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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549



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FORM 10-Q



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|x | Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
|- | ----------------------------------------------------------------------------------------



For the quarterly period ended September 30, 2004



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: 0-22419



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CARDIMA, INC.

(Exact name of registrant as specified in its charter)



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|                                                               |  |                                     
|-------------------------------------------------------------- |  | ------------------------------------
|Delaware                                                       |  | 94-3177883                          
|(State or Other Jurisdiction of Incorporation or Organization) |  | (I.R.S. Employer Identification No.)



47266 Benicia
Street, Fremont, CA 94538-7330

(Address of Principal Executive Offices) (Zip Code)



Registrants telephone number, including area code: (510) 354-0300



---



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) had been subject to such filing requirements for the past 90 days.    x  Yes ̈No



Indicate by check mark whether the registrant is an accelerated filer (as
defined in Rule 12b-2 of the Securities Exchange Act of 1934). ̈Yes    x  No



As of October 31,
2004, there were 84,840,174 shares of Registrants Common Stock outstanding.



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##### Table of Contents

CARDIMA, INC.



TABLE OF CONTENTS



PART I. Financial
Information



|                           |  |                                                                                                    |  |   
|-------------------------- |  | -------------------------------------------------------------------------------------------------- |  | --
|Description                |  | Page                                                                                              
|                           |  |                                                                                                   
|Item 1.                    |  | Financial Statements (unaudited)                                                                   |  | 3 
|                           |  |                                                                                                   
|                           |  | Condensed Balance Sheets as of September 30, 2004 and December 31, 2003                            |  | 3 
|                           |  |                                                                                                   
|                           |  | Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2004 and 2003 |  | 4 
|                           |  |                                                                                                   
|                           |  | Condensed Statement of Cash Flows for the Nine Months Ended September 30, 2004 and 2003            |  | 5 
|                           |  |                                                                                                   
|                           |  | Notes to Condensed Financial Statements                                                            |  | 6 
|                           |  |                                                                                                   
|Item 2.                    |  | Managements Discussion and Analysis of Financial Condition and Results of Operations              |  | 12
|                           |  |                                                                                                   
|                           |  | Factors Affecting Future Results                                                                   |  | 18
|                           |  |                                                                                                   
|Item 3.                    |  | Quantitative and Qualitative Disclosure About Market Risk                                          |  | 37
|                           |  |                                                                                                   
|Item 4.                    |  | Controls and Procedures                                                                            |  | 37
|                           | 
|PART II. Other Information |  |                                                                                                   
|                           | 
|Description                |  | Page                                                                                              
|                           |  |                                                                                                   
|Item 1.                    |  | Legal Proceedings                                                                                  |  | 38
|                           |  |                                                                                                   
|Item 2.                    |  | Unregistered Sales of Equity Securities and Use of Proceeds                                        |  | 38
|                           |  |                                                                                                   
|Item 3.                    |  | Defaults Upon Senior Securities                                                                    |  | 38
|                           |  |                                                                                                   
|Item 4.                    |  | Submission of Matters to a Vote of Security Holders                                                |  | 38
|                           |  |                                                                                                   
|Item 5.                    |  | Other Information                                                                                  |  | 38
|                           |  |                                                                                                   
|Item 6.                    |  | Exhibits                                                                                           |  | 39
|                           | 
|Signatures                 |  | 39                                                                                                



2



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##### Table of Contents

PART I.



Item 1.Financial Statements



CARDIMA, INC.

CONDENSED BALANCE SHEETS

(In thousands, except share amounts)



|                                                                                                                                                                                                                        |  |                              |          |   |                      |   |          |  
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |  | ---------------------------- | -------- | - | -------------------- | - | -------- | -
|                                                                                                                                                                                                                        |  | September 30,2004(Unaudited) |          |   | December 31,2003 (1) |  
|ASSETS                                                                                                                                                                                                                  |  |                              |          |   |                      |   |          |  
|Current assets:                                                                                                                                                                                                         |  |                              |          |   |                      |   |          |  
|Cash and cash equivalents                                                                                                                                                                                               |  | $                            | 2,081    |   |                      | $ | 6,446    |  
|Accounts receivable, net of $85 allowances for doubtful accounts at September 30, 2004 and $87 at December 31, 2003                                                                                                     |  |                              | 247      |   |                      |   | 299      |  
|Inventories                                                                                                                                                                                                             |  |                              | 757      |   |                      |   | 991      |  
|Prepaid expenses                                                                                                                                                                                                        |  |                              | 602      |   |                      |   | 325      |  
|Other current assets                                                                                                                                                                                                    |  |                              | 23       |   |                      |   | 31       |  
|                                                                                                                                                                                                                        |  |                              |          |   |                      |   |          |  
|Total current assets                                                                                                                                                                                                    |  |                              | 3,710    |   |                      |   | 8,092    |  
|Property and equipment, net                                                                                                                                                                                             |  |                              | 414      |   |                      |   | 554      |  
|Notes receivable from officers                                                                                                                                                                                          |  |                              | 572      |   |                      |   | 626      |  
|Other assets                                                                                                                                                                                                            |  |                              | 38       |   |                      |   | 38       |  
|                                                                                                                                                                                                                        |  |                              |          |   |                      |   |          |  
|                                                                                                                                                                                                                        |  | $                            | 4,734    |   |                      | $ | 9,310    |  
|                                                                                                                                                                                                                        |  |                              |          |   |                      |   |          |  
|LIABILITIES AND STOCKHOLDERS EQUITY                                                                                                                                                                                    |  |                              |          |   |                      |   |          |  
|Current liabilities:                                                                                                                                                                                                    |  |                              |          |   |                      |   |          |  
|Accounts payable                                                                                                                                                                                                        |  | $                            | 1,005    |   |                      | $ | 910      |  
|Accrued compensation                                                                                                                                                                                                    |  |                              | 668      |   |                      |   | 869      |  
|Warrant liability                                                                                                                                                                                                       |  |                              |         |   |                      |   | 658      |  
|Other current liabilities                                                                                                                                                                                               |  |                              | 287      |   |                      |   | 279      |  
|Credit obligation                                                                                                                                                                                                       |  |                              | 189      |   |                      |   | 125      |  
|Capital lease obligation - current portion                                                                                                                                                                              |  |                              | 36       |   |                      |   | 42       |  
|                                                                                                                                                                                                                        |  |                              |          |   |                      |   |          |  
|Total current liabilities                                                                                                                                                                                               |  |                              | 2,185    |   |                      |   | 2,883    |  
|                                                                                                                                                                                                                        |  |                             
|Deferred rent                                                                                                                                                                                                           |  |                              | 46       |   |                      |   | 45       |  
|Capital lease obligation - noncurrent portion                                                                                                                                                                           |  |                              | 57       |   |                      |   | 82       |  
|                                                                                                                                                                                                                        |  |                              |          |   |                      |   |          |  
|Total liabilities                                                                                                                                                                                                       |  |                              | 2,288    |   |                      |   | 3,010    |  
|                                                                                                                                                                                                                        |  |                              |          |   |                      |   |          |  
|Commitments and Contingencies                                                                                                                                                                                           |  |                              |          |   |                      |   |          |  
|                                                                                                                                                                                                                        |  |                             
|Stockholders equity:                                                                                                                                                                                                   |  |                              |          |   |                      |   |          |  
|Common stock, $0.001 par value; 150,000,000 shares authorized, 84,790,174 shares issued and outstanding at September 30, 2004; 125,000,000
shares authorized, 80,333,798 issued and outstanding as of December 31, 2003 |  |                              | 113,869  |   |                      |   | 109,988  |  
|Accumulated deficit                                                                                                                                                                                                     |  |                              | (111,423 | ) |                      |   | (103,688 | )
|                                                                                                                                                                                                                        |  |                              |          |   |                      |   |          |  
|Total stockholders equity                                                                                                                                                                                              |  |                              | 2,446    |   |                      |   | 6,300    |  
|                                                                                                                                                                                                                        |  |                              |          |   |                      |   |          |  
|                                                                                                                                                                                                                        |  | $                            | 4,734    |   |                      | $ | 9,310    |  
|                                                                                                                                                                                                                        |  |                              |          |   |                      |   |          |  

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|(1) | The balance sheet as of December 31, 2003 was derived from the audited financial statements included in the Companys 2003 Annual Report on Form 10-K filed with the Securities
and Exchange Commission, but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.
|--- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



See accompanying notes to condensed financial statements



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CARDIMA, INC.

CONDENSED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)



|                                                              |  |                                 |        |   |                                 |   |        |      |  |   |        |   |  |   |         |  
|------------------------------------------------------------- |  | ------------------------------- | ------ | - | ------------------------------- | - | ------ | ---- |  | - | ------ | - |  | - | ------- | -
|                                                              |  | Three months endedSeptember 30, |        |   | Nine months ended September 30, |  
|                                                              |  | 2004                            |        |   | 2003                            |   |        | 2004 |  |   | 2003   |  
|Net sales                                                     |  | $                               | 569    |   |                                 | $ | 561    |      |  | $ | 1,783  |   |  | $ | 1,690   |  
|Cost of goods sold                                            |  |                                 | 893    |   |                                 |   | 709    |      |  |   | 2,121  |   |  |   | 2,347   |  
|                                                              |  |                                 |        |   |                                 |   |        |      |  |   |        |   |  |   |         |  
|Gross margin                                                  |  |                                 | (324   | ) |                                 |   | (148   | )    |  |   | (338   | ) |  |   | (657    | )
|                                                              |  |                                 |        |   |                                 |   |        |      |  |   |        |   |  |   |         |  
|Operating expenses:                                           |  |                                 |        |   |                                 |   |        |      |  |   |        |   |  |   |         |  
|Research and development                                      |  |                                 | 1,016  |   |                                 |   | 1,098  |      |  |   | 3,208  |   |  |   | 3,811   |  
|Selling, general and administrative                           |  |                                 | 1,370  |   |                                 |   | 1,603  |      |  |   | 4,145  |   |  |   | 5,296   |  
|                                                              |  |                                 |        |   |                                 |   |        |      |  |   |        |   |  |   |         |  
|Total operating expenses                                      |  |                                 | 2,386  |   |                                 |   | 2,701  |      |  |   | 7,353  |   |  |   | 9,107   |  
|                                                              |  |                                 |        |   |                                 |   |        |      |  |   |        |   |  |   |         |  
|Operating loss                                                |  |                                 | (2,710 | ) |                                 |   | (2,849 | )    |  |   | (7,691 | ) |  |   | (9,764  | )
|                                                              |  |                                 |        |  
|Interest and other income, net                                |  |                                 | 9      |   |                                 |   | 15     |      |  |   |       |   |  |   | 48      |  
|Other non-cash expense                                        |  |                                 |       |   |                                 |   | (904   | )    |  |   | (33    | ) |  |   | (904    | )
|Interest expense                                              |  |                                 | (3     | ) |                                 |   | (4     | )    |  |   | (11    | ) |  |   | (10     | )
|                                                              |  |                                 |        |   |                                 |   |        |      |  |   |        |   |  |   |         |  
|Net loss                                                      |  | $                               | (2,704 | ) |                                 | $ | (3,742 | )    |  | $ | (7,735 | ) |  | $ | (10,630 | )
|                                                              |  |                                 |        |   |                                 |   |        |      |  |   |        |   |  |   |         |  
|Basic and diluted net loss per share                          |  | $                               | (0.03  | ) |                                 | $ | (0.05  | )    |  | $ | (0.09  | ) |  | $ | (0.18   | )
|                                                              |  |                                 |        |   |                                 |   |        |      |  |   |        |   |  |   |         |  
|Shares used in computing basic and diluted net loss per share |  |                                 | 84,684 |   |                                 |   | 70,071 |      |  |   | 83,785 |   |  |   | 59,391  |  
|                                                              |  |                                 |        |   |                                 |   |        |      |  |   |        |   |  |   |         |  



See accompanying notes
to condensed financial statements



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CARDIMA, INC.

STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)



|                                                                      |  |                                |        |   |      |   |         |  
|--------------------------------------------------------------------- |  | ------------------------------ | ------ | - | ---- | - | ------- | -
|                                                                      |  | Nine months endedSeptember 30, |       
|                                                                      |  | 2004                           |        |   | 2003 |  
|CASH FLOWS FROM OPERATING ACTIVITIES                                  |  |                                |        |   |      |   |         |  
|                                                                      |  |                               
|Net loss                                                              |  | $                              | (7,735 | ) |      | $ | (10,630 | )
|Adjustments to reconcile net loss to net cash provided by operations: |  |                                |        |   |      |   |         |  
|                                                                      |  |                               
|Depreciation and amortization                                         |  |                                | 191    |   |      |   | 521     |  
|Other non-cash expense related to warrants                            |  |                                | 33     |   |      |   |        |  
|Non-cash stock-based compensation                                     |  |                                | 63     |   |      |   |        |  
|Derivative revaluation                                                |  |                                |       |   |      |   | 904     |  
|Loss on disposal of assets                                            |  |                                | 5      |   |      |   | 9       |  
|Non-cash interest (income) charge on notes receivable from officers   |  |                                |       |   |      |   | (23     | )
|Receivable from officers                                              |  |                                | 54     |   |      |   |        |  
|Changes in operating assets and liabilities:                          |  |                                |        |   |      |   |         |  
|Accounts receivable, net                                              |  |                                | 52     |   |      |   | 14      |  
|Inventories, net                                                      |  |                                | 234    |   |      |   | 54      |  
|Prepaid expenses                                                      |  |                                | 80     |   |      |   |        |  
|Other current assets                                                  |  |                                |       |   |      |   | 90      |  
|Other assets                                                          |  |                                | 8      |   |      |   | 50      |  
|Accounts payable                                                      |  |                                | 95     |   |      |   | (925    | )
|Accrued compensation                                                  |  |                                | (201   | ) |      |   | (252    | )
|Other current liabilities                                             |  |                                | 8      |   |      |   | (3      | )
|Deferred rent                                                         |  |                                | 1      |   |      |   | 35      |  
|                                                                      |  |                                |        |   |      |   |         |  
|Net cash used in operating activities                                 |  |                                | (7,112 | ) |      |   | (10,156 | )
|                                                                      |  |                                |        |   |      |   |         |  
|CASH FLOWS FROM INVESTING ACTIVITIES                                  |  |                                |        |   |      |   |         |  
|                                                                      |  |                               
|Capital expenditures                                                  |  |                                | (56    | ) |      |   | (144    | )
|                                                                      |  |                                |        |   |      |   |         |  
|Net cash used in investing activities                                 |  |                                | (56    | ) |      |   | (144    | )
|                                                                      |  |                                |        |   |      |   |         |  
|CASH FLOWS FROM FINANCING ACTIVITIES                                  |  |                                |        |   |      |   |         |  
|                                                                      |  |                               
|Principal payments under leases and credit obligations                |  |                                | (324   | ) |      |   | 196     |  
|Payments of issuance costs                                            |  |                                | (105   | ) |      |   |        |  
|Net proceeds from sale of common stock                                |  |                                | 3,232  |   |      |   | 13,015  |  
|                                                                      |  |                                |        |   |      |   |         |  
|Net cash provided by financing activities                             |  |                                | 2,803  |   |      |   | 13,211  |  
|                                                                      |  |                                |        |   |      |   |         |  
|NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS                  |  |                                | (4,365 | ) |      |   | 2,911   |  
|                                                                      |  |                               
|CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD                        |  |                                | 6,446  |   |      |   | 3,385   |  
|                                                                      |  |                                |        |   |      |   |         |  
|CASH AND CASH EQUIVALENTS, END OF PERIOD                              |  | $                              | 2,081  |   |      | $ | 6,296   |  
|                                                                      |  |                                |        |   |      |   |         |  
|Supplemental Disclosure:                                              |  |                                |        |   |      |   |         |  
|Non-cash Financing activities:                                        |  |                                |        |   |      |   |         |  
|                                                                      |  |                               
|Financing of insurance premium                                        |  |                                | 358    |   |      |   | 297     |  



See accompanying notes
to condensed financial statements



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##### Table of Contents

CARDIMA, INC.



NOTES TO CONDENSED
FINANCIAL STATEMENTS

September 30, 2004

(Unaudited)



1. BASIS OF PRESENTATION



The accompanying unaudited
condensed financial statements have been prepared by the Company according to the rules and regulations of the Securities and Exchange Commission for interim financial information and in accordance with the instructions to Form 10-Q and Article 10
of Regulation S-X. Accordingly, they do not include all of the financial information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all
adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation have been included.



The operating results for the three and nine month periods ended September 30, 2004 are not necessarily indicative of the results that may be expected for
the fiscal year ending December 31, 2004 or for future operating results. The accompanying financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Companys Annual Report on
Form 10-K for the fiscal year ended December 31, 2003. The accompanying balance sheet at December 31, 2003 has been derived from those audited financial statements.



Certain reclassifications have been made to prior year amounts to conform to the current year presentation. These reclassifications had no
effect on prior reported results of operations or retained earnings.



2. MANAGEMENTS PLANS



As
of September 30, 2004 Cardima, Inc. had approximately $2,081,000 in cash and cash equivalents, working capital of $1,525,000 and an accumulated deficit of $111,423,000. Management expects the Company to continue to incur additional losses in the
foreseeable future as the Company works towards regulatory approval and commercialization of the REVELATION® Tx in the United States, commercialization of the Cardima Surgical Ablation System and the commercialization of the REVELATION® Helix in Europe. We currently estimate that our cash balances as of September 30, 2004,
will be sufficient to fund planned expenditures only for a very limited period of time, but this cannot be predicted with certainty. Although our management recognizes the need to raise funds in the immediate future, there can be no assurance that
we will be successful in consummating any fundraising transaction, or, if we do consummate such a transaction, that its terms and conditions will not be unfavorable to us. Any failure by us to obtain additional funding will have a material adverse
effect upon us and will likely result in our inability to continue as a going concern. Our independent auditors have stated in their opinion on our December 31, 2003 financial statements that there is substantial doubt as to our ability to continue
as a going concern.



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Cardima, Inc., continues to pursue regulatory approvals and distribution relationships in significant market
opportunities worldwide. We currently have distribution agreements for various products covering eight countries with an emphasis on Europe and the Pacific Rim, and we are currently seeking a strategic transaction for our Surgical Ablation System,
which received United States Food and Drug Administration 510(k) clearance for use in ablating cardiac tissue in 2003. We have arranged for warehousing capacity in Europe to support both distribution and direct customer sales. Securing FDA approval
of the REVELATION® Tx remains one of our primary
goals. On May 28, 2004 we received a letter, dated May 21, 2004, from the FDA, stating that our pre-market approval application, or PMA, for the REVELATION Tx linear ablation microcatheter system was not approvable based on the requirements of
applicable regulations. At a meeting with the FDA on June 18, 2004, the FDA reiterated its view, as stated in its not approvable letter that data from an additional study would be necessary to demonstrate the effectiveness of the
REVELATION Tx for atrial fibrillation, and that the nature of the trials primary goal would be to require a randomized clinical trial design. We plan to continue to pursue U.S. regulatory approvals for the REVELATION Tx, as well as other
therapeutic products already approved in Europe and in other markets which we believe have both the clinical potential and adequate medical support structure to accept a developing technology application. We are continuing to develop broader
applications of our Surgical Ablation System as a minimally invasive, stand-alone surgical procedure to treat atrial fibrillation. We cannot assure you that we will be able to obtain or maintain any necessary regulatory approvals or that, if such
regulatory approvals are obtained, that we will be able to successfully market our products, or that we will be able to establish a successful distribution channel for our Surgical Ablation System.



3. CRITICAL ACCOUNTING POLICIES



Use of Estimates



We have prepared our financial statements in conformity with generally
accepted accounting principles in the United States, which requires management to make estimates and assumptions that effect the amounts reported in financial statement and accompanying notes. Actual results could differ from these estimates.
Significant estimates made by us include those related to accounts receivable and inventory reserves.



Stock-Based Compensation



We have elected to follow Accounting Principles Board Opinion No. (APB) 25, Accounting for Stock Issued to Employees and related
interpretations in accounting for our employee stock options, including Financial Accounting Standard Board Interpretation (FIN) 44, Accounting for Certain Transactions Involving Stock Compensation.



Compensation expense is based on the difference, if any, between the fair
value of our common stock and the exercise price of the option or share right on the measurement date, which is typically the grant date. This amount is recordable as deferred stock compensation in the Balance Sheets and amortized as a
charge to operations over the vesting period of the applicable options or share rights. In accordance with Statement of Financial Accounting Standards



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(SFAS) No. 123, Accounting for Stock-Based Compensation, as amended by SFAS 148, Accounting
for Stock-Based Compensation  Transition and Disclosure, we have provided below the pro forma disclosures of the effect on net loss and loss per share as if SFAS 123 had been applied in measuring compensation expense for all periods
presented.



The following information regarding pro forma net
loss and net loss per share has been determined as if we had accounted for our employee stock options and employee stock plan under the fair value method prescribed by SFAS 123. The resulting effect on net loss and net loss per share pursuant to
SFAS 123 is not likely to be representative of the effects on net loss and loss per share pursuant to SFAS 123 in future periods, due to subsequent periods including additional grants and periods of vesting.



The Black-Scholes option valuation model was developed for use in estimating
the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because our
employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in managements opinion the existing models
do not necessarily provide a reliable single measure of the fair value of its employee stock options.



For purposes of disclosures pursuant to SFAS 123 as amended by FAS 148, the estimated fair value of options is amortized to expense over the options
vesting period.



The following table illustrates the effect on
reported net loss per share if we had applied the fair value recognition provisions of SFAS 123 to stock-based employee compensation (in thousands, except per share amounts):



|                                                                                                                                       |  |                                 |        |   |                                |        |   |      |        |   |      |         |  
|-------------------------------------------------------------------------------------------------------------------------------------- |  | ------------------------------- | ------ | - | ------------------------------ | ------ | - | ---- | ------ | - | ---- | ------- | -
|                                                                                                                                       |  | Three MonthsEnded September 30, |        |   | Nine MonthsEnded September 30, |       
|                                                                                                                                       |  | 2004                            |        |   | 2003                           |        |   | 2004 |        |   | 2003 |        
|Net loss applicable to common shareholders - as reported                                                                               |  | $                               | (2,704 | ) |                                | (3,742 | ) |      | (7,735 | ) |      | (10,630 | )
|Add:                                                                                                                                   |  |                                 |        |   |                                |        |   |      |        |   |      |         |  
|Stock-based employee compensation expense included in reported net income, net of applicable tax effects                               |  |                                 |       |   |                                |       |   |      |       |   |      |        |  
|Deduct:                                                                                                                                |  |                                 |        |   |                                |        |   |      |        |   |      |         |  
|Total stock-based employee compensation expense determined under fair value based method for all awards, net of applicable tax
effects |  |                                 | (222   | ) |                                | (170   | ) |      | (808   | ) |      | (919    | )
|                                                                                                                                       |  |                                 |        |   |                                |        |   |      |        |   |      |         |  
|Pro forma net loss                                                                                                                     |  | $                               | (2,926 | ) |                                | (3,912 | ) |      | (8,543 | ) |      | (11,549 | )
|                                                                                                                                       |  |                                 |        |   |                                |        |   |      |        |   |      |         |  
|Basic and diluted net loss per share:                                                                                                  |  |                                 |        |   |                                |        |   |      |        |   |      |         |  
|As reported                                                                                                                            |  | $                               | (0.03  | ) |                                | (0.05  | ) |      | (0.09  | ) |      | (0.18   | )
|                                                                                                                                       |  |                                 |        |   |                                |        |   |      |        |   |      |         |  
|Pro forma                                                                                                                              |  | $                               | (0.03  | ) |                                | (0.06  | ) |      | (0.10  | ) |      | (0.19   | )
|                                                                                                                                       |  |                                 |        |   |                                |        |   |      |        |   |      |         |  
|Shares used in computing basic and diluted net loss per share                                                                          |  |                                 | 84,684 |   |                                | 70,071 |   |      | 83,785 |   |      | 59,391  |  
|                                                                                                                                       |  |                                 |        |   |                                |        |   |      |        |   |      |         |  



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The fair value of options was estimated at the date of grant using the Black-Scholes option valuation
model with the following weighted-average assumptions:



|                      |  |                                 |   |  |        |  
|--------------------- |  | ------------------------------- | - |  | ------ | -
|                      |  | Nine Months Ended September 30, |  
|                      |  | 2004                            |   |  | 2003   |  
|Expected life (years) |  | 4.0                             |   |  | 4.0    |  
|Interest Rate         |  | 3.14                            | % |  | 2.23   | %
|Volatility            |  | 129.07                          | % |  | 131.02 | %
|Dividend Yield        |  | 0                               | % |  | 0      | %



Revenue Recognition



We recognize revenue from two types of customersend
users and distributors. Revenue is recognized in accordance with Staff Accounting Bulletin 104, Revenue Recognition in Financial Statements, when all of the following criteria are met: persuasive evidence of an agreement exists, shipment
of the product has occurred, sales price is fixed and determinable, and title of products transferred, generally at the point of shipment, the payment for the product is reasonably assured and no substantive obligations to the customer remain.
Customers are not entitled to rights of product return.



Inventories



Inventories, which are composed
of purchased parts and subassemblies, work in process and finished goods, are valued at the lower of cost or market with cost being determined by the first-in, first-out method. Inventories are shown net of reserves for excess and obsolete inventory
at the lower of cost or market. We provide reserves for potential excess quantities and obsolescence as a result of technological advancements which impact inventories on hand. We have analyzed the level of inventory on hand, its cost in relation to
market value and estimated customer requirements to determine whether write-downs for excess or slow-moving inventory are required. Actual customer requirements in any future periods are inherently uncertain and thus may differ from estimates. If
actual and or expected requirements were significantly greater or lower than the established reserves, a reduction or increase to the obsolescence allowance would be recorded in the period in which such a determination was made. We have established
reserves for excess and slow-moving inventories and believe the reserve of $742,000 at September 30, 2004 is adequate.



Allowance for Doubtful Accounts



We establish estimates of the uncollectability of accounts receivable. Our management analyzes accounts receivable, historical write-offs as bad debts,
customer concentrations, current economic trends and changes in customer payment terms when evaluating the adequacy of the allowance for doubtful accounts. We maintain an allowance for doubtful accounts at an amount that we estimate to be sufficient
to provide adequate protection against losses resulting from collecting less than full payment on receivables. We have not experienced significant bad debt expense and we believe our reserve for doubtful accounts of $85,000 should be adequate for
any exposure to loss in our September 30, 2004 accounts receivable.



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Research and Development



Research and development costs, which include clinical and regulatory costs, are charged to expense as incurred.



4. WARRANTS



All of the warrants that we issued on August 13, 2003, as well as a portion
of the warrants issued on August 14 and August 18, 2003, were exercised in the first quarter of 2004 for a total of 4,144,839 shares of common stock. Warrant exercise prices ranged from $0.7282 to $0.8375 per share. We had issued a notice of
redemption on October 10, 2003 in connection with our election to redeem all outstanding warrants issued on August 13, 2003. Total net proceeds from the exercise of these warrants was $3.1 million.



The Company filed a registration statement with the SEC with respect to the
shares underlying the warrants issued in December 2003, which was declared effective in February 2004. Accordingly, the warrant liability was transferred to additional paid in capital during the first quarter of 2004.



5. INVENTORIES



Inventories consist of the following (in thousands):



|                |  |                   |     |                  |   |    
|--------------- |  | ----------------- | --- | ---------------- | - | ---
|                |  | September 30,2004 |     | December 31,2003
|Raw materials   |  | $                 | 119 |                  | $ | 336
|Work-in-process |  |                   | 87  |                  |   | 164
|Finished goods  |  |                   | 551 |                  |   | 491
|                |  |                   |     |                  |   |    
|                |  | $                 | 757 |                  | $ | 991
|                |  |                   |     |                  |   |    



Inventory amounts
shown above are net of reserves for excess and obsolete inventory of $742,000 and $412,000 at September 30, 2004 and December 31, 2003, respectively. The Company provides reserves for inventory amounts by considering the potential excess inventory
in relation to sales forecasts and the obsolescence of inventory as a result of technological advancements.



6. STOCK OPTION RE-PRICING



On March 20, 2000, the Companys Board of Directors approved a reduction, effective June 2, 2000, in the exercise price of 462,576 outstanding stock
options held by executive officers and employees of the Company to the fair market value of the Companys common stock on June 2, 2000, which was $1.16 per share. These options were granted between July 29, 1997 and July 6, 1999 at exercise
prices ranging from $1.91 to $5.88 per share.



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Of the initial 462,576 shares that were repriced, 432,876 shares have been cancelled, 29,700 shares have
been exercised and no shares remain outstanding as of September 30, 2004. The cumulative non-cash compensation expense from the re-valuation of these re-priced options is $25,000 from the date of re-pricing in 2000 until September 30, 2004. No
expenses related to the re-pricing were recorded for the quarter ended September 30, 2004 because the closing price of $0.45 per share on September 30, 2004 is below the repriced exercise price of $1.16 per share and therefore, no adjustment was
required. No re-priced options remain outstanding; therefore, no additional compensation expenses will be recognized in the future.



7. NET LOSS PER SHARE



Net loss per share has been computed using the weighted average number of shares of common stock outstanding during the period. We have excluded all
warrants and stock options from the computation of basic and diluted earnings per share because all such securities are anti-dilutive for all periods presented. Excluded common stock equivalent shares included the following:



|                           |  |                   |  |                 
|-------------------------- |  | ----------------- |  | ----------------
|                           |  | September 30,2004 |  | December 31,2003
|Warrants                   |  | 16,771,543        |  | 22,336,445      
|Stock Options              |  | 7,925,167         |  | 6,693,513       
|                           |  |                   |  |                 
|Total Warrants and Options |  | 24,696,710        |  | 29,029,958      
|                           |  |                   |  |                 



8.
RECENT ACCOUNTING PRONOUNCEMENTS



In November 2003, the
Emerging Issues Task Force (EITF) of the Financial Accounting Standards Board released Issue No. 03-6, Participating Securities and the Two-Class Method under FASB Statement No. 128, which provides for a two-class method of
calculating earnings per share computations that relate to certain securities that would be considered to be participating in conjunction with certain common stock rights. This guidance is applicable to the Company as of the quarter ending September
30, 2004, and did not have a material impact on our financial statements.



9. COMMITMENTS AND CONTINGENCIES



The Company currently is a party to various claims, including claims from private placement agents in conjunction with private placements. While the Company currently believes that the ultimate outcome of these proceedings and claims will
not have a material adverse effect on our results of operations, litigation is subject to inherent uncertainties, and unfavorable rulings



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could occur. Depending on the amount and timing, an unfavorable outcome of some or all of these matters could have a
material adverse effect on the Companys cash flows, business, results of operations or financial position. An estimate of potential loss from pending proceedings and claims cannot be made at this time.



Item 2. Managements Discussion And Analysis Of Financial Condition And Results Of Operations



This quarterly report on Form 10-Q, including managements discussion and analysis of financial condition and results of operations, contains
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding our goals,
plans and efforts to secure regulatory approvals and to raise necessary capital, marketing plans, operating results and capital requirements. Except for historical information, the matters discussed in this Form 10-Q are forward-looking statements
that are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected, estimated or contemplated by the forward-looking statements. These factors include the risk that we will not be able to
raise additional capital when needed to continue operations, the risk that our common stock will be delisted from Nasdaq, the risk that we will be unable to obtain U.S. Food and Drug Administration, or FDA, approval for our pre-market approval
application, or PMA, for the REVELATION® Tx linear
ablation microcatheter system, including uncertainties associated with our ability to revise our study design and collect data acceptable to the FDA, the risk that the approval process for the REVELATION Tx or any other product, including additional
clinical trials, will require substantial unanticipated expenses and management attention, the limited number of cases employing our products and the limited amount follow-up information involving these cases, the possibility of business disruption
or unanticipated expenses due to our staffing reduction and financing efforts, and uncertainties associated with our ability to conduct successful clinical trials, obtain and maintain regulatory approvals, gain acceptance for our products from the
marketplace, secure distribution, licensing or other strategic partners or successfully manufacture, market, sell and distribute our products, as well as the risk factors discussed below under Factors Affecting Future Results and those
disclosed from time to time in our SEC reports. We assume no obligation to update the forward-looking statements included in this Form 10-Q. This discussion and analysis should be read in conjunction with the Financial Statements and related Notes
thereto included elsewhere in this Form 10-Q and in the Companys most recent Annual Report on Form 10-K.



Overview



Since our
incorporation in November 1992, we have developed, produced and sold a variety of microcatheters, including those for the diagnosis of ventricular tachycardia. Since 2001, however, our efforts have primarily focused on developing differentiated
products that diagnose and treat atrial fibrillation, including our REVELATION® Tx microcatheter for use in the Electrophysiology (EP) market and our Surgical Ablation System for use in ablating cardiac tissue in the surgical market.



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Our EP products allow for the mapping (diagnosis) and ablation (treatment) of the two most common forms
of cardiac arrhythmias: atrial fibrillation and ventricular tachycardia. Arrhythmias are abnormal electrical heart rhythms that adversely affect the mechanical activities of the heart and can significantly affect a persons quality of life and
can be potentially fatal. We have developed microcatheter-based systems designed (1) to locate and provide more extensive and less traumatic access to arrhythmia-causing tissue for diagnosing the arrhythmia, referred to as mapping, and (2) to
restore normal heart rhythms by isolating and destroying the arrhythmia-causing tissue using radio frequency energy, referred to as ablation. Our microcatheters incorporate multiple electrodes at the distal end to record electrical signals for
mapping and, with certain microcatheters, to transfer radio frequency energy for tissue ablation, allowing physicians to both map and ablate arrhythmias using the same microcatheter. Our microcatheters are designed with variable stiffness guidewire
technology and a highly flexible distal tip to allow more extensive and less traumatic access to the chambers and vasculature of the heart. In addition, all of our microcatheters are disposable, single-use products that we believe can be adapted to
and used with all conventional ECG-recording systems and with existing compatible radio frequency generators, eliminating the need for significant new investment in capital equipment by hospitals.



More recently, we have leveraged our proprietary technologies for treating
atrial fibrillation, or AF, into the development of products for the surgical market. On January 29, 2003, we received notice from the FDA that it had approved for commercialization the Cardima Surgical Ablation System for use in ablating cardiac
tissue during cardiac surgery. This new system connects the Cardima Surgical Ablation Probe, a deflectable multi-electrode linear array microcatheter technology, to a commercially available electrosurgical radio frequency generator through the
INTELLITEMP®, a multi-channel radio frequency, or
RF, energy management device. This system allows surgeons to direct RF energy through any combination of up to eight probe electrodes simultaneously into atrial tissue, a feature which can significantly reduce the time required to perform an
ablation-based maze procedure. Since September 2003, the Surgical Ablation System has been utilized on a limited basis as an adjunct procedure to valve replacement. In the first quarter of 2004, the Surgical Ablation System (SAS) was
utilized in two less invasive cases, opening the door to the prospect of the SAS technology being broadly used in a stand alone procedure to treat atrial fibrillation, or AF. Six-month patient follow-up data has been obtained for these two cases and
is currently being analyzed.



We have generated revenues of
approximately $18.7 million from inception to September 30, 2004. Prior to January 1997, these revenues were generated primarily in Europe and Japan from sales of our PATHFINDER and TRACER microcatheter systems for diagnosing ventricular tachycardia
and our REVELATION microcatheter system for diagnosing atrial fibrillation, as well as ancillary products such as the VENAPORT guiding catheters. Since 1997 and the U.S. Food and Drug Administrations clearance of certain of our products, sales
in the United States consist primarily of our PATHFINDER and REVELATION lines of microcatheters for diagnosing ventricular tachycardia and atrial fibrillation, respectively. To date, our international sales have been made through our small direct
sales force, which currently consists of one salesperson, and distributors who sell our products to physicians and hospitals. European sales consist primarily of the REVELATION Tx, REVELATION T-Flex and REVELATION Helix microcatheters for treatment
of atrial fibrillation following receipt of CE Mark for those products in December 1998, December 2001 and November 2002, respectively.



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We have a limited history of operations and have experienced significant operating losses since
inception. We expect that our operating losses will continue for the foreseeable future as we continue to invest substantial resources in product development, pre-clinical and clinical trials, obtaining regulatory approval, sales and marketing and
manufacturing.



Obtaining and maintaining regulatory approvals
is critical to our business. We are required to conduct clinical trials, demonstrate safety and effectiveness and obtain either 510(k) or PMA approval from the FDA in order to legally sell any of our products for treating atrial fibrillation or
ventricular tachycardia in the United States. While the Surgical Ablation System has received 510(k) approval from the FDA for use in ablating cardiac tissue, PMA approval will be required prior to the introduction in the United States of the
REVELATION Tx, REVELATION T-Flex and REVELATION Helix microcatheter systems for treating atrial fibrillation. Obtaining a PMA for any of these products will require additional clinical trials, which will require substantial time and expense. Outside
of the United States, our strategy has been to obtain regulatory approvals in those geographies that offer existing infrastructure to support medical technology as well as offer the potential for adequate product demand with the goal of positioning
us to expand into these geographies once we have sufficient capital and other resources. To date, we have emphasized obtaining regulatory approvals in Western Europe and select portions of Asia. We cannot assure you that we will be able to obtain or
maintain regulatory approvals.



Our primary focus is to obtain
FDA approval in the United States of the REVELATION® Tx microcatheter system for the treatment of atrial fibrillation. On September 30, 2002, we submitted a PMA application for this system to the FDA. On November 5, 2002, the PMA was granted expedited review status. On
May 29, 2003, we met with the Circulatory System Devices Panel which recommended that the FDA not approve our PMA for the REVELATION Tx linear ablation microcatheter system. The Circulatory System Devices Panel commented favorably on the safety and
need for this type of device. However, the Panel felt that efficacy data was not sufficiently clear and supportive for the approval. The Panel provided several suggestions on how to possibly reexamine the existing data or how to collect more data on
existing patients. On June 26, 2003 we received a letter from the FDA, which stated that the FDA concurred with the Panels non-approval recommendation. On January 20, 2004 we submitted an amendment to our PMA filing, in which we provided new
analysis and an expanded patient base. On May 28, 2004 we received a letter, dated May 21, 2004, from the FDA, stating that our PMA for the REVELATION Tx linear ablation microcatheter system was not approvable based on the requirements of applicable
regulations. The letter stated that, although we had provided information on an additional 32 patients in the clinical trial in our PMA amendment submitted in January 2004, the concerns identified in the FDAs initial non-approvable letter of
June 26, 2003 remain unresolved. Among other things, the FDAs letter stated that the FDA believes that the least burdensome approach to demonstrate the safety and effectiveness of REVELATION Tx for the intended indication is to collect
additional clinical data using a randomized clinical trial design. We have been engaged in continuing dialogue with the FDA since our receipt of the non-approvable letter on May 28, 2004. At a meeting with the FDAs Center for Devices and
Radiological Health on June 18, 2004, the FDA representatives reiterated the view that data from an additional study would be necessary to demonstrate the effectiveness of REVELATION Tx for atrial fibrillation, and that the nature of the
trials primary goal would require a randomized clinical trial design. The development and implementation of a new clinical trial would require substantial expenditures and management attention, and the timing and success of any such trial
cannot be assured.



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We had cash and cash equivalents of approximately $2.1 million as of September 30, 2004. Our management
believes that our cash balances as of that date will be sufficient to fund planned future expenditures only for a very limited period of time, although the actual amount of expenditures is inherently uncertain. Although our management recognizes the
need to raise funds in the immediate future, we cannot assure you that we will be successful in consummating any fundraising transaction, or, if we do consummate such a transaction, that its terms and conditions will not be unfavorable to us. Any
failure by us to obtain additional funding will have a material and adverse effect upon us and will likely result in our inability to continue as a going concern. In their opinion accompanying our December 31, 2003 financial statements, our
independent auditors concluded that there is substantial doubt as to our ability to continue as a going concern for a reasonable period of time, and have, therefore, modified their report in the form of an explanatory paragraph describing the events
that have given rise to this uncertainty.



Results Of Operations 
Three and Nine Months Ended September 30, 2004 and 2003



Net Sales



For the nine-month period ended September 30, 2004, net
sales increased 6% to $1,783,000 in 2004 from $1,690,000 for the same period in 2003. By region, net sales in the United States increased 24% to $864,000 for the nine-month period ended September 30, 2004 from $697,000 for the same period in 2003,
while European sales decreased 13% to $282,000 for the nine-month period ended September 30, 2004 from $322,000 for the same period in 2003. In the United States, clinical product sales increased to $67,000 for the nine-month period ended September
30, 2004 compared to $7,000 in the same period in 2003. Therapeutic product sales increased for the nine-month period ended September 30, 2004 to $211,000 from $69,000 net sales for the same period in 2003, while diagnostic product sales decreased
6% across all regions to $1,123,000 for the nine-month period ended September 30, 2004 from $1,198,000 for the same period in 2003. Guiding catheters sales increased 10% to $394,000 for the nine-month period ended September 30, 2004 from $359,000
for the same period in 2003.



Net sales for the quarter ended
September 30, 2004 increased 1% to $569,000 from $561,000 for the same period in 2003. Regionally, net sales in the Europe decreased 49% to $63,000 in the third quarter of 2004, from $123,000 for in the same period of 2003. Net sales in the United
States increased 29% to $282,000 in the third quarter of 2004 from $219,000 for the same period in 2003. Asian net sales increased 2% to $224,000 in the third quarter of 2004 from $219,000 for the same period in 2003. The increase in domestic
revenue was primarily the result of higher sales of diagnostic and surgical products.



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Accounts receivable decreased 17% to $247,000 as of September 30, 2004 from $299,000 as of December 31,
2003 due to increased emphasis on collections. The allowance for doubtful accounts was $85,000 as of September 30, 2004 and $87,000 as of December 31, 2003.



Cost of Goods Sold



Cost of goods sold primarily includes raw materials costs, catheter fabrication costs, system assembly and testing costs and manufacturing labor and
overhead. Cost of goods sold for the quarter ended September 30, 2004 increased 26%, or $184,000, to $893,000 from $709,000 for the same period in 2003. Cost of goods sold for the nine-month period ended September 30, 2004 decreased 10% to
$2,121,000 from $2,347,000 for the same period in 2003. These decreases in the cost of goods sold were due in part to lower expenses realized following the reduction in force in June 2003, and increased cost allocations to research and development.
This was offset by an increase in inventory reserves of $209,000 to write off inventory related to slow moving products.



Research and Development Expenses



Research and development expenses include product development, clinical testing and regulatory expenses. Total research and development expenses for the
quarter ended September 30, 2004 decreased 7% to $1,016,000 from $1,098,000 for the same period in 2003. Total research and development expenses for the nine months ended September 30, 2004 decreased 16% to $3,208,000 from $3,811,000 for the same
period in 2003. This decrease was due to a reduction in regulatory and clinical expenses for the first nine months of 2004 of $874,000, or 42%, when compared to the same period in 2003, which was attributable to the reduction of expenses following
the finalization of Phase III clinical trials in 2003 and a decrease in expenses following the submission of the REVELATION® Tx PMA to the FDA. These reductions in research and development expenses were partially offset by an increase in our direct product development costs
for the first nine months of 2004 of $271,000, or 16%, to $1,984,000 from $1,713,000 for the same period in 2003, due to expenses incurred in the development of the INTELLITEMP and products related to the Surgical Ablation System.



Clinical trials of our products and regulatory approval efforts have required
substantial financial and management resources. We will be required to fund additional clinical trials to obtain U.S. FDA approval of REVELATION Tx and other products for which we plan to seek U.S. regulatory approval. These trials will be expensive
and time-consuming. In addition, clinical trials may identify significant technical or other obstacles that we will have to overcome before obtaining the necessary regulatory approvals or market acceptance. Due to the uncertainties associated with
our ability to complete clinical trials, demonstrate product safety and effectiveness and obtain regulatory approval for our products, it is difficult for us to accurately predict the time or cost until completion of product development efforts.



Selling, General and Administrative Expenses



Selling, general and administrative expenses for the quarter ended September
30, 2004 decreased $233,000, or 15%, to $1,370,000 from $1,603,000 for the same period in 2003.



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Selling, general and administrative expenses for the nine months ended September 30, 2004 decreased $1,151,000, or 22%,
to $4,145,000 from $5,296,000 for the same period in 2003. More specifically, selling expenses for the first nine months of 2004 decreased $617,000, or 43%, to $814,000 from $1,431,000 for the first nine months of 2003. This decrease is attributable
to lower headcount after our June 2003 reduction in force and our decreased international sales presence as we continue to focus our resources on securing regulatory approval for the REVELATION® Tx in the United States. General and administrative expenses for the first nine months
of 2004 also decreased by $376,000, or 11%, to $2,966,000 from $3,342,000 for the first nine months of 2003. The decrease in general and administrative expenses in this period is primarily a result of the direct and indirect expenses resulting from
the reduction in force in June 2003 offset in part by increased costs associated with our status as a public company. Marketing expenses for the first nine months of 2004 also decreased $158,000, or 30%, to $365,000 from $523,000 for the same period
in 2003 due to reduced promotional and marketing efforts while we focus our efforts in obtaining FDA approval for REVELATION® Tx.



Other Non-Cash Expense



Other non-cash expense for the nine months ended September 30, 2004 decreased to $33,000 from $904,000 for the same period in 2003. The non-cash expense of $33,000 for the nine months ended September 2004 related to the warrants issued in
connection with our December 2003 private placement that were carried as liabilities, and represented the difference of the warrants valuation between their date of issuance and the date of registration of the shares underlying the warrants.
The non-cash expense of $904,000 for the year-earlier period was due to the valuation of warrants issued in association with the closing of the August 2003 private placements that were also carried as liabilities for the difference in valuation
between the dates of issuance and the registration of the shares underlying the warrants.



Liquidity and Capital Resources



We had cash and cash equivalents of approximately $2.1 million as of September 30, 2004 and approximately $0.9 million as of November 12, 2004. Our management currently estimates our current cash balance will be sufficient to fund planned
expenditures only for a very limited period of time, although the actual level of expenditures cannot be predicted with certainty. Management currently estimates that, assuming no change in our cash utilization rate from recent months, our existing
cash balance would be exhausted before the end of December 2004, and possibly substantially before then. Although our management recognizes the need to raise funds in the immediate future, there can be no assurances that we will be successful in
doing so, or, if we do consummate a financing transaction, that the terms and conditions of such financing will not be unfavorable to us, particularly in light of the FDAs recent non-approvable letter with respect to REVELATION Tx. Any failure
by us to obtain additional funding will have a material effect upon us and will likely result in our inability to continue as a going concern. If this occurs, you will likely lose your entire investment in our company.



We have financed our operations, to date, principally through (1) private
placements of equity securities, (2) our initial public offering of Common Stock in June 1997, together with interest income on such proceeds, (3) borrowings under a $3,000,000 former line of credit, (4) sale of certain of our non-core patents to
Medtronic, Inc. for $8,000,000 in 2002 and 2003 and (5) equipment leases to finance certain capital equipment.



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Net cash used in operating activities for the first nine months of 2004 was approximately $7,112,000,
compared to the net cash used of $10,156,000 for the first nine months of 2003. The decrease of $3,044,000, or 30%, in net cash used in operating activities is due to the overall decrease in operating expenses primarily resulting from the reduction
in force implemented on June 30, 2003. Net cash provided by financing and investing activities for the first nine months of 2004 was approximately $2,747,000, compared to $13,067,000 for the first nine months of 2003. We received $3,117,000 upon
exercise of warrants during the first quarter of 2004, and $13,187,000 from private placements of common stock in the first nine months of 2003.



Our future liquidity and capital requirements will depend upon numerous factors, including whether we succeed in raising adequate funding in the immediate
term whether we are successful in consummating a strategic sale, distribution or licensing transaction for our surgical business, the scope and cost of new clinical trial activities that may be required by the FDA or other regulatory agencies, the
progress of our clinical trials, the progress and cost of our product development efforts, actions relating to regulatory matters, the costs and timing of expansion of product development, the level of sales and marketing activities, manufacturing
costs, the extent to which our products gain market acceptance, the outcome of legal proceedings, and competitive developments.



Factors Affecting Future Results



If we fail to raise additional capital in the immediate future, our business will fail.



We have very limited cash resources and need to raise additional capital in the immediate future through public or private financings or other
arrangements in order to continue operations. If we are unable to do so, our business will fail. Even assuming no increase in our cash utilization rate from recent months, management estimates that our current cash balance will be exhausted before
the end of the calendar 2004, and possibly substantially before then. We cannot assure you that additional capital will be available to us when needed, if at all, or, if available, will be obtained on terms attractive to us. If we succeed in closing
a financing, its terms will probably place substantial restrictions on our ability to raise the further funding that we will need to continue our operations, and will likely include requirements that will impair our ability to operate our business
and that will further dilute your investment in us, such as requirements that we issue warrants to our funding sources or give them anti-dilution protection in the event of a subsequent financing. We had negative cash flow from operations for the
nine months ended September 30, 2004 of over $7.1 million, and we expect to continue to incur substantial negative cash flow from operations for the foreseeable future. We may be required to expend greater than anticipated funds if unforeseen
difficulties arise in the course of completing the development, approval and marketing of our products, such as the additional clinical trial activities that the FDA recently stated would be required with respect to our PMA for REVELATION Tx, or in
other aspects of our business. Even if we raise capital in the near term, our future cash needs may, at a minimum; cause us to delay, scale back or eliminate some or all of our product research and development programs, to limit the marketing of our
products, or to license or sell to third parties the rights to commercialize our products or technologies that we would otherwise develop and market ourselves. Furthermore, debt or equity financing, if available, will likely involve restrictive
covenants and other restrictions that will impair our ability to raise additional capital and operate our business. Our failure to raise capital when needed would likely cause us to cease our operations.



We have financed our operations since inception primarily through the private
placement of equity securities, proceeds from our initial public offering in June 1997, loan facilities and the sale of certain of our patents and other intellectual property. Although our management recognizes the need to raise funds in the
immediate future, there can be no assurance that we will be



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successful in consummating any fundraising transaction, or if we do consummate such a transaction, that its terms and
conditions will not require us to give investors valuable rights with respect to our products or technology, warrants or other valuable rights to purchase additional interests in our company, or be otherwise unfavorable to us. Among other things,
the agreements under which we issued some of our existing securities include, and any securities that we may issue in the future will likely include, terms that could impede our ability to raise additional funding, such as terms requiring the
consent of certain security holders before we issue or register additional securities and anti-dilution protection giving those holders the right to receive additional shares of our common stock depending on the terms of our later financings. We may
be required to issue preferred stock, debt or other securities with rights and preferences senior to the rights of holders of our common stock. In addition, the issuance of additional securities will likely dilute the interests of existing common
stockholders, and could impose additional restrictions on how we operate and finance our business.



We have sold a limited number of our products, and we will continue to incur substantial losses for the foreseeable future.



We have sold only a limited number of our microcatheter and surgical
products. In addition, we will continue to incur substantial losses into the foreseeable future because of research and product development, clinical trials, regulatory approval efforts and manufacturing, sales, marketing and other expenses as we
seek to obtain necessary approvals and bring our microcatheters and surgical products to market. Since our inception, we have experienced losses, and we expect to experience substantial net losses into the foreseeable future.



Our net losses were approximately $7.7 million for the nine months ended
September 30, 2004 and approximately $13.2 million, $12.6 million and $9.4 million for the years ended December 31, 2003, 2002 and 2001, respectively. As of September 30, 2004, our accumulated deficit was approximately $111.4 million. Our limited
sales history makes it difficult to assess our future results. We cannot be certain that we will ever generate substantial revenue or achieve profitability. Our failure to generate substantial revenues would harm our business.



Our stock may be delisted from Nasdaq and may become subject to penny
stock rules, which would make it more difficult for investors to sell their shares and may lead to financial penalties under certain of our agreements.



Currently, our common stock trades on the Nasdaq SmallCap Market. We cannot assure you that we will be able to maintain our listing on Nasdaq or any other
established trading market. Among other things, Nasdaq has considerable discretion with respect to listing standards, which include qualitative criteria as well as quantitative criteria, such as minimum stock price and stockholders equity
requirements, some of which we currently do not meet and which are out of our control.



Among other things, Nasdaq listing rules require a company to maintain at least $2.5 million in stockholders equity or a market capitalization of at least $35 million to remain listed on Nasdaq, except if it
meets specified profitability requirements that we do not meet. Our stockholders equity was $2.4 million on September 30, 2004 and the market value of our listed securities is currently less than $35 million. We expect to continue to incur net
losses, which will cause continued reductions in our stockholders equity. Accordingly, we are not in compliance with the listing requirements and our ability to comply with these listing requirements will depend on our ability to raise
substantial additional equity capital or on our market capitalization



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increasing above $35 million, over which we have limited or no control.

In addition, Nasdaqs rules provide that if the closing bid price of a companys stock is below $1.00 for more than thirty consecutive trading
days, the company faces possible delisting. On May 10, 2004, we received a letter from Nasdaq stating that for the last thirty consecutive business days the closing bid price of our common stock had remained below the minimum $1.00 per share
required for continued inclusion under Marketplace Rule 4310(c)(4)(the Rule). In accordance with Marketplace Rule 4310 (c)(8)(D), we were provided 180 calendar days, or until November 8, 2004, to regain compliance. Although we had not
regained compliance with the Rule by November 8, 2004, Nasdaq recently notified us that Nasdaq has granted us an additional 180 calendar days, or until May 5, 2005, to regain compliance. However, Nasdaq has filed a proposed rule change, which would
impact our ability to remain listed beyond May 5, 2005 if we have not regained compliance by that date (see SEC Release No. 34-50541, available at www.sec.gov). Further, the 180 day period relates exclusively to the bid price deficiency. We may be
delisted during the 180 day period for failure to maintain compliance with any other listing requirements for which we are currently on notice or which occurs during the 180 day period. If we do not regain compliance with the Rule, Nasdaq will
provide written notification that our securities will be delisted.



We have faced possible delisting from Nasdaq in the past and even if we comply with the requirements for the minimum bid price of our common stock by May 5, 2005 as stated in Nasdaqs recent letter to us and regain compliance with
Nasdaqs other quantitative requirements, we may receive additional notices of potential delisting in the future. For example, the NASD advised us that beginning on April 9, 2001, our common stock would no longer be listed on the Nasdaq
SmallCap Market. We appealed the NASDs decision and met the continued listing requirements in June 2001. In addition, due to our stock trading below $1.00 per share over various prior periods, we have received other notices from the NASD that
our stock could be delisted if its closing bid price did not close at $1.00 per share or more over specified periods. For example, we received notices of this kind on October 28, 2002, July 22, 2003 and May 10, 2004.



We cannot assure you that we will be able to maintain our listing on the
Nasdaq SmallCap Market. Delisting would have material and adverse effects on our business and the value of your investment. If our common stock were to be delisted from the Nasdaq SmallCap Market, our common stock would be considered a penny stock
under regulation of the Securities and Exchange Commission and would therefore be subject to rules that impose additional sales practice requirements on broker-dealers who sell our securities. The additional burdens imposed upon broker-dealers by
these requirements could discourage broker-dealers from effecting transactions in our common stock, which could severely limit the market liquidity of the common stock and your ability to sell our securities in the secondary market. Delisting could
also make it difficult or impossible for us to raise additional capital, which would likely cause us to cease operations.



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In addition, the purchase agreements signed in connection with our December 31, 2002 and January 22, 2003
private placements provide that if at any time during the two year period beginning on their respective closing dates, our common stock is delisted from the NASDAQ National SmallCap Market for any reason, the investors shall receive an amount in
cash equal to 1.5% of the aggregate purchase price of all shares and warrants purchased under those agreements for each month or portion thereof from the date of such delisting until our common stock is again listed on the NASDAQ National SmallCap
Market. We may also incur other substantial liabilities under the terms of other financings if our common stock is delisted.



Our need to raise additional capital in the future could have a dilutive effect on your investment.



In order to continue operations, we will need to raise additional capital.
One possibility for raising additional capital is the public or private sale of our common stock or securities convertible into or exercisable for our common stock.



If we sell additional shares of our common stock or warrants, such sales will further dilute the percentage of our equity
that you own. In addition, our recent private placement financings have involved the issuance of securities at a price per share that represented a discount to the closing price of our common stock and if we close future private placements they will
likely involve the issuance of securities at a discount to prevailing market prices. Depending upon the price per share of securities that we sell in the future, your interest in us could be further diluted by any adjustments to the number of shares
and the applicable exercise price required pursuant to the terms of the agreements under which we previously issued securities. No assurance can be given that previous or future investors, finders or placement agents will not claim that they are
entitled to additional antidilution adjustments or dispute the Companys calculation of any such adjustments. Any such claim or dispute could require us to incur material costs and expenses regardless of the resolution and, if resolved
unfavorably to us, to effect dilutive securities issuances or adjustments to previously issued securities. In addition, certain of our prior securities issuances have included, and future financings may also include, provisions requiring us to make
additional payments to the investors if we fail to obtain or maintain the effectiveness of SEC registration statements by specified dates or take other specified action. Our ability to meet these requirements may depend on actions by regulators and
other third parties, over which we will have no control. These provisions may require us to make payments or issue additional dilutive securities, or could lead to costly and disruptive disputes. In addition, these provisions could require us to
record additional non-cash expenses, as we were required to do in the third quarter of 2003 with respect to certain warrants issued in that quarter.



The audit report accompanying our 2003 financial statements indicates there is substantial doubt as to our ability to continue as a going concern.



As a result of our losses to date and accumulated
deficit, the audit report on our 2003 financial statements contains an explanatory paragraph indicating that there is substantial doubt as to our ability to continue as a going concern. The audit reports on our 2002 and 2001 financial statements
contained similar explanatory paragraphs. Our continuation as a going concern will



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depend upon our ability to generate or obtain sufficient cash to meet our obligations on a timely basis and ultimately to
attain profitable operations. Concern about our ability to continue as a going concern may make it more difficult for us to obtain additional funding to meet our obligations or adversely affect the terms of any additional funding we are able to
obtain. We anticipate that we will continue to incur significant losses until successful commercialization of one or more of our products. There can be no assurance that we can or will operate profitably in the future, or that we will continue as a
going concern.



Although we received 510(k) clearance for
the use of our Surgical Ablation System to ablate cardiac tissue, none of our ablation products for electrophysiology has received regulatory approval in the United States. Our failure to receive these approvals will harm our business.



To date, although we received 510(k) clearance for the
use of the Surgical Ablation System to ablate cardiac tissue; none of our electrophysiology products in development for the ablation of atrial fibrillation or ventricular tachycardia has received regulatory approval in the United States. Our
Surgical Ablation System has received 510(k) clearance only for ablating cardiac tissue and not for any other purpose or any specified treatment. If we cannot gain U.S. regulatory approvals our business will be materially harmed and we may be unable
to secure the funding needed to continue operations. Even if our ablation products are successfully developed and we obtain the required regulatory approvals, we cannot be certain that our ablation products and their associated procedures will
ultimately gain market acceptance. Because our sole product focus is to design and market microcatheter systems to map and ablate atrial fibrillation and ventricular tachycardia, our failure to obtain regulatory approval for and successfully
commercialize these systems would materially harm our business.



In the United States, we are required to seek a PMA for our ablation products, including the REVELATION Tx microcatheter, since they have been classified as Class III devices. The process of obtaining a PMA is expensive, lengthy and
uncertain and requires clinical trials to demonstrate the safety and effectiveness of the product. In December 1997, the FDA approved a 10-patient atrial fibrillation feasibility study for mapping and ablation with the REVELATION Tx. We received FDA
approval to conduct a Phase III clinical trial for this system in 2000, and filed portions of the PMA application in 2001. On September 20, 2002, we submitted our PMA application to the FDA with data on more than 80 patients treated with our
REVELATION Tx microcatheter system and on November 5, 2002, we announced that the FDA had accepted our filing. We met with the Circulatory Systems Device Panel on May 29, 2003, and on that date, the Panel recommended that the FDA not approve our PMA
for the REVELATION Tx linear ablation microcatheter system. The Circulatory System Devices Panel felt that the efficacy data was not sufficiently clear and supportive for the approval. The Panel provided the FDA and the Company with several
suggestions on how to possibly reexamine the existing data or how to collect more data on existing patients. On June 26, 2003, we received a letter from the FDA, which reiterated the recommendation of the Panel and stated the FDA concurred with the
recommendation of the Panel. On January 20, 2004, we submitted an amended PMA that provided new analysis, including data from an expanded patient base, to the FDA.



On May 28, 2004 we received a letter, dated May 21, 2004, from the FDA, stating that our PMA for the REVELATION Tx linear
ablation microcatheter system was not approvable based on the requirements of applicable regulations. The letter stated that, although we had provided information on an additional 32 patients in the clinical trial in our PMA amendment submitted in



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January 2004, the concerns identified in the FDAs initial non-approvable letter of June 26, 2003 remain unresolved.
Among other things, the FDAs letter stated that the FDA believes that the least burdensome approach to demonstrate the safety and effectiveness of REVELATION Tx for the intended indication is to collect additional clinical data using a
randomized clinical trial design. At a meeting with the FDAs Center for Devices and Radiological Health on June 18, 2004, the FDA representatives reiterated the view that data from an additional study would be necessary to demonstrate the
effectiveness of REVELATION Tx for atrial fibrillation, and that the nature of the trials primary goal would require a randomized clinical trial design. The development and implementation of a new clinical trial would require substantial
expenditures and management attention, and the timing and success of any such trial cannot be assured.



We must obtain governmental approvals or clearances before we can sell our products.



Our products are considered to be medical devices and are subject to regulation in the United States and internationally.
These regulations are wide ranging and govern, among other things:



| |  | product design and development;
| | - | -------------------------------



| |  | product testing;
| | - | ----------------



| |  | product labeling;
| | - | -----------------



| |  | product storage;
| | - | ----------------



| |  | premarket clearance and approval;
| | - | ---------------------------------



| |  | advertising and promotion; and
| | - | ------------------------------



| |  | product sales and distribution.
| | - | -------------------------------



Before we can market any of our products in the United States or other countries, we must demonstrate that our products are safe and effective and obtain
approval or clearance from the applicable governmental authorities. In the United States, we must obtain from the FDA 510(k) pre-market notification clearance for devices that are classified as Class II or lower, or a PMA for devices classified as
Class III, such as REVELATION Tx, in order to market a product. We have received 510(k) pre-market notification clearances for our PATHFINDER, PATHFINDER mini and TRACER microcatheter systems for mapping ventricular tachycardia, for the REVELATION
microcatheter system for mapping atrial fibrillation and for the Cardima Surgical Ablation System to ablate cardiac tissue during cardiac surgery using radio frequency energy. Currently, the process for 510(k) clearance requires approximately 120
days and PMA review process requires approximately six to twelve months. The PMA review process is in addition to the time required to conduct clinical trials demonstrating safety and effectiveness. However, the timing of such processes can be
uncertain and may involve significantly more time. We cannot guarantee either the timing or receipt of regulatory approval or clearance for any of our products in development. The FDA may request extensive clinical data to support either 510(k)
clearance or



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a PMA. The approval process, including any necessary clinical trials, can involve substantial expense. No assurance can
be given that we will ever be able to obtain the necessary approvals for any of our products. Our failure to do so on a timely basis would have a material adverse effect on our business, financial condition and results of operations.



We filed an investigational device exemption (IDE) application for a
feasibility trial with the THERASTREAM microcatheter system in December 1998 and received permission to expand that trial in July 2000. We have postponed the THERASTREAM clinical trial while we focus our resources on obtaining regulatory approval of
our REVELATION Tx. There can be no assurance that any additional clinical studies that we may propose will be permitted by the FDA, will be completed or, if completed, will provide data and information that supports a PMA. Furthermore, we cannot
assure you that our Phase III clinical trial for ablation of atrial fibrillation will provide us with data and information that supports a PMA.



Even if regulatory approvals are obtained, the applicable regulatory agencies may limit the indications for which they approve or clear any of our
products. Further, the FDA or regulatory agencies in other countries may restrict or withdraw approval or clearance of a product if additional information becomes available to support such action. Delays in the approval or clearance process,
limitation of our labeling claims or denial of our applications or notifications would cause our business to be materially and adversely affected.



Pre-clinical and clinical trials are inherently unpredictable. If we do not successfully conduct these trials, we may be unable to market or sell our
products.



Through pre-clinical studies and clinical
trials, we must demonstrate that our products are safe and effective for their indicated uses. Results from pre-clinical studies and early clinical trials may not allow us to predict results in later-stage testing. No assurance can be given that our
future clinical trials will demonstrate the safety and effectiveness of any of our products or will result in regulatory approval to market our products. As a result, if we are unable to commence and complete our clinical trials as planned, or
demonstrate the safety and effectiveness of our products, our business will be harmed. In addition, no assurance can be given that we can begin any future clinical trials or successfully complete these trials once started. We may never meet our
development schedule for any of our products in development. Even if a product is successfully developed and clinically tested, we cannot be certain that it will be approved by the FDA or other regulatory agency on a timely basis or at all. If the
FDA does not approve our products for commercial sales, our business will be harmed. As described above, we have devoted considerable resources to developing, testing and seeking regulatory approval for our REVELATION Tx microcatheter systems
designed for ablation of atrial fibrillation. On May 28, 2004 we received a letter, dated May 21, 2004, from the FDA, stating that our PMA for the REVELATION Tx linear ablation microcatheter system was not approvable based on the requirements of
applicable regulations. Among other things, the FDAs letter stated that the FDA believes that the least burdensome approach to demonstrate the safety and effectiveness of REVELATION Tx for the intended indication is to collect additional
clinical data using a randomized clinical trial design. At a meeting with the FDAs Center for Devices and Radiological Health on June 18, 2004, the FDA representatives reiterated the view that data from an additional study would be necessary
to demonstrate the effectiveness of REVELATION Tx for atrial fibrillation, and that the nature of the trials primary goal would require a randomized clinical trial design. The development and implementation of a new clinical trial would
require



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substantial expenditures and management attention, and the timing and success of any such trial cannot be assured. We
must receive PMA approval before marketing our products for ablation in the United States.



In December 2001, the REVELATION Helix received the CE mark allowing sales in the European Economic Area. We also received in December 1999 approval for an IDE to begin clinical testing of our THERASTREAM
microcatheter system for ablation of ventricular tachycardia and during calendar year 2000 approval to expand that trial; however, we have postponed the clinical feasibility trial for the THERASTREAM microcatheter system for ablation of ventricular
tachycardia to focus on obtaining regulatory approval of our REVELATION Tx for atrial fibrillation. We have no estimate as to when, or if, we will resume the clinical trial for our THERASTREAM microcatheter system. If we resume that trial,
completing it could take several years.



Current or future
clinical trials of our microcatheter systems will require substantial financial and management resources. In addition, the clinical trials may identify significant technical or other obstacles that we will need to overcome before obtaining the
necessary regulatory approvals or market acceptance. Our failure to complete our clinical trials, demonstrate product safety and clinical effectiveness, or obtain regulatory approval for the use of our microcatheter system for the ablation of atrial
fibrillation would have a material adverse effect on our business, financial condition and results of operations.



Delays in enrolling patients in our clinical trials could increase our expenses and harm our business.



The rate at which we may complete our pre-clinical and clinical trials is
dependent upon, among other things, the rate of patient enrollment. Patient enrollment depends on many factors, including the size of the patient population, the nature of the procedure, the proximity of patients residences to clinical sites,
the eligibility criteria for the study and impact of other clinical studies competing for the same patient population and/or the same physicians time and research efforts. Delays in planned patient enrollment may result in increased costs and
delays, which could cause our business results to suffer.



We have entered into engagement letters in connection with our actual and proposed private placements that have in the past and may in future lead to disputes and also may lead to additional payments of cash or issuances of securities in
connection with past or future sales of our securities.



We have entered into several agreements with parties to act as our financial advisors, finders or agents in connection with actual and proposed equity financings, including agreements entered into in April 2001 and on July 15, 2002,
November 13, 2002, December 9, 2002, December 28, 2002 (with another agreement signed with the same party in January 2003), March 11, 2003, July 15, 2003, July 18, 2003, August 2003 (oral agreement), November 2003, September 2004 and October 2004.
These agreements have provided that we will pay cash fees, generally expressed as 6% to 8% of the funds raised, and issue warrants to purchase specified numbers of shares of our common stock, generally not exceeding 10% of the number of shares sold,
to these parties in connection with our financings. Additional details concerning the terms of these various



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agreements, and the fees and warrants previously paid to these parties, can be reviewed in our Annual Report on Form 10-K
as filed with the Securities and Exchange Commission on March 31, 2004.



In connection with our prior financings, some of these advisors, finders and agents have alleged that they are owed additional cash and warrant compensation to which we have felt they were not entitled, and which would be in addition to
fees and warrants paid to other advisors with respect to the same investors. Our financial advisors, finders and agents may assert similar claims in the future.



For example, the advisor that assisted us with a 2001 private placement, which we refer to as the 2001 Advisor, communicated to us in 2002 that it
believes that it is entitled to cash fees and warrants in connection with the August 2002 private placement. We strongly disagree with the 2001 Advisors interpretation of its letter agreement with us. In August 2002, we sent the 2001 Advisor a
termination letter relating to its 2001 agreement. If the 2001 Advisor prevails on its claims in connection with the August 2002 private placement, we would be required to pay this advisor $381,570, or 7.5% of the gross proceeds that we received
from the sale of common stock, and issue to the advisor warrants to purchase up to 698,287 shares of common stock (and if all of the warrants issued to the investors in that private placement are exercised, an additional $133,549 in cash. We also
received letters from this advisor in early 2003 asserting that it is also owed approximately $300,000 plus warrants to purchase approximately 533,332 shares of our common stock at an exercise price of $0.8245 per share, arising in connection with
private placements we consummated in December 2002 and January 2003. Any additional payments made to this advisor would be in addition to fees and warrants paid to another advisor and finder There can be no guarantee that the 2001 Advisor will not
claim additional fees or warrants in connection with our financings closed after January 2003 or in connection with any future financing.



In addition, by letters dated September 19, 2003 and January 29, 2004, an advisor that we had retained in November 2002 (under an agreement that we
terminated effective May 18, 2003) has claimed that under its November 13, 2002 agreement with us, we are obligated to pay such advisor cash fees of $82,500 and warrants to purchase Units comprising 207,698 shares of our common stock and
warrants to purchase 62,309 shares of common stock at an exercise price per share of $0.7282) at an exercise price per Unit of $0.58256, in connection with three enumerated purchasers investments in our August 2003 private placement. This
advisor has also stated its belief that we would have additional obligations to the advisor in the event that other investors in the August 2003 private placement were investors as to which the advisor is entitled to compensation under its
agreement. In the advisors letter dated January 29, 2004 submitted information alleged to support a portion of its claim, and stated its belief that we are obligated to register the claimed securities for resale. In our opinion, this advisor
has not established the merits of its claim. We cannot predict whether additional claims will be made, or the resolution of any current or future claims, by this former advisor.



In August 2003, one of the advisors that we retained in connection with our August 2003 private placement notified us of its
belief that it was entitled to an additional fee of approximately $35,000 and additional warrants to purchase approximately 47,000 shares of common stock, in connection with the August 2003 private placement. We responded that, based on the
information in our possession, we believed that such advisor is not entitled to such fees and warrants. To date, we have received no further information from such advisor in support of its claim.



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Due to the existence of these various letter agreements, we may be obligated to pay cash fees and issue
warrants to one or more financial advisors in connection with the closing of any of our private placements. In addition, we may in the future enter into further agreements with financial advisors, finders or placement agents, similar to those
discussed above, in connection with private or public offerings of our securities. We might agree to pay to these parties a commission on any sales of securities to investors introduced to us by such parties or a commission based upon the exercise
price of any warrants or other securities exercised by investors introduced to us by such parties, and that such commissions will be in addition to commissions payable to other financial advisors, finders and placement agents working on our behalf.
In addition, we may agree to issue to these additional financial advisors, finders and placement agents securities such as warrants to purchase shares of our common stock, which could dilute your investment in our company. We also may be obligated
to pay termination or break-up fees to our current or future financial advisors, finders and placement agents in connection with our financings. These commissions paid or warrants or other securities issued may be in addition to the commissions
payable or securities issuable to other financial advisors, finders or placement agents in respect of the same transaction, and could be substantial. Disputes have arisen from time to time concerning our financial advisors entitlement to cash
and equity compensation associated with our past financings, and additional disputes may arise in the future. These disputes will tend to divert managements time and attention from running our business and may cause us to incur material costs
and expenses.



We have limited sales and limited experience
in the sale, marketing and distribution of our products. Our failure to establish an effective direct or indirect sales and marketing force will cause our revenues to decline.



We have only limited experience marketing and selling our products in commercial quantities. Currently, we are solely
responsible for marketing and distributing our products in the United States. We had previously signed an exclusive three-year distribution agreement with St. Jude Medical Corporation in 2000, but St. Jude did not meet the first year minimum annual
sales quota under the distribution agreement and, in June 2001, we mutually agreed with St. Jude to terminate the agreement. If we receive FDA approval of our PMA for REVELATION® Tx, we may not have an adequate marketing and sales force to adequately sell that product. Expanding our marketing and
sales capability to support sales in commercial quantities adequately will require substantial effort and require significant management and financial resources. Our failure to establish an effective sales and marketing force will prevent us from
being able to generate significant revenues from the sale of our products.



We have only a single direct salesperson in Europe. Building and managing a larger remote sales force effectively, in Europe or elsewhere, would require additional resources, time and expense, which could have a
material adverse effect on our business, financial condition and results of operations. We cannot be certain that we will be able to build a successful European business. Failure to do so would harm our business.



Currently, international sales and marketing of our PATHFINDER, PATHFINDER
mini, REVELATION and TRACER microcatheter systems are conducted through a number of



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exclusive distributors in certain European countries and Japan and a direct salesperson in Europe. We have sold only a
limited number of systems through these distributors. We cannot be certain that these distributors will be able to effectively market and sell our products. For example, we have terminated several distribution arrangements in Europe because of the
distributors failure to meet minimum sales levels under those agreements. We do not currently plan to market our Surgical Ablation System ourselves, and are currently seeking a strategic transaction for this system. We cannot assure you that
we will be able to enter into such an agreement on a timely basis or at all, that any distributor or licensee will devote adequate resources to selling our products, or that distribution relationships will not lead to costly and disruptive disputes.
Our failure to establish and maintain successful distribution relationships would harm our business.



We rely on multiple third parties to conduct and collect data for the clinical trials of our products. If we are unable to access this data or the FDA
refuses to accept the data in a filing, the commercialization of our products will be delayed and our business will be harmed.



We often rely on multiple third parties, such as hospitals and universities, to conduct and collect data for our clinical trials. We depend on these third
parties to provide access to data and cooperate with us in completing regulatory filings for the approval or clearance of our products. In order for the FDA and other regulatory agencies to accept and rely on the data of a filing, the data
collection, analysis and summarization must meet certain standards. We cannot be certain that the clinical data collected by the third parties meet the standards of the FDA or other regulatory agencies. If we are unable to rely on the clinical data
collected by third parties, or if these third parties do not perform their contractual obligations, the FDA or other regulatory agencies may require us to gather additional clinical data. This could significantly delay commercialization of our
products, require us to spend additional capital on our clinical trials and harm our business.



We cannot assure the safety or effectiveness of our products.



To obtain and maintain required regulatory approvals and secure the confidence of physicians and others whose acceptance is needed for our products, we
will need to demonstrate that our products are safe and effective. We cannot assure you that our products will be deemed safe and effective. Many of our products, such as our surgical ablation system, which has begun to be used by cardiac surgeons
only recently, have not been used to a sufficient extent to permit us to predict their safety and effectiveness. In addition, our products include components and materials supplied by third parties, whose safety and reliability we cannot guarantee.
We have occasionally experienced quality issues with some elements of our products, and we may face additional issues in the future. The perceived safety and effectiveness of our products can also depend on their manner of use by physicians and
other third parties, which we cannot control. If safety and effectiveness issues arise with any of our products in the future, we may incur liabilities to third parties, lose any regulatory approvals for the applicable product, or be required to
redesign the product. These issues will reduce our sales and increase our expenses, possibly substantially.



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Our products and their related procedures are novel to the market and will require the special
training of physicians. If the market does not accept our products and procedures, our revenues will decline.



Our microcatheter systems represent novel approaches to diagnosing and treating atrial fibrillation and ventricular tachycardia and our surgical abalation
system represents a novel approach to ablating cardiac tissue during surgery. Acceptance of our products and procedures by physicians, patients and health care payors will be necessary in order for us to be successful. If the market does not accept
our products and the procedures involved in their use, our business would be harmed and our revenues would decline.



Our products must be safe, effective and cost efficient in order for them to effectively compete against more established treatments. If we cannot
compete with these treatments, our revenues will decline.



The market for catheters to diagnose or treat atrial fibrillation and ventricular tachycardia is highly competitive. Our microcatheter systems for the mapping and ablation of atrial fibrillation and ventricular tachycardia are new
technologies. Safety, cost efficiency and effectiveness are the primary competitive factors in this market. Other competitive factors include the length of time required for products to be developed and receive regulatory approval and, in some
cases, reimbursement approval. Existing treatments with which we must compete include:



| |  | conventional catheters using the drag and burn or dot to dot technique;
| | - | ---------------------------------------------------------------------------



| |  | anti-arrhythmic and anti-coagulant drugs;
| | - | -----------------------------------------



| |  | external electrical shock to restore normal heart rhythms and defibrillation;
| | - | -----------------------------------------------------------------------------



| |  | implantable defibrillators;
| | - | ---------------------------



| |  | purposeful destruction of the atrial-ventricular node followed by implantation of a pacemaker; and
| | - | --------------------------------------------------------------------------------------------------



| |  | open-heart surgery known as the maze procedure.
| | - | -------------------------------------------------



Physicians will not recommend the use of our systems unless they can conclude that our systems provide a safe, effective and cost-efficient alternative to
current technologies for the mapping and ablation of atrial fibrillation or ventricular tachycardia. If our clinical data and other studies do not show that our products are safe and effective, the FDA and other regulators will not approve our
products for sale. If our products are not approved, we will not be able to enter the market and we will not be able to generate revenues from their sale.



If we do not comply with applicable domestic laws and regulations after obtaining approvals or clearances, our business results may suffer.



After initial regulatory approval or clearance of our
products, we will continue to be subject to extensive domestic regulatory requirements. Our failure to comply with applicable regulatory requirements can result in enforcement actions by the FDA, and other regulatory agencies, including, but not
limited to:



| |  | fines;
| | - | ------



| |  | injunctions;
| | - | ------------



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| |  | recall or seizure of products;
| | - | ------------------------------



| |  | withdrawal of marketing approvals or clearances;
| | - | ------------------------------------------------



| |  | refusal by the FDA to grant clearances or approvals; and
| | - | --------------------------------------------------------



| |  | civil and criminal penalties.
| | - | -----------------------------



We also are required to demonstrate and maintain compliance with the FDAs Quality System Regulations for all of our products. The FDA enforces the
Quality System Regulations through periodic inspections, including a pre-approval inspection for PMA products. The Quality System Regulations relates to product testing and quality assurance, as well as the maintenance of records and documentation.
If we do not, or any third-party manufacturer of our products does not, comply with the Quality System Regulations and cannot be brought into compliance, we will be required to find alternative manufacturers. Identifying and qualifying alternative
manufacturers would likely be a long and difficult process. We also are required to provide information to the FDA on deaths or serious injuries alleged to have been associated with the use of our medical devices, as well as product malfunctions
that could contribute to death or serious injury. If we fail to comply with these applicable regulations, we may incur substantial business disruption, expenses, penalties, fines and other liabilities and our business results and financial condition
could suffer.



If we do not comply with foreign regulatory
requirements to market our products outside the United States, our business will be harmed.



Sales of medical devices outside the United States are subject to international regulatory requirements that vary from country to country. The time
required for approval varies from country to country and may be longer or shorter than the time required in the United States. In order to market any of our products in the member countries of the European Union, we are required to obtain CE Mark
certification. CE Mark certification is an international symbol of adherence to quality assurance standards and compliance with the European Medical Device Directives. We have received CE Mark certification to sell our PATHFINDER, PATHFINDER mini,
REVELATION, REVELATION Tx, REVELATION Helix, and TRACER microcatheters and VENAPORT, VUEPORT and NAVIPORT guiding catheters for mapping in the European Union, and approval to sell some of our products in Canada. We received CE Mark Clearance for the
INTELLITEMP radio frequency energy management devices during the first quarter of 2004.



We intend to submit data in support of additional CE Mark applications. However, there can be no assurance we will be successful in obtaining or maintaining the CE Mark for any of our products, as the case may be.
Failure to receive or maintain approval to affix the CE Mark would prohibit us from selling these products in member countries of the European Union, and would require significant delays in obtaining individual country approvals. No assurance can be
given that we will ever obtain or maintain such approvals. If we do not receive or maintain these approvals, our business could be harmed.



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In July 2003, we received a Section 40 Letter (intention to suspend a medical device license) from the
Medical Devices Bureau of the Health Products and Food Branch of Health Canada. On December 1, 2003, after meeting with the Medical Devices Bureau and providing additional analysis from our current trial, we received notification from the Bureau
that the medical device license would not be suspended. We may receive similar notices in the future from U.S. or foreign agencies relating to approvals previously obtained or pending regulatory submissions.



Reuse of our single-use products could cause our revenues to decline.



Although we label all of our microcatheter systems for
single-use only, we are aware that some physicians potentially may reuse these products. Reuse of our microcatheter systems could reduce revenues from product sales and could cause our revenues to decline. In addition, such misuse of our products
could result in personal injury and death. See Factors Affecting Future ResultsWe may face product liability claims related to the use or misuse of our products.



Difficulties presented by international factors could negatively affect our business.



A component of our strategy is to expand our international sales revenues.
We believe that we will face risks in doing business abroad that we do not face domestically. Among the international risks we believe are most likely to affect us are:



| |  | export license requirements for our products;
| | - | ---------------------------------------------



| |  | exchange rate fluctuations or currency controls;
| | - | ------------------------------------------------



| |  | changes in the regulation of medical products by the European Union or other international regulatory agencies;
| | - | ---------------------------------------------------------------------------------------------------------------



| |  | the difficulty in managing a direct sales force from abroad;
| | - | ------------------------------------------------------------



| |  | the financial condition, expertise and performance of our international distributors and any future international distributors;
| | - | -------------------------------------------------------------------------------------------------------------------------------



| |  | domestic or international trade restrictions; or
| | - | ------------------------------------------------



| |  | changes in tariffs.
| | - | -------------------



Any of these factors could damage our business results.



We may be unable to successfully commercialize our microcatheter or surgical products, as the industry for them is highly competitive.



The market for catheters to map and/or ablate atrial fibrillation and
ventricular tachycardia is highly competitive, as is the market for surgical ablation products. Several of our competitors are developing different approaches and products for these procedures. These approaches include mapping systems using contact
mapping, single-point spatial mapping and non-contact, multi-site electrical mapping technologies, and ablation systems using radio frequency, ultrasound, microwave, laser and cryoblation technologies. Other companies are also developing surgical



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procedures that could allow physicians to perform the open-heart surgical maze procedure for the treatment of atrial
fibrillation in a minimally invasive manner. If any of these new approaches or products proves to be safe, effective and cost effective, our products could be rendered non-competitive or obsolete, which would harm our business.



Many of our competitors have an established presence in the field of
interventional cardiology and electrophysiology, or the study of the electrical system of the heart. These competitors include C.R. Bard, Inc., Medtronic, Inc., Boston Scientific, through its EP Technologies and Cardiac Pathways divisions, Johnson
& Johnson, through its Biosense-Webster division and St. Jude Medical, Inc., through its Daig division. These competitors have substantially greater financial and other resources than we do, including larger research and development staffs and
greater experience and capabilities in conducting clinical trials, obtaining regulatory approvals, and manufacturing, marketing and distributing products. In addition, other companies are developing proprietary systems for the diagnosis and
treatment of cardiac arrhythmias, including Biosense-Webster, a division of Johnson & Johnson, and Endocardial Solutions, Inc. Other companies are also developing, marketing and selling alternative approaches for the treatment of atrial
fibrillation and ventricular tachycardia, including manufacturers of implantable defibrillators such as Guidant Corporation, Medtronic, Inc. and St. Jude Medical, Inc. We cannot be certain that we will succeed in developing and marketing
technologies and products that are safer, more clinically effective and cost-effective than the more established treatments or the new approaches and products being developed and marketed by our competitors. Furthermore, there can be no assurance
that we will succeed in developing new technologies and products that will be available before those of our competitors, particularly because of our financial position. Our failure to demonstrate the competitive advantages and achieve market
acceptance of our products would significantly harm our business.



We license portions of our product technology from potential competitors, and the termination of any of these licenses would harm our business.



We rely on license agreements for some of our product technology from potential competitors. A license from Target Therapeutics, Inc., a subsidiary of
Boston Scientific Corporation, is the technological basis for our microcatheter systems for mapping and ablation. Boston Scientific Corporation currently has research efforts in the field of electrophysiology that may compete with our products.
Under the Target Therapeutics license agreement we have an exclusive license under specific issued United States patents. The exclusive license from Target Therapeutics covers the diagnosis and treatment of electrophysiological disorders in areas
other than the central nervous system. In addition, we have obtained a non-exclusive license to use Target Therapeutics technology, provided we have made a substantial improvement of such technology, for the diagnosis or treatment of diseases
of the heart, other than by balloon angioplasty. The license will terminate upon the expiration or invalidation of all claims under the underlying patents. In addition, Target Therapeutics has the right to terminate the license earlier if we fail to
comply with various commercialization, sublicensing, insurance, royalty, product liability, indemnification, non-competition and other obligations. Furthermore, either party can terminate the license if a material breach remains uncured for thirty
days or if either party ceases to be actively engaged in its present business for a period of twelve months. The loss of our exclusive rights to the Target Therapeutics-based microcatheter technology would significantly harm our business.



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In December 2000, we sold certain patents and related intellectual property pertaining to intravascular
sensing and signal detection to Medtronic, Inc., which currently has research efforts in the field of electrophysiology that may compete with our products. We received a perpetual, worldwide license at no cost from Medtronic to use these patents and
related intellectual property in our products for mapping and ablation of arrhythmia-causing tissue. In addition, Medtronic agreed not to sublicense the patents within our field of use to any non-affiliated party. We have also licensed a proprietary
surface-coating material from another vendor used on certain of our microcatheters.



We cannot be certain that these licenses will continue to be available to us or will be available to us on reasonable terms. The loss of or inability to maintain any of these licenses could result in delays in
commercial shipments until we could internally develop or identify, license and integrate equivalent technology. These delays would have a material adverse effect on our business, financial condition and results of operations.



We may not be able to commercialize our products under development if they
infringe existing patents or patents that have not yet issued.



We believe that our patent applications and products do not interfere with existing patents. However, we cannot be sure that relevant patents have not been issued that could block our ability to obtain patents or commercialize our products.
Moreover, because U.S. patent applications are not a matter of public record, a patent application could currently be on file that would prevent us from obtaining a patent issuance. In addition, Congress recently amended the U.S. patent laws to
exempt physicians, other health care professionals and affiliated entities from infringement liability for medical and surgical procedures performed on patients. The issuance of any potentially competing patent could harm our business.



We have received in the past and expect to continue to receive letters
from others threatening to enforce patent or other intellectual rights against us. We cannot be certain that we will not become subject to patent or intellectual property infringement claims or litigation, interference proceedings in the U.S. Patent
and Trademark Office to determine the priority of inventions, or oppositions to patent grants in foreign countries. Any such claim, litigation or proceeding, regardless of the outcome, would likely require us to expend substantial defense costs and
would disrupt our business. An adverse determination in litigation, interference or opposition proceedings could subject us to significant liabilities to third parties, require us to cease using important technology invalidate our intellectual
property rights, or require us to license disputed rights from third parties. However, we cannot be certain that any licenses will be available to us on commercially reasonable terms or at all. Our inability to obtain such a license could materially
delay the commercialization of our products, require us to expend substantial resources to design and develop alternative to the disputed technology, and otherwise harm our business. Our license with Target Therapeutics does not provide us with
indemnification against claims brought by third parties alleging infringement of patent rights. Consequently, we would bear the liability resulting from such claims. We cannot be certain that we will have the financial resources to protect and
defend our intellectual property, as such defense is often costly and time-consuming. Our failure to protect our patent rights, trade secrets, know-how or other intellectual property would harm our business.



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If healthcare providers do not receive adequate reimbursement for procedures using our products, the
market may not accept our products and our revenues may decline.



U.S. healthcare providers, including hospitals and physicians, that purchase microcatheter products generally rely on third-party payors, principally federal Medicare, state Medicaid and private health insurance plans, to reimburse all or a
part of the costs and fees associated with the procedures performed using our products. The success of our products will depend upon the ability of healthcare providers to obtain satisfactory reimbursement for medical procedures in which our
microcatheter systems are used. If these healthcare providers are unable to obtain reimbursement from third-party payors, the market may not accept our products and our revenues may decline.



Third-party payors may deny reimbursement if they determine that a prescribed
device (1) has not received appropriate regulatory clearances or approvals, (2) is not used in accordance with cost-effective treatment methods as determined by the payor, or (3) is experimental, unnecessary or inappropriate. If we receive FDA
clearance or approval, third-party reimbursement also would depend upon decisions by the United States Health Care Financing Administration for Medicare, as well as by individual health maintenance organizations, private insurers and other payors.
Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals may be obtained on a country-by-country basis. Many international markets have government-managed health
care systems that control reimbursement for new devices and procedures. In most markets, there are private insurance systems as well as government-managed systems. There can be no assurance that (1) reimbursement for our products will be available
domestically or internationally, (2) if available, that such reimbursement will be available in sufficient amounts in the United States or in international markets under either government or private reimbursement systems, or (3) that physicians will
support and advocate reimbursement for procedures using our products. Failure by hospitals and other users of our products to obtain reimbursement from third-party payors or changes in government and private third-party payor policies toward
reimbursement for procedures employing our products would harm our business. Moreover, we are unable to predict what additional legislation or regulation, if any, relating to the health care industry or third-party coverage and reimbursement may be
enacted in the future, or what effect such legislation or regulation would have on our business.



We cannot be certain that we will be able to manufacture our products in high volumes at commercially reasonable costs.



We currently manufacture our microcatheter systems in limited quantities for
U.S. and international sales and for pre-clinical and clinical trials. However, we have limited experience manufacturing our products in the amounts necessary to achieve significant commercial sales. For example, we currently do not have the ability
to manufacture one of the components of our Surgical Ablation System in substantial quantities. We expect that if U.S. sales of our PATHFINDER microcatheter products, our REVELATION® microcatheter products, or our Surgical Ablation System increase or if we receive FDA clearance or approvals for other products, we will need to expend
significant capital resources and develop additional manufacturing capacity to establish large-scale manufacturing capabilities. However, we could encounter problems related to:



| |  | capacity constraints;
| | - | ---------------------



| |  | production yields;
| | - | ------------------



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 quality control; and



 shortages of qualified personnel.



Such problems could affect our ability to adequately scale-up production of our products and fulfill customer orders on a
timely basis, which could harm our business.



Our manufacturing
facilities are subject to periodic inspection by regulatory authorities. Our operations must either undergo Quality System Regulations compliance inspections conducted by the FDA or receive an FDA exemption from such compliance inspections in order
for the FDA to permit us to produce products for sale in the United States. Our facilities and manufacturing processes are subject to inspections from time to time by the FDA, the State of California and European Notified Bodies. We have
demonstrated compliance with EN 46001 (ISO 13485 or ISO 9001) quality standards, as well as compliance with 93/42/EEC, the Medical Device Directive. We comply with procedures to produce products for sale in Europe. Any failure by us to comply with
the Quality System Regulations requirements or to maintain our compliance with EN 46001 (ISO 13485 or ISO 9001) standards and 93/42/EEC, the Medical Device Directive, will require us to take corrective actions, such as modification of our policies
and procedures. In addition, we may be required to cease all or part of our operations for some period of time until we can demonstrate that appropriate steps have been taken to comply with Quality System Regulations or EN 46001 (ISO 13485 or ISO
9001) standards. There can be no assurance that we will be found in compliance with the Quality System Regulations by regulatory authorities, or that we will maintain compliance with EN 46001 (ISO 13485 or ISO 9001) standards in future audits. Our
failure to comply with state or FDA Quality System Regulations, maintain compliance with EN 46001 (ISO 13485 or ISO 9001) standards, or develop our manufacturing capability in compliance with such standards, would have a material adverse effect on
our business, financial condition and results of operations.



Our facilities and manufacturing processes have undergone a successful annual surveillance audit by the European Notified Body in November 2002 and a pre-PMA inspection in December 2003. In November 2000 and in January 2003, the FDA
conducted an inspection of our quality system, which we successfully passed. There is no assurance that our manufacturing facilities will continue to meet such compliance audits and will maintain such compliance standards.



If our sole-source suppliers are unable to meet our demands, our business
results will suffer.



We purchase certain key components
for some of our products, from sole, single or limited source suppliers. For some of these components, there are relatively few alternative sources of supply. Establishing additional or replacement suppliers for any of the numerous components used
in our products, if required, may not be accomplished quickly and could involve significant additional costs. Any supply interruption from vendors or failure to obtain alternative vendors for any of the numerous components used to manufacture our
products would limit our ability to manufacture our products. Any such limitation on our ability to manufacture our products would cause our business results to suffer.



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We may face product liability claims related to the use or misuse of our products.



We face an inherent business risk of product liability claims in the event
that the use or misuse of our products results in personal injury or death. We have received claims of this type in the past and may receive additional claims in the future. We cannot be certain, in particular after commercial introduction of our
products, that we will not experience losses due to product liability claims. Although we currently have general liability and product liability insurance coverage, this coverage is subject to per-occurrence and annual limitations, as well as
substantial deductibles. We cannot be certain that such coverage will be adequate or continue to be available to us on reasonable terms, if at all. In addition, there can be no assurance that all of the activities encompassed within our business are
or will be covered under our policies. Although we label our microcatheter products for single-use only, we are aware that some physicians are re-using such products. Moreover, despite labeling our microcatheters for diagnostic use only, we believe
that physicians are using such mapping microcatheters for ablation. Multiple use or off-label use of our microcatheters could subject us to increased exposure to product liability claims, which could have a material adverse effect on our
business, financial condition and results of operations. We may require additional product liability coverage if we significantly expand commercialization of our products. Such additional coverage is expensive, difficult to obtain and may not be
available in the future on acceptable terms, if at all. Any claims or series of claims against us, regardless of their merit or eventual outcome, could have a material adverse effect on our business, financial condition and results of operations.



We are dependent upon our key personnel.



Our ability to operate successfully depends in significant part upon the
continued service of certain key scientific, technical, clinical, regulatory and managerial personnel, and our continuing ability to attract and retain additional highly qualified personnel in these areas. Competition for such personnel is intense,
especially in the San Francisco Bay Area. We cannot be certain that we can retain such personnel or that, if we are able to raise additional capital in amounts sufficient to maintain and expand our operations, we will be able to attract or retain
other highly qualified scientific, technical, clinical, regulatory and managerial personnel in the future.



We do not intend to pay cash dividends on our stock.



We have never paid cash dividends on our capital stock and do not anticipate paying cash dividends in the foreseeable future. Instead, we intend to retain
future earnings for reinvestment in our business.



Substantial future sales of our common stock in the public market could cause our stock price to fall.



Among other factors contributing to the potential volatility of our stock price, additional sales of our common stock in the public market, or the
perception that such sales could occur, could cause the market price of our common stock to decline.



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Delaware law, our corporate charter and bylaws and our stockholder rights plan could delay or
discourage takeover attempts that stockholders may consider favorable.



Provisions in our certificate of incorporation and bylaws may have the effect of delaying or preventing a change of control of our company. These provisions include:



| |  | the ability of the board of directors to alter our bylaws without stockholder approval;
| | - | ---------------------------------------------------------------------------------------



| |  | the ability of the board of directors to issue, without stockholder approval, up to five million shares of preferred stock with rights set by the board of directors, which rights
could be senior to those of our common stock; and
| | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| |  | the elimination of the rights of stockholders to act by written consent.
| | - | ------------------------------------------------------------------------



Each of these provisions could discourage potential takeover attempts.



In May 2002, we adopted a stockholder rights plan and declared a dividend distribution of one right for each outstanding
share of common stock on May 21, 2002. Each right, when exercisable, entitles the registered holder to purchase from us one one-hundredth of a share of a new series of preferred stock on the terms stated in our rights plan. The rights will generally
separate from the common stock and become exercisable if any person or group acquires or announces a tender offer to acquire 15% or more of our outstanding common stock without the consent of our board of directors. Because the rights may
substantially dilute the stock ownership of a person or group attempting to take us over without the approval of our board of directors, our stockholder rights plan could make it more difficult for a third party to acquire us (or a significant
percentage of our outstanding capital stock) without first negotiating with our board of directors. In addition, we are governed by provisions of Delaware law that may prohibit large stockholders, in particular those owning 15% or more of our
outstanding voting stock, from merging or combining with us.



These provisions in our charter, bylaws and rights plan and under Delaware law could discourage takeover attempts that our stockholders would otherwise favor, or otherwise reduce the price that investors might be willing to pay for our
common stock in the future.



Item 3. Quantitative and Qualitative Disclosure about Market Risk



Since we did not have a short-term investment or a line of credit obligation as of June 30, 2004, we do not have any material quantitative disclosures
about market risk.



Item 4: Controls and Procedures



Evaluation of disclosure controls and procedures. We maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the
Exchange Act), that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in
Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial



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Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our
disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and
procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design
of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future
conditions.



Based on their evaluation as of the end of the
period covered by this Quarterly Report on Form 10-Q, our Chief Executive Officer and Chief Financial Officer have concluded that, subject to the limitations noted above, our disclosure controls and procedures were effective to ensure that material
information relating to us, including our consolidated subsidiaries, is made known to them by others within those entities, particularly during the period in which this Quarterly Report on Form 10-Q was being prepared.



Changesin internal control over financial reporting. There
were no changes in our internal control over financial reporting during the quarter ended September 30, 2004, that have materially affected, or are reasonably like to materially affect, our internal controls over financial reporting.



PART II. OTHER INFORMATION



Item 1.Legal Proceedings



From time to time, we are subject to certain legal proceedings that arise in the ordinary course of business. In the opinion of management, no pending legal proceedings are reasonably likely to have a material adverse
effect on our financial condition, liquidity or results of operations. However, the results of legal proceedings cannot be predicted with certainty. Should we fail to prevail in any legal proceedings, our operating results for a particular reporting
period could be materially adversely affected.



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



None.



Item 3.Defaults Upon Senior Securities



None.



Item 4.Submission of Matters to a Vote of the Security Holders



None.



Item 5.Other Information



None.



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Item 6.Exhibits



|     |  |                                                                                                                                                  
|---- |  | -------------------------------------------------------------------------------------------------------------------------------------------------
|31.1 |  | Certification of the Chief Executive Officer of Cardima, Inc., pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.             
|     | 
|31.2 |  | Certification of the Interim Chief Financial Officer of Cardima, Inc., pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.     
|     | 
|32.1 |  | Certification furnished pursuant to Section 1350 of Chapter 63 of 18 U.S.C. as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 
|     | 
|32.2 |  | Certification furnished pursuant to Section 1350 of Chapter 63 of 18 U.S.C. as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.



CARDIMA, INC.



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.



|                        |  |                                               
|----------------------- |  | ----------------------------------------------
|DATE: November 15, 2004 |  | CARDIMA, INC.                                 
|                        | 
|                        |  | /s/    Gabriel B. Vegh                        
|                        |  | GABRIEL B. VEGH                               
|                        |  | Chairman, Chief Executive Officer and Director
|                        | 
|                        |  | /s/    Barry D. Michaels                      
|                        |  | BARRY D. MICHAELS                             
|                        |  | Interim Chief Financial Officer and Secretary 



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