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| |  FDA Approves Clinical Trials for Female Continence Device STEWARTVILLE, Minn., Aug. 28, 1996 -- Rochester Medical Corporation (Nasdaq: ROCM) today announced receipt of FDA approval to begin clinical studies of the FemSoft* urethral insert for the management of female stress incontinence. The FemSoft device is a soft, fluid-filled, conformable insert that assists the weakened muscles of the urethra and bladder neck to maintain urethral closure by conforming to the natural contours of the urethra and bladder neck. It is simply inserted, worn and removed for voiding. It requires no inflation, deflation, syringes, or valving mechanisms. Although intended principally for the management of female stress incontinence, the FemSoft device may also be suitable for the management of some conditions of urge incontinence. The clinical studies will be conducted over the coming months at nationally recognized medical institutions. The results of the studies will be submitted to the FDA as part of a Premarket Approval Application (PMA) for approval to market the FemSoft device. "We have reached an important milestone," said Anthony J. Conway, company president. "We are optimistic that these studies will provide the clinical data necessary to demonstrate the safety and effectiveness of the FemSoft device in extended use by a significant patient population. We believe that the unique fluid filled design provides significant and important benefits over competitive devices. These benefits should enhance ease of use, comfort, and patient acceptance while reducing side effects and complications. Our FemSoft device has a soft, fluid filled sleeve, and is designed to conform to the natural shape of the urethra and to gently reciprocate the tiny movements of the urethra during periods of exercise such as walking or running. These clinical studies will demonstrate whether the FemSoft device performs in use as we expect it will." The immediately preceding statement contains forward looking statements that involve risks and uncertainties, including the timing and results of clinical studies yet to be conducted, FDA review and response times, as well as other risk factors listed from time to time in the Company's SEC reports, including, without limitation, the section entitled "Risk Factors" in the Company's Annual Report on Form 10-KSB (Part II, Item 6) for the year ended September 30, 1996, and in the Company's Prospectus dated July 25, 1996. Rochester Medical Corporation develops, manufactures and markets latex free disposable medical catheters and devices for urological and continence care applications. The Company markets its products under its own Rochester Medical* brand and under existing private label arrangements, including its strategic marketing alliance with ConvaTec, a division of the Bristol-Myers Squibb Company. * Rochester Medical and FemSoft are trademarks of Rochester Medical Corporation
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