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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549



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FORM 10-Q/A



Amendment No. 1



| | x |  | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934. | 
| | - |  | ---------------------------------------------------------------------------------------- | 



| |  |  | For the quarterly period ended June 30, 2003
| |  |  | --------------------------------------------



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)



|Delaware                          |  | 94-3177883         
|--------------------------------- |  | -------------------
|(State or Other Jurisdiction      |  | (I.R.S. Employer   
|of Incorporation or Organization) |  | 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



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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.    Yes  x    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 ̈No  x



As of August 4, 2003, there were 62,950,415 shares of
Registrants Common Stock outstanding.



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EXPLANATORY NOTE



This Form 10-Q/A is being filed for the sole purpose of revising Notes 2, 4 and 12 of the Notes to Condensed Financial
Statements, the Overview and Liquidity and Capital Resources under Managements Discussion and Analysis of Financial Condition and Results of Operations and the Factors Affecting Future Results to discuss the closings on August 13 and August
14, 2003 of our private placement. There are no changes to the earnings per share or other reported amounts in the selected financial data.



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CARDIMA, INC.



TABLE OF CONTENTS



PART I.    Financial Information



|                               |  | Description                                                                                               |  | Page
|------------------------------ |  | --------------------------------------------------------------------------------------------------------- |  | ----
|                               |  |                                                                                                          
|Item 1.                        |  | Financial Statements (unaudited)                                                                          |  | 4   
|                               |  |                                                                                                          
|                               |  | Condensed Balance Sheets as of June 30, 2003 and December 31, 2002                                        |  | 4   
|                               |  |                                                                                                          
|                               |  | Condensed Statements of Operations for the Three and Six Months Ended June 30, 2003 and December 31, 2002 |  | 5   
|                               |  |                                                                                                          
|                               |  | Condensed Statement of Cash Flows for the Six Months Ended June 30, 2003 and 2002                         |  | 6   
|                               |  |                                                                                                          
|                               |  | Notes to Condensed Financial Statements                                                                   |  | 7   
|                               |  |                                                                                                          
|Item 2.                        |  | Managements Discussion and Analysis of Financial Condition and Results of Operations                     |  | 13  
|                               |  |                                                                                                          
|                               |  | Factors Affecting Future Results                                                                          |  | 19  
|                               |  |                                                                                                          
|Item 3.                        |  | Quantitative and Qualitative Disclosure About Market Risk                                                 |  | 35  
|                               |  |                                                                                                          
|Item 4.                        |  | Controls and Procedures                                                                                   |  | 35  
|                               | 
|PART II.     Other Information |  |                                                                                                          
|                               |  |                                                                                                          
|                               |  | Description                                                                                               |  | Page
|                               |  |                                                                                                          
|Item 1.                        |  | Legal Proceedings                                                                                         |  | 36  
|                               |  |                                                                                                          
|Item 2.                        |  | Changes in Securities and Use of Proceeds                                                                 |  | 36  
|                               |  |                                                                                                          
|Item 3.                        |  | Default Upon Senior Securities                                                                            |  | 37  
|                               |  |                                                                                                          
|Item 4.                        |  | Submission of Matters to a Vote of Security Holders                                                       |  | 37  
|                               |  |                                                                                                          
|Item 5.                        |  | Other Information                                                                                         |  | 38  
|                               |  |                                                                                                          
|Item 6.                        |  | Exhibits and Reports on Form 8-K                                                                          |  | 38  
|                               | 
|Signatures                     |  | 39                                                                                                       



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PART I.



Item 1.Financial Statements



CARDIMA, INC.

CONDENSED BALANCE SHEETS

(In thousands, except share and per share amounts)



|ASSETS                                                                                                                                                                                                 |  | June 30, 2003 (Unaudited) |         |   | December 31, 2002 (1) |  
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |  | ------------------------- | ------- | - | --------------------- | -
|Current assets:                                                                                                                                                                                        |  |                           |         |   |                       |  
|Cash and cash equivalents                                                                                                                                                                              |  | $                         | 2,165   |   |                       | $
|Accounts receivable, net of allowances for doubtful accounts of $85 at June 30, 2003 and $79 at December 31, 2002                                                                                      |  |                           | 216     |   |                       |  
|Inventories                                                                                                                                                                                            |  |                           | 1,209   |   |                       |  
|Other current assets                                                                                                                                                                                   |  |                           | 444     |   |                       |  
|                                                                                                                                                                                                       |  |                           |         |   |                       |  
|Total current assets                                                                                                                                                                                   |  |                           | 4,034   |   |                       |  
|Property and equipment, net                                                                                                                                                                            |  |                           | 778     |   |                       |  
|Notes receivable from officers                                                                                                                                                                         |  |                           | 610     |   |                       |  
|Other assets                                                                                                                                                                                           |  |                           | 39      |   |                       |  
|                                                                                                                                                                                                       |  |                           |         |   |                       |  
|                                                                                                                                                                                                       |  | $                         | 5,461   |   |                       | $
|                                                                                                                                                                                                       |  |                           |         |   |                       |  
|                                                                                                                                                                                                       |  |                          
|LIABILITIES AND STOCKHOLDERS EQUITY                                                                                                                                                                   |  |                           |         |   |                       |  
|Current liabilities:                                                                                                                                                                                   |  |                           |         |   |                       |  
|Accounts payable                                                                                                                                                                                       |  | $                         | 1,034   |   |                       | $
|Accrued compensation                                                                                                                                                                                   |  |                           | 978     |   |                       |  
|Other current liabilities                                                                                                                                                                              |  |                           | 272     |   |                       |  
|Capital lease obligationcurrent portion                                                                                                                                                               |  |                           | 177     |   |                       |  
|                                                                                                                                                                                                       |  |                           |         |   |                       |  
|Total current liabilities                                                                                                                                                                              |  |                           | 2,461   |   |                       |  
|                                                                                                                                                                                                       |  |                          
|Deferred rent                                                                                                                                                                                          |  |                           | 27      |   |                       |  
|Capital lease obligationnoncurrent portion                                                                                                                                                            |  |                           | 104     |   |                       |  
|                                                                                                                                                                                                       |  |                          
|Commitments                                                                                                                                                                                            |  |                           |         |   |                       |  
|                                                                                                                                                                                                       |  |                          
|Stockholders equity:                                                                                                                                                                                  |  |                           |         |   |                       |  
|Common stock, $0.001 par value; 125,000,000 shares authorized, 62,950,415 shares issued and outstanding at June 30, 2003;
54,394,264 issued and outstanding as of December 31, 2002; at amount paid in |  |                           | 100,210 |   |                       |  
|Accumulated deficit                                                                                                                                                                                    |  |                           | (97,341 | ) |                       |  
|                                                                                                                                                                                                       |  |                           |         |   |                       |  
|Total stockholders equity                                                                                                                                                                             |  |                           | 2,869   |   |                       |  
|                                                                                                                                                                                                       |  |                           |         |   |                       |  
|                                                                                                                                                                                                       |  | $                         | 5,461   |   |                       | $
|                                                                                                                                                                                                       |  |                           |         |   |                       |  

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|(1) |  | The balance sheet as of December 31, 2002 was derived from the audited financial statements included in the Companys 2002 Annual Report on Form 10-K filed with the Securities
and Exchange Commission but do 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 ended June 30, |        |   | Six months ended June 30, |  
|------------------------------------------------------------- |  | --------------------------- | ------ | - | ------------------------- | -
|                                                              |  | 2003                        |        |   | 2002                      |  
|Net sales                                                     |  | $                           | 491    |   |                           | $
|Operating expenses:                                           |  |                             |        |   |                           |  
|Cost of goods sold                                            |  |                             | 821    |   |                           |  
|Research and development                                      |  |                             | 1,495  |   |                           |  
|Selling, general and administrative                           |  |                             | 1,859  |   |                           |  
|                                                              |  |                             |        |   |                           |  
|Total operating expenses                                      |  |                             | 4,175  |   |                           |  
|                                                              |  |                             |        |   |                           |  
|Operating loss                                                |  |                             | (3,684 | ) |                           |  
|Interest and other income                                     |  |                             | 21     |   |                           |  
|Interest expense                                              |  |                             | (4     | ) |                           |  
|                                                              |  |                             |        |   |                           |  
|Net income (loss)                                             |  | $                           | (3,667 | ) |                           | $
|                                                              |  |                             |        |   |                           |  
|Basic and diluted net loss per share                          |  | $                           | (0.06  | ) |                           | $
|                                                              |  |                             |        |   |                           |  
|Shares used in computing basic and diluted net loss per share |  |                             | 62,391 |   |                           |  
|                                                              |  |                             |        |   |                           |  



See accompanying notes
to financial statements



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CARDIMA, INC.

STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

|                                                                      |  | Six months ended June 30, |       
|--------------------------------------------------------------------- |  | ------------------------- | ------
|                                                                      |  | 2003                      |       
|CASH FLOWS FROM OPERATING ACTIVITIES                                  |  |                           |       
|Net loss                                                              |  | $                         | (6,888
|Adjustments to reconcile net loss to net cash provided by operations: |  |                           |       
|Depreciation and amortization                                         |  |                           | 384   
|Reversal of stock-based compensation                                  |  |                           |      
|Loss on disposal of assets                                            |  |                           | 9     
|Non-cash interest income on notes receivable from officers            |  |                           | (15   
|Changes in operating assets and liabilities:                          |  |                           |       
|Accounts receivable                                                   |  |                           | 102   
|Inventories                                                           |  |                           | 17    
|Other current assets                                                  |  |                           | 178   
|Other assets                                                          |  |                           | 50    
|Accounts payable                                                      |  |                           | (995  
|Accrued employee compensation                                         |  |                           | (260  
|Other current liabilities                                             |  |                           | (4    
|Deferred rent                                                         |  |                           | 23    
|                                                                      |  |                           |       
|Net cash used in operating activities                                 |  |                           | (7,399
|CASH FLOWS FROM INVESTING ACTIVITIES                                  |  |                           |       
|Capital expenditures                                                  |  |                           | (141  
|                                                                      |  |                           |       
|Net cash used in investing activities                                 |  |                           | (141  
|CASH FLOWS FROM FINANCING ACTIVITIES                                  |  |                           |       
|Principal payments under leases                                       |  |                           | 113   
|Net proceeds from sale of common stock                                |  |                           | 6,207 
|                                                                      |  |                           |       
|Net cash provided by (used in) financing activities                   |  |                           | 6,320 
|                                                                      |  |                           |       
|NET DECREASE IN CASH AND CASH EQUIVALENTS                             |  | $                         | (1,220
|                                                                      |  |                           |       
|CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD                        |  | $                         | 3,385 
|                                                                      |  |                           |       
|CASH AND CASH EQUIVALENTS, END OF PERIOD                              |  | $                         | 2,165 
|                                                                      |  |                           |       



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CARDIMA, INC.



NOTES TO
CONDENSED FINANCIAL STATEMENTS

June 30, 2002

(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 six month period ended June 30, 2003 are not necessarily indicative of the results that may be expected for the fiscal year
ending December 31, 2003 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, 2002. The accompanying balance sheet at December 31, 2002 has been derived from these audited financial statements.



2.    MANAGEMENTS PLANS



As of June 30, 2003 the Company has approximately $2,165,000 in cash and cash equivalents, working capital of $1,573,000 and an accumulated deficit of
$97,341,000. Management expects to continue to incur additional losses in the foreseeable future as the Company works towards completion of its key clinical trial in the United States, commercialization of the REVELATION® Tx in the United States and commercialization of the REVELATION® Helix in Europe. Following the closings on August 13
and August 14, 2003 of our private placement, we will have cash and cash equivalents of approximately $6.5 million. Our management currently estimates that our cash balances as of August 14, 2003 will be sufficient to fund planned
expenditures into 2004, but this cannot be predicted with certainty. Although our management recognizes the need to raise funds in the near future and is currently negotiating with certain third parties the terms and conditions of financing
transactions in addition to the private placement that closed in August 2003, there can be no assurance that we will be successful in consummating any such transaction, or, if we do consummate such a transaction, that the terms and conditions of
such financing will not be unfavorable to us. Furthermore, certain provisions in the documents governing the private placement closed in August 2003 will hinder our ability to raise additional equity financing in the future. In particular, the
investors in the August 2003 private placement have a preemptive right to participate in our next equity financing which raises gross proceeds of more than $1,000,000, and we are prohibited, except in certain circumstances, from selling additional
shares of common stock without the consent of those investors prior to or within thirty days after the effectiveness of a registration statement covering the sale of their shares purchased in the August 2003 private placement. Any failure by
management to obtain additional funding will result in our inability to continue as a going concern.



The Company continues to initiate relationships with new distributors worldwide. As of June 30, 2003, the Company had distributors in place in eight
countries that provide service and sales support in twelve countries; consultants and sales agents in place in two countries that provide service and sales support in five countries; and a European distribution center in place which provides
services and sales support to an additional nine European countries. The Company is currently seeking regulatory approval of all its therapeutic products in China, but cannot predict



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whether its products will ultimately be approved for sale in that region. In addition, the Company cannot predict whether or not it will be successful in
marketing and selling its diagnostic and therapeutic products in China or other Asian countries. Recent additions to the Companys product registrations include Canadian Device License acceptance for the REVELATION® Tx, REVELATION® T-Flex and REVELATION® Helix product lines of cardiac ablation catheters by the Canadian Therapeutic Products
Directorate to enable commercial distribution throughout Canada.



3.    CRITICAL ACCOUNTING POLICIES



Critical Accounting Policies



Use of
Estimates



We have prepared our financial statement 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.



Revenue Recognition



We recognize revenue when products are shipped. We recognize revenue from
two types of customersend users and distributors. Revenue is recognized upon the shipment of product, provided the title of products has been transferred at the point of shipment, there is persuasive evidence of an agreement, 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



Our inventories are stated at the lower of cost or market. Cost is based on actual costs computed on a first-in, first-out basis. Inventories are shown
net of reserves for excess and obsolete inventory at the lower cost or market. We provide reserves for potential excess quantities and obsolescence as a result of technological advancements which impact inventories on hand.



4.    PRIVATE PLACEMENTS



On December 31, 2002 and January 22, 2003, we sold by means of a private
placement an aggregate of 5,333,319 shares of our common stock at a price per share of $0.74955 for an aggregate net proceeds of approximately $3.5 million. In addition, we issued to the investors warrants to purchase 2,400,000 shares of our common
stock at an exercise price of $0.8245 per share. The warrants became exercisable on March 1, 2003 and March 23, 2003, respectively. The warrants allow for a cashless exercise whereby the exercising party may use shares issuable upon
exercise of the warrant in payment of the exercise price. We may not redeem the warrants and the warrants are subject to a mandatory exchange or termination in the case of certain reorganizations, mergers, or divestitures. We paid to the party who
acted as finder in connection with this private placement a fee of $25,000 in cash plus 66,667 shares of our common stock upon execution of a letter agreement. Upon the closing of the



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transactions, we also paid to the finder a total of $300,000 in cash and issued to the finder warrants to purchase 533,331 shares of our common stock at an
exercise price of $0.8245. The warrants issued to the finder are not redeemable and allow for cashless exercise whereby the finder may use shares issuable upon exercise of the warrant in payment of the exercise price.



On March 28, 2003, we sold by means of a private placement an aggregate of
2,941,175 shares of our common stock at a price of $0.85 per share for net proceeds of approximately $2.3 million. In addition, we issued to the investors warrants to purchase 1,176,470 shares of our common stock at an exercise price of $1.25 per
share. The warrants will be exercisable beginning on September 28, 2003 and will be reduced on a share-by-share basis to the extent that an investor sells our common stock or other securities during the six (6) month period between the closing and
September 28, 2003. We may redeem the warrants for a price of $0.001 per share of common stock if the average closing price per share of our common stock has been at least $1.70 (as adjusted for subsequent stock splits and the like) for fifteen
consecutive trading days. We paid to the party that acted as agent in connection with this private placement upon the March 28, 2003 closing of the transaction, a total of $175,000 in cash and issued to the agent warrants to purchase 294,117 shares
of our common stock at an exercise price of $0.935.



On April
11, 2003, we sold by means of a private placement an additional 4,395,587 shares of our common stock at a price of $0.85 per share for net proceeds of approximately $3.5 million. In addition, we issued to the investors warrants to purchase 1,758,234
shares of our common stock at an exercise price of $1.25 per share. The warrants will be exercisable beginning on October 11, 2003 and will be reduced on a share-by-share basis to the extent that an investor sells our common stock or other
securities during the six (6) month period between the closing and October 11, 2003. We may redeem the warrants for a price of $0.001 per share of common stock if the average closing price per share of our common stock has been at least $1.70 (as
adjusted for subsequent stock splits and the like) for fifteen consecutive trading days. We are obligated to issue to a party which acted as finder in connection with this closing of the private placement 24,746 shares of our common stock as
consideration for its execution of a new letter agreement. We also paid to the parties that acted as agents in connection with this private placement upon the April 11, 2003 closing of the transaction, a total of $270,000 in cash and issued to the
agents warrants to purchase 448,557 shares of our common stock at an exercise price of $0.935.



Subsequent to the quarter end, on August 13 and August 14, 2003, we sold by means of a private placement an aggregate of approximately 10,282,800 shares of our common stock at a price of $0.5296 per share and
approximately 979,600 shares of common stock at a price of $0.5664 per share for net proceeds of approximately $5.58 million. In addition, we issued to the investors warrants to purchase approximately 3,084,840 shares of our common stock at an
exercise price of $0.7282 per share and warrants to purchase approximately 293,880 shares of our common stock at an exercise price of $0.7788 per share. We may redeem the warrants for a price of $0.001 per share of common stock if the average
closing price per share of our common stock has been at least $1.0592 or $1.1328, respectively, (as adjusted for subsequent stock splits and the like) for fifteen consecutive trading days, so long as our stock remains listed on specified securities
exchanges or trading markets and a registration statement covering the resale of the warrant shares is effective. Redemptions initiated during the first six months after the closing are subject to deferral and certain other conditions. We paid a
total of $420,000 in cash to the parties that acted as agents in connection with this private placement, and issued to the agents warrants to purchase approximately 272,602 shares of our common stock at an exercise price of $0.8375 and warrants to
purchase approximately 350,401 shares of our common stock at an exercise price of $1.10. The closing of this transaction will cause additional shares of common stock to be issuable under the antidilution provisions of certain of our previously
issued securities.



5.    RESTRUCTURING



On June 30,
2003, our workforce was reduced by 21 employees, of which fifteen (15) were in operations, four (4) in research and development and two (2) in marketing and general and administration in order to concentrate all resources on continued efforts to
resubmit data to the FDA for the approval of the REVELATION Tx. Additionally, the Company accepted the resignation of former Chief Financial Officer and Secretary, Ronald E. Bourquin, who left to pursue other interests. Barry D. Michaels joined the
company on June 30, 2003 as Interim Chief Financial Officer and Secretary. Restructuring charges are expected to be approximately $325,000 with $117,000 in research and development, $137,000 in marketing and general and administration and $71,000 in
operations. Approximately $60,000 of the total costs were paid out on June 30, 2003 and we expect $184,000 to be paid in the third quarter of 2003 and $71,000 in the fourth quarter of 2003.



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6.    INVENTORIES



Inventories consist of the following (in thousands):



|                |  | June 30,2003 |       | December 31, 2002
|--------------- |  | ------------ | ----- | -----------------
|Raw materials   |  | $            | 451   |                  
|Work-in-process |  |              | 241   |                  
|Finished goods  |  |              | 517   |                  
|                |  |              |       |                  
|                |  | $            | 1,209 |                  
|                |  |              |       |                  



Inventory amounts
shown above are net of reserves for excess and obsolete inventory of $189,000 and $242,000 at June 30, 2003 and December 31, 2002, respectively. The Company provides reserves for potential excess quantities and obsolescence as a result of
technological advances which impact inventories on hand.



7.    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.



Of the initial 462,576 shares that were repriced, 25,011 shares have been
cancelled, 29,700 shares have been exercised and 407,865 shares remain outstanding as of June 30, 2003. 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 June 30, 2003. No expenses related to the re-pricing were recorded for the quarter ended June 30, 2003 because the closing price of $0.72 on June 30, 2003 is below the repriced exercise price of $1.16 per share and, therefore, no adjustment
was required.



8.    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. The Company has excluded all warrants and stock



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options from the computation of basic and diluted earnings per share because all such securities are anti-dilutive for all periods presented.



9.    COMPREHENSIVE INCOME (LOSS)



Comprehensive loss equaled net loss for all periods presented.



10.    RECENT ACCOUNTING PRONOUNCEMENTS



In January 2003, the FASB issued Interpretation No. 46 (or FIN 46),
Consolidation of Variable Interest Entities. FIN 46 requires a variable interest entity to be consolidated by a company if that company is subject to a majority of the risk of loss from the variable interest entitys activities or
entitled to receive a majority of the entitys residual returns or both. A variable interest entity is a corporation, partnership, trust, or any other legal structures used for business purposes that either (a) does not have equity investors
with voting rights or (b) has equity investors that do not provide sufficient financial resources for the entity to support its activities. A variable interest entity often holds financial assets, including loans or receivables, real estate or other
property. A variable interest entity may be essentially passive or it may engage in research and development or other activities on behalf of another company. The consolidation requirements of FIN 46 apply immediately to variable interest entities
created after January 31, 2003. The consolidation requirements apply to older entities in the first fiscal year or interim period beginning after June 15, 2003. Certain of the disclosure requirements apply to all financial statements issued after
January 31, 2003, regardless of when the variable interest entity



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was established. The adoption of FIN 46 in January 2003 did not have a material impact on the Companys financial position or results of operations.



11.    STOCK-BASED
COMPENSATION



The following information regarding pro forma net
loss and net loss per share prepared in accordance with FAS 123 has been determined as if we had accounted for our employee stock options and employee stock plan under the fair value method proscribed by FAS 123. The resulting effect on net loss and
net loss per share pursuant to FAS 123 is not likely to be representative of the effects on net loss and loss per share pursuant to FAS 123 in future periods, due to subsequent periods including additional grants and periods of vesting. The fair
value of options was estimated at the date of grant using a Black-Scholes option valuation model with the following weighted-average assumptions for the six months ended June 30, 2003 and 2002, respectively: risk-free interest rates of 2.16% and
2.50%; dividend yields of 0%; volatility factors of the expected market price of our Common Stock of 103% and 85%; and a weighted-average expected life of the option of four years.



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 FAS 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 FAS 123 to stock-based employee compensation (in thousands, except per share amounts):



|                                                                                                        |  | Three MonthsEnded June 30, |        |   | Six Months Ended June 30, |  
|------------------------------------------------------------------------------------------------------- |  | -------------------------- | ------ | - | ------------------------- | -
|                                                                                                        |  | 2003                       |        |   | 2002                      |  
|Net lossas reported                                                                                    |  | $                          | (3,667 | ) |                           |  
|Add:                                                                                                    |  |                            |        |   |                           |  
|Stock-based employee compensation (benefit) expense included in reported net loss                       |  |                            |        |   |                           |  
|                                                                                                        |  |                            |        |  
|Deduct:                                                                                                 |  |                            |        |   |                           |  
|Total stock-based employee compensation expense determined under fair value based method for all awards |  |                            | (316   | ) |                           |  
|                                                                                                        |  |                            |        |   |                           |  
|Pro forma net loss                                                                                      |  | $                          | (3,983 | ) |                           | $
|                                                                                                        |  |                            |        |   |                           |  
|Basic and diluted net loss per share:                                                                   |  |                            |        |   |                           |  
|As reported                                                                                             |  | $                          | (0.06  | ) |                           | $
|                                                                                                        |  |                            |        |   |                           |  
|Pro forma                                                                                               |  | $                          | (0.06  | ) |                           | $
|                                                                                                        |  |                            |        |   |                           |  



12.    SUBSEQUENT EVENTS



On July
16, 2003, we received notice from the Canadian Medical Devices Bureau that they may suspend our license to sell the REVELATION® family of products because they believe the products may no longer meet the safety and effectiveness requirements. We have requested a hearing and it
has been granted, with a date scheduled for August 28, 2003.



Currently, our common stock trades on the Nasdaq SmallCap Market. On July 22, 2003, we received notification from the NASD that our common stock had closed below the minimum $1.00 per share required for continued inclusion on the Nasdaq for
a period of more than thirty consecutive trading days. In its notification, the NASD informed us that we have 180 calendar days, or until January 12, 2004, to comply with NASD Marketplace Rule 4310(c)(4). In order to comply with this rule, the bid
price of our common stock must close at $1.00 per share or more for a minimum of ten consecutive trading days at any time before January 12, 2004. Furthermore, the NASD will require that we meet all of the applicable listing requirements. See
Factors Affecting Future ResultsOur stock may become subject to penny stock rules, which may make it more difficult for investors to sell their shares and may lead to financial penalties under certain of our agreements.



On August 13 and August 14, 2003, we sold by means of a
private placement an aggregate of 10,282,800 shares of our common stock at a price of $0.5296 per share and 979,600 shares of our common stock at a price of $0.5664 per share for net proceeds of $5.44 million. In addition, we issued to the
investors warrants to purchase 3,084,840 shares of our common stock at an exercise price of $0.7282 per share. We may redeem the warrants for a price of $0.001 per share of common stock if the average closing price per share of our common stock has
been at least $1.0592 or $1.1328, respectively, (as adjusted for subsequent stock splits and the like) for fifteen consecutive trading days and certain other conditions are met, including the continued listing of our common stock on specified
securities exchanges or trading markets and the effectiveness of a registration statement covering the resale of the warrant shares. Redemptions initiated during the first six months after the closing are subject to deferral and certain other
conditions. We cannot assure you that we will be able to redeem the warrants. We paid a total of $420,000 in cash to the parties that acted as agents in connection with this private placement, and issued to the agents warrants to purchase 272,602
shares of our common stock at an exercise price of $0.8375 and warrants to purchase 350,401 shares of our common stock at an exercise price of $1.10.



We relied on the exemption provided by Rule 506 under Regulation D and Section 4(2) of the Securities Act of 1933, as amended, in connection with the
August 2003 placement. A registration statement on Form S-3 will be filed with the SEC in connection with that placement. The terms of the private placement agreements will require us to make specified payments to the investors if we fail to file
this registration statement, cause it to be declared effective or make it continuously available for resales, within specified time periods.



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



This 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
regulatory approvals, 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. Such factors include the Companys ability to obtain adequate funding, whether we will re-submit our premarket approval application, or PMA, for the REVELATION Tx linear ablation microcatheter
system, and whether the re-submitted PMA will be approved by the U.S. Food and Drug Administration, whether we will be able to conduct successful clinical trials, whether we will be able to obtain timely regulatory approvals and gain acceptance from
the marketplace for its products, whether we will be able to successfully market, sell and derive sufficient revenue from our products, as well as the risk factors discussed below in Factors Affecting Future Results and those listed from
time to time in the Companys 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 Annual Report on Form 10-K.



Overview



Since our
incorporation in November 1992, we have engaged in the design, research, development, manufacturing and testing of microcatheter systems 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 be potentially fatal. We
develop microcatheter 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 also designed with variable stiffness guidewire technology and a highly flexible distal
tip to allow more extensive and less traumatic access to the chambers and



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vasculature of the heart. In addition, we believe all of our microcatheters are disposable, single-use products that 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.



We have generated revenues of approximately $16.1 million from inception to June 30, 2003. 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 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.



We have obtained the right to affix the CE Mark
to our REVELATION, REVELATION Tx, REVELATION T-Flex, REVELATION Helix, REVELATION Helix ST and REVELATION Helix STX microcatheter systems for both mapping and ablation of atrial fibrillation and for our PATHFINDER, PATHFINDER mini and TRACER
microcatheter systems for mapping ventricular tachycardia, permitting us to market these products in the member countries of the European Union. We received 510(k) clearances for the (1) REVELATION microcatheter for mapping and pacing diagnostic
electrophysiology studies including atrial fibrillation; (2) PATHFINDER, PATHFINDER mini and the TRACER microcatheters for mapping and pacing epicardial electrophysiological studies from the coronary venous vasculature including ventricular
tachycardia; (3) VUEPORT balloon guiding catheter and (4) Naviport deflectable tip guiding catheter. On January 29, 2003, we received notice from the FDA that they had approved for commercialization the Cardima Surgical Ablation System for use in
cardiac surgery. This new system connects the Cardima Surgical Ablation Probe with deflectable multi-electrode linear array microcatheter technology to a commercially available electro-surgical radio frequency generator and the INTELLITEMP®, an RF energy management device, which allows surgeons
to apply RF energy through up to eight probe electrodes simultaneously.



We will be required to conduct clinical trials, demonstrate safety and effectiveness and obtain PMA approval from the FDA in order to sell any of the Companys products for treating atrial fibrillation or ventricular tachycardia in the
United States. Specifically, 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.



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While we produce and sell microcatheters for the diagnosis of ventricular tachycardia, our current
efforts focus on the development of microcatheters to diagnose and treat atrial fibrillation. During 2001, management decided to conserve and concentrate resources on the clinical trials for our atrial fibrillation products with the objective of
completing the regulatory approval process in both the United States and in Europe. We completed the Phase III clinical trial in the United States of the REVELATION Tx microcatheter system for the treatment of atrial fibrillation and on September
30, 2002 submitted the PMA application to the FDA. On November 5, 2002, the PMA was accepted by the FDA and was granted expedited review status. On March 6, 2003, we were notified by the FDA that we would meet with the Circulatory Systems Device
Panel on May 29, 2003. On May 29, 2003, the Circulatory System Devices Panel recommended that the U.S. Food and Drug Administration not approve our premarket approval application, or 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 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 panel recommendation. We have subsequently requested a meeting with the FDA, in which we intend to provide new analysis, including data from an expanded patient base, and clarification of previously submitted data.



We completed a left-sided atrial clinical trial in Germany with the
REVELATION Helix microcatheter system for the treatment of atrial fibrillation originating in the pulmonary veins. By the end of the study which was completed in August 2002, 43 patients had been treated at five sites. The purpose of this study was
to gain clinical data that will be important to future marketing efforts of the REVELATION Helix in Europe and potentially used as initial data for our planned REVELATION Helix clinical trial in the United States. We received CE mark approval for
the REVELATION Helix in the European Union in December 2001, for the REVELATION Helix ST in May 2002 and for the REVELATION Helix STX in July 2003.



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, clinical trials, obtaining regulatory approval, sales and marketing and manufacturing.



Following the closings on August 13 and August 14, 2003 of our private
placement, we will have cash and cash equivalents of approximately $6.5 million. Our management currently estimates that our cash balances as of August 14, 2003 will be sufficient to fund planned expenditures into 2004, but this cannot be predicted
with certainty. Although our management recognizes the need to raise funds in the near future and is currently negotiating with certain third parties the terms and conditions of financing transactions in addition to the private placement closed on
August 2003, there can be no assurance that we will be successful in consummating any such transaction, or, if we do consummate such a transaction, that its terms and conditions will not be unfavorable to us. Furthermore, certain provisions in the
documents governing the private placement closed on August 2003 will hinder our ability to raise additional equity financing in the future. In particular, the investors in the August 2003 private placement have a preemptive right to participate in
our next equity financing which raises gross proceeds of more than $1,000,000, and we are prohibited, except in certain circumstances, from selling additional shares of common stock without the consent of those investors prior to or within thirty
days after the effectiveness of a registration statement covering the sale of their shares purchased in the August 2003 private placement. Our failure to raise capital as needed will have a material adverse effect on our business and financial
condition and will likely cause us to cease our operations. Our independent auditors have concluded that there is a substantial doubt as to our ability to continue as a going concern for a reasonable period of time and have, therefore, modified
their report included in our Report on Form 10-K for the year ended December 31, 2002 in the form of an explanatory paragraph describing events that have given rise to this uncertainty.



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We continue to focus our resources primarily on gaining FDA approval of our submitted REVELATION® Tx microcatheter system PMA. We have submitted
preliminary information and requested a meeting with officials from the FDA to discuss in further detail those issues necessary for approval. At the FDA meeting, we intend to present new analyses, data from additional patients who have completed six
months of follow-up, and to clarify existing records that demonstrate substantial compliance with the original study protocol. In addition, we are finalizing design of our surgical delivery system and are pursuing additional European distribution
channels for our products.



Results Of OperationsThree and Six Months
Ended June 30, 2003 and 2002



Net Sales



Net sales for the quarter ended June 30, 2003 increased 16% to $491,000
from $423,000 for the same period in 2002. This increase was due in part to a 47% increase in domestic sales and a significant increase of 110% in revenues from the Asian/Pacific region, partially attributed to a new distribution agreement in China.
These increases were partially offset by a decrease of 74% in European revenues due to decreased international sales efforts as the Company continues to focus efforts on the long-term revenue plan for therapeutic products and the launch of the
REVELATION® Tx microcatheter system in the United
States. For the six-month period ended



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June 30, 2003, net sales decreased 5% to $1,129,000 in 2003 from $1,189,000 for the same six-month period in 2002. The decrease in 2003 is primarily
attributable to the one-time European sales of the REVELATION® Helix in Europe, reported in 2002. This decrease was partially offset by strong diagnostic product sales in the United States and Japan during the six-month period ended June 30, 2003.



Accounts receivable decreased 32% to $216,000 as of June 30, 2003 from
$318,000 as of December 31, of 2002 as a result of decreased revenues and increased collection efforts during the first six months of 2003. Allowance for doubtful accounts increased to $85,000 as of June 30, 2003 from $79,000 as of December 31,
2002.



We continue to focus our resources primarily on gaining
FDA approval of our submitted REVELATION® Tx
microcatheter system PMA. We have submitted preliminary information and requested a meeting with officials from the FDA to discuss in further detail those issues necessary for approval. At the FDA meeting, we intend to present new analyses, data
from additional patients who have completed six months of follow-up, and to clarify existing records that demonstrate substantial compliance with the original study protocol. In addition, we are finalizing design of our surgical delivery system and
are pursuing additional European distribution channels for our products.



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 June 30, 2003 increased 17% to $821,000
from $703,000 for the same period in 2002. For the six-month period ended June 30, 2003 cost of goods sold increased 20% to $1,906,000 from $1,593,000 for the same six-month period in 2002. This increase was partially due to the decrease in sales of
the higher-margin therapeutic products sold in 2003 when compared to the product mix sold in the first six months of 2002. Inventory reserves for excess and obsolete inventory decreased $52,000, or 21%, from December 31, 2002 to June 30, 2003. This
decrease was primarily due to the disposition and write-off of excess and obsolete obsolete raw material and finished goods. We reserve 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 and shelf life expirations. When we write-off specific inventory or have determined that inventory is obsolete, the inventory is subsequently disposed of.



Research and Development Expenses



Research and development expenses include product development, clinical
testing and regulatory expenses. Total research and development expenses, including regulatory and clinical functions for the quarter ended June 30, 2003 increased 23% to $1,495,000 from $1,213,000 for the same period in 2002. For the six-month
period ended June 30, 2003, total research and development expenses increased $399,000, or 20%, to $2,445,000 from $2,046,000 for the same six-month period in 2002. More specifically, our product development costs for the first six months of 2003
decreased $220,000, or 19%, when compared to the first six months of 2002, as all programs not directly related to the atrial fibrillation clinical trial have



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been postponed. This decrease was partially offset by a significant increase in regulatory and clinical expenses for the first six months of 2003 of
$619,000, or 70%, when compared to the same period in 2002. The increase was attributable to the costs associated with finalizing Phase III clinical trials and preparing all of the supporting data in preparation for the May 29, 2003 meeting of the
Circulatory Systems Device Panel of the FDA.



Selling,
General and Administrative Expenses



Selling, general and
administrative expenses for the quarter ended June 30, 2003 increased $171,000, or 10%, to $1,859,000 from $1,688,000 for the same period in 2002. For the six month period ended June 30, 2003, total selling, general and administrative expenses
increased $372,000, or 11%, to $3,693,000 from $3,321,000 for the first six months of 2002. More specifically, selling expenses for the first six months of 2003 decreased $248,000, or 18%, to $1,095,000 from $1,343,000 for the first six months of
2002. This decrease is attributable to the decreased international sales presence as focus was directed on the long-term revenue plan for therapeutic products and the launch of the REVELATION® Tx in the United States. This decrease was partially offset by an increase in general
and administrative expenses for the first six months of 2003 of $518,000, or 31%, to $2,196,000 from $1,678,000 for the first six months of 2002. The increase in general and administrative expenses in this period is due primarily to the non-cash
compensation expense of warrants issued to consultants and increased expenses related to investor and public relation activities. Marketing expenses for the first six months of 2003 also increased $100,000, or 33%, to $401,000 from $301,000 for the
same period in 2002 as preparations were being made for the launch of therapeutic products worldwide.



Interest and Other Income



Interest and other income for the quarter ended June 30, 2003 increased to $21,000 from $19,000 for the same period in 2002. For the six month period
ended June 30, 2003, interest and other income decreased $14,000, or 30%, to $33,000 from $47,000 for the same six month period in 2002. The decrease was primarily due to lower average cash balances and a decrease in interest rates during the first
six months of 2003 compared to the same period in 2002.



Interest Expense



Interest expense for the
quarter ended June 30, 2003 decreased to $4,000 from $6,000 for the same period in 2002. For the six month period ended June 30, 2003, interest expense decreased $8,000, or 57%, to $6,000 from $14,000 for the same six month period in 2002. This
decrease was primarily due to the expiration and payoff of certain capital equipment leases.



Liquidity And Capital Resources





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Following the closing on August 13 and August 14, 2003 of our private placement, we will have cash and cash equivalents of approximately $6.5 million. Our
management currently estimates that our cash balances as of August 14, 2003 will be sufficient to fund planned expenditures into 2004, but the actual level of expenditures cannot be predicted with certainty. Although our management recognizes the
need to raise funds in the near future and is currently negotiating with certain third parties the terms and conditions of financing transactions in addition to the private placement closed in August 2003, there can be no assurance that we will be
successful in consummating any such transaction, or, if we do consummate such a transaction, that its terms and conditions will not be 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 may also include, terms that could impede our ability to raise additional funding, such as terms requiring the consent of certain security holders before we issue additional securities.
Furthermore, certain provisions in the documents governing the private placement closed in August 2003 will hinder our ability to raise additional equity financing in the future. In particular, the investors in the August 2003 private placement have
a preemptive right to participate in our next equity financing which raises gross proceeds of more than $1,000,000, and we are prohibited, except in certain circumstances, from selling additional shares of common stock without the consent of those
investors prior to or within thirty days after the effectiveness of a registration statement covering the sale of their shares purchased in the August 2003 private placement. 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. Our failure to raise capital as needed will have a material adverse effect on our business and financial condition and will likely
cause us to cease our operations. Our independent auditors have concluded that there is a substantial doubt as to our ability to continue as a going concern for a reasonable period of time and have, therefore, modified their report included in our
Report on Form 10-K for the year ended December 31, 2002 in the form of an explanatory paragraph describing events that have given rise to this uncertainty.



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 line of credit, (4) sale of certain of our non-core patents to Medtronic for $8,000,000 and (5) equipment leases to finance certain capital equipment.



Net cash used in operating activities for the first six months
of 2003 was approximately $7,399,000, compared to the net cash used of $5,545,000 for the first six months of 2002. The increase of $1,854,000, or 33%, in net cash used in operating activities is due to the higher cash requirements for regulatory
and clinical expenses associated with the PMA submission to the FDA for the REVELATION® Tx and the increased general and administrative costs related to financing activities and increased investor relations. Net cash provided by financing and investing activities for the first six months of 2003
was approximately $6,179,000, compared to net cash used by financing and investing activities of $524,000 for the first six months of 2002. This change was primarily due to the closing of sales of shares of our common stock in private placements in
January, March and April of 2003 and the expiration and subsequent payoff of certain capital leases during the second quarter of 2002.



Our future liquidity and capital requirements will depend upon numerous factors, including receipt of adequate funding, sales and marketing activities,
the progress of the our product development efforts, the progress of our clinical trials, actions relating to regulatory matters, the costs and timing of expansion of product development, manufacturing, the extent to which our products gain market
acceptance and competitive developments.



Factors Affecting Future Results



If we fail to raise additional capital to develop and market our microcatheter systems, our business will fail.



We will need to raise additional capital through public or private financings or other arrangements in order to complete our clinical trials and market
our microcatheter systems. In addition, we may be required to expend greater than anticipated funds if unforeseen difficulties arise in the course of completing the development and marketing of our products or in other aspects of our business. We
cannot assure you that additional capital will be available to us when needed, if at all, or, if available, on terms attractive to us. If we cannot obtain sufficient capital, we may be forced 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 to third parties the rights to commercialize our products or technologies that



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we would otherwise develop and market ourselves. Furthermore, debt financing, if available, may involve restrictive covenants that could affect our ability
to raise additional capital. Our failure to raise capital when needed could 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. Following the closing on August 13 and August 14, 2003 of our private placement, we will have cash and cash equivalents of approximately
$6.5 million. Our management currently estimates that our cash balances as of August 14, 2003 will be sufficient to fund planned expenditures into 2004, but the actual level of expenditures cannot be predicted with certainty. Although our
management recognizes the need to raise funds in the near future and is currently negotiating with certain third parties the terms and conditions of financing transactions in addition to the private placement closed in August 2003, there can be no
assurance that we will be successful in consummating any such transaction, or, if we do consummate such a transaction, that its terms and conditions will not be 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 may also include, terms that could impede our ability to raise additional funding, such as terms requiring the consent of certain security holders before we issue
additional securities. Furthermore, certain provisions in the documents governing the private placement closed in August 2003 will hinder our ability to raise additional equity financing in the future. In particular, the investors in the August 2003
private placement have a preemptive right to participate in our next equity financing which raises gross proceeds of more than $1,000,000, and we are prohibited, except in certain circumstances, from selling additional shares of common stock without
the consent of those investors prior to or within thirty days after the effectiveness of a registration statement covering the sale of their shares purchased in the August 2003 private placement. 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. Any failure by management to obtain additional funding will have a material effect upon us and will likely
result in our inability to continue as a going concern.



We
have sold a limited number of our microcatheter products, and we will continue to incur substantial costs in bringing our microcatheter products to market.



We have sold only a limited number of our microcatheter systems. In addition, we will continue to incur substantial losses into the foreseeable future
because of research and product development, clinical trials, manufacturing, sales, marketing and other expenses as we seek to bring our microcatheters 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 $12.6 million, $9.3 million and $7.8 for the years ended December 31, 2002, 2001 and 2000, respectively. As of June 30, 2003, our accumulated deficit was approximately $97,341,000. 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 need to raise additional capital in the future could have a dilutive
effect on your investment.



In order to complete the
required regulatory approval process and commercialize our products, we will need to raise additional capital. One possibility for raising additional capital is the public or private sale of our common stock.



On December 31, 2002 and January 22, 2003, we sold by means of a private
placement an aggregate of 5,333,319 shares of our common stock a price per share of $0.74955 for an aggregate purchase price of $4.0 million. In addition, we issued to the investors warrants to purchase 2,400,000 shares of our common stock at an
exercise price of $0.8245 per share. The warrants became exercisable beginning on March 1, 2003 and March 23, 2003, respectively, and will be reduced on a share-by-share basis to the extent that an investor sells our common stock or other securities
during the sixty (60) day period between each of the closing dates and March 1, 2003 and March 23, 2003, respectively. The warrants allow for a cashless exercise whereby the exercising party may use shares issuable upon exercise of the
warrant in payment of the exercise price. We may not redeem the warrants and the warrants are subject to a mandatory exchange or termination in the case of certain reorganizations, mergers, or divestitures. We paid to the party which acted as finder
in connection with this private placement a fee of $25,000 in cash plus 66,667 shares of our common stock upon execution of a letter agreement. Upon the closing of the transactions, we also paid to the finder a total of $300,000 in cash and issued
to the finder warrants to purchase 533,331 shares of our common stock at an exercise price of $0.8245. The warrants issued to the finder are not redeemable and allow for cashless exercise whereby the finder may use shares issuable upon
exercise of the warrant in payment of the exercise price.



On
March 28, 2003, we sold by means of a private placement an aggregate of 2,941,175 shares of our common stock at a price of $0.85 per share for gross proceeds of $2,500,000. In addition, we issued to the investors warrants to purchase 1,176,470
shares of our common stock at an exercise price of $1.25 per share. The warrants will be exercisable beginning on September 28, 2003 and will be reduced on a share-for-share basis to the extent that an investor sells our common stock or other
securities during the six (6) month period between the closing and September 28, 2003. We may redeem the warrants for a price of $0.001 per share of common stock if the average



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closing price per share of our common stock has been at least $1.70 (as adjusted for subsequent stock splits and the like) for fifteen consecutive trading
days. We paid to the party that acted as agent in connection with this private placement upon the closing of the transaction, a total of $175,000 in cash and issued to the agent warrants to purchase 294,117 shares of our common stock at an exercise
price of $0.935.



On April 11, 2003, we sold by means of a
private placement an additional 4,395,587 shares of our common stock at a price of $0.85 per share for gross proceeds of approximately $3,700,000. In addition, we issued to the investors warrants to purchase 1,758,234 shares of our common stock at
an exercise price of $1.25 per share. The warrants will be exercisable beginning on October 11, 2003 and will be reduced on a share-for-share basis to the extent that an investor sells our common stock or other securities during the six (6) month
period between the closing and October 11, 2003. We may redeem the warrants for a price of $0.001 per share of common stock if the average closing price per share of our common stock has been at least $1.70 (as adjusted for subsequent stock splits
and the like) for fifteen consecutive trading days. We paid to the parties that acted as agents in connection with this private placement upon the closing of the transaction, a total of $270,000 in cash and issued to the agents warrants to purchase
448,557 shares of our common stock at an exercise price of $0.935.



On August 13 and August 14, 2003, we sold by means of a private placement an aggregate of 10,282,800 shares of our common stock at a price of $0.5296 per share for net proceeds of $5.44 million. In addition, we issued to the investors
warrants to purchase 3,084,840 shares of our common stock at an exercise price of $0.7282 per share. We may redeem the warrants for a price of $0.001 per share of common stock if the average closing price per share of our common stock has been at
least $1.0592 or $1.1328, respectively, (as adjusted for subsequent stock splits and the like) for fifteen consecutive trading days. We paid to the parties that acted as agents in connection with this private placement upon the closing transaction,
a total of $420,000 in cash and issued to the agents warrants to purchase 272,602 shares of our common stock at an exercise price of $0.8375 and warrants to purchase 350,401 shares of our common stock at an exercise price of $1.10.



If we sell additional shares of our common stock, such sales will further
dilute the percentage of our equity that you own. In addition, the price per share of the common stock sold in the December 31, 2002 and the January 22, 2003 closings of our private placement and the exercise price of the warrants issued to the
investors who participated in the closings were discounted from the closing price of our common stock on those dates. Also, the price per share of the common stock sold in the March 28, April 11, and August 13, 2003 private placements were at a
discount to the closing price of our common stock on these dates. It is possible that we may close future private placements involving the issuance of securities at a price per share that represents a discount to the closing price of our common
stock. 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 certain shares of our common stock and certain warrants were issued. Currently, the number of shares of our common stock issued to the investors who participated in the December 31, 2002 and January 22, 2003 closings of our
recent private placement and the number of shares of common stock issuable upon the exercise of warrants held by those investors and the number of shares of common stock issuable upon exercise of warrants held by the participants in our 1999 and
2000 private placements have antidilution protections that have been triggered by private placement such as the private placement that we completed on August 13, 2003 and may be triggered in the future in certain instances. The August 2003
private placements will result in a substantial number of additional shares being issued to the holders of the stock and warrants issued in the December 31, 2002 and the January 22, 2003 closings of our private placement and the holders of the
warrants issued in our 1999 and 2000 private placements.



Our stock may become subject to penny stock rules, which may 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. During the
past year, our stock, at times, traded below $1.00 per share. 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, met the continued
listing requirements and on June 7, 2001, the NASD notified us that our common stock would continue to trade on the Nasdaq SmallCap Market. Nasdaq listing 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 from Nasdaq.



On October 28, 2002, we received notification from the NASD that our common stock had closed below the minimum $1.00 per share required for continued inclusion on the Nasdaq for a period of more than thirty
consecutive trading days. In its notification, the NASD informed us that we have 180 calendar days, or until April 28, 2003, to comply with NASD Marketplace Rule 4310(c)(4). In order to comply with this rule, the bid price of our common stock must
close at $1.00 per share or more for a minimum of ten consecutive trading days at any time before April 28, 2003.



As of January 23, 2003, the closing bid price of our common stock had remained equal to $1.00 per share or greater for more than ten consecutive trading
days. On January 29, 2003, we received affirmative notification from Nasdaq that we had regained compliance with Rule 4310(c)(4), and that the matter was therefore closed.



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Our common stock closed below $1.00 per share from May 30, 2003 through July 11, 2003. Consequently, we
received notification from the NASD, dated July 14, 2003, that our common stock had closed below the minimum $1.00 per share required for continued inclusion on the Nasdaq for a period of more than thirty consecutive trading days. Since the date of
the notice, our common stock has continued to trade below $1.00 per share. In its notification, the NASD informed us that we have 180 calendar days, or until January 12, 2004, to comply with NASD Marketplace Rule 4310(c)(4). In order to comply with
this rule, the bid price of our common stock must close at $1.00 per share or more for a minimum of ten consecutive trading days at any time before January 12, 2004. Furthermore, the NASD will additionally require that we meet all other applicable
NASD listing requirements. Ultimately, whether we meet these requirements or not, our continued listing will be at the NASDs discretion.



We cannot assure you that the closing bid price of our common stock will close at $1.00 per share or more before January 12, 2004. If we were to be
delisted from the Nasdaq SmallCap Market, our common stock would be considered a penny stock under regulations 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. We cannot assure you that we will be able to maintain our listing on the Nasdaq SmallCap Market.



In addition, the purchase agreements signed in connection with the December 31, 2002 and the January 22, 2003 closings of
our recent private placement provide that if at any time during the two year period beginning on the respective closing dates of that placement 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.



Our independent auditors
believe that there is substantial doubt as to our ability to continue as a going concern.



As a result of our losses to date, working capital deficiency and accumulated deficit, our independent auditors have concluded that there is substantial doubt as to our ability to continue as a going concern for a
reasonable period of time, and have modified their report in the form of an explanatory paragraph describing the events that have given rise to this uncertainty. Our continuation as a going concern will depend upon our ability to generate or obtain
sufficient cash to meet our obligations on a timely basis and ultimately to attain profitable operations. Our independent auditors going concern modification 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.



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.



In connection with our private placement of units of common stock and warrants in 2001, we entered into a letter agreement in April 2001, or the 2001
Letter Agreement, with a financial advisor. This financial advisor, or the 2001 Advisor, assisted us with our 2001 private placement of units and received a commission in connection with the 2001 offering. The 2001 Advisor has the right to continue
to provide certain services to us in connection with the development of potential strategic alliances.



On July 15, 2002, we retained a different financial advisor, or the July 2002 Advisor, in connection with a proposed offer and sale of shares of our
common stock and warrants to purchase shares of our common stock. The letter agreement with the July 2002 Advisor, or the July 2002 Letter Agreement, provides for the payment of fees to the July 2002 Advisor equal to 7% of the gross proceeds of the
offering. In addition to the cash fee, the July 2002 Advisor has the right to receive warrants to purchase that number of shares of our common stock equal to 10% of the



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number of shares sold in the offering. The July 2002 Advisor will also receive cash proceeds equal to 7% of the aggregate exercise price of any warrants
issued to the investors in the offering and subsequently exercised.



Shortly before the August 5, 2002 closing of our August 2002 private placement which was arranged by the July 2002 Advisor, the 2001 Advisor communicated to us that it believes that it is entitled under the 2001 Letter Agreement to fees and
warrants in connection with the August 2002 private placement. We strongly disagree with the 2001 Advisors interpretation of the 2001 Letter Agreement. Even if the 2001 Advisors interpretation is determined to be correct, we believe that
the 2001 Advisor waived any rights to compensation it might have in connection with the August 2002 private placement.



We sent to the 2001 Advisor on August 21, 2002 a termination letter relating to the 2001 Letter Agreement. Pursuant to the terms of the 2001 Letter
Agreement, our obligations to pay the 2001 Advisor a commission or to issue to it warrants in connection with sales of our securities terminated thirty (30) days from the date of this termination letter, or September 20, 2002. On August 29, 2002,
the 2001 Advisor sent to us an invoice for cash commissions and warrants that the 2001 Advisor claims are owed to it pursuant to the 2001 Letter Agreement as a result of the closing of the August 2002 private placement. On September 10, 2002, we
sent a letter to the 2001 Advisor to express our position that no fees or warrants are due to the 2001 Advisor in connection with the closings of the August 2002 private placement. On September 26, 2002 we received a letter from legal counsel to the
2001 Advisor reasserting the 2001 Advisors claim that it must receive payment of commissions and warrants in connection with the August 2002 private placement.



In the event the 2001 Advisor prevails on any claims in connection with the August 2002 private placement, we would be
required to pay to the 2001 Advisor $381,570, or 7.5% of the gross proceeds that we received from the sale of shares of common stock, and issue to the 2001 Advisor warrants to purchase up to 698,287 shares of common stock, or 10% of the number of
shares of common stock sold in the August 2002 private placement. In the event of the warrants issued to the investors in the August 2002 private placement are exercised, we would be required to pay to the 2001 Advisor an additional cash amount
equal to $133,549 or 7% of the aggregate exercise price of those warrants. Any payments to the 2001 Advisor or warrants issued to the 2001 Advisor would be in addition to placement fees and warrants paid to the July 2002 Advisor in connection with
the terms of the July 2002 Letter Agreement.



On November 13,
2002, we retained a party to act as our financial advisor and finder in connection with a proposed offer and sale of shares of our common stock and warrants to purchase shares of our common stock. The letter agreement with this advisor, or the
November 2002 Advisor, provides for, among other things, the payment of fees to the November 2002 Advisor equal to 7.5% of the gross proceeds of the offering, including any proceeds from the exercise of the warrants. In addition to the cash fee, the
November 2002 Advisor has the right to receive warrants to purchase a number of shares equal to 10% of the number of securities sold in such offering. The letter agreement also provided for the payment of a cash fee of $25,000 upon execution of the
agreement, and a break-up fee of $100,000 (net of the fee paid upon execution) for financings or transactions undertaken by us without the November 2002 Advisors assistance. The December 2002 and January 2003 closings of our private placements
were undertaken without the November 2002 Advisors assistance, and in April 2003 we paid to the November 2002 Advisor a net break-up fee of $75,000. On April 17, 2003, we terminated this letter agreement, effective May 18, 2003. The November
2002 Advisor has acknowledged and agreed to the terms of that termination, including that no additional fees will be owed by use under this letter agreement other than those owed on subsequent exercise of any warrants held by purchaser introduced
through the November 2002 Advisor.



On December 9, 2002, we
retained another party as our financial advisor and finder in connection with a proposed offer and sale of shares of our common stock and warrants to purchase shares of our common stock. The letter agreement with this advisor, or the December 2002
Advisor, provides for, among other things, the payment of fees to the December 2002 Advisor equal to 8% of the gross proceeds of the offering, including any proceeds from the exercise of the warrants. In addition to the cash fee, the December 2002
Advisor has the right to receive warrants to purchase a number of shares equal to 7.5% of the number of securities issued in such offering.



On December 28, 2002, we retained another party to act as our financial advisor and finder in connection with the offer and sale of shares of Company
common stock and warrants to purchase shares of our common stock that



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closed on December 31, 2002 and January 22, 2003. The December 2002 Finder received a cash finders fee of $300,000 and warrants to purchase 533,331
shares of our common stock at a price per share of $0.8245 in connection with the December 31, 2002 and January 23, 2003 closings of our private placements. On January 13, 2003, we entered into a new letter agreement with the December 2002 Finder
(hereinafter, the January 2003 Finder) to act as our financial advisor and finder in connection with the offer and sale of shares of Company common stock and warrants to purchaser shares of our common stock that close on March 28, 2003 and April 11,
2003. The January 2003 Finder received 24,746 shares of our common stock upon execution of the letter agreement. The letter agreement with this finder also provides for the payment of fees to the January 2003 Finder equal to 7.5% of the gross
proceeds of the March 28, 2003 and April 11, 2003 closings of the private placement, including any proceeds from the exercise of the Warrants. In addition to the cash fee, the January 2003 Finder received warrants to purchase a number of shares
equal to 10% of the number of shares sold in the March 28, 2003 and April 11, 2003 closings of the private placement.



On March 11, 2003, we retained another party as our financial advisor in connection with a proposed debt or equity financing. The letter agreement with
this advisor, or the March 2003 Advisor, provided for, among other things, the payment of fees to the advisor equal to 6% of the gross proceeds of the offering. In addition to the cash fee, the advisor had the right to receive warrants to purchase a
number of shares equal to 6% of the number of securities issued in such offering at 110% of the market price. On April 29, 2003, we terminated this letter agreement, effective May 6, 2003. The March 2003 Advisor has acknowledged and agreed to the
terms of that termination, including that no fees are owed by us under this letter agreement.



Despite the termination letter that we delivered to the 2001 Advisor on August 21, 2002 terminating our obligations to pay the 2001 Advisor a commission or to issue them warrants in connection with sales of our
securities after September 20, 2002, we received on January 7, 2003, a letter from the 2001 Advisor asserting that it also is owed (i) approximately $245,000 plus (ii) five year warrants to purchase approximately 436,000 shares of the our common
stock at an exercise price of $0.8245 per share, in each case arising in connection with a private placement of securities consummated by us in December 2002. In addition, on February 2, 2003 we received another letter from the 2001 Advisor
asserting that it is also owed (i) approximately $54,717 plus (ii) five year warrants to purchase approximately 97,332 shares of our common stock at an exercise price of $0.8245 per share, in each case in connection with the January 22, 2003 closing
of our private placement. Any payments to the 2001 Advisor or warrants issued to the 2001 Advisor would be in addition to placement fees and warrants paid to the December 2002 Finder pursuant to the terms of our letter agreement with the December
2002 Finder. We have not yet received a letter from the 2001 Advisor claiming additional fees or warrants in connection with the March 28, 2003 and April 11, 2003 closings of our recent private placement, but there can be no guarantee that such a
claim will not be made.



In connection with the March 28, 2003
and April 11, 2003 closings of our private placement, in addition to the cash fee and warrants to purchase common stock issued to the January 2003 Finder, (i) the July 2002 Advisor received an aggregate cash finders fee of $351,400 and
warrants to purchase 590,588 shares of our common stock at a price per share of $0.935, (ii) the November 2002 Advisor received an aggregate cash finders fee of $15,937.50 and warrants to purchase 25,000 shares of our common stock at a price
per share of $0.935 and (iii) the December 2002 Advisor received an aggregate cash finders fee of $40,000 and warrants to purchase 44,117 shares of our common stock at a price per share of $0.935, in each case, for placement of securities with
parties introduced through the respective advisor.



On July 15,
2003, we retained another party as our financial advisor in connection with a proposed debt or equity financing. The letter agreement with this advisor, or the July 2003 Advisor, provides for, among other things, the payment of fees to the advisor
equal to 7% of the purchase price of shares sold to purchasers introduced to us by the July 2003 Advisor. In addition to the cash fee, the advisor has the right to receive warrants to purchase 93,750 shares of our common stock per $1 million raised
by this advisor (up to a maximum of 750,000 shares) at a price per share of $0.8375.



On July 18, 2003, we retained another party as our financial advisor in connection with a proposed debt or equity financing. The letter agreement with this advisor, or the July 2003 Agent, provides for, among other
things, the payment of fees to the agent equal to 7% of the gross subscription proceeds of any equity offering by us from purchasers procured by the July 2003 Agent. In addition to the cash fee, the agent has the right to receive warrants to
purchase six percent (6%) for every dollar raised by the July 2003 Agent in connection with the placement at an exercise price equal to 125% of the closing bid price of our common stock on the date of the closing.



Pursuant to an oral agreement entered into in August 2003, we retained
another party as our financial advisor in connection with a proposed debt or equity financing. Our oral agreement with this advisor, or the August 2003 Advisor, provides for cash fees and warrants to be issued to this advisor with respect to
investors introduced by this advisor, at the same rates as described above with respect to the July 2003 Advisor.



In connection with the August 2003 private placement, we paid to the July 2003 Advisor, the July 2003 Agent and the August 2003 Advisor aggregate cash
fees of $420,000. In addition, to these cash fees, (i) the July 2003 Advisor received warrants to purchase 122,602 shares of our common stock at an exercise price of $0.8375, (ii) the July 2003 Agent received warrants to purchase 350,401 shares of
our common stock at an exercise price of $1.10 and (iii) the August 2003 Advisor received warrants to purchase 150,000 shares of our common stock at an exercise price of $0.8375, in each case, for placement of securities with parties introduced
through the respective advisor.



Due to the existence of these
various letter agreements, there is a possibility that we may be obligated to pay fees, cash commissions, 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 placements of our securities. There is the possibility that 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 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 warrants to purchase shares of
our common stock. 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 the recent closings of our private placement or subsequent placements. These



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commissions paid or warrants issued to the may be in addition to the commissions payable or warrants issuable to other financial advisors, finders or
placement agents in respect of the same transaction.



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. In January 2000, we signed an exclusive three-year distribution agreement with St. Jude Medical Corporation whereby St. Judes Daig division was to distribute our diagnostic products in the United States. St. Jude did not
meet the first year minimum annual sales quota under the distribution agreement. In June 2001, we mutually agreed with St. Jude to terminate the agreement and to allow for a transition period to transfer customer accounts by the termination date of
September 1, 2001. As a result, we expanded our own small sales force to three sales representatives in the United States. Therefore, we will be solely responsible for marketing and distributing our products in the United States. If we receive FDA
approval of our PMA, we may not have an adequate marketing and sales force to adequately sell our 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 also have terminated several distribution arrangements in Europe because
of the distributors failure to meet minimum sales levels under those agreements. Our ability to operate a remote sales force effectively will 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 European distribution or direct business, that it will be cost-effective or that its efforts will be successful. Failure to establish an
adequate business in Europe would harm our business.



Currently, sales and marketing of our PATHFINDER, PATHFINDER mini, REVELATION and TRACER microcatheter systems are conducted through a number of exclusive distributors in certain European countries and Japan and a small direct sales force
in Europe. We have sold only a limited number of PATHFINDER, PATHFINDER mini, REVELATION and TRACER microcatheter systems through these distributors. We have approval to sell the REVELATION, REVELATION Tx, REVELATION T-Flex, REVELATION Helix and
REVELATION Helix ST in the European Union, Hong Kong and Canada. We cannot be certain that these distributors will be able to effectively market and sell our products in these markets. In addition, we cannot assure you that we will be able to enter
into additional agreements with desired distributors on a timely basis or at all, or that these distributors will devote adequate resources to selling our products. Our failure to establish and maintain appropriate 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 date, we have received from the FDA 510(k) pre-market
clearances with respect to our PATHFINDER and PATHFINDER mini microcatheter systems for venous mapping of ventricular tachycardia, and our REVELATION



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microcatheter system for mapping the atria of the heart. We also received FDA 510(k) clearance for our VENAPORT, VUEPORT and NAVIPORT guiding catheters and
our TRACER microcatheter for mapping ventricular tachycardia. We have further received FDA 510(k) clearance for Cardimas Cardiac Ablation System to ablate cardiac tissue during heart surgery using radio frequency (RF) energy.



We are in the final stages of developing, testing and obtaining regulatory
approval for our REVELATION Tx microcatheter systems designed for ablation of atrial fibrillation. We completed the mapping phase of this atrial fibrillation feasibility study in August 1997 and the ablation feasibility study in December 1998. We
received approval of an investigational device exemption, or IDE, supplement in December 1998 allowing us to expand the ablation study. In June 2000, we received permission from the FDA to expand the clinical trial to Phase III pivotal study with up
to 128 patients at up to 20 centers. On September 20, 2002, we submitted to the FDA our PMA application for our REVELATION Tx microcatheter system, data from a trial involving 80 patients and follow-up data relating to those 80 patients for the six
months after completion of the trial. As part of the submission of the PMA application, we have asked the FDA for an expedited review of our PMA. On November 5, 2002, the FDA accepted our request for expedited review. On March 6, 2003, we were
notified by the FDA that we would meet with the Circulatory Systems Device panel on May 29, 2003. On May 29, 2003, the Circulatory System Devices Panel recommended that the U.S. Food and Drug Administration not approve our premarket approval
application, or 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 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 panel recommendation. We have subsequently requested a meeting with the FDA, in which we intend to provide new analysis, including data from an expanded
patient base, and clarification of previously submitted data. We must receive PMA approval before marketing our products for ablation in the United States.



Additionally, in August 2001, we began a clinical trial in Germany involving our REVELATION Helix microcatheter in the treatment of atrial fibrillation
originating from the pulmonary veins. Enrollment in this study was completed in June 2002. By December 2002, all enrolled study subjects had completed the six month follow-up. Data from the six month follow-up on these subjects will be analyzed and
prepared for publication targeted for the first half of 2003. 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 completing our REVELATION Tx clinical trial 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 the
clinical trial for our THERASTREAM microcatheter system, the completion of this clinical trial could take several years.



Clinical trial 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.



Our microcatheter 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 a novel approach to diagnosing and treating atrial fibrillation and ventricular tachycardia. 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 microcatheter 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.



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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 microcatheter 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 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.



None of our ablation products for electrophysiology have received regulatory approval in the United States. Our failure to receive these approvals will
harm our business.



To date, none of our products in
development for the ablation of atrial fibrillation or ventricular tachycardia has received regulatory approval in the United States. If we cannot gain U.S. regulatory approval, our business will be materially harmed. 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 successfully commercialize these systems would materially harm our business.



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.



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;
| | - |  | -----------------



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| |  |  | 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 Europe, we must demonstrate that our products are safe and effective and obtain approval
or clearance from the applicable governmental authorities and Notified Bodies. In the United States, we must obtain from the FDA 510(k) pre-market notification clearance or a PMA 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; and for the REVELATION microcatheter system for mapping atrial fibrillation and for the Cardima Ablation System
to ablate Cardiac tissue during cardiac surgery using radio-frequency energy. Currently, the process for 510(k) clearance requires approximately 90 days and PMA approval is six to twelve months. 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. These products may require a PMA, and the FDA may request extensive clinical data
to support either 510(k) clearance or a PMA.



We are required
to seek a PMA for our ablation products, including the REVELATION Tx microcatheter. The process of obtaining a PMA is much more expensive, lengthy and uncertain than the 510(k) pre-market notification clearance process. In order to complete our PMA
application, we will be required to complete clinical trials to demonstrate the safety and effectiveness of these products. In December 1997, the FDA approved a 10-patient atrial fibrillation feasibility study for mapping and ablation with the
REVELATION Tx. In June 2000, we received conditional approval from the FDA and full approval in August 2000 for our Phase III clinical trial. In March 2001, the FDA allowed us to file a modular PMA for our REVELATION Tx in Phase III clinical trial.
Under the modular PMA submission, we filed four of five modules in 2001. The fifth module is the clinical data and formal PMA application. Three of the first four modules have been accepted and closed by the FDA and the remaining module will be left
open for reference during the review of the clinical data in the fifth and final module. On September 20, 2002, we submitted our PMA application to the FDA with the fifth module containing data on more than 80 patients treated with our REVELATION Tx
microcatheter system. Subsequently, on November 5, 2002, we announced that the FDA had accepted our filing and granted our request for expedited review. The modular PMA submission process may reduce the time for FDA approval by allowing an applicant
to submit data on pre-clinical testing while clinical testing is occurring. In addition, dialogue with the FDA during the modular submission process allows us to improve our final submission. Closure and acceptance of any one module does not allow
marketing of any part of the product. On March 6, 2003, we were notified by the FDA that we would meet with the Circulatory Systems Device panel on May 29, 2003. On May 29, 2003, the Circulatory System Devices Panel recommended that the U.S. Food
and Drug Administration not approve our premarket approval application, or 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 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 panel recommendation. We have subsequently requested a meeting with the FDA, in which we
intend to provide new analysis, including data from an expanded patient base, and clarification of previously submitted data.



We are restricted from selling the product until the entire PMA process is complete and approved by the FDA. No assurance can be given that we will ever
be able to obtain a PMA for any of our ablation products. Our failure to obtain a PMA on a timely basis would have a material adverse effect on our business, financial condition and results of operations.



We filed an 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 completing our atrial fibrillation Phase III clinical trial. 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.



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Regulatory agencies may limit the indications for which they approve or clear any of our products.
Further, the FDA 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 our products
and our revenues may decline.



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 on a timely basis or at all. If the FDA does
not approve our products for commercial sales, our business will be harmed.



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.



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, including, but not limited to:



| |  |  | fines;
| | - |  | ------



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



| |  |  | 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



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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, our business results may 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.



We received approval to sell our PATHFINDER, PATHFINDER Mini,
REVELATION, and TRACER in Japan and Australia, and to sell our PATHFINDER, TRACER, VENAPORT, VUEPORT and NAVIPORT in Canada. We also received CE Mark certification to sell our REVELATION, REVELATIONTx, REVELATION T-Flex, REVELATION Helix, REVELATION
Helix ST and REVELATION® Helix STX microcatheter
systems for both mapping and ablation of atrial fibrillation, permitting us to market these products in the member countries of the European Union. On January 29, 2003, we received notice from the FDA that they had cleared for commercial
distribution the Cardima Surgical Ablation System for use in cardiac surgery. This new system connects the Cardima Surgical Ablation Probe with deflectable multi-electrode linear array microcatheter technology to a commercially available
electro-surgical radio frequency generator and the INTELLITEMP, an RF energy management device that allows surgeons to apply RF energy through up to eight probe electrodes simultaneously.



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 these 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.



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.
| | - |  | -------------------



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Any of these factors could damage our business results.



We derive a portion of our revenues from the sale of our products in the
European Union. The adoption of the Eurodollar presents uncertainties for our international business.



All European countries that are part of the European Monetary Union, or EMU, began operating with the new Euro currency in 2002. A significant
amount of uncertainty exists as to the effect the Euro will have on the marketplace in general. In particular, as a portion of our sales revenue is derived from sales to EMU countries, the adoption by these participating countries of a single
currency could result in greater price transparency, making the EMU a more competitive environment for our products. We have assessed the effect the introduction of the Euro could possibly have on our internal accounting systems and potential sales
of our products. Recently, we have routinely updated our accounting and financial software, which included appropriate accounting for foreign currencies, including the Euro. This issue and its related costs could have a material adverse effect on
our business, financial condition and results of operations.



We may be unable to successfully commercialize our microcatheter 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. 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 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 Boston Scientific, through its EP Technologies and Cardiac Pathways divisions, C.R. Bard, Inc., Johnson & Johnson,
through its Biosense-Webster division, St. Jude Medical, Inc., through its Daig division, and Medtronic, Inc. 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. 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 Therapeutic license agreement we have an exclusive license under specific issued United States patents. The exclusive license from Target Therapeutic 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 Therapeutics technology, provided we have



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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 Therapeutic 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 Therapeutic-based microcatheter technology would significantly harm our business.



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 have conducted searches to determine whether our patent applications interfere with existing patents. Based upon these searches, 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.



Although we have not received any letters from others threatening to enforce intellectual property rights against us, we cannot be certain that we will
not become subject to patent 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. An adverse determination
in litigation, interference or opposition proceedings could subject us to significant liabilities to third parties, require us to cease using such technology, or require us to license disputed rights from third parties. However, we cannot be certain
that at such time any licenses will be available to us, or if available, on commercially reasonable terms. Our inability to license any disputed technology could materially delay the commercialization of our products and 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.



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



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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. We currently believe that
our manufacturing capacity will be sufficient through December 2004. We expect that if U.S. sales for the PATHFINDERand REVELATION®microcatheter systems
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;
| | - |  | ------------------



| |  |  | 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



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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 re-certification inspection by the European Notified Body in November 2001 and a successful annual inspection in November 2002. In November 2000 and in January
2003, the FDA conducted a QSIT-Audit 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.



We are dependent upon our key personnel and will need to hire additional key personnel in the future.



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 we can attract or retain other highly qualified scientific, technical, clinical, regulatory and managerial personnel in the future, including
key sales and marketing personnel.



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 cannot be certain, in particular after commercial introduction of our products, that
we will not experience losses due to product liability claims. We currently have general liability insurance with coverage in the amount of $1.0 million per occurrence, subject to a $2.0 million annual limitation. We have product liability insurance
with coverage in the amount of $5.0 million per occurrence, subject to a $5.0 million annual limitation. 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 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.



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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, 2003, 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 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.



Changes in internal control over financial reporting. There were no significant changes in our internal control over financial reporting or, to our
knowledge, in other factors that could significantly affect these controls subsequent to the date of their evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.





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PART II.    OTHER INFORMATION



Item 1.Legal Proceedings

None.



Item 2.Changes in Securities and Use of Proceeds





On April 11, 2003, we sold by means of a private placement an additional 4,395,587 shares of our common stock at a price of $0.85 per share for gross
proceeds of approximately $3,700,000. In addition, we issued to the investors warrants to purchase 1,758,234 shares of our common stock at an exercise price of $1.25 per share. The warrants will be exercisable beginning on October 11, 2003 and will
be reduced on a share-for-share basis to the extent that an investor sells our common stock or other securities during the six (6) month period between the closing and October 11, 2003. We may redeem the warrants for a price of $0.001 per share of
common stock if the average closing price per share of our common stock has been at least $1.70 (as adjusted for subsequent stock splits and the like) for fifteen consecutive trading days. We paid to the parties that acted as agents in connection
with this private placement upon the



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closing transaction, a total of $270,000 in cash and issued to the agents warrants to purchase 448,557 shares of our common stock at an exercise price of
$0.935.



We used the proceeds received from the sale of our
securities on April 11, 2003 for working capital, including, without limitation, costs and expenses relating to our Phase III trial for the treatment of atrial fibrillation, efforts to obtain FDA approval for our microcatheter planned marketing
efforts, expansion of sales efforts and for such other general corporate purposes as our Board of Directors may determine.



We relied on the exemption provided by Rule 506 under Regulation D and Section 4(2) of the Securities Act of 1933, as amended in connection with the April
11, 2003 closing of our private placement. We filed with the SEC a registration statement on Form S-3 in connection with that placement.



Item 3.Default Upon Senior Securities

None.



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



On June 19, 2003, the Company held its Annual Meeting of Stockholders. The following actions were taken at the Annual Meeting. As of April 24, 2003, the
record date, 62,898,390 shares were entitled to vote at the Annual Meeting.



| | 1. |  | As listed below, all of managements nominees for directors were elected:
| | -- |  | -------------------------------------------------------------------------



| |  |  | Gabriel B. Vegh  43,184,422 shares voted in favor, 9,624,590 withheld.
| |  |  | -----------------------------------------------------------------------



| |  |  | Jesse D. Erickson  52,144,826 shares voted in favor, 664,186 withheld
| |  |  | ----------------------------------------------------------------------



| |  |  | Rodolfo C. Quijano, M.D., Ph.D.  52,284,226 shares voted in favor, 524,786 withheld
| |  |  | ------------------------------------------------------------------------------------



| |  |  | Phillip C. Radlick, Ph.D.  52,154,276 shares voted in favor, 654,736 withheld.
| |  |  | -------------------------------------------------------------------------------



| |  |  | Lawrence J. Siskind  52,214,226 shares voted in favor, 594,786 withheld.
| |  |  | -------------------------------------------------------------------------



| | 2. |  | The proposal to approve and ratify our 2003 Stock Option Plan with 2,200,000 shares reserved for this plan was approved with 27,774,852 shares voting in favor, 8,200,574 shares
voting against and 251,004 shares abstaining.
| | -- |  | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 3. |  | The proposal to consider and approve the issuance of shares of our Common Stock and warrants to purchase shares of our Common Stock in connection with our proposed private placement
was approved with 34,780,122 shares voting in favor, 1,346,430 shares voting against and 99,878 shares abstaining.
| | -- |  | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



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| | 4. |  | The proposal to amend our Certificate of Incorporation authorizing the Board of Directors to increase our number of authorized shares of Common Stock from 100,000,000 to 125,000,000
and to increase the number of total authorized shares from 105,000,000 to 130,000,000 was approved with 34,662,523 shares voting in favor, 1,442,689 shares voting against and 121,218 shares abstaining.
| | -- |  | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| | 5. |  | The appointment of Ernst & Young LLP as independent auditors of the Company for the fiscal year ending December 31, 2003 was ratified with 52,650,935 shares voting in favor,
102,557 shares voting against and 55,520 shares abstaining.
| | -- |  | -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Item 5.Other Information



None



Item 6.Exhibits and Reports on Form 8-K



| | (a) |  | 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 |  | Section 302 Certification of the 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 Acto 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.
| | ---- |  | -------------------------------------------------------------------------------------------------------------------------------------------------



| | (b) |  | Reports on Form 8-K during the second quarter
| | --- |  | ---------------------------------------------



On April 1, 2003, we filed a report on Form 8-K to disclose the terms of the March 28, 2003 and April 11, 2003 private placements.



On May 7, 2003, we filed a report on Form 8-K, with an exhibit attached
thereto, furnishing information relating to the Companys financial results for the three months ended March 31, 2003.



On May 9, 2003, we filed, pursuant to Item 12, a report on Form 8-K to disclose the termination of two private placement advisors.



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##### Table of Contents

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:  August 14, 2003 |  |  |  |  |  | CARDIMA, INC.
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