RALEIGH, N.C., Aug. 27 /PRNewswire/ -- CLOSURE Medical Corporation
(Nasdaq: CLSR) announced today that it has received U.S. Food and Drug
Administration (FDA) approval for market release of its DERMABOND* Topical
Skin Adhesive.
DERMABOND Topical Skin Adhesive, which is used to replace sutures,
staples, and adhesive strips for closing certain topical incisions and
lacerations, is the first such product to be approved by the FDA for the U.S.
market. CLOSURE Medical filed the pre-market approval application (PMA) with
the FDA in December 1996 whereupon the application was granted "expedited
processing" because of the potential public health benefit of DERMABOND
Topical Skin Adhesive to reduce patient pain and anxiety. An FDA panel
unanimously recommended approval of DERMABOND adhesive on January 30, 1998.
DERMABOND Topical Skin Adhesive will compete in a worldwide market of
approximately 90 million procedures and annual suture and staple sales of
$2.6 billion.
In March 1996, CLOSURE Medical licensed exclusive worldwide marketing and
distribution rights for DERMABOND Topical Skin Adhesive to Ethicon, Inc., a
subsidiary of Johnson & Johnson. "The FDA approval of DERMABOND Topical Skin
Adhesive represents a major milestone for CLOSURE Medical Corporation and our
vision to develop products that will change the face of wound care," said
Robert V. Toni, president and CEO of CLOSURE Medical Corporation. "We also
believe that Ethicon, the leader in suture sales, is well positioned to bring
DERMABOND adhesive to U.S. physicians, surgeons and other health care
providers."
In August 1997, CLOSURE received CE Mark approval allowing the company to
ship DERMABOND Topical Skin Adhesive to Ethicon to support its launch in
European Union countries. DERMABOND adhesive is currently marketed by Ethicon
in over 23 countries outside the U.S.
CLOSURE Medical (http://www.closuremed.com) develops, commercializes and
manufactures medical cohesive products for wound closure 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 cohesives for internal wound closure and management.
Currently marketed products include: DERMABOND, CLOSURE's non-absorbable
adhesive used for certain topical wound closure applications marketed and
distributed exclusively by Ethicon, Inc., a subsidiary of Johnson & Johnson;
Octyldent(R), used in conjunction with antibiotics to treat adult periodontal
disease; and, Nexaband(R), a line of topical cohesives used in veterinary
wound closure and management.
* DERMABOND is a trademark of Ethicon, Inc., a subsidiary of Johnson &
Johnson.
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, scale-up of manufacturing processes;
technological uncertainties; competition from other products; dependence on
marketing partners; and dependence on patents and trade scerets, as well as
those detailed in the Company's Annual Report on Form 10-K for the year ended
December 31, 1997 and filed with the Securities and Exchange Commission.
SOURCE CLOSURE Medical Corporation
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Related links:
http://www.closuremed.com
CONTACT:
Robert V. Toni, President & CEO, or J. Blount
Swain, CFO, both of CLOSURE Medical Corporation, 919-876-7800;
Media Info, Barbara Box of Golin-Harris, 312-729-4143, for
CLOSURE Medical; or General Info, Paul G. Henning, or Analyst
Info, Brian Gill, both of The Financial Relations Board,
212-661-8030
NOTE TO EDITORS: 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.
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