##### Table of Contents

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549



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FORM 10-Q



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



FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2005



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 NO. 000-31519



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CURON MEDICAL, INC.

(Exact name of registrant as specified in its charter)



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|                                                               |  |                                     
|-------------------------------------------------------------- |  | ------------------------------------
|Delaware                                                       |  | 77-0470324                          
|(State or other jurisdiction of incorporation or organization) |  | (I.R.S. Employer Identification No.)



46117 Landing
Parkway

Fremont, CA 94538

(Address of principal executive offices, including zip code)



(510) 661-1800

(Registrants telephone number, including area code)



---



Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.    Yes   x    No ̈



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



As of May 4, 2005, 29,867,001 shares of the Registrants Common Stock
were outstanding.



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##### Table of Contents

CURON MEDICAL, INC.

INDEX



|           |  |                       |  |                                                                                                           |  |     
|---------- |  | --------------------- |  | --------------------------------------------------------------------------------------------------------- |  | ----
|           |  |                       |  |                                                                                                           |  | Page
|PART I.    |  | FINANCIAL INFORMATION |  |                                                                                                          
|           |  |                       | 
|           |  | Item 1.               |  | Financial Statements (unaudited)                                                                          |  |     
|           |  |                       | 
|           |  |                       |  | Condensed Consolidated Balance Sheets as of March 31, 2005 and December 31, 2004                          |  | 3   
|           |  |                       | 
|           |  |                       |  | Condensed Consolidated Statements of Operations for the three month periods ended March 31, 2005 and 2004 |  | 4   
|           |  |                       | 
|           |  |                       |  | Condensed Consolidated Statements of Cash Flows for the three month periods ended March 31, 2005 and 2004 |  | 5   
|           |  |                       | 
|           |  |                       |  | Notes to Condensed Consolidated Financial Statements                                                      |  | 6   
|           |  |                       | 
|           |  | Item 2.               |  | Managements Discussion and Analysis of Financial Condition and Results of Operations                     |  | 10  
|           |  |                       | 
|           |  | Item 3.               |  | Quantitative and Qualitative Disclosures of Market Risk                                                   |  | 20  
|           |  |                       | 
|           |  | Item 4.               |  | Controls and Procedures                                                                                   |  | 20  
|           |  |                      
|PART II.   |  | OTHER INFORMATION     |  |                                                                                                          
|           |  |                       | 
|           |  | Item 1.               |  | Legal Proceedings                                                                                         |  | 20  
|           |  |                       | 
|           |  | Item 6.               |  | Exhibits                                                                                                  |  | 21  
|           | 
|SIGNATURES |  | 22                   



2



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##### Table of Contents

PART I FINANCIAL INFORMATION



Item 1. Financial Statements



CURON MEDICAL, INC.

Condensed Consolidated Balance Sheets

(Unaudited, in thousands)



|                                           |  |                |         |   |                   |   |         |  
|------------------------------------------ |  | -------------- | ------- | - | ----------------- | - | ------- | -
|                                           |  | March 31, 2005 |         |   | December 31, 2004 |  
|Assets                                     |  |                |         |   |                   |   |         |  
|Current assets:                            |  |                |         |   |                   |   |         |  
|Cash and cash equivalents                  |  | $              | 2,908   |   |                   | $ | 374     |  
|Marketable securities                      |  |                |        |   |                   |   | 5,518   |  
|Accounts receivable, net                   |  |                | 601     |   |                   |   | 620     |  
|Inventories, net                           |  |                | 863     |   |                   |   | 777     |  
|Prepaid expenses and other current assets  |  |                | 683     |   |                   |   | 987     |  
|                                           |  |                |         |   |                   |   |         |  
|Total current assets                       |  |                | 5,055   |   |                   |   | 8,276   |  
|                                           |  |               
|Property and equipment, net                |  |                | 511     |   |                   |   | 551     |  
|Other assets                               |  |                | 299     |   |                   |   | 330     |  
|                                           |  |                |         |   |                   |   |         |  
|Total assets                               |  | $              | 5,865   |   |                   | $ | 9,157   |  
|                                           |  |                |         |   |                   |   |         |  
|Liabilities and Stockholders Equity       |  |                |         |   |                   |   |         |  
|Current liabilities:                       |  |                |         |   |                   |   |         |  
|Accounts payable                           |  | $              | 428     |   |                   | $ | 473     |  
|Accrued liabilities                        |  |                | 1,243   |   |                   |   | 1,121   |  
|Notes payable                              |  |                |        |   |                   |   | 57      |  
|                                           |  |                |         |   |                   |   |         |  
|Total current liabilities                  |  |                | 1,671   |   |                   |   | 1,651   |  
|                                           |  |               
|Warrant obligation                         |  |                | 131     |   |                   |   | 469     |  
|Other                                      |  |                | 123     |   |                   |   | 124     |  
|                                           |  |                |         |   |                   |   |         |  
|Total liabilities                          |  |                | 1,925   |   |                   |   | 2,244   |  
|                                           |  |                |         |   |                   |   |         |  
|Contingencies and commitments (Note 5)     |  |                |         |   |                   |   |         |  
|                                           |  |               
|Stockholders equity:                      |  |                |         |   |                   |   |         |  
|Common stock                               |  |                | 25      |   |                   |   | 25      |  
|Additional paid-in capital                 |  |                | 101,722 |   |                   |   | 101,739 |  
|Accumulated deficit                        |  |                | (97,573 | ) |                   |   | (94,607 | )
|Treasury stock                             |  |                | (234    | ) |                   |   | (234    | )
|Accumulated other comprehensive loss       |  |                |        |   |                   |   | (10     | )
|                                           |  |                |         |   |                   |   |         |  
|Total stockholders equity                 |  |                | 3,940   |   |                   |   | 6,913   |  
|                                           |  |                |         |   |                   |   |         |  
|Total liabilities and stockholders equity |  | $              | 5,865   |   |                   | $ | 9,157   |  
|                                           |  |                |         |   |                   |   |         |  



See accompanying notes
to condensed consolidated financial statements



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##### Table of Contents

CURON MEDICAL, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except per share
amounts)



|                                                               |  |                                      |        |   |      |   |        |  
|-------------------------------------------------------------- |  | ------------------------------------ | ------ | - | ---- | - | ------ | -
|                                                               |  | For the Three Months Ended March 31, |       
|                                                               |  | 2005                                 |        |   | 2004 |  
|Revenues                                                       |  | $                                    | 857    |   |      | $ | 906    |  
|Cost of goods sold                                             |  |                                      | 982    |   |      |   | 1,022  |  
|                                                               |  |                                      |        |   |      |   |        |  
|Gross loss                                                     |  |                                      | (125   | ) |      |   | (116   | )
|                                                               |  |                                      |        |   |      |   |        |  
|Operating expenses:                                            |  |                                      |        |   |      |   |        |  
|Research and development                                       |  |                                      | 293    |   |      |   | 497    |  
|Clinical and regulatory                                        |  |                                      | 200    |   |      |   | 353    |  
|Sales and marketing                                            |  |                                      | 1,785  |   |      |   | 2,069  |  
|General and administrative                                     |  |                                      | 939    |   |      |   | 985    |  
|                                                               |  |                                      |        |   |      |   |        |  
|Total operating expenses                                       |  |                                      | 3,217  |   |      |   | 3,904  |  
|                                                               |  |                                      |        |   |      |   |        |  
|Operating loss                                                 |  |                                      | (3,342 | ) |      |   | (4,020 | )
|                                                               |  |                                     
|Interest income                                                |  |                                      | 17     |   |      |   | 39     |  
|Decrease in warrant obligation                                 |  |                                      | 338    |   |      |   | 443    |  
|Other income (expense), net                                    |  |                                      | 21     |   |      |   | (14    | )
|                                                               |  |                                      |        |   |      |   |        |  
|Net loss                                                       |  | $                                    | (2,966 | ) |      | $ | (3,552 | )
|                                                               |  |                                      |        |   |      |   |        |  
|Net loss per share, basic and diluted                          |  | $                                    | (0.12  | ) |      | $ | (0.16  | )
|                                                               |  |                                      |        |   |      |   |        |  
|Shares used in computing net loss per share, basic and diluted |  |                                      | 24,810 |   |      |   | 22,659 |  
|                                                               |  |                                      |        |   |      |   |        |  



See accompanying notes
to condensed consolidated financial statements



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##### Table of Contents

CURON MEDICAL, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited, in thousands)



|                                                                            |  |                                       |        |   |      |   |         |  
|--------------------------------------------------------------------------- |  | ------------------------------------- | ------ | - | ---- | - | ------- | -
|                                                                            |  | For the Three Months Ended, March 31, |       
|                                                                            |  | 2005                                  |        |   | 2004 |  
|Cash Flows From Operating Activities                                        |  |                                       |        |   |      |   |         |  
|Net loss                                                                    |  | $                                     | (2,966 | ) |      | $ | (3,552  | )
|Adjustments to reconcile net loss to net cash used in operating activities: |  |                                       |        |   |      |   |         |  
|Depreciation and amortization                                               |  |                                       | 75     |   |      |   | 118     |  
|Stock-based compensation                                                    |  |                                       | (11    | ) |      |   | 31      |  
|Loss on disposal of fixed assets                                            |  |                                       |       |   |      |   | 3       |  
|Decrease of warrant obligation                                              |  |                                       | (338   | ) |      |   | (443    | )
|Amortization of premium on securities                                       |  |                                       | 28     |   |      |   | 100     |  
|Changes in assets and liabilities:                                          |  |                                       |        |   |      |   |         |  
|Accounts receivable, net                                                    |  |                                       | 19     |   |      |   | 160     |  
|Inventories, net                                                            |  |                                       | (86    | ) |      |   | (274    | )
|Prepaid expenses and other current assets                                   |  |                                       | 304    |   |      |   | 58      |  
|Other assets                                                                |  |                                       | 31     |   |      |   |        |  
|Accounts payable                                                            |  |                                       | (45    | ) |      |   | (11     | )
|Accrued liabilities                                                         |  |                                       | 71     |   |      |   | 209     |  
|Decrease in liability settlement reserve                                    |  |                                       |       |   |      |   | (1,250  | )
|Other long-term assets and liabilities                                      |  |                                       | (1     | ) |      |   | 49      |  
|                                                                            |  |                                       |        |   |      |   |         |  
|Net cash used in operating activities                                       |  |                                       | (2,919 | ) |      |   | (4,802  | )
|                                                                            |  |                                       |        |   |      |   |         |  
|Cash Flows From Investing Activities                                        |  |                                       |        |   |      |   |         |  
|Purchase of property and equipment                                          |  |                                       | (35    | ) |      |   | (116    | )
|Purchase of marketable securities                                           |  |                                       |       |   |      |   | (11,960 | )
|Proceeds from maturities of marketable securities                           |  |                                       | 5,500  |   |      |   | 1,750   |  
|                                                                            |  |                                       |        |   |      |   |         |  
|Net cash provided by (used in) investing activities                         |  |                                       | 5,465  |   |      |   | (10,326 | )
|                                                                            |  |                                       |        |   |      |   |         |  
|Cash Flows From Financing Activities                                        |  |                                       |        |   |      |   |         |  
|Proceeds from issuance of common stock and warrants, net of issuance costs  |  |                                       |       |   |      |   | 12,690  |  
|Exercise of stock options and ESPP                                          |  |                                       | 45     |   |      |   | 117     |  
|Principal payments on notes payable                                         |  |                                       | (57    | ) |      |   |        |  
|                                                                            |  |                                       |        |   |      |   |         |  
|Net cash (used in) provided by financing activities                         |  |                                       | (12    | ) |      |   | 12,807  |  
|                                                                            |  |                                       |        |   |      |   |         |  
|Net increase (decrease) in cash and cash equivalents                        |  |                                       | 2,534  |   |      |   | (2,321  | )
|Cash and cash equivalents at beginning of period                            |  |                                       | 374    |   |      |   | 4,865   |  
|                                                                            |  |                                       |        |   |      |   |         |  
|Cash and cash equivalents at end of period                                  |  | $                                     | 2,908  |   |      | $ | 2,544   |  
|                                                                            |  |                                       |        |   |      |   |         |  



See accompanying notes
to the condensed consolidated financial statements



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##### Table of Contents

CURON MEDICAL, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited, tabular amounts in thousands, except per share amounts)



NOTE 1. The Company and Summary of Significant Accounting Policies



The Company



Curon Medical, Inc. (the Company) was incorporated in the State of Delaware in May 1997 as Conway-Stuart Medical Inc. and changed its name to Curon Medical
Inc., in March 2000. The Company develops, manufactures and markets proprietary products for the treatment of gastrointestinal disorders.



The Company has been financing its operations primarily through its cash and cash equivalents, revenues, marketable securities, and financing activities. On April 7 and
April 19, 2005, the Company signed definitive agreements for the private placement of common stock and warrants to institutional investors for a total of $12.0 million, before transaction fees and expenses. The placement is structured to be
completed in two closings, with the first closing having occurred on April 8, 2005, and the second closing being subject to stockholder approval. In this first closing, the Company raised approximately $3.2 million by issuing a total of 4,962,614
shares of common stock at a price of $0.65 per share. Investors received five-year warrants to purchase an aggregate of 2,481,298 shares of common stock at a price of $1.00 per share. An additional amount of approximately $8.8 million has been
deposited to escrow and will be released to the Company in the event that the Company obtains stockholder approval for the subsequent sale of securities. The Company intends to seek stockholder approval at its Annual Meeting to be held on or about
May 31, 2005. The terms of the second closing are identical to those of the first closing. In the event that stockholder approval is received, net proceeds to the Company from the second closing will be approximately $8.4 million. Management
believes if the Company is successful in obtaining stockholder approval, with the proceeds from the second closing it will have enough cash to fund operations for at least the next twelve months. If the Company is unable to obtain stockholder
approval for the subsequent sale of securities, operations will need to be substantially reduced in order to conserve working capital and the Company will have to explore other options, such as a sale of the Company or a portion of its assets
including selling or licensing some of its proprietary technologies.



Basis
of Presentation



The condensed consolidated financial statements include
the accounts of the Company and its wholly owned subsidiaries after elimination of all intercompany balances and transactions. The Company operates in one reportable segment.



The accompanying unaudited condensed consolidated financial statements have been prepared by the Company in accordance with accounting
principles generally accepted in the United States of America for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X promulgated by the Securities and Exchange Commission (SEC).
Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. The unaudited interim condensed consolidated financial statements have been prepared on the
same basis as the annual consolidated financial statements and, in the opinion of management, contain all adjustments (all of which are normal and recurring in nature) necessary to state fairly the financial position, results of operations and cash
flows of the Company for the periods indicated. Interim results of operations are not necessarily indicative of the results to be expected for the full year or any other interim periods.



These condensed consolidated financial statements should be read in conjunction with the audited financial statements included in the Annual
Report on Form 10-K for the year ended December 31, 2004, as filed with the SEC.



Net Loss Per Share



Basic and diluted net loss per share is
calculated as follows:



|                                           |  |                                      |        |   |      |   |        |  
|------------------------------------------ |  | ------------------------------------ | ------ | - | ---- | - | ------ | -
|                                           |  | For the Three Months Ended March 31, |       
|                                           |  | 2005                                 |        |   | 2004 |  
|Net loss (numerator):                      |  |                                      |        |   |      |   |        |  
|Net loss                                   |  | $                                    | (2,966 | ) |      | $ | (3,552 | )
|                                           |  |                                      |        |   |      |   |        |  
|Shares (denominator):                      |  |                                      |        |   |      |   |        |  
|Weighted average common shares outstanding |  |                                      | 24,810 |   |      |   | 22,659 |  
|                                           |  |                                      |        |   |      |   |        |  
|Net loss per share-basic and diluted       |  | $                                    | (0.12  | ) |      | $ | (0.16  | )
|                                           |  |                                      |        |   |      |   |        |  



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Equity instruments that could dilute basic earnings per share in the future, that were not included in the computation of
diluted earnings per share as their effect is antidilutive, are as follows:



|                                               |  |           |  |      
|---------------------------------------------- |  | --------- |  | -----
|                                               |  | March 31,
|                                               |  | 2005      |  | 2004 
|Shares issuable through ESPP                   |  | 44        |  | 89   
|Shares issuable upon exercise of stock options |  | 3,380     |  | 3,621
|Shares issuable upon exercise of warrants      |  | 1,475     |  | 1,475
|                                               |  |           |  |      
|Total                                          |  | 4,899     |  | 5,185
|                                               |  |           |  |      



Stock-Based Compensation



The Company accounts for stock-based employee compensation arrangements
in accordance with provisions of Accounting Principles Board Opinion, APB, No. 25, Accounting for Stock Issued to Employees and complies with the disclosure provisions of Statement of Financial Accounting Standards, SFAS, No. 123,
Accounting for Stock-Based Compensation, as amended by SFAS No. 148, Accounting for Stock-Based Compensation, Transition and Disclosure. Under APB No. 25, unearned stock compensation is based on the difference, if any, on the
date of grant, between the fair value of the Companys common stock and the exercise price. Had the Company determined its stock-based compensation based on the fair value at the grant dates for the awards under a method prescribed by SFAS No.
123, the Companys net loss would have been increased to the FAS 123 adjusted amounts indicated below, as amended by SFAS No. 148:



|                                                                                                          |  |                                      |        |   |      |   |        |  
|--------------------------------------------------------------------------------------------------------- |  | ------------------------------------ | ------ | - | ---- | - | ------ | -
|                                                                                                          |  | For the Three Months Ended March 31, |       
|                                                                                                          |  | 2005                                 |        |   | 2004 |  
|Net loss, as reported                                                                                     |  | $                                    | (2,966 | ) |      | $ | (3,552 | )
|Add: Stock-based employee compensation expense in reported net income                                     |  |                                      |       |   |      |   | 4      |  
|Deduct : Total stock-based employee compensation expense determined under fair value based for all awards |  |                                      | (186   | ) |      |   | (146   | )
|                                                                                                          |  |                                      |        |   |      |   |        |  
|Net loss - FAS 123 adjusted                                                                               |  | $                                    | (3,152 | ) |      | $ | (3,694 | )
|                                                                                                          |  |                                      |        |   |      |   |        |  
|Net loss per share - as reported Basic and diluted                                                        |  | $                                    | (0.12  | ) |      | $ | (0.16  | )
|                                                                                                          |  |                                      |        |   |      |   |        |  
|Net loss per share - FAS 123 adjusted Basic and diluted                                                   |  | $                                    | (0.13  | ) |      | $ | (0.16  | )
|                                                                                                          |  |                                      |        |   |      |   |        |  



The Company accounts for equity
instruments issued to non-employees in accordance with the provisions of SFAS No. 123 and Emerging Issues Task Force No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services. The equity instruments are valued using the Black-Scholes model. All unvested shares are marked to market until such options vest.



Product Warranty



The Company generally warrants its capital equipment products against defects for a period of one year and records a liability for such product warranty obligations at
the time of sale based upon historical experience. The Company also sells separately priced extended warranties to provide additional warranty coverage and recognizes the related revenue on a straight-line basis over the extended warranty period,
which is generally one to four years. Costs associated with services performed under the extended warranty obligation are expensed as incurred.



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Changes in product warranty obligations, including separately priced extended warranty obligations, for the three months
ended March 31, 2005 and 2004 are as follows:



|                                                                               |  |                                      |    |   |      |   |    |  
|------------------------------------------------------------------------------ |  | ------------------------------------ | -- | - | ---- | - | -- | -
|                                                                               |  | For the Three Months Ended March 31, |   
|                                                                               |  | 2005                                 |    |   | 2004 |  
|Balance as of the beginning of the period                                      |  | $                                    | 83 |   |      | $ | 58 |  
|Add: Accruals for warranties issued                                            |  |                                      | 6  |   |      |   | 5  |  
|Less: Revenue recognized under separately priced extended warranty obligations |  |                                      | (2 | ) |      |   | (3 | )
|                                                                               |  |                                      |    |   |      |   |    |  
|Balance as of the end of the period                                            |  | $                                    | 87 |   |      | $ | 60 |  
|                                                                               |  |                                      |    |   |      |   |    |  





NOTE 2. Issuance of Common Stock and Warrants



In February 2004, the Company raised approximately $13.5 million in gross proceeds from the private placement of common stock and warrants to several institutional
investors. Net proceeds to the Company after estimated offering costs and expenses were approximately $12.6 million. The transaction involved the sale of 4,025,000 newly issued shares of the Companys common stock at a price of $3.36 per share
and warrants to purchase an aggregate of 905,625 shares of common stock an exercise price of $4.71 per share. The common stock warrants have a five-year term and became exercisable in August 2004. In addition, commencing in August 2007, should the
Companys stock price close at or above 175% of the exercise price on any 15 out of 30 consecutive trading days, and other certain conditions are met as defined in the warrant agreement, the Company has the right, on one occasion, to require
the holders of the common stock warrants to exercise such common stock warrants. These warrants provide for cash redemption by the warrant holders upon the occurrence of certain events outside the control of the Company. As a result, the aggregate
fair value of the warrants of $1.7 million was recorded as a liability with the remaining net proceeds of $10.9 million recorded as equity in the accompanying condensed consolidated balance sheet. The warrants were valued in February 2004, using the
Black-Scholes model with the following assumptions: 5 year expected life, risk free interest rate of 3.23 %, dividend yield of zero, volatility of 73%.



The fair value of the warrants and the corresponding liability is re-measured at the end of each reporting period utilizing current inputs to the Black-Scholes model,
with any change in fair value being recorded as a non-operating item in the statement of operations. The aggregate fair value of the warrant decreased from $469,000 at December 31, 2004, to $131,000 at March 31, 2005. The warrants were valued on
March 31, 2005, using the Black-Scholes model with the following assumptions: 3.8 year expected life, risk free interest rate of 4.22%, dividend rate of zero and volatility of 65%.



NOTE 3. Inventories



|                |  |                |     |                   |   |    
|--------------- |  | -------------- | --- | ----------------- | - | ---
|                |  | March 31, 2005 |     | December 31, 2004
|Inventories:    |  |                |     |                   |   |    
|Raw materials   |  | $              | 549 |                   | $ | 563
|Work-in-process |  |                | 137 |                   |   | 13 
|Finished goods  |  |                | 177 |                   |   | 201
|                |  |                |     |                   |   |    
|                |  | $              | 863 |                   | $ | 777
|                |  |                |     |                   |   |    





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##### Table of Contents

NOTE 4. Non-Employee Stock Compensation



Stock-based compensation (benefit) expense included in the Condensed Consolidated Statements of Operations is as follows:



|                         |  |                                       |     |   |      |   |   
|------------------------ |  | ------------------------------------- | --- | - | ---- | - | --
|                         |  | For the Three Months Ended, March 31,
|                         |  | 2005                                  |     |   | 2004
|Research and development |  | $                                     |    |   |      | $ | 1 
|Clinical and regulatory  |  |                                       | (9  | ) |      |   | 26
|Sales and marketing      |  |                                       | (2  | ) |      |   | 4 
|                         |  |                                       |     |   |      |   |   
|                         |  | $                                     | (11 | ) |      | $ | 31
|                         |  |                                       |     |   |      |   |   



NOTE 5. Contingencies



The Company is involved in routine legal and administrative proceedings
that arise from the normal conduct of business. Management believes that the ultimate disposition of these matters will not have a material adverse effect on the financial results or condition of the Company.



In June 2001, a civil action was filed against the Company in the United States District
Court, Western District of Kentucky, Louisville Division, alleging that the plaintiff sustained injury when undergoing a procedure utilizing the Stretta System, caused by defects in design and manufacture. This matter was amicably resolved in
February 2005 without material financial impact on the Company.



In April 2003,
a civil action was filed against the Company in United States District Court for the Northern District of California by Federal Insurance Corporation, the Companys insurance carrier, for rescission, reformation, and restitution in connection
with the Companys liability insurance policy. This policy covers, among other things, product liability claims made against the Company by people treated with the Companys product. In October 2004, the plaintiffs summary judgment
motion was granted. The Company has decided not to appeal the result of the summary judgment and is engaged with settlement discussions with Federal Insurance Corporation. The Company believes that the resolution of this matter will not have a
material effect, if any, on its business, financial position, and results of operations and cash flows.



NOTE 6. Subsequent Event



On April 8,
2005 and April 19, 2005, the Company signed definitive agreements for the private placement of 18,445,078 shares of its common stock at a price of $0.65 per share. The private placement involves the issuance of five-year warrants, expiring in 2010,
to purchase 9,775,891shares of our common stock at an exercise price of $1.00 per share. The placement is structured to be completed in two closings. The terms of two closings are identical.



The first closing occurred on April 8, 2005. At this first closing the Company raised
approximately $3.2 million in gross proceeds by issuing a total of 4,962,614 shares of common stock, representing 19.9% of its total outstanding shares prior to this offering. Investors received warrants to purchase an aggregate of 2,481,298 shares
of common stock. The Company paid to the parties that acted as its agent in connection with this private placement an initial fees of $593,000 in cash and issued warrant to purchase 148,878 shares of its common stock as additional consideration. The
terms of this warrant is identical to those issued to the Investors.



An
additional amount of approximately $8.8 million has been deposited to escrow and will be released to the Company in the event the Company obtains stockholder approval for an additional 50,000,000 shares and the subsequent sale of securities. The
Company intends to seek such approval at its Annual Meeting to be held on or about May 31, 2005. The terms of the subsequent closing are identical to those of the first closing. Net proceeds to the Company from the second closing would be
approximately $8.4 million. In a similar manner to the warrants issued in February 2004, the Company will account for the warrants as a liability based on fair market value at the date of sale. The Company will re-measure the value of the liability
each quarter based on the fair market value at the end of the quarter using the Black-Scholes method with a contractual volatility of 100%.



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



The following discussion should be read in conjunction with the attached financial statements and notes thereto, and with our audited financial statements and notes
thereto for the fiscal year ended December 31, 2004.



This quarterly report,
including the following sections, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include statements relating to our expectations as to the rates of market adoption of
our products, the timing and effect on market adoption of reimbursement approvals, the timing and extent of technical improvements to our products, and our ability to achieve higher sales volume for this fiscal year. These forward-looking statements
involve risks and uncertainties. The cautionary statements set forth below and those contained in Factors That May Affect Future Results, commencing on page 16, identify important factors that could cause actual results to differ
materially from those predicted in any such forward-looking statements.



Overview



We were incorporated in Delaware in May 1997 as
Conway-Stuart Medical Inc. and changed our name to Curon Medical Inc., in March 2000. We develop, manufacture and market innovative proprietary products for the treatment of gastrointestinal disorders. Our products consist of radiofrequency
generators and single-use disposable devices.



Our first product, the
Stretta® System, received United States Food and
Drug Administration FDA, clearance in April 2000 for the treatment of gastroesophageal reflux disease, or GERD, which affects approximately 15 million U.S. adults on a daily basis. In patients with GERD, acidic stomach contents reflux
backward from the stomach into the esophagus, causing a wide range of symptoms and complications, including, most commonly, persistent heartburn and chest pain. Unlike medication, which addresses GERD symptoms, our Stretta System applies
radiofrequency energy to treat the causes of GERD. The Stretta System consists of a disposable catheter with needle electrodes and our control module, which is a radiofrequency energy generator. Using the Stretta System, the physician delivers
temperature-controlled radiofrequency energy to the muscle of the lower esophageal sphincter and upper portion of the stomach. The delivery of this energy creates heat, causing tissue contraction and creating thermal lesions that resorb over time,
resulting in improved sphincter function. Clinical studies show a significant reduction in GERD symptom scores, esophageal acid exposure, and use of anti-secretory medications.



We commercially launched the Stretta System in May 2000. As of March 31, 2005, we have sold 374 control modules and approximately more than
7,000 patients have been treated with the Stretta Procedure.



Our second
product, the Secca® System, is a radiofrequency energy-based system for the treatment of bowel incontinence (referred to as Fecal
incontinence). Bowel incontinence is caused by damage to the anal sphincter due to childbirth, surgery, neurological disease, injury or age, and affects up to 16 million adults in the United States. Using the Secca System, physicians deliver
radiofrequency energy to the anal sphincter muscle in the anal canal. Clinical studies have shown a reduction in bowel incontinence symptoms and improvement in general quality of life. In March 2002, we received 510(k) clearance from the FDA to
market the Secca System for the treatment of fecal incontinence in patients who have failed more conservative therapies such as diet modification and biofeedback. We undertook a limited test launch of Secca in June 2002, and fully launched the
product commercially in May 2003.



We have a direct sales force to market and
sell our products in the United States. We market the Stretta System, as an alternative to anti-reflux surgery, primarily to high volume general surgeons and gastroenterologists. In the United States, we estimate that there are approximately 4,500
general surgeons and 7,000 gastroenterologists who actively perform endoscopy. We market the Secca System primarily to colon and rectal surgeons and to those general surgeons who perform colorectal surgery. We estimate that there are approximately
1,200 colon and rectal surgeons and up to 3,000 general surgeons that routinely perform colorectal surgery in the United States.



Our Stretta System has also received European, Australian and Canadian regulatory approval, and our Secca System has also received regulatory approval in Europe. We
incorporated a subsidiary company in Belgium in November 2000 to manage distribution of our products in Europe, the Middle East and Africa. In March 2003, we entered into distribution agreements for the Stretta System in Switzerland, Austria, and
the Netherlands, and have international distribution agreements with a distributor for the Far East, giving us representation in the countries of the Peoples Republic of China, Taiwan, Hong Kong, South Korea, Singapore, Malaysia, Indonesia, Vietnam,
Thailand and India. To date, we have international distribution agreements for our products in 11 European and Middle Eastern countries and in South Africa. The Secca System is also sold through distributors in Europe. The first European Secca
procedures were performed in Germany, Denmark and Italy in March 2002, as part of our clinical trials. The first international



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commercial Secca procedure was performed in March 2003. We are organized into a single reportable segment consisting of
the development, manufacture, and marketing of proprietary products for the treatment of gastrointestinal disorders. We use one measurement of profitability and do not disaggregate our business for internal reporting.



The American Medical Association recently issued a Category I CPT code for the Stretta
procedure that became effective January 1, 2005, which will make it easier for physicians to code for the procedure.



RESULTS OF OPERATIONS



Periods of three months ended March 31, 2005 and 2004.



Revenues



Our revenues are
comprised of sales of our Stretta and Secca generators and disposable devices. Revenues for the quarter ended March 31, 2005 were $857,000, compared to $906,000 for the same quarter in 2004. The decrease compared to 2004 was due primarily to a
decline in sales of our Stretta System products of $356,000, partially offset by an increase in Secca System products of $311,000. Stretta System products accounted for $483,000, or 57%, and Secca System products accounted for $365,000, or 43%, of
the quarters revenues. In the first quarter of 2004, Stretta System products accounted for $839,000, or 94%, and Secca System products were $54,000, or 6%, of the quarters revenues. The Stretta Control Module and Catheter accounted for
$103,000, or 21%, and $341,000, or 71%, respectively, of the Stretta product line sales for the quarter ended March 31, 2005, compared to $355,000, or 42%, and $445,000, or 53%, respectively, for the same period in 2004. The Secca Control Module and
Hand-pieces accounted for $92,000, or 25%, and $261,000, or 71%, respectively, of the Secca product line sales for the quarter ended March 31, 2005, compared to $0, or 0%, and $54,000, or 100%, respectively, for the same period in 2004.
International sales accounted for $135,000 in the quarter ended March 31, 2005, compared to $9,000 in the same quarter of 2004.



Cost of goods sold



Our costs of goods sold represent the cost of producing generators and disposable devices. Cost of goods sold was $982,000 in the quarter ended March 31, 2005, and
$1,022,000 for the same period in 2004. Our sales have not yet reached a level that would absorb our manufacturing capacity to the extent that we would experience positive gross profit.



Research and development expenses



Research and development expenses consist primarily of personnel costs, professional services, patent application and maintenance costs, materials, supplies and
equipment. Research and development expenses were $293,000 for the three months ended March 31, 2005, a decrease of $204,000 or 41% over research and development expenses of $497,000 for the three months ended March 31, 2004. The decrease in
spending for the three months ended March 31, 2005 was due primarily to the reduced headcount in our research and development department as we implemented cost reduction measures in September 2004. We expect that research and development expenses
will remain near current levels for the remainder of the current fiscal year.



Clinical and regulatory expenses



Clinical and
regulatory expenses consist primarily of expenses associated with the costs of clinical trials, clinical support personnel, the collection and analysis of the results of these trials, and the costs of submission of the results to regulatory
agencies. Clinical and regulatory expenses were $200,000 for the three months ended March 31, 2005, a decrease of $153,000 or 43% over clinical and regulatory expenses of $353,000 for the three months ended March 31, 2004. Cost reduction measures
and reduced clinical trial activity have reduced expenses in the first quarter of 2005, as compared to the first quarter of 2004. We expect that clinical and regulatory expenses will remain near current levels for the remainder of the current fiscal
year.



Sales and marketing expenses



Sales and marketing expenses consist of personnel related costs, advertising, public
relations and attendance at selected medical conferences. Sales and marketing expenses for the three months ended March 31, 2005 were $1,785,000, a decrease of $284,000 or 14% over sales and marketing expenses of $2,069,000 for the three months
ended March 31, 2004. The decrease of $148,000 from 2004 to 2005 was primarily attributable to trade shows and medical conferences. We also reduced our spending on consulting, travel



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and recruitment in the first quarter 2005 compared to 2004. We have recently put in place some new programs that we
believe will accelerate sales growth through 2005 and beyond. We expect the sales and marketing expenses to increase due to the new program expenses for the remainder of the current fiscal year, and will fluctuate primarily as a result of both
commission expenses that are related to sales levels and timing of various medical conferences that we attend.



General and administrative expenses



General and administrative expenses consist primarily of the cost of corporate operations and personnel, legal, accounting and other general operating expenses of our company. General and administrative expenses for the three months ended
March 31, 2005 were $939,000, a decrease of $46,000 or 5% over general and administrative expenses of $985,000 for the three months ended March 31, 2004. This decrease in general and administrative expenses for the three months ended March 31, 2005
was primarily due to decreased legal and professional fees. We anticipate that general and administrative expenses for the fiscal year 2005 will increase related to implementation of Section 404 of the Sarbanes-Oxley Act, which requires our
management to assess the effectiveness of our internal controls over financial reporting.



Interest Income, net



During the
quarter ended March 31, 2005, compared to the quarter ended March 31, 2004, net interest income decreased by $22,000. The decrease was due to an average cash and investment decrease of approximately $15.0 million, partially offset by an increase in
investment yields to approximately 2.4% from 1.5%. Interest expense was not material for either period.



Decrease in warrant liability



Our sale of 4,025,000 newly issued shares in February 2004, included warrants to purchase an additional 905,625 shares of common stock. These warrants provide for cash redemption by the holders upon the occurrence of certain events outside
our control. As a result, the aggregate fair value of the warrants of $1.7 million, determined using the Black-Scholes model, was recorded as a liability with subsequent changes to the fair value of the warrants being recorded as a non-operating
item through the statement of operations. The fair value of the warrant decreased from $469,000 at December 31, 2004 to $131,000 at March 31, 2005, resulting in us recording a benefit of $338,000.



LIQUIDITY AND CAPITAL RESOURCES



At March 31, 2005, we had $3.4 million in working capital and our primary source of
liquidity was $2.9 million in cash and cash equivalents and marketable securities, compared to $6.6 million and $5.9 million, respectively, as of December 31, 2004. We have been financing our operations primarily through our cash and cash
equivalents, revenues, marketable securities, and financing activities. On April 7 and April 19, 2005, we signed definitive agreements for the private placement of our common stock to institutional investors for a total of $12.0 million, before
transaction fees and expenses. The placement is structured to be completed in two closings, with the first closing having occurred on April 8, 2005, and the second closing being subject to stockholder approval. In this first closing, we raised
approximately $3.2 million by issuing a total of 4,962,614 shares of common stock at a price of $0.65 per share. Investors received five-year warrants to purchase an aggregate of 2,481,298 shares of common stock at a price of $1.00 per share. An
additional amount of approximately $8.8 million has been deposited to escrow and will be released to us in the event that we obtain stockholder approval for the subsequent sale of securities. We intend to seek stockholder approval at our Annual
Meeting to be held on or about May 31, 2005. The terms of the second closing are identical to those of the first closing. In the event that stockholder approval is received, net proceeds to us from the second closing will be approximately $8.4
million. We believe if we are successful in obtaining the stockholder approval, we will have enough cash to fund operations for at least the next twelve months. If we are unable to obtain the stockholder approval for the subsequent sale of
securities, operations will need to be substantially reduced in order to conserve working capital and we will have to explore other options, such as a sale of the Company or a portion of our assets including selling or licensing some of our
proprietary technologies.



Cash used in operating activities was $2.9 million
in the three month period ended March 31, 2005, and $4.8 million in the same period in 2004. In the first quarter 2004, included $1.25 million that we paid to settle legal liability reserve. Remaining decrease of cash used in operating activities
relates primarily to decrease in net loss of $3.6 million in the first quarter 2004 compared to $3.0 million in the first quarter of 2005. We substantially decreased sales and marketing, clinical and regulatory spending, together with the staff
headcount in research and development.



Cash used in investing activities was
$5.5 million in the three months ended March 31, 2005, which consisted primarily of net proceeds from net maturities of marketable securities used to fund operations. As of March 31, 2005, we had no material commitments for capital expenditures. For
the three months ended March 31, 2004, net cash provided by investing activities was $10.3 million, which consisted primarily of net purchases of marketable securities, as we invested the cash received from our private placement financings in
February 2004.



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Cash used in financing activities was $12,000 in the three months ended March 31, 2005, primarily related to the proceeds
from the exercise of stock options offset by the payoff of a note payable to finance insurance policies. For the same period in 2004, cash provided by financing activities was $12.8 million, related to the private placement of common stock and
warrants to a group of institutional investors in the net amount of $12.7 million, in addition to $117,000 from the exercise of stock options.



Contractual Obligations



The following table sets forth our contractual obligations at March 31, 2005 and the years in which such obligations are expected to be settled.



|                                 |  |      |     |      |   |      |  |       |    |  |   |      
|-------------------------------- |  | ---- | --- | ---- | - | ---- |  | ----- | -- |  | - | -----
|                                 |  | 2005 |     | 2006 |   | 2007 |  | Total
|Future minimum lease commitments |  | $    | 306 |      | $ | 348  |  | $     | 20 |  | $ | 674  
|Inventory purchase commitments   |  |      | 623 |      |   |     |  |       |   |  |   | 623  
|                                 |  |      |     |      |   |      |  |       |    |  |   |      
|                                 |  | $    | 929 |      | $ | 348  |  | $     | 20 |  | $ | 1,297
|                                 |  |      |     |      |   |      |  |       |    |  |   |      



In August 2002, we announced that our
Board of Directors had authorized a stock repurchase program permitting the purchase of up to 1,000,000 shares of our Common Stock in open market transactions at prices deemed appropriate by management, and administered pursuant to Rule 10b-18 of
the Securities Exchange Act of 1934. Shares have not been repurchased under this plan since 2002.



Recent Accounting Pronouncements



At
its March 2004 meeting, the EITF reached a consensus on recognition and measurement guidance previously discussed under EITF 03-01. The consensus clarifies the meaning of other-than-temporary impairment and its application to investments classified
as either available-for-sale or held-to-maturity under SFAS No. 115 and investments accounted for under the cost method or the equity method. The recognition and measurement guidance for which the consensus was reached in the March 2004 meeting is
to be applied to other-than-temporary impairment evaluations in reporting periods beginning after June 15, 2004. We do not believe that this consensus on the recognition and measurement guidance will have an impact on our results of operations.



In November 2004, the FASB issued SFAS No. 151, Inventory Costs.
SFAS 151 amends the guidance in ARB No. 43, Chapter 4, Inventory Pricing, to clarify the accounting for abnormal amounts of idle facility expense, freight, handling costs and spoilage. This statement requires that these items be expensed as incurred
and not included in overhead. In addition, SFAS 151 requires that allocation of fixed production overhead to conversion costs should be based on normal capacity of the production facilities. This Statement is effective for inventory costs incurred
during fiscal years beginning after June 15, 2005. The adoption of SFAS No. 151 is not expected to have a material impact on our financial position and results of operations.



In December 2004, the FASB issued Statement No. 123(R) (SFAS 123(R)), Share-Based Payment. This statement replaces
Statement of Financial Accounting Standards No. 123 (SFAS 123), Accounting for Stock-Based Compensation, and supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees. SFAS 123(R) will require
compensation costs related to share-based payment transactions to be recognized in the financial statements (with limited exceptions). The amount of compensation cost will be measured based on the grant-date fair value of the equity or liability
instruments issued. Compensation cost will be recognized over the period that an employee provides service in exchange for the award. This statement is effective as of the beginning of the first interim or annual reporting period that begins after
June 15, 2005. We are currently in the process of evaluating the impact from this standard on our results of operations and financial position.



Factors That May Affect Future Results



We have limited capital resources and will need to obtain stockholder approval of our recent financing if we want to continue our current level of operations, which we
may not be able to do.



On April 7 and April 19, 2005, we signed
definitive agreements for the private placement of common stock to institutional investors for a total of $12.0 million, before transaction fees and expenses. The placement is structured to be completed in two closings, with the first closing for
approximately $3.2 million having occurred on April 8, 2005, and the remaining closing for $8.8 million being subject to stockholder approval. We intend to seek stockholder approval at our Annual Meeting to be held on or about May 31, 2005. As of
April 30, 2005, we had cash and cash equivalents of approximately $3.9 million. If we are not successful in obtaining stockholder approval, we will not have enough cash to fund operations for at least the next twelve months. In this event,
operations would need to be substantially reduced in order to conserve working capital and we would have to explore other options, such as a sale of the Company or a portion of our assets including selling or licensing some of our proprietary
technologies.



We may never achieve or maintain significant revenues or
profitability.



We have incurred losses every year since we began
operations. In particular, we incurred net losses of $15.3 million in 2004, $15.6 million in 2003, and $15.4 million in 2002 and $3.0 million for the three months ended March 31, 2005. As of March 31, 2005, we had an accumulated deficit of
approximately $97.6 million. Our revenues are, and will be, derived from the sale of radiofrequency generators and our disposable devices, such as the Stretta Catheter and Secca Handpiece. We have generated limited revenues, and it is possible that
we will never generate significant revenues from product sales. Even if we do achieve significant revenues from our product sales, we expect to incur significant net losses over the next several years and these losses may increase. It is possible
that we will never achieve profitable operations. The fact that we have very limited cash resources, cannot assure you that additional capital will be available to us when needed, if at all, or, if available, will be obtained on terms attractive to
us and our failure to generate substantial revenues would harm our business.



Our internal controls may not be sufficient to ensure timely and reliable financial information.



In October 2004, we restated our financial results for the quarter ended March 31, 2004 to reflect adjustments to our previously reported financial information. The
restatements arose, in part, out of an internal investigation by the Audit Committee. As a result of the investigation, management and the Audit Committee determined that certain sales employees had improperly offered rights of return and exchange
in violation of our revenue recognition policy, and a manufacturers representative had not actually made sales that it had reported to the Company. As a result of this investigation, we were also unable to timely file the Form 10-Q for the
quarter ended June 30, 2004. In connection with the restatement of our financial results for the quarter ended March 31, 2004, our independent registered public accounting firm identified material weaknesses in our internal controls and procedures.



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Our Audit Committee, with the assistance of independent legal and accounting advisors, evaluated the effectiveness of our
disclosure controls and procedures. As a result of this evaluation, our Board of Directors has directed management to implement and management has implemented additional measures designed to ensure that information required to be disclosed in our
periodic reports is recorded, processed, summarized and reported accurately. These measures include the adoption of a Disclosure Committee Charter, the adoption of a written revenue recognition policy, further controls on shipment of products for
revenue transactions, and additional training of our sales and marketing staff to minimize the risk of revenue recognition errors. The effectiveness of our controls and procedures remain limited by a variety of factors including:



| |  | Faulty human judgment and simple errors, omissions or mistakes;
|- |  | ---------------------------------------------------------------



| |  | Fraudulent action of an individual or collusion of two or more people;
|- |  | ----------------------------------------------------------------------



| |  | Inappropriate management override of procedures; and
|- |  | ----------------------------------------------------



| |  | The possibility that our enhanced controls and procedures may still not be adequate to assure timely and accurate financial information.
|- |  | ----------------------------------------------------------------------------------------------------------------------------------------



If we fail to have effective internal control over financial reporting in place, we could be
unable to provide timely and accurate financial information and be subject to delisting from Nasdaq, and civil or criminal sanctions.



We may be delisted from the Nasdaq SmallCap Market if we fail to timely file our periodic reports. This may adversely affect trading in our stock and our ability to
raise capital.



Due to our inability to timely file our Form 10-Q for the
quarter ended June 30, 2004, we became subject to delisting from the Nasdaq SmallCap Market. Subsequent to an appeal proceeding, the Nasdaq Listing Qualifications Panel determined to continue our listing on the Nasdaq SmallCap Market, conditioned
upon the timely filing of all periodic reports with the Securities and Exchange Commission and Nasdaq for all reporting periods beginning with September 30, 2004 and ending on September 30, 2005. Should we fail to make any filing in accordance with
this condition, we will not be entitled to a new hearing with Nasdaq and our securities may be immediately delisted from the Nasdaq SmallCap Market.



There are no assurances that we will timely make our filings in accordance with the terms of Nasdaqs conditional continued listing determination. If we are
delisted, trading in our common stock could be subject to the so-called penny stock rules that impose additional sales practice and market making requirements on broker-dealers who sell and/or make a market in those securities.
Consequently, removal from the Nasdaq SmallCap Market, if it were to occur, could affect the ability or willingness of broker-dealers to sell and/or make a market on our common stock and the ability of purchasers of our common stock to sell their
securities in the secondary market. These rules could further limit the market liquidity of our common stock and the ability of investors to sell our common stock in the secondary market. If we are delisted from the Nasdaq SmallCap Market, our stock
price is likely to decline significantly.



If health care providers are not
adequately reimbursed for the procedures which use our products, or for the products themselves, we may never achieve significant revenues.



Our physician customers continue to encounter difficulties in readily obtaining adequate reimbursement for the Stretta procedure on a case-by-case basis, and this
continues to impact our ability to market and sell the Stretta System.



While
the American Medical Association has issued a Level I CPT code for the Stretta procedure effective January 1, 2005, there is no assurance that the established level of coverage will encourage physicians to perform the Stretta procedure or that local
Medicare or private payers will choose to pay for this procedure. We have in the past received unfavorable Medicare coverage determinations. Physicians, hospitals and other health care providers are unlikely to purchase our products if they are not
adequately reimbursed for the Stretta procedure or the products. Some payers may refuse adequate reimbursement even though significant peer-reviewed data has been published. If users of our products cannot obtain sufficient reimbursement from health
care payers for the Stretta or Secca procedures or the Stretta or Secca Systems disposables, then it is unlikely that our products will ever achieve increased market acceptance.



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Reimbursement from third-party health care payers is uncertain due to factors beyond our control and changes in
third-party health care payers policies could adversely affect our sales growth.



Even if third-party payers provide adequate reimbursement for our procedures or products, adverse changes in third-party payers policies toward reimbursement could preclude market acceptance for our products and
have a material adverse effect on our sales and revenue growth. We are unable to predict what changes will be made in the reimbursement methods used by third-party health care payers.



For example, some health care payers are moving toward a managed care system in which providers contract to provide comprehensive health
care for a fixed cost per person. We cannot assure you that in a prospective payment system, which is used in many managed care systems, the cost of our products will be incorporated into the overall payment for the procedure or that there will be
adequate reimbursement for our products separate from reimbursement for the procedure.



Internationally, market acceptance of our products is dependent upon the availability of adequate reimbursement within prevailing health care payment systems. Reimbursement and health care payment systems in international markets vary
significantly by country and include both government-sponsored health care and private insurance. Although we are seeking international reimbursement approvals, we cannot assure you that any such approvals will be obtained in a timely manner or at
all. If foreign third-party payers do not adequately reimburse providers for the Stretta procedure and the products used with it, then our sales and revenue growth may be limited.



If physicians do not adopt our products, we will not achieve future sales growth.



To achieve increasing sales, our products must continue to gain recognition and adoption by
physicians who treat gastrointestinal disorders. Our products represent a significant departure from conventional treatment methods. We believe that physicians will not increase rates of adoption of our systems unless they determine, based on
published peer-reviewed journal articles, long-term clinical data and their professional experience, that our systems provide effective and attractive alternatives to conventional means of treatment. Currently, there are approximately 27
peer-reviewed journal articles on the Stretta procedure, including the results of our Stretta randomized trial, and three peer-reviewed journal articles on the Secca procedure. Some physicians may be slow to adopt new products and treatment
practices, partly because of perceived liability risks and uncertainty of third-party reimbursement. Future adverse events or recalls could also impact future acceptance rates. Additionally, some of our customers and potential customers may find the
time necessary to perform a Stretta procedure to be a limiting issue, as their endoscopy unit schedule is typically dominated by short diagnostic procedures. If we cannot achieve increasing physician adoption rates of our products, we may never
achieve significant revenues or profitability.



Failure in our physician
education efforts could significantly reduce product sales.



It is
important to the success of our sales efforts to educate physicians in the techniques of using our products. We rely on physicians to spend their time and money to attend pre-sale educational sessions. Positive results using the Stretta and Secca
Systems are highly dependent upon proper physician technique. If physicians use either system improperly, they may have unsatisfactory patient outcomes or cause patient injury, which may give rise to negative publicity or lawsuits against us, any of
which could have a material adverse effect on our sales and profitability.



We face competition from more established GERD treatments and from competitors with greater resources, which will make it difficult for us to achieve significant market penetration.



Companies that have well-established products, reputations and resources dominate the market
for the treatment of GERD. Our primary competitors are large medical device manufacturers such as Ethicon Endo Surgery and United States Surgical, manufacturers of instrumentation for anti-reflux surgery, C.R. Bard, Wilson Cook and NDO Surgical,
each of which manufactures an endoscopic sewing device for treating GERD, and Boston Scientific, which manufactures an injectable product for the treatment of GERD. Other competitive devices may be developed.



Most of these competitors are larger companies that enjoy several competitive advantages over
us, which may include:



| |  |  | Existing anti-reflux surgical procedures and devices for the treatment of GERD;
| | - |  | -------------------------------------------------------------------------------



| |  |  | Established reputations within the surgical and gastroenterological community;
| | - |  | ------------------------------------------------------------------------------



| |  |  | Established distribution networks that permit these companies to introduce new products and have such products accepted by the physician community promptly;
| | - |  | ------------------------------------------------------------------------------------------------------------------------------------------------------------



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| |  |  | Established relationships with health care providers and payers that can be used to facilitate reimbursement for new treatments; and
| | - |  | ------------------------------------------------------------------------------------------------------------------------------------



| |  |  | Greater resources for product development and sales and marketing.
| | - |  | ------------------------------------------------------------------



We do not feel that we compete with large pharmaceutical companies, such as AstraZeneca, Takeda Abbott Pharmaceutical, Wyeth Laboratories and Eisai, because candidate
patients for Stretta are intolerant to drug therapy or have failed, or only partially responded to, drug therapy. However, these companies have an established relationship with the gastroenterology community and generate over $12 billion in annual
U.S. revenues from the proton pump inhibitor drug class. We could be adversely affected if one or more pharmaceutical companies elects to market aggressively against our product, or if a new, more effective, pharmaceutical product is developed.



We have limited sales and marketing experience, and failure to manage our
sales force or to market and distribute our products effectively will hurt our revenues.



We have limited sales and marketing experience. As of March 31, 2005, we relied on 14 direct sales territories for the sale of our products in the United States. We also deploy an indirect sales channel of six
manufacturers representative firms, which adds 15 salespeople available to sell and market our products across the United States. The success of this sales channel will depend upon a number of factors, many of which are beyond our control, including
the willingness of such distributors to prioritize the sale of our products, and their effectiveness in such sales efforts.



There are significant risks involved in building and managing our sales force and marketing our products, including our:



| |  |  | Inability to hire a sufficient number of qualified sales people with the skills and understanding to sell the Stretta and Secca Systems effectively;
| | - |  | ----------------------------------------------------------------------------------------------------------------------------------------------------



| |  |  | Failure to adequately train our sales force in the use and benefits of our products, making them less effective promoters; and
| | - |  | ------------------------------------------------------------------------------------------------------------------------------



| |  |  | Failure to accurately price our products as attractive alternatives to conventional treatments.
| | - |  | -----------------------------------------------------------------------------------------------



Our failure to adequately address these risks will harm our ability to sell our products.



Internationally, we rely on third-party distributors to sell our products, and we cannot
assure you that these distributors will commit the necessary resources to effectively market and sell our products.



Internationally, we rely on a network of distributors to sell our products and we will need to attract additional distributors to grow our business and expand the
territories into which we sell our products. Distributors may not commit the necessary resources to market and sell our products to the level of our expectations. If current or future distributors do not perform adequately, we may not realize
expected international revenue growth.



We depend on suppliers who provide
materials and components used in our products, and if we lose our relationship with any individual supplier, we will face regulatory requirements with regard to replacement suppliers that could delay the manufacture of our products.



Third-party suppliers provide materials and components used in our products, some of
which are the single or sole source for the components they provide. If any of our suppliers become unwilling or unable to supply us with our requirements, replacement or alternative sources might not be readily obtainable due to regulatory
requirements applicable to our manufacturing operations. Obtaining components from a new supplier may require a new or supplemental filing with applicable regulatory authorities and clearance or approval of the filing before we could resume product
sales. This process may take a substantial period of time, and we cannot assure you that we would be able to obtain the necessary regulatory clearance or approval. This could create supply disruptions that would reduce our product sales and revenue.



If we, or our suppliers, fail to comply with the FDA Quality System
Regulation, manufacturing operations could be delayed and our business could be harmed.



Our manufacturing processes are required to comply with the Quality System Regulation, or QSR, which covers the methods and



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documentation of the design, testing, production, control, quality assurance, labeling, packaging and shipping of our
products. The FDA enforces the QSR through inspections. Our first QSR inspection was in March 2001, and we were also inspected in July 2003. There were no significant findings from either inspection. If we fail any future QSR inspections, our
operations could be disrupted and our manufacturing delayed. Failure to take appropriate corrective action in response to a QSR inspection could force a shut-down of our manufacturing operations, a recall of our products, and potentially a
revocation of the FDA 510(k) clearance of our products, which would have a material adverse effect on our product sales, revenues, expected revenues and profitability. Furthermore, we cannot assure you that our key component suppliers are, or will
continue to be, in compliance with applicable regulatory requirements, will not encounter any manufacturing difficulties, or will be able to maintain compliance with regulatory requirements. Any such event could have a material adverse effect on our
available inventory and product sales.



Our failure to obtain or maintain
necessary FDA clearances or approvals could hurt our ability to commercially distribute and market our products in the United States.



Our products are medical devices and are therefore subject to extensive regulation in the United States and in foreign countries where we intend to do business. Unless an
exemption applies, each new Class II or III medical device that we wish to market in the United States must first receive either 510(k) clearance or premarket approval from the FDA. Either process can be lengthy and expensive. The FDAs 510(k)
clearance process usually takes from four to twelve months, but may take longer. The premarket application, or PMA, approval process is much more costly, lengthy and uncertain. It generally takes from one to three years or even longer. Delays in
obtaining regulatory clearance or approval will adversely affect our ability to generate revenues and profitability from new products. We cannot assure you that the FDA will ever grant 510(k) clearance or premarket approval for any new product we
propose to market. If the FDA withdraws or refuses to grant approvals, we will be unable to market such products in the United States.

|
|



If we market our products
for uses that the FDA has not approved, we could be subject to FDA enforcement action.



Our Stretta and Secca Systems are cleared by the FDA, the Stretta System for the treatment of GERD and the Secca System for the treatment of bowel incontinence in patients who have failed more conservative therapies
such as diet modification and biofeedback. FDA regulations prohibit us from promoting or advertising either system, or any future cleared or approved devices, for uses not within the scope of our clearances or approvals. These determinations can be
subjective, and the FDA may disagree with our promotional claims. If the FDA requires us to revise our promotional claims or takes enforcement action against us based upon our labeling and promotional materials, our sales could be delayed, our
profitability could be harmed and we could be required to pay significant fines or penalties.



Modifications to our marketed devices may require new 510(k) clearances or PMA approvals or require us to cease marketing or recall the modified devices until such clearances are obtained.



Any modification to an FDA 510(k)-cleared device that could significantly affect its safety
or effectiveness, or that would constitute a major change in its intended use, requires a new FDA 510(k) clearance or, possibly, PMA approval. The FDA requires every manufacturer to make this determination in the first instance, but the FDA can
review any such decision. We have modified aspects of our products, but we believe that new 510(k) clearances are not required. We may modify future products after they have received clearance or approval, and, in appropriate circumstances, we may
determine that new clearance or approval is unnecessary. Though we believe these changes fall within the acceptable scope of changes allowed for Class II devices, we cannot assure you that the FDA would agree with any of our decisions not to seek
new clearance or approval. If the FDA requires us to seek 510(k) clearance or PMA approval for any modification to a previously cleared product, we also may be required to cease marketing or recall the modified device until we obtain such clearance
or approval. Also, in such circumstances, we may be subject to significant regulatory fines or penalties.



We face risks related to our international operations, including the need to obtain necessary foreign regulatory approvals.



To date we have international distribution agreements for Europe, Asia, and South Africa. We have obtained regulatory clearance to market
the Stretta System in the European Union, Australia and Canada and to market the Secca System in the European Union, but we have not obtained any other international regulatory approvals for other markets or products. We cannot assure you that we
will be able to obtain or maintain such approvals. Furthermore, although contracts already signed with European distributors specify payment in U.S. dollars, future international sales may be made in currencies other than the U.S. dollar. As a
result, currency fluctuations may impact the demand for our products in countries where the U.S. dollar has increased compared to the local currency. Engaging in international business involves the following additional risks:



| |  |  | Export restrictions, tariff and trade regulations, and foreign tax laws;
| | - |  | ------------------------------------------------------------------------



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| |  |  | Customs duties, export quotas or other trade restrictions;
| | - |  | ----------------------------------------------------------



| |  |  | Economic or political instability;
| | - |  | ----------------------------------



| |  |  | Shipping delays; and
| | - |  | --------------------



| |  |  | Longer payment cycles.
| | - |  | ----------------------



In addition, contracts may be difficult to enforce and receivables difficult to collect through a foreign countrys legal system, and the protection of intellectual property in foreign countries may be more
difficult to enforce. Any of these factors could cause our international sales to decline, which would impact our expected sales and growth rates.



Product liability suits against us may result in expensive and time-consuming litigation, payment of substantial damages and an increase in our insurance rates.



The development, manufacture and sale of medical products involves a
significant risk of product liability claims. The use of any of our products may expose us to liability claims, which could divert managements attention from our core business, could be expensive to defend, and could result in substantial
damage awards against us. For example, we have been party to product liability lawsuits in which there were allegations that our products were defectively designed and that we were negligent in our manufacturing.



We maintain product liability insurance at coverage levels we believe to be commercially
acceptable, and we re-evaluate annually whether we need to obtain additional product liability insurance. However there can be no assurance that product liability or other claims will not exceed such insurance coverage limits or that such insurance
will continue to be available on the same or substantially similar terms, or at all. Any product liabilities claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing any
coverage in the future.



We have limited protection for our intellectual
property. If our intellectual property does not sufficiently protect our products, third parties will be able to compete against us more directly and more effectively.



We rely on patent, copyright, trade secret and trademark laws to protect our products, including our Stretta Catheter, our Secca Handpiece
and our Curon Control Module, from being duplicated by competitors. However, these laws afford only limited protection. Our patent applications and the notices of allowance we have received may not issue as patents or, if issued, may not issue in a
form that will be advantageous to us. Patents we have obtained and may obtain in the future may be challenged, invalidated or legally circumvented by third parties. We may not be able to prevent the unauthorized disclosure or use of our technical
knowledge or other trade secrets by consultants, vendors, former employees or current employees, despite the existence of nondisclosure and confidentiality agreements and other contractual restrictions. Furthermore, the laws of foreign countries may
not protect our intellectual property rights to the same extent as the laws of the United States. If our intellectual property rights do not adequately protect our commercial products, our competitors could develop new products or enhance existing
products to compete more directly and effectively with us and harm our product sales and market position.



Because, in the United States, patent applications are secret unless and until issued as patents, or corresponding applications are published in other countries, and because publication of discoveries in the
scientific or patent literature often lags behind actual discoveries, we cannot be certain that we were the first to file patent applications for such inventions. Litigation or regulatory proceedings, which could result in substantial cost and
uncertainty, may also be necessary to enforce patent or other intellectual property rights or to determine the scope and validity of other parties proprietary rights. There can be no assurance that we will have the financial resources to
defend our patents from infringement or claims of invalidity.



Because of
our reliance on unique technology to develop and manufacture innovative products, we depend on our ability to operate without infringing or misappropriating the proprietary rights of others.



There is a substantial amount of litigation over patent and other intellectual property
rights in the medical device industry. Because we rely on unique technology to develop and manufacture innovative products, we are especially sensitive to the risk of infringing intellectual property rights. While we attempt to ensure that our
products do not infringe other parties patents and proprietary rights, our competitors may assert that our products and the methods they employ may be covered by patents held by them or invented by them before they were invented by us.
Although we may seek to obtain a license or other agreement under a third partys intellectual property rights to bring an end to certain claims or actions asserted against us, we may not be able to obtain such an agreement on reasonable terms
or at all. If we were not successful in obtaining a license or redesigning our products, our product sales and profitability could suffer, and we could be subject to litigation and potentially substantial damage awards.





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Also, one or more of our products may now be infringing inadvertently on existing patents. As the number of competitors
in our markets grows, the possibility of a patent infringement claim against us increases. Whether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Infringement and other
intellectual property claims, with or without merit, can be expensive and time-consuming to litigate and divert managements attention from our core business. If we lose in this kind of litigation, a court could require us to pay substantial
damages or grant royalties, and prohibit us from using technologies essential to our products. This kind of litigation is expensive to all parties and consumes large amounts of managements time and attention. In addition, because patent
applications can take many years to issue, there may be applications now pending of which we are unaware and which may later result in issued patents that our products may infringe.



If we lose our rights to intellectual property that we have licensed we may be forced to develop new technology and we may not be able to
develop that technology or may experience delays in manufacturing as a result.



Our license with Gyrus Group PLC, a public company incorporated and existing under the laws of England and Wales, allows us to manufacture and sell our products using their radiofrequency generator technology. In addition, the University of
Kansas license allows us to apply radiofrequency energy to tissue. To the extent these license interests become jeopardized through termination or material breach of the license agreements, our operations may be harmed. We may have to develop new
technology or license other technology. We cannot provide any assurance that we will be able to develop such technology or that other technology will be available for license. Even if such technology is available, we may experience delays in our
manufacturing as we transition to a different technology.



If we are unable
to attract and retain qualified personnel, we will be unable to expand our business.



We believe our future success will depend upon our ability to successfully manage our employees, which includes attracting and retaining engineers and other highly skilled personnel. Our employees are at-will
employees and are not subject to employment contracts. The loss of services of one or more key employees could materially adversely affect our growth. In addition, our stock price is depressed and the results of our operations have been less
successful than anticipated. This history of performance may make it difficult to attract and retain qualified personnel. Failure to attract and retain personnel, particularly management and technical personnel, would materially harm our ability to
grow our business rapidly and effectively.



Our directors, executive
officers and principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders.



Our officers, directors and principal stockholders holding more than 5% of our common stock together control over 50% of our outstanding common stock. As a result, these
stockholders, if they act together, will be able to control the management and affairs of our company and all matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions. This
concentration of ownership may have the effect of delaying or preventing a change in control and might adversely affect the market price of our common stock. This concentration of ownership may not be in the best interest of our other stockholders.



Our stockholder rights plan, certificate of incorporation, bylaws and
Delaware law contain provisions that could discourage a takeover.



In
November 2001, we adopted a stockholder rights plan. The purpose of the plan is to assure fair value in the event of a future unsolicited business combination or similar transaction involving Curon. If an individual or entity accumulates 15% of our
stock, or 20% in the case of certain existing stockholders, the rights become exercisable for additional shares of our common stock or, if followed by a merger or other business combination where Curon does not survive, additional shares of the
acquirers common stock. The intent of these rights is to force a potential acquirer to negotiate with the Board to increase the consideration paid for our stock. The existence of this plan, however, may deter a potential acquirer, which could
negatively impact shareholder value.



In addition, our basic corporate
documents and Delaware law contain provisions that might enable our management to resist a takeover. Any of the above provisions might discourage, delay or prevent a change in the control of our company or a change in our management. The existence
of these provisions could adversely affect the voting power of holders of common stock and limit the price that investors might be willing to pay in the future for shares of our common stock.



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Item 3. Quantitative and Qualitative Disclosures of Market Risk



We invest our excess cash primarily in U.S. government securities and marketable debt securities of financial institutions and corporations with strong credit ratings. These instruments have maturities of eighteen
months or less when acquired, with an average maturity date of at least six months. We do not utilize derivative financial instruments, derivative commodity instruments or other market risk sensitive instruments, positions or transactions in any
material fashion. Accordingly, we believe that while the instruments we hold are subject to changes in the financial standing of the issuer of such securities, we are not subject to any material risks arising from changes in interest rates, foreign
currency exchange rates, commodity prices, equity prices or other market changes that affect market risk sensitive instruments.



Item 4. Controls and Procedures



(a) 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.



Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the quarter covered by this Quarterly Report on Form 10-Q. Based on that evaluation, the Chief Executive Officer and
Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures were effective.



(b) Changes in internal control over financial reporting.



There were no changes in our internal control over financial reporting during the quarter ended March 31, 2005, that have materially affected, or are reasonably likely
to materially affect, our internal control over financial reporting.



PART II OTHER INFORMATION



Item 1. Legal Proceedings



In June 2001, a civil
action was filed against us in the United States District Court, Western District of Kentucky, Louisville Division, alleging that the plaintiff sustained injury when undergoing a procedure utilizing the Stretta System, caused by defects in design
and manufacture. This matter was amicably resolved in February 2005 without material financial impact on us.



In April 2003, a civil action was filed against us in United States District Court for the Northern District of California by Federal Insurance Corporation, our insurance carrier, for rescission, reformation, and
restitution in connection with the our liability insurance policy. This policy covers, among other things, product liability claims made against us by people treated with our product. In October 2004, the Plaintiffs summary judgment motion was
granted. We have decided not to appeal the result of the summary judgment and are engaged with settlement discussions with Federal Insurance Corporation. We believe that the resolution of this matter will not have a material effect, if any, on our
business, financial position, and results of operations and cash flows.





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Item 6. Exhibits



(a) Exhibits.



|            |  |                                                                                                                                                  
|----------- |  | -------------------------------------------------------------------------------------------------------------------------------------------------
|Exhibit No. |  | Description                                                                                                                                      
|31.1        |  | Chief Executive Officers Certification Pursuant to 15 U.S.C. Section 7241, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|            | 
|31.2        |  | Chief Financial Officers Certification Pursuant to 15 U.S.C. Section 7241, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|            | 
|32.1        |  | Certificate of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 
|            | 
|32.2        |  | Certificate of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 





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CURON MEDICAL, 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.



|                  |  |                                  |  |                                                                                                                                  
|----------------- |  | -------------------------------- |  | ---------------------------------------------------------------------------------------------------------------------------------
|                  |  | CURON MEDICAL, INC. (Registrant)
|                  |  |                                 
|Date: May 6, 2005 |  | By:                              |  | /s/ LARRY C. HEATON II                                                                                                           
|                  |  |                                  |  | Larry C. Heaton II President and Chief Executive Officer (Principal Executive Officer)                                           
|                  |  |                                 
|                  |  | By:                              |  | /s/ ALISTAIR F. MCLAREN                                                                                                          
|                  |  |                                  |  | Alistair F. McLaren Vice President of Finance Chief Financial Officer and Chief Information Officer (Principal
Financial Officer)





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