To: Joe Copia who wrote (18202 ) 7/22/1999 12:44:00 PM From: Investor Clouseau Read Replies (1) | Respond to of 25711
good news for blake? (PR NEWSWIRE) New Female Incontinence Device Gains European Clearance with New Female Incontinence Device Gains European Clearance with CE Mark STEWARTVILLE, Minn., July 22 /PRNewswire/ -- Rochester Medical Corporation (Nasdaq: ROCM) received notice this week that its FEMSOFT(R) Insert has received regulatory clearance for marketing in Europe. The FemSoft Insert is used to manage female stress urinary incontinence, which is estimated to affect approximately 6.6 million U.S. women and a similar number in Europe. It is a small, soft device that a women inserts into her urethra. The latex-free device consists of a soft, thin, fluid filled silicone sleeve. As a woman inserts the device, the soft liquid sleeve easily slides into and conforms to her urethra forming an effective seal at the neck of the bladder to prevent unintended urine leakage. It is removed during regular bathroom visits where it is discarded and then replaced by a fresh insert. Other options for management of female stress incontinence include absorbent pads, surgery, and pelvic muscle strengthening techniques. The Company's recently presented clinical study results show that its FemSoft Insert is an effective and highly acceptable treatment option for women with stress incontinence. Rochester Medical Corporation President Anthony J. Conway said, "This is excellent news. The CE Mark is issued by TUV Product Service after full review of all Quality and Manufacturing Operations as well as Design History Files (product validations, stability studies, risk analysis, biocompatibility testing) and Clinical Study results. The mark gives us regulatory clearance for marketing the FemSoft Insert in Europe and confirms compliance with the ISO 9001/EN 46001 Quality System and the European Medical Device Directive." The FemSoft Insert device is not currently available for sale. The U.S. Food and Drug Administration (FDA) is currently reviewing the company's pre-market approval (PMA) application. "We anticipate receiving FDA clearance in time to begin a phased market launch of the product before calendar year end," said Conway. "Sales in Europe will follow market introduction in the U.S., but receipt of the CE Mark at this time will allow selected European clinicians to start gaining experience with the device in local populations while we continue discussions with potential European distribution partners." The immediately preceding document contains forward-looking statements that involve risks and uncertainties. The FemSoft Insert has not been authorized by the FDA for commercial sale, and the commercial success of the FemSoft Insert is subject to the uncertainty of market acceptance of the device. Other risks and uncertainties include the timing and results of FDA review, the results of product evaluations, the timing of purchases by customers, manufacturing capacity for both current and future products, the results of clinical tests, the timing of clinical preference testing and product instructions, 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 10K (Part II, Item 6) for the fiscal year ended September 30, 1998. SOURCE Rochester Medical Corporation -0- 07/22/99 /CONTACT: Brian J. Wierzbinski, Chief Financial Officer, 507-533-9604, or Anthony J. Conway, Chief Executive Officer, 507-533-9600, both of Rochester Medical Corporation; or General Inquiries, Craig Dickson, Analyst Inquiries, Leslie Loyet, or Media Inquiries, Joyce Hanson, of The Financial Relations Board, 312-266-7800/ (ROCM) CO: Rochester Medical Corporation ST: Minnesota IN: MTC HEA SU: PDT