Chemfab Announces Plans to Explore the Commercialization of Urology Devices.Business/Technology Editors MERRIMACK, N.H.--(BUSINESS WIRE)--March 27, 2000 Chemfab Corporation (NYSE NYSE See: New York Stock Exchange :CFA (Computer Fraud and Abuse Act of 1986) Signed into law in 1986, the CFA was a significant step forward in criminalizing unauthorized access to computer systems and networks. The Act applies to "federal interest computers" that include any system used by the U.S. and www.chemfab.com) today announced that it will explore the commercialization of two unique urological products in Europe and will seek a partner in the U.S. for the potential commercialization of these products domestically. The two products use the On-Command(R) catheter catheter /cath·e·ter/ (kath´e-ter) 1. a tubular, flexible surgical instrument that is inserted into a cavity of the body to withdraw or introduce fluid. 2. urethral c. technology which was acquired by Chemfab as part of the UroQuest acquisition in December of 1999. The products are disposable intraurethral (inside the urethra urethra (y rē`thrə), canal in most mammals that carries urine from the bladder to the outside of the body; in the male it also serves as a genital duct. ) catheters incorporating a
proprietary anchoring system and a proprietary patient controlled,
magnetically activated valve used to control urine flow. The catheters
are intended to be left in place for up to 29 days.
The Company estimates that the European market for the urinary control devices is in excess of $1 billion and that the domestic U.S. market is slightly larger than the European market. The On-Command(R) catheter products are designed to enable persons with either urinary incontinence Urinary Incontinence Definition Urinary incontinence is unintentional loss of urine that is sufficient enough in frequency and amount to cause physical and/or emotional distress in the person experiencing it. or urinary retention Urinary retention The result of progressive obstruction of the urethra by an enlarging prostate, causing urine to remain in the bladder even after urination. problems to manage their condition without restricted mobility, medical complications, discomfort and embarrassment generally associated with many of the existing management alternatives. It is estimated that nearly 2 million people in the U.S. suffer from some form of chronic urinary incontinence or retention. John W. Verbicky, the Company's President and Chief Executive Officer said, "We have completed our initial internal reviews of the On-Command(R) technology. Based upon the market opportunity and the potential benefits and features that the On-Command(R) devices offer those suffering from chronic urinary conditions, we believe it makes sense to seriously explore the commercialization of these products. We will be seeking partners in the urological and medical device markets who may be interested in jointly pursuing FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval of the product and can provide access to effective domestic distribution channels." Verbicky added, "The On-Command(R) catheter product has already received the European CE mark which allows the commercialization process to begin in Europe." The Company expects to reach a decision in this area by December of 2000. Chemfab expects the cost impact of this activity over the next 12 months to be minimal. NOTE: This press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, as amended. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from those projected or suggested due to certain risks and uncertainties, including any difficulties that may be encountered in the evaluation, requisite to regulatory approval and commercialization of a new medical product. Additional information concerning certain other risks and uncertainties relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the Company's base business and that of its customers worldwide that could cause actual results to differ materially from those projected or suggested, is contained in the Company's filings with the Securities and Exchange Commission (SEC) over the last 12 months, copies of which are available from the SEC or the Company upon request. The forward-looking statements contained herein represent the Company's judgment as of the date of this release, and the Company cautions readers not to place undue reliance on such statements. |
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