To: Jerry Olson who wrote (83512 ) 2/17/2000 4:39:00 PM From: JEB Respond to of 120523
URMD news: FDA Clearance Granted for Device to be Used in Colorectal Cancer Surgery - the Third Most Common Cancer NORWOOD, Mass.--(BW HealthWire)--Feb. 17, 2000--UroMed Corporation (NASDAQ SmallCap: URMD) of Norwood, MA announced that the U.S. Food and Drug Administration (FDA) has cleared UroMed's CaverMap(R) Surgical Aid for U.S. marketing and distribution for use in colorectal surgery in men. The CaverMap Surgical Aid is currently used to assist surgeons in performing prostate cancer surgery in identifying and sparing sensitive nerves responsible for erectile function. According to the American Cancer Society, colorectal cancer is the third most common cancer in the U.S. with 129,000 cases diagnosed in 1999, approximately 60% of which were men in. According to our clinical consultants, many of these men may be candidates for colorectal surgery, which is the most common form of treatment. This surgery may involve the removal of all or part of the colon or rectum, depending on the location and progression of the cancer. Unfortunately, impotence is a common complication as sensitive nerve bundles are sometimes damaged. The CaverMap Surgical Aid may help colorectal cancer surgeons identify the location of these nerve bundles, and, in doing so, may aid in the preservation of sexual function for their patients. "I have been using the CaverMap Surgical Aid for the past year and view it as a promising new intraoperative strategy to facilitate nerve preservation for patients undergoing surgical treatment for rectal cancer,"commented Alfred M. Cohen, M.D., Chief of Colorectal Surgery at Memorial Sloan-Kettering Cancer Center in New York, N.Y. "We are excited to be able to offer surgeons and their patients access to this nerve sparing technology" commented Dan Muscatello, President and CEO of UroMed Corporation. "We at UroMed are very concerned about the quality of life issues that face patients and their families after colorectal and radical prostatectomy surgeries and hope that our CaverMap Surgical Aid technology can help ease this burden. Because over 100 hospitals across North America and now Europe have access to the CaverMap technology, many colorectal surgeons may be able to utilize CaverMap in their surgeries in the near future." COMPANY MISSION UroMed is dedicated to establishing itself as a leader in providing interventional urological products, with primary emphasis on the treatment of prostate cancer. The Company seeks to market a portfolio of products including its two main proprietary products for the treatment of prostate cancer: the CaverMap(R) Surgical Aid, available to aid physicians in preserving vital nerves during prostate cancer and colorectal surgery in men, and the Symmetra(TM) I-125 radioactive seeds, used in brachytherapy procedures to treat localized prostate cancer. The Company also markets brachytherapy introducer needles. UroMed, through its approximate one-third ownership of Assurance Medical Inc., has supported the development of 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 its strategic platform. RISK FACTORS AND FORWARD-LOOKING STATEMENTS The Company recognizes that the previous paragraphs contain forward-looking statements relating to the Company's future activities, including development and commercialization of the company's CaverMap(R) Surgical Aid and Symmetra(TM) I-125 radioactive seeds, and future growth. These forward-looking statements are based largely on the Company's expectations and are subject to a number of risks and uncertainties beyond the Company's control. Actual results could differ materially from these forward-looking statements as the result of certain risks, including the risk that physicians will not use its products in significant numbers, the risk that physicians using its products will not develop into long-term users, the Company's ability to successfully reduce costs, the uncertainty of securing additional alliances, the uncertainty of manufacturing scale-up and general market acceptance of the Company's Symmetra I-125 radioactive seeds, and the CaverMap(R) Surgical Aid , as well as the Company's dependence on these products going forward, and the risk that the Company will not be able to successfully develop any new products. There can be no assurance that these risks would not have a material adverse effect on the Company. Other relevant risks are described in the Company's Annual Report on Form 10-K for the year ended December 31, 1998, under the headings "Forward-Looking Statements and Associated Risks" and "Risk Factors," which are incorporated herein by reference. CaverMap(R) Surgical Aid is a registered trademark of UroMed Corporation and Symmetra (TM) I-125 Seeds is a trademark of UroMed Corporation.