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biz.yahoo.com
Tuesday May 18, 1:56 pm Eastern Time
Company Press Release
UroMed Corporation Announces FDA Market Clearance for Symmetra I-125 Radioactive Seed
Symmetra(tm) I-125 Seed Joins CaverMap(tm) Surgical Aid In UroMed's Unique Prostate Cancer Product Family
NORWOOD, Mass.--(BW HealthWire)--May 18, 1999-- UroMed Corporation (NASDAQ SmallCap:URMD - news) announced today that the U.S. Food and Drug Administration (FDA) has cleared for U.S. marketing and distribution UroMed's Symmetra(tm) I-125 brachytherapy seed. The Symmetra seed is designed to be used in prostate cancer radiation seed implant procedures.
''We are pleased that this milestone has been achieved as expected,'' commented John G. Simon, chairman of the board and chief executive officer of UroMed Corporation. ''Together with a talented team of physicists and engineers, we have utilized our knowledge of prostate cancer therapy to design a seed which we believe will have optimal treatment properties. With respect to dosimetry, fluoroscopic and CT imaging, integrity, and quality, we are hopeful that Symmetra I-125 seeds will meet market needs in a valuable way.''
''If everything continues according to plan, we look forward to commencing targeted commercial release shipments of the Symmetra seeds within the next 60 days, and we hope to expand our seed business to significant levels in the second half of the year,'' Simon continued. ''Our goal with our Symmetra seeds in prostate cancer brachytherapy, similar to our goal with the CaverMap(tm) Surgical Aid in prostate cancer surgery, is to help leading physicians optimize their prostate cancer therapy. We are pleased to be able to offer an expanded product line to the medical community.''
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 Surgical Aid, available to aid physicians in preserving vital nerves during prostate cancer surgery, and the Symmetra I-125 radioactive seed used in brachytherapy procedures to treat localized prostate cancer. The Company also markets brachytherapy introducer needles and minimally invasive incontinence products. The Company has also developed technology and assets in incontinence care products, an area where the Company hopes to leverage its assets and technology via corporate partnerships and/or strategic alliances. 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 Symmetra brachytherapy technology and CaverMap Surgical Aid, 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 uncertainty of manufacturing scale-up, required approvals, and general market acceptance of the Company's Symmetra brachytherapy technology and the CaverMap Surgical Aid, as well as the Company's dependence on these products going forward; 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; 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(tm) Surgical Aid and Symmetra(tm) I-125 Seed are registered trademarks of the UroMed Corporation.
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Contact:
UroMed Corporation
Lisa French
781-762-2080 |
