RALEIGH, N.C., Oct. 7 /PRNewswire/ -- CLOSURE Medical Corporation
(Nasdaq: CLSR), a medical tissue cohesive products company, today announced
that the Food and Drug Administration has issued a warning letter to CLOSURE
Medical Corporation regarding two products, Octyldent(R) and Nexacryl(TM).
The letter is not related to Dermabond(R), which is currently under review at
the FDA.
CLOSURE Medical officials said the warning letter received on September
15th was a follow-up to a previous inspection. CLOSURE submitted its response
to the FDA on September 30, 1997. A re-inspection will be scheduled as soon
as possible.
CLOSURE believes that the issues noted by the FDA can be resolved soon.
It should be noted that the FDA raised no concerns about safety or efficacy of
the products and sought no delay in the shipping of any products.
The Company is now implementing the corrective actions. Revisions have
been made to customer complaint handling, investigation and reporting
procedures. An aggressive vendor audit program is being conducted at this
time and will be completed by the end of October 1997. The validations noted
by the FDA have been or will be completed shortly. The majority of these
changes involve the creation and maintenance of more detailed record keeping
by the Company.
Octyldent(R) is an adhesive used in combination with a drug delivery fiber
to hold the fiber in place to treat periodontal disease and has been on the
market since July 1994. Nexacryl(TM) is awaiting final FDA approval for use
in the treatment of corneal lacerations and perforations.
CLOSURE Medical develops, commercializes and manufactures medical cohesive
products based on its proprietary cyanoacrylate technology. CLOSURE's
nonabsorbable products may be used to replace sutures and staples for certain
topical wound closure applications, while its absorbable products can
potentially be used as surgical sealants and adhesives for internal wound
closure and management. Currently marketed products include Octyldent(R),
used in conjunction with antibiotics to treat adult periodontal disease, and
Nexaband(R), a line of topical adhesives used in veterinary wound closure and
management.
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.
This release contains certain forward-looking statements which involve
known and unknown risks, delays, uncertainties or other factors not under the
Company's control which may cause actual results, performance or achievements
of the Company to be materially different from the results, performance, or
other expectations implied by these forward-looking statements. These
factors include, but are not limited to the early stage of commercialization
of the Company products; the need for regulatory approval and effects of
governmental regulation; technological uncertainties; dependence on marketing
partners; and dependence on patents and trade secrets, as well as those
detailed in the Company's Annual Report on Form 10-K for the year ended
December 31, 1996 filed with the Securities and Exchange Commission.
SOURCE CLOSURE Medical Corporation
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CONTACT: Robert V. Toni, President & CEO, or J. Blount Swain, CFO, of CLOSURE Medical Corporation, 919-876-7800; or General Info: Paul G. Henning, Analyst Info: Brian Gill, or Media Info: Deanne Eagle, all of The Financial Relations Board, 212-661-8030
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