RALEIGH, N.C., Dec. 18 /PRNewswire/ -- CLOSURE Medical Corporation
(Nasdaq: CLSR), 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
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CONTACT: Robert V. Toni, President & CEO, or J. Blount Swain, CFO, both of CLOSURE Medical Corporation, 919-876-7800; or General Info: Paul G. Henning, Analysts: Brian Gill, or Media: Deanne Eagle, all of The Financial Relations Board, 212-661-8030, for CLOSURE Medical
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