Curon Medical Announces Presentation of Positive Results of Two Clinical Trials Evaluating the Secca(TM) System for Treatment of Fecal Incontinence

- Results of Two Separate Studies of the Secca System Highlighted In Podium Presentations at the American Society of Colon & Rectal Surgeons Annual Meeting in Chicago, Illinois -

SUNNYVALE, Calif., June 11 /PRNewswire-FirstCall/ -- Curon Medical, Inc. (NASDAQ: CURN) today announced the presentation of positive results from two separate studies evaluating its Secca(TM) System for the treatment of fecal incontinence in patients who have failed more conservative therapy such as diet modification and biofeedback. Dr. Jonathan Efron of Cleveland Clinic Florida presented results of a 50 patient, open label trial conducted at five centers in the United States, which demonstrated effectiveness in a broad group of patients with fecal incontinence. In the same session, Dr. Takeshi Takahashi of Mexico City presented long-term results of a ten patient, single center pilot study, which demonstrated two-year durability of the Secca procedure.

Fecal incontinence affects up to 16 million, or one out of 13, U.S. adults and is associated with significant social disability, stigmatization and impaired quality of life. Patients may develop fecal incontinence as a result of childbirth injury, injury from hemorrhoid or other surgery, or simply because of the effects of aging on muscle tone. To date, there have been few treatment options for the condition.

The Secca System comprises a radiofrequency generator and disposable energy delivery device. It is used in a minimally invasive, outpatient procedure by delivering radiofrequency energy to the muscles of the anal canal in order to decrease the symptoms of fecal incontinence.

U.S. Study Results Demonstrate Effectiveness of Secca Procedure

Results of the study were presented on Friday, June 7, in the scientific sessions of the American Society of Colon & Rectal Surgeons annual meeting held in Chicago, Illinois. Dr. Efron presented results of a 50 patient, five center study conducted at Cleveland Clinic Florida, Ft. Lauderdale; Washington University, St. Louis; University of Southern California, Los Angeles; Graduate Hospital, Philadelphia and University of Michigan, Ann Arbor. The primary objective of the study was to determine whether the Secca procedure had a significant effect in reducing fecal incontinence symptoms versus baseline.

Secondary objectives were determination of the effects of the Secca procedure on quality of life endpoints versus baseline. Dr. Efron presented results showing that patients had statistically significant improvements in fecal incontinence symptoms as well as quality of life endpoints. Sixty percent of patients reported a clinical response to treatment with the Secca System, with a median 70 percent improvement in fecal incontinence symptoms. This outcome is significant because a large number of incontinence patients fail conservative therapies and are not candidates for surgery, thus Secca represents one of the only options for these patients. In addition, surgical options involve several days of inpatient stay and several months for recovery of normal function, so for patients who are surgical candidates but do not desire surgery, Secca represents a less invasive, interim option.

"The data we presented from this study demonstrates the efficacy of a new option for the treatment of patients with fecal incontinence," stated Dr. Efron. "Due to its minimally-invasive nature, the Secca procedure may be a very attractive option for patients that currently are not being treated or are uncomfortable with or unfit to undergo a surgical procedure."

Pilot Study Results Demonstrate Durability of Secca Procedure at Two Years

Also in the same session, Dr. Takeshi Takahashi of Instituto Nacional de Ciencias Medicas Salvador Zubiran in Mexico City presented two-year results of the ten patient pilot study conducted at his center. At two years, patients showed statistically significant improvements in both fecal incontinence severity and in quality of life outcomes versus baseline. In addition, patients reported a significant reduction in pad use. There was not a difference between outcomes after one year and after two years, demonstrating that the effect of the Secca procedure persists out to two years after treatment.

"This is the longest follow-up data we have seen to date on the Secca procedure," stated Dr. Takahashi. "We are encouraged that the improvement persisted to the two-year follow-up. This data increases the attractiveness of the Secca procedure as an alternative for patients with fecal incontinence."

The Secca System was commercially launched last week during the American Society of Colon & Rectal Surgeons annual meeting in Chicago, Illinois. John W. Morgan, Curon Medical's President and Chief Executive Officer, commented, "We are extremely pleased that this data was presented at the premier meeting of colon and rectal surgeons. We believe that the strength of the open trial data and the availability of two-year durability data will be influential in driving adoption of the Secca technology, particularly as the minimally-invasive nature of the Secca System makes it an attractive alternative to other treatments for incontinence."

About the Secca System

The Secca System provides physicians with devices to perform a minimally invasive, outpatient and cost-effective procedure for the treatment of fecal incontinence in patients who have failed more conservative therapies such as diet modification and biofeedback. The Secca System utilizes the same technology and treatment concepts as Curon Medical's Stretta(R) System for treatment of gastroesophageal reflux disease. Using the Curon Control Module and the Company's Secca disposable handpiece, physicians deliver radiofrequency energy into the muscle of the anal sphincter to improve its barrier function.

About Curon Medical, Inc.

Curon Medical, Inc. develops, manufactures and markets innovative proprietary products for the treatment of gastrointestinal disorders. The Company's products and products under development consist of radiofrequency generators and single use disposable devices. Its first product, the Stretta System, received U.S. Food and Drug Administration clearance in April 2000 for the treatment of gastroesophageal reflux disease, commonly referred to as GERD. Its second product, the Secca(TM) System, received U.S. Food and Drug Administration clearance in March 2002 for the treatment of fecal incontinence. For more information, please visit the Company's website at http://www.curonmedical.com/.

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning future adoption of the Stretta system within the medical community are forward-looking statements within the meaning of the Safe Harbor. These statements are based on management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from the forward-looking statements contained herein. Curon's expectations are preliminary and involve risks and uncertainties, as a result of which actual results may differ materially. Further information on potential risk factors that could affect Curon, its business and its financial results are detailed in the Company's periodic filings with the Securities and Exchange Commission, including, but not limited to, those risks and uncertainties listed in the section entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations - Factors Affecting Future Results," in Curon's Quarterly report of Form 10-Q for the fiscal quarter ended March 31, 2002. Curon undertakes no obligation to release publicly any revisions to any forward-looking statements contained herein to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.


Source: Curon Medical, Inc.
CONTACT: John W. Morgan, President and Chief Executive Officer,
+1-408-733-9910, jmorgan@curonmedical.com, or Alistair F. McLaren, Vice
President, Chief Financial Officer, +1-408-733-9910,
amclaren@curonmedical.com, both of Curon Medical; Investors - Melody A. Carey
of Rx Communications Group, LLC, +1-917-322-2571, mcarey@rxir.com, for Curon
Medical

Web site: http://www.curonmedical.com/