, the per unit purchase price
payable by us is inversely related to the number of units we purchase per annum. The distribution agreement has an initial term of two years and is
subject to automatic renewal for additional one-year periods unless either party indicates an intent to terminate the agreement prior to the end of the
then current term. The distribution agreement may be terminated by either party upon the other partys default.




The company has signed
distribution agreements with Restoration Medical, McRay Medical, Alamo Scientific and Morey Medical. These distributors will assist Bioheart with
introducing its Home Heart Failure




32


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Monitoring Systems to
physicians, home healthcare agencies and hospitals throughout the United States. McRay Medical will distribute the systems in Northern California;
Alamo Scientific will distribute in Texas, Louisiana and Arkansas; Morey Medical will distribute in Okalahoma and parts of Kansas; Restoration Medical
will distribute the monitoring systems in the rest of the country.




Effective as of October 22, 2009,
the Company entered into a distribution agreement with Morey Medical Inc. pursuant to which Morey was granted exclusive rights to market and promote
the Bioheart 3370-1 Heart Failure Monitor throughout a specific territory. In consideration for identifying purchasers who purchase or rent the
Bioheart 3370-1 Heart Failure Monitor from the Company, the Company will pay to Morey a set fee. Morey is required to meet certain quarterly minimum
purchase commitments under the agreement. The agreement has an initial term of one year and is subject to automatic renewal for additional one-year
periods unless either party indicates intent to terminate the agreement no less than 60 days prior to the end of the then current
term.




Effective as of December 10,
2009, the Company entered into a distribution agreement with McRay Medical, LLC, pursuant to which McRay was granted exclusive rights to market and
promote the Bioheart 3370-1 Heart Failure Monitor throughout a specific territory. In consideration for identifying purchasers who purchase or rent the
Bioheart 3370-1 Heart Failure Monitor from the Company the Company will pay to McRay a set fee. McRay is required to meet certain quarterly minimum
purchase commitments under the agreement. The agreement has an initial term of one year and is subject to automatic renewal for additional one-year
periods unless either party indicates intent to terminate the agreement no less than 60 days prior to the end of the then current
term.




Effective as of October 22, 2009,
the Company entered into a distribution agreement with Alamo Scientific, Inc. pursuant to which Alamo was granted exclusive rights to market and
promote the Bioheart 3370-1 Heart Failure Monitor throughout a specific territory. In consideration for identifying purchasers who purchase or rent the
Bioheart 3370-1 Heart Failure Monitor from the Company the Company will pay to Alamo a set fee. Alamo is required to meet certain quarterly minimum
purchase commitments under the agreement. The agreement has an initial term of one year and is subject to automatic renewal for additional one-year
periods unless either party indicates intent to terminate the agreement no less than 60 days prior to the end of the then current
term.




Effective as of December 18,
2009, the Company entered into a distribution agreement with Restoration Medical Inc. pursuant to which Restoration was granted exclusive rights to
market the Bioheart 3370-1 Heart Failure Monitoring System throughout those territories not covered by Morey Medical, McRay Medical and Alamo
Scientific. In consideration for identifying purchasers who purchase or lease the Bioheart 3370-1 Heart Failure Monitoring System from the Company, the
Company will pay to Restoration a set fee. Restoration is required to meet certain quarterly minimum purchase commitments under the agreement. The
agreement has an initial term of one year and is subject to automatic renewal for additional one-year periods unless either party indicates intent to
terminate the agreement no less than 60 days prior to the end of the then current term.




The heart failure monitors are
reimbursed by Medicare to home health companies. In 2009, reimbursement was added to the National Episode Rate for cardiac patients. The monitors in
conjunction with the nurses visit are essential to the well being of chronic heart failure patients. Care Plan Oversight (CPO) reimbursement also
allows physicians to bill Medicare for their time overseeing the care of home care or hospice patients.




The Company has placed the
program on hold as it seeks to secure the additional funding necessary to further develop our device related software.




33


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Operations




We conduct operations in one
business segment. We may organize our business into more discrete business units when and if we generate significant revenue from the sale of our
product candidates. Substantially all of our revenue since inception has been generated in the United States, and the majority of our long-lived assets
are located in the United States.




Critical Accounting Policies




Our discussion and analysis of
our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and
assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. We base our estimates on historical experience and on
various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the
carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under
different assumptions or conditions. While our critical accounting policies are described in Note 1 to our consolidated financial statements appearing
elsewhere in this report, we believe the following policies are important to understanding and evaluating our reported financial
results:




Stock-Based Compensation




On January 1, 2006, we adopted
the provisions of Statement of Financial Accounting Standards No. 123R, Share-Based Payment (SFAS No. 123R) using the modified
prospective transition method. SFAS No. 123R requires us to measure all share-based payment awards granted after January 1, 2006, including those with
employees, at fair value. Under SFAS No. 123R, the fair value of stock options and other share-based compensation must be recognized as expense in the
statements of operations over the requisite service period of each award.




The fair value of share-based
awards granted subsequent to January 1, 2006 is determined using the Black-Scholes valuation model and compensation expense is recognized on a
straight-line basis over the vesting period of the awards. Beginning January 1, 2006, we also began recognizing compensation expense under SFAS No.
123R for the unvested portions of outstanding share-based awards previously granted under our stock option plans, over the periods these awards
continue to vest. Our future share-based compensation expense will depend on the number of equity instruments granted and the estimated value of the
underlying common stock at the date of grant.




We account for certain
share-based awards, including warrants, with non-employees in accordance with SFAS No. 123R and related guidance, including EITF Issue No. 96-18,
Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods or Services. We
estimate the fair value of such awards using the Black-Scholes valuation model at each reporting period and expense the fair value over the vesting
period of the share-based award, which is generally the period in which services are provided.




Revenue Recognition




Since inception, we have not
generated any material revenues from our MyoCell product candidate. In accordance with Staff Accounting Bulletin No. 101, Revenue Recognition in
Financial Statements, as amended by SEC Staff Accounting Bulletin No. 104, Revenue Recognition, our revenue policy is to recognize revenues
from product sales and service transactions generally when persuasive evidence of an arrangement exists, the price is fixed or determined, collection
is reasonably assured and delivery of product or service has occurred.




34


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We initially recorded payments
received by us pursuant to our agreements with ACS as deferred revenue. Revenues are recognized on a pro rata basis as the catheters are delivered
pursuant to those agreements.




Research and Development
Activities




Research and development
expenditures, including payments to collaborative research partners, are charged to expense as incurred. We expense amounts paid to obtain patents or
acquire licenses as the ultimate recoverability of the amounts paid is uncertain.




Results of Operations




We are a development stage
company and neither our MyoCell product candidate nor our other product candidates has received regulatory approval or generated any material revenues
and neither is expected to in the near future, if ever. We have generated substantial net losses and negative cash flow from operations since inception
and anticipate incurring significant net losses and negative cash flows from operations for the foreseeable future as we continue clinical trials,
undertake new clinical trials, apply for regulatory approvals, make capital expenditures, add information systems and personnel, make payments pursuant
to our license agreements upon our achievement of certain milestones, continue development of additional product candidates using our technology,
establish sales and marketing capabilities and incur the additional cost of operating as a public company.




Comparison of the three and nine months ended September 30,
2010 and 2009




Revenues




We recognized revenues of $6,422
in the three month period ended September 30, 2010 compared to revenues of $17,250 in the three month period ended September 30, 2009. Our revenue in
the three month period ended September 30, 2010 was generated mainly from the sale of Cardio Devices and TGI Products and the revenue in the three
month period ended September 30, 2009 was also generated from the sale of MyoCath catheters and TGI Products.




We recognized revenues of $42,888
in the nine month period ended September 30, 2010 compared to revenues of $224,135 in the nine month period ended September 30, 2009. Our revenue in
the nine month period ended September 30, 2010 was generated mainly from the sale of Cardio Devices and Myocath catheters, and the revenue in the nine
month period ended September 30, 2009 was generated mainly from the sale of MyoCath catheters.




Cost of Sales




Cost of sales was $2,827 in the
three month period ended September 30, 2010 compared to $10,933 in the three month period ended September 30, 2009.




Cost of sales was $19,626 in the
nine month period ended September 30, 2010 compared to $123,714 in the nine month period ended September 30, 2009.




Research and Development




Research and development expenses
were approximately $173,800 in the three month period ended in September 30, 2010, an decrease of approximately $1,050,200 from research and
development expenses of $1,224,000 in same three month period in 2009. The decrease was primarily attributable to the reduction in the amount of funds
allocated to our clinical trials.




35


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Research and development expenses
were approximately $1,267,400 in the nine month period ended in September 30, 2010, an decrease of approximately $998,300 from research and development
expenses of $2,265,700 in same nine month period in 2009. The decrease was primarily attributable to the reduction in the amount of funds allocated to
our clinical trials.




The timing and amount of our
planned research and development expenditures is dependent on our ability to obtain additional financing. See  Existing Capital
Resources and Future Capital Requirements and Item 1A. Risk Factors  We will need to secure additional financing
....




Marketing, General and Administrative




Marketing, general and
administrative expenses were approximately $430,900 in the three month period ended September 30 2010, a decrease of $116,500 from marketing, general
and administrative expenses of approximately $547,400 in the same three month period in 2009. The decrease in marketing, general and administrative
expenses is attributable, in part, to a decrease in legal fees.




Marketing, general and
administrative expenses were approximately $1,244,950 in the nine month period ended September 30 2010, a decrease of approximately $422,000 from
marketing, general and administrative expenses of approximately $1,666,500 in the same nine month period in 2009. The decrease in marketing, general
and administrative expenses is attributable, in part, to a decrease in insurance, legal and rent expenses.




Interest Income




Interest income consists of
interest earned on our cash and cash equivalents. Interest income was $.43 in the three months ended September 30. 2010 compared to interest income of
$2 in the same three month period ended September 30, 2009. Interest income was $2 in the nine month period ended September 30, 2010 compared to
interest income of $18 in the same nine month period in 2009. The decrease in interest income was primarily attributable to lower cash balances in the
three and nine month period ended September 30, 2010 and 2009.




Interest Expense




On June 1, 2007, we entered into
the BlueCrest Loan and the Bank of America Loan, both in the principal amount of $5.0 million, with interest rates of 12.85% and 4.75% (prime plus
1.5%), respectively, at December 31, 2008. On August 20, 2008, we borrowed $1.0 million from a third party at an interest rate of 13.5% per annum.
Interest expense primarily consists of interest incurred on the principal amount of these loans, accrued fees and interest earned by the guarantors of
the Bank of America Loan, the amortization of related deferred loan costs and the amortization of the fair value of warrants issued in connection with
the BlueCrest and Bank of America Loans. The fair value of the warrants originally issued in connection with the Bank of America Loan was amortized by
the end of January 2008.




Interest expense was $567,348 in
the three month period ended September 30, 2010 compared to interest expense of $428,796 in the same three month period in 2009. Interest incurred on
the principal amount of our outstanding loans and interest and fees earned by the guarantors totaled $190,423 in the three month period ended September
30, 2010 and $310,834 in the same three month period in 2009. Amortization of deferred loan costs and amortization of the fair value of warrants issued
in connection with the BlueCrest and Bank of America loans totaled $376,925 in the three month period ended September 30, 2010 compared to $117,962 in
the same three month period in 2009.




Interest expense was $1,705,762
in the nine month period ended September 30, 2010 compared to interest expense of $1,764,604 in the same nine month period in 2009. Interest incurred
on the principal amount of our outstanding loans and interest and fees earned by the guarantors totaled $719,755 in the nine month
period




36


---



ended September 30, 2010 and
$896,839 in the same nine month period in 2009. Amortization of deferred loan costs and amortization of the fair value of warrants issued in connection
with the BlueCrest and Bank of America loans totaled $986,006 in the nine month period ended September 30, 2010 compared to $867,765 in the same nine
month period in 2009.




Liquidity and Capital Resources




In the nine month period ended
September 30, 2010, we continued to finance our considerable operational cash needs with cash generated from financing activities.




Operating Activities




Net cash used in operating
activities was $1,109,386 in the nine month period ended September 30, 2010 as compared to $1,477,979 of cash used in the same nine month period in
2009.




Our use of cash for operations in
the nine months ended September 30, 2010 reflected a net loss generated during the period of $4.1 million, adjusted for non-cash items such as
stock-based compensation of $141,894, amortization of the fair value of warrants granted in connection with the BlueCrest Loan and Bank of America loan
of $731,491, amortization of loan costs incurred in connection with the BlueCrest Loan and Bank of America Loan of $69,208. An increase in prepaid and
other current assets of $32,159 and an increase in accounts payable of $135,063 contributed to our use of operating cash in 2010. The increase in
prepaid expenses and other current assets was due mainly to the increase in prepaid insurance. Partially offsetting these uses of cash were in increase
in accrued expenses of $962,215.




Investing Activities




Net cash used in investing
activities was $0.00 for the nine month period ended September 30, 2010, compared to $2,019 for the same nine month period in 2009. There were none
investing activities for the nine month periods ended September 30, 2010.




Financing Activities




Net cash provided by financing
activities was $1,179,651 in the nine month period ended September 30, 2010 as compared to $1,517,425 for the same nine month period in
2009.




Existing Capital Resources and Future Capital
Requirements




Neither our MyoCell product
candidate nor our other product candidates has received regulatory approval or generated any material revenues. We do not expect to generate any
material revenues or cash from sales of our MyoCell and other product candidates in the near future, if ever. We have generated substantial net losses
and negative cash flow from operations since inception and anticipate incurring significant net losses and negative cash flows from operations for the
foreseeable future. Historically, we have relied on proceeds from the sale of our common stock and our additional debt to provide the funds necessary
to conduct our research and development activities and to meet our other cash needs.




At September 30, 2010 we had cash
and cash equivalents totaling $145,296. However, our working capital deficit as of such date was $11.8 million. Our independent registered public
accounting firm has issued its report dated March 31, 2010 in connection with the audit of our financial statements as of December 31, 2009 that
included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going
concern.




37


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Off-Balance Sheet Arrangements




We do not have any off-balance
sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition,
revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.




Recent Accounting Pronouncements




Refer to Note 1. Organization
and Summary of Significant Accounting Policies in the notes to our consolidated financial statements for a discussion of recent accounting
pronouncements.


|Item
3. |  | Quantitative and Qualitative Disclosures About Market
Risk
|------- |  | ----------------------------------------------------------



Not Applicable.


|Item
4. |  | Controls and Procedures
|------- |  | -----------------------



Disclosure Controls and Procedures




We have established disclosure
controls and procedures to ensure that material information relating to us is made known to the officers who certify our financial reports, as well as
to other members of senior management and the Board of Directors.




We carried out an evaluation,
under the supervision and with the participation of our management, including our Principal Executive Officer, as well as our Principal Financial and
Accounting Officer of the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the
Exchange Act as of the end of the period covered by this quarterly report on Form 10-Q. Based on such evaluation, our Principal Executive Officer, as
well as our Principal Financial and Accounting Officer concluded that, as of September 30, 2010, our disclosure controls and procedures were effective.
In making this assessment, we used the criteria set forth in Internal Control-Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission.




This Quarterly Report on Form
10-Q does not, and is not required to, include an attestation report of the Companys independent registered public accounting firm regarding
internal control over financial reporting.




Changes In Internal Control Over Financial
Reporting




There were no changes in our
internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended
September 30, 2010 that have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.




38


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PART II  OTHER INFORMATION


|Item
1. |  | Legal Proceedings
|------- |  | -----------------



Our company is not involved in
any material litigation and we are unaware of any threatened material litigation. However, the biotechnology and medical device industries have been
characterized by extensive litigation regarding patents and other intellectual property rights. In addition, from time to time, we may become involved
in litigation relating to claims arising from the ordinary course of our business.


|Item
1A. |  | Risk Factors
|-------- |  | ------------



In addition to the risk factors
disclosed in our Annual Report on Form 10K and 10K/A for the fiscal year ended December 31, 2009 the Company believes there are the additional risk
factors related to our products, business, and financial condition;




We may not be able to obtain additional inventory of our
essential MyoCath Catheter.




Our current inventory has been
exhausted and while the company endeavors to contract with a manufacturer for additional inventory there is no assurance that it will be successful in
identifying or contracting with a manufacturer on acceptable terms. Our inability to obtain additional MyoCath inventory would have a material adverse
affect on our business, financial condition and ability to continue as a going concern.




Our Software based devices may develop software
errors.




The software that enables some of
our devices is early stage and when tested in the field may develop or reveal software errors requiring further software development. There can be no
assurance that we will have sufficient funds to adequately test, develop, or where appropriate fix our device related software which could have a
material adverse effect on our business, financial condition and ability to continue as a going concern.




The management of the REGEN Trial is within the control of
persons whom are no longer affiliates of the Company.




The company with whom we
contracted to manage our REGEN Trial at the time was managed by two persons who were members of our Board of Directors. These persons since have
resigned as Officers and Directors of the Company. Although at this time we believe that this former related party intends to perform its REGEN Trial
related obligations under its agreement with us, a default in the performance of those obligations could have a material adverse effect on our business
and financial condition.


|Item
2. |  | Unregistered Sales of Equity Securities and Use of
Proceeds
|------- |  | -----------------------------------------------------------



Private Placement  Common Stock and
Warrants




From January 2010 thru June 2010,
the Company sold, in a private placement, an aggregate of 1,512,890 shares of the Companys common stock and warrants to purchase 2,051,052 shares
of the Companys common stock for aggregate gross cash proceeds of $858,041.00. The warrants are (i) exercisable solely for cash at an exercise
price of $0.54 to $0.84 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time
during the period commencing on the date that is six months and one day following the date of issuance and ending on the third year anniversary of the
date of issuance.




39


---



In July 2010, the Company sold,
in a private placement, an aggregate of 1,460,135 shares of the Companys common stock for aggregate gross cash proceeds of
$219,020.




In August 2010, the Company sold,
in a private placement, an aggregate of 93,750 shares of the Companys common stock for aggregate gross cash proceeds of $15,000.




In September 2010, the Company
sold, in a private placement, an aggregate of 340,360 shares of the Companys common stock and warrants to purchase 170,180 shares of the
Companys common stock for aggregate gross cash proceeds of $51,054. The warrants are (i) exercisable solely for cash at an exercise price of
$0.18 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time during the period
commencing on the date that is six months and one day following the date of issuance and ending on the third year anniversary of the date of
issuance.




Each of the listed sales was
exempt from registration in reliance upon Section 4(s) of the Securities Act of 1933, as amended (the Securities Act), for transactions by
an issuer not involving a public offering. The offer and sale of such securities was made without general solicitation or advertising to
accredited investors as defined in Rule 501(a) of Regulation D promulgated by the Securities Act.


|Item
3. |  | Defaults Upon Senior Securities
|------- |  | -------------------------------



On July 16, 2010, the Company
received a written notice of default under the Bank of America loan documents by reason of the Companys failure to pay the loan in full at
maturity on July 5, 2010 and failure to pay the extension fee of $30,000 by June 28, 2010, as required by the loan documents, as amended. The Company
is engaged in discussions with the guarantors, who have provided the loan collateral, regarding a restructuring of the indebtedness in the event Bank
of America seeks recourse against the collateral and those guarantors, by reason of such action, become successors to the Bank of America rights and
interests under the Bank of America Loan. On October 25, 2010 the Company entered into a Loan Agreement with Seaside National Bank and Trust for a
$980,000 loan that was used to refinance the Companys loan with Bank of America. In addition, a member of the Companys Board of Directors
whom was also one of the guarantors of the Bank of America loan paid down the remaining debt of $367,244. See, Bank of America Note Payable, in
Note 5, Notes Payable, Notes to Consolidated Interim Financial Statements.


|Item
4. |  | Removed and Reserved
|------- |  | --------------------

|Item
5. |  | Other Information
|------- |  | -----------------



As reported in the Companys
Current Report on Form 8-K, filed with the Securities and Exchange Commission on July 9, 2010, the Board of Directors of the Company appointed
Catherine Sulawske-Guck as Chief Operating Officer. Ms. Sulawske-Guck has served as the Vice President of Administration and Human Resources since
January 2007. She joined Bioheart in the full-time capacity as Director of Administration and Human Resources in January 2004 after having served in a
consulting capacity since December 2001.




On July 20, 2010, the Company
announced that it closed its offering under Regulation D (the Offering). The Company received total gross cash proceeds in the amount of
$1,046,986 from the placement of restricted common stock and warrants under the Offering. The number of shares of common stock issued in connection
with the Offering was 1,768,720 shares. The Company also issued to the purchasers of those shares of common stock, warrants to purchase an additional
530,616 shares of common stock. Total compensation paid to third parties consisted of $4,350 in cash and warrants to purchase 2,456 shares of common
stock. In addition, the Company issued 5,323,950 shares of common stock in consideration for $3,207,075 of outstanding nonconvertible debt, and issued
to the holders of that debt warrants to purchase an additional 1,597,185 shares of common stock.




40


---



On August 13, 2010 Peggy A.
Farley resigned as a director of the Company.




As reported in the Companys
Current Report on Form 8-K, filed with the Securities and Exchange Commission on September 28, 2010, the Board of Directors of the Company appointed
Kristin Comella as Chief Science Officer. Ms. Comella joined Bioheart in September 2004 and has served as the Vice President of Research and Corporate
Development since December 2008. Ms. Comella holds an M.S. in Chemical Engineering from The Ohio State University. Howard Leonhardt will continue to
serve as Founder and Chief Technology Officer and Chairman of the Scientific Advisory Board.




On September 29, 2010 the Company
announced that it closed its offering under Regulation D (the Offering). The Company received total gross cash proceeds in the amount of
$234,020 from the placement of restricted common stock under the Offering. The number of shares of common stock issued in connection with the Offering
was 1,553,885 shares.




As reported in the Companys
Current Report on Form 8-K, filed with the Securities and Exchange Commission on November 1, 2010 Bioheart, Inc. (the Company) received a
written notice of termination of Customer Agreement and Distribution Agreement, dated as of March 15, 2007 and December 12, 2006 respectively (as
amended from time to time, the TGI Agreements), between Tissue Genesis Incorporated and the Company on October 26, 2010. The notice stated
that it is being given as a result of breach of the payment obligations under the agreement. The letter also indicated that Tissue Genesis Incorporated
was open to discussing collaborations with the Company in the future.




As reported in the Companys
Current Report on Form 8-K, filed with the Securities and Exchange Commission on November 3, 2010, the Company received a letter from Karl E. Groth,
Ph.D. on October 28, 2010 resigning as a Director and as the Chairman of the Board of Directors. His resignation did not indicate as a reason any
dispute with the Board of Directors, or the management of the Company and a copy of this current report on Form 8-K was furnished to the director for
review prior to its filing.




As reported in the Companys
Current Report on Form 8-K, filed with the Securities and Exchange Commission on November 3, 2010, the Board of Directors of Bioheart, Inc. (the
Company) appointed William P. Murphy, Jr., M.D. as the Companys Chairman of the Board on November 2, 2010. Dr. Murphy has served as a
member of the Companys Board of Directors since June 2003. Dr. Murphys experience in the healthcare industry and medical background
together with his experience serving on the Companys Board of Directors makes him well-qualified to serve as Chairman of the Board of
Directors.




41


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|Item
6. |  | Exhibits
|------- |  | --------






|Exhibit No. |  |  |  | Exhibit Description                                                                                                                                         
|----------- |  |  |  | ------------------------------------------------------------------------------------------------------------------------------------------------------------
|3.1(6)      |  |  |  | Amended and Restated Articles of Incorporation of the registrant, as amended                                                                                
|3.2(9)      |  |  |  | Articles of Amendment to the Articles of Incorporation of the registrant                                                                                    
|3.3(8)      |  |  |  | Amended and Restated Bylaws                                                                                                                                 
|4.1(5)      |  |  |  | Loan and Security Agreement, dated as of May 31, 2007 by and between BlueCrest Capital Finance, L.P. and the registrant                                     
|4.2(12)     |  |  |  | Notice of Event of Default, from BlueCrest Venture Finance Master Fund Limited to the Company, dated January 28, 2009                                       
|4.3(12)     |  |  |  | Notice of Acceleration, from BlueCrest Venture Finance Master Fund Limited to the Company, dated February 2, 2009                                           
|4.4(13)     |  |  |  | Amendment to Loan and Security Agreement, between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2,
2009                  
|4.5(13)     |  |  |  | Grant of Security Interest (Patents), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2,
2009                      
|4.6(13)     |  |  |  | Security Agreement (Intellectual Property), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2,
2009                
|4.7(13)     |  |  |  | Subordination Agreement, by Hunton & Williams, LLP in favor of BlueCrest Venture Finance Master Fund Limited, entered into and effective
April 2, 2009      
|4.8(13)     |  |  |  | Amended and Restated Promissory Note, dated April 2, 2009, by the Company to BlueCrest Venture Finance Master Fund Limited                                  
|4.9(13)     |  |  |  | Warrant to purchase 1,315,542 shares of the registrants common stock, dated April 2, 2009, issued to BlueCrest Venture Finance Master
Fund Limited         
|4.10(14)    |  |  |  | Warrant to purchase 451,043 shares of the registrants common stock, dated April 2, 2009, issued to Rogers Telecommunications
Limited                       
|4.11(14)    |  |  |  | Warrant to purchase 173,638 shares of the registrants common stock, dated April 2, 2009, issued to Hunton & Williams,
LLP                                  
|10.1**(1)   |  |  |  | 1999 Officers and Employees Stock Option Plan                                                                                                               
|10.2**(1)   |  |  |  | 1999 Directors and Consultants Stock Option Plan                                                                                                            
|10.2(a)     |  |  |  |                                                                                                                                                             
|10.3(1)     |  |  |  | Form of Option Agreement under 1999 Officers and Employees Stock Option Plan                                                                                
|10.4(3)     |  |  |  | Form of Option Agreement under 1999 Directors and Consultants Stock Option Plan                                                                             
|10.5**(4)   |  |  |  | Employment Letter Agreement between the registrant and Scott Bromley, dated August 24, 2006.                                                                
|10.6(1)     |  |  |  | Lease Agreement between the registrant and Sawgrass Business Plaza, LLC, as amended, dated November 14, 2006.                                               
|10.7(1)     |  |  |  | Asset Purchase Agreement between the registrant and Advanced Cardiovascular Systems, Inc., dated June 24, 2003.                                             
|10.8(4)     |  |  |  | Conditionally Exclusive License Agreement between the registrant, Dr. Peter Law and Cell Transplants International, LLC, dated February 7,
2000, as amended.
|10.9(4)     |  |  |  | Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the registrant, Howard J. Leonhardt and Brenda
Leonhardt           
|10.10(4)    |  |  |  | Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the registrant and William P. Murphy Jr.,
M.D.                     
|10.11(4)    |  |  |  | Loan Agreement, dated as of June 1, 2007, by and between the registrant and Bank of America, N.A.                                                           
|10.12(4)    |  |  |  | Warrant to purchase shares of the registrants common stock issued to Howard J. Leonhardt and Brenda Leonhardt                                              
|10.13(4)    |  |  |  | Warrant to purchase shares of the registrants common stock issued to Howard J. Leonhardt and Brenda Leonhardt                                              



42


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|Exhibit No. |  |  |  | Exhibit Description                                                                                                                                             
|----------- |  |  |  | ----------------------------------------------------------------------------------------------------------------------------------------------------------------
|10.14(4)    |  |  |  | Warrant to purchase shares of the registrants common stock issued to William P. Murphy Jr., M.D.                                                               
|10.15(4)    |  |  |  | Warrant to purchase shares of the registrants common stock issued to the R&A Spencer Family Limited Partnership                                                
|10.16(4)    |  |  |  | Supply and License Agreement, dated June 7, 2007, by and between the registrant and BioLife Solutions, Inc.***                                                  
|10.17(5)    |  |  |  | Warrant to purchase shares of the registrants common stock issued to BlueCrest Capital Finance, L.P.                                                           
|10.18(6)    |  |  |  | Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the registrant and Samuel S. Ahn,
M.D.                           
|10.19(6)    |  |  |  | Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the registrant and Dan Marino                                    
|10.20(6)    |  |  |  | Warrant to purchase shares of the registrants common stock issued to Samuel S. Ahn, M.D.                                                                       
|10.21(6)    |  |  |  | Loan Guarantee, Payment and Security Agreement, dated as of September 19, 2007, by and between the registrant and Jason
Taylor                                  
|10.22(7)    |  |  |  | Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and Howard and Brenda
Leonhardt                     
|10.23(7)    |  |  |  | Warrant to purchase shares of the registrants common stock issued to Howard and Brenda Leonhardt                                                               
|10.24(7)    |  |  |  | Second Amendment to Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and Howard and
Brenda Leonhardt 
|10.25(7)    |  |  |  | Second Amendment to Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and William P.
Murphy, Jr., M.D.
|10.26**(10) |  |  |  | Bioheart, Inc. Omnibus Equity Compensation Plan                                                                                                                 
|10.27(11)   |  |  |  | Form of Warrant Agreement for October 2008 Private Placement                                                                                                    
|10.28(11)   |  |  |  | Form of Registration Rights Agreement for October 2008 Private Placement                                                                                        
|10.29(19)   |  |  |  | 10% Convertible Promissory Note Due July 23, 2010, in the amount of $20,000, payable to Dana Smith                                                              
|10.30(19)   |  |  |  | 10% Convertible Promissory Note Due July 23, 2010, in the amount of $100,000, payable to Bruce Meyers                                                           
|10.31(19)   |  |  |  | Registration Rights Agreement, dated July 23, 2009                                                                                                              
|10.32(19)   |  |  |  | Subordination Agreement, dated July 23, 2009                                                                                                                    
|10.33(19)   |  |  |  | Note Purchase Agreement, dated July 23, 2009                                                                                                                    
|10.34(19)   |  |  |  | Closing Confirmation of Conversion Election, dated July 23, 2009                                                                                                
|           
|31.1*       |  |  |  | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002                                          
|31.2*       |  |  |  | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002                                          






|* |  | Filed herewith
|- |  | --------------

|** |  | Indicates management contract or compensatory plan.
|-- |  | ---------------------------------------------------

|(1) |  | Incorporated by reference to the Companys Form S-1 filed
with the Securities and Exchange Commission on February 13, 2007
|--- |  | --------------------------------------------------------------------------------------------------------------------------

|(2) |  | Reserved
|--- |  | --------

|(3) |  | Incorporated by reference to Amendment No. 2 to the
Companys Form S-1 filed with the Securities and Exchange Commission on July 12, 2007
|--- |  | -----------------------------------------------------------------------------------------------------------------------------------------



43


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|(4) |  | Incorporated by reference to Amendment No. 3 to the
Companys Form S-1 filed with the Securities and Exchange Commission on August 9, 2007
|--- |  | ------------------------------------------------------------------------------------------------------------------------------------------

|(5) |  | Incorporated by reference to Amendment No. 4 to the
Companys Form S-1 filed with the Securities and Exchange Commission on September 6, 2007
|--- |  | ---------------------------------------------------------------------------------------------------------------------------------------------

|(6) |  | Incorporated by reference to Amendment No. 5 to the
Companys Form S-1 filed with the Securities and Exchange Commission on October 1, 2007
|--- |  | -------------------------------------------------------------------------------------------------------------------------------------------

|(7) |  | Incorporated by reference to Post-effective Amendment No. 1 to
the Companys Form S-1 filed with the Securities and Exchange Commission on October 11, 2007
|--- |  | -----------------------------------------------------------------------------------------------------------------------------------------------------------

|(8) |  | Incorporated by reference to the Companys Current Report
on Form 8-K filed with the Securities and Exchange Commission on July 3, 2008
|--- |  | ---------------------------------------------------------------------------------------------------------------------------------------

|(9) |  | Incorporated by reference to the Companys Current Report
on Form 8-K filed with the Securities and Exchange Commission on August 8, 2008
|--- |  | -----------------------------------------------------------------------------------------------------------------------------------------

|(10) |  | Incorporated by reference to the Companys Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2008
|---- |  | ---------------------------------------------------------------------------------------------------------------------------------------------

|(11) |  | Incorporated by reference to the Companys Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2008
|---- |  | -----------------------------------------------------------------------------------------------------------------------------------------------

|(12) |  | Incorporated by reference to the Companys Current Report
on Form 8-K filed with the Securities and Exchange Commission on February 3, 2009
|---- |  | -------------------------------------------------------------------------------------------------------------------------------------------

|(13) |  | Incorporated by reference to the Companys Current Report
on Form 8-K filed with the Securities and Exchange Commission on April 8, 2009
|---- |  | ----------------------------------------------------------------------------------------------------------------------------------------

|(14) |  | Incorporated by reference to the Companys Annual Report on
Form 10-K filed with the Securities and Exchange Commission on April 15, 2009
|---- |  | -----------------------------------------------------------------------------------------------------------------------------------------

|(15) |  | Incorporated by reference to the Companys Annual Report on
Form 10-K/A filed with the Securities and Exchange Commission on April 30, 2009
|---- |  | -------------------------------------------------------------------------------------------------------------------------------------------

|(16) |  | Incorporated by reference to the Companys Current Report
on Form 8-K filed with the Securities and Exchange Commission on May 18, 2009
|---- |  | ---------------------------------------------------------------------------------------------------------------------------------------

|(17) |  | Incorporated by reference to the Companys Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission on May 20, 2009
|---- |  | ------------------------------------------------------------------------------------------------------------------------------------------

|(18) |  | Incorporated by reference to the Companys Current Report
on Form 8-K filed with the Securities and Exchange Commission on July 9, 2009
|---- |  | ---------------------------------------------------------------------------------------------------------------------------------------

|(19) |  | Incorporated by reference to the Companys Current Report
on Form 8-K filed with the Securities and Exchange Commission on July 23, 2009
|---- |  | ----------------------------------------------------------------------------------------------------------------------------------------

|(20) |  | Incorporated by reference to the Companys Current Report
on Form 8-K filed with the Securities and Exchange Commission on August 3, 2009
|---- |  | -----------------------------------------------------------------------------------------------------------------------------------------

|(21) |  | Incorporated by reference to the Companys Current Report
on Form 8-K filed with the Securities and Exchange Commission on August 18, 2009
|---- |  | ------------------------------------------------------------------------------------------------------------------------------------------

|(22) |  | Incorporated by reference to Exhibit 4.6 to the Companys
Post Effective Amendment to Registration Statement on Form S-8/A, filed with the Securities and Exchange Commission on April 28, 2010
|---- |  | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



44


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SIGNATURES




Pursuant to the requirements 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.







|                        |  |  |  | Bioheart, Inc.                                                     
|----------------------- |  |  |  | -------------------------------------------------------------------
|                       
|Date: November
15, 2010 |  |  |  | By: /s/ Mike Tomas Mike Tomas Chief Executive Officer and President



45


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