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Biotech / Medical : Closure Medical (CLSR) fomerly Tri-Point Medical (TPMC) -- Ignore unavailable to you. Want to Upgrade?

To: Paul W who wrote (64)	12/18/1997 1:11:00 PM
From: Phil Bennett	Read Replies (1) \| Respond to of 184

Just on on the wire.... Looking good!! Company Press Release SOURCE: CLOSURE Medical Corporation CLOSURE Medical Advised of DERMABOND(TM) Review By FDA Advisory Panel on January 30, 1998 RALEIGH, N.C., Dec. 18 /PRNewswire/ -- CLOSURE Medical Corporation (Nasdaq: CLSR - news), a medical tissue cohesive products company, announced that the U.S. Food and Drug Administration (FDA), advised the Company that the General and Plastic Surgery Devices Panel will meet on January 30, 1998 to review the Company's PreMarket Approval (PMA) Application for DERMABOND(TM), its topical tissue adhesive for wound closure. Physicians in ten clinical centers in the U.S. conducted an extensive clinical study that included 818 patients and a variety of wound types, to evaluate the performance of DERMABOND as a wound closure device. The PMA application was submitted to the FDA in December 1996 and provides clinical data which document the use of DERMABOND as a wound closure device replacing the use of topical sutures in many incisions and lacerations. The Company must finalize product labeling, complete DERMABOND manufacturing scale-up and exhibit to the FDA that the Company is GMP compliant and has adequate control of the manufacturing process and complete validation of those processes prior to final approval by the FDA. In March 1996, the Company entered into an agreement with Ethicon, Inc., a subsidiary of Johnson & Johnson, for exclusive worldwide marketing and distribution of DERMABOND. CLOSURE Medical, headquartered in Raleigh, North Carolina, develops, commercializes, and manufactures medical tissue cohesive products based on its proprietary cyanoacrylate technology. CLOSURE's nonabsorbable tissue cohesive products may be used to replace sutures and staples for certain topical wound closure applications, while its absorbable tissue cohesive products can potentially be used as surgical sealants and tissue cohesives for internal wound closure and management. Currently marketed tissue cohesive products include Octyldent(R), used as an adjunct in the treatment of adult periodontal disease, Nexaband(R), a line of topical tissue cohesives used in veterinary wound closure and management and Dermabond(TM), a nonabsorbable cohesive used in Europe for certain topical wound closure applications. To receive CLOSURE's latest news release and other corporate documents via FAX -- at no cost -- dial 1-800-PRO-INFO. Use Company's ticker-CLSR. The discussion contained in this press release relating to approval and commercialization of the Company's products, market opportunities and therapeutic benefits involves risks and uncertainties. No assurance can be given that the Company will successfully obtain Food and Drug Administration or other regulatory approvals for DERMABOND (or that any such approvals will be obtained on a timely basis), scale up manufacturing process, launch its products within indicated timeframes, or successfully commercialize any such products. These and other risks are detailed in the Company's publicly available filings at the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 1996. Actual results may differ materially from those currently anticipated as a result of such risks. SOURCE: CLOSURE Medical Corporation More Quotes and News: Closure Medical Corp (Nasdaq:CLSR - news) Related News Categories: medical/pharmaceutical