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Biotech / Medical : URMD -- Huge market potential -- Ignore unavailable to you. Want to Upgrade?

To: E'Lane who wrote (274)	5/20/1998 5:01:00 PM
From: Milk	Read Replies (1) \| Respond to of 369

E'Lane, Here is something positive for a change: Wednesday May 20, 11:11 am Eastern Time Company Press Release UroMed Announces Recommendation For Extension Of Its CE Certification To Include Its CaverMap Surgical Aid Important step in making technology available to European Community NEEDHAM, Mass.--(BW HealthWire)--May 20, 1998-- UroMed Corporation (NASDAQ:URMD - news) announced today that it has made progress toward obtaining the CE Mark for the CaverMap(tm) Surgical Aid. Its Notified Body, SGS Yarsley International Certifications Services Ltd., United Kingdom, has reviewed UroMed's Technical File and has recommended extension for the scope of UroMed's CE Certification to include the CaverMap Surgical Aid product line. The CaverMap Surgical Aid is the first technology cleared for marketing by the U.S. Food and Drug Administration (FDA) to assist surgeons during prostate cancer surgery in locating and helping to spare the cavernosal nerves which are responsible for potency. The most frequent complication of this life-saving surgery is impotence, often caused by intraoperative damage to the cavernosal nerves. Protecting these nerves and preserving potency with the help of the CaverMap(tm) Surgical Aid may offer significant quality of life benefits to the patient. When achieved, the CE Mark on the CaverMap Surgical Aid will signify that the product meets the mandatory health and safety requirements to be marketed in the 15-member European Union (EU). Industry sources estimate that the rate of prostate cancer cases in the EU is comparable to the U.S. market. It is estimated by industry sources that well over 200,000 new cases of prostate cancer will be diagnosed in the U.S. this year with a large number of these cases expected to be treated by prostate cancer surgery. The CaverMap Surgical Aid system is a breakthrough technology that uses state-of-the-art electronics to intra-operatively stimulate and sense the function of the cavernosal nerves responsible for erectile function. This proprietary system integrates leading edge nerve stimulation methods, ultra-sensitive technology and ergonomic design tailored for use deep in the pelvic cavity. ''The recommendation to extend the CE Mark to include the CaverMap Surgical Aid complements the FDA clearance that UroMed received in November 1997,'' commented John G. Simon, UroMed's chairman of the board and chief executive officer. ''We are pleased to lay the foundation for eventually expanding our marketing efforts to include the European community. Later this year, we plan to examine distribution partnership(s) as the most cost-effective way to potentially achieve European market entry for this business opportunity.'' UroMed, founded in October 1990, is dedicated to establishing itself as a leader in the development of male and female healthcare products. UroMed has developed or acquired technology in three core areas: prostate cancer, urinary incontinence, and breast cancer. UroMed's direct hospital-based business lines include its CaverMap(tm) Surgical Aid, intended to aid physicians in preserving vital nerves during prostate cancer surgery, Iodine125 prostate cancer brachytherapy seeds and its BEACON Technology System(tm), a minimally invasive incontinence surgical line. UroMed's office-based continuum of continence care product lines include the Reliance(R) Insert, the INTROL(R) Bladder Neck Support Prosthesis, and the Impress(tm) Softpatch. In breast cancer screening, UroMed is developing its investigational BreastExam(tm), BreastCheck(tm) and Breast View(tm) electronic palpation technology in order to aid physicians and patients in the important mission of finding suspicious breast lumps earlier. UroMed also continues to dedicate resources to the development and/or acquisition of product lines that fit into UroMed's strategic platform. INTROL(R) Bladder Neck Support Prosthesis and Reliance(R) Urinary Control Insert are registered trademarks of UroMed Corporation. Impress(tm) Softpatch, PelvicFlex(tm) Personal Trainer Video , BEACON Technology System(tm), BreastCheck(tm) BreastExam(tm) BreastView(tm) and CaverMap(tm) Surgical Aid are trademarks of UroMed Corporation. -------------------------------------------------------------------------------- Contact: UroMed Corporation Corporate Investor Contact: Kristen Galfetti, (781) 433-0033 Ext. 329 OR Corporate Media Contact: Larry Cronin, (781) 433-0033 Ext. 252 --------------------------------------------------------------------------------