RALEIGH, N.C., Sept. 7 /PRNewswire/ -- CLOSURE Medical Corporation
(Nasdaq: CLSR), a medical tissue cohesive products company, today announced it
has received FDA clearance to market its SOOTHE-N-SEAL(TM) Canker Sore Relief
product.
"SOOTHE-N-SEAL(TM) is the first cyanoacrylate adhesive approved by the FDA
for the over-the-counter consumer market. Based upon primary market research,
we believe that there are about 40 million households within the U.S. alone in
which one or more members have suffered from oral ulcers within the past 6
months," said Mr. Robert V. Toni, President and CEO of CLOSURE Medical
Corporation.
The approval is based in part on the findings of a sponsored 155-patient
multi-center clinical study conducted at Brigham & Women's Hospital,
UNC-Chapel Hill, and the Forsyth Institute. In the multi-center study,
SOOTHE-N-SEAL(TM) Canker Sore Relief was found to provide relief of pain
associated with oral ulcers. In addition, SOOTHE-N-SEAL(TM) provided a
protective barrier that reduced the pain associated with irritation from
eating and drinking.
CLOSURE Medical Corporation is currently in discussions for a marketing
distribution agreement for SOOTHE-N-SEAL(TM) Canker Sore Relief. CLOSURE
believes SOOTHE-N-SEAL(TM) is the first of a number of OTC consumer products
utilizing its proprietary cyanoacrylate technology.
CLOSURE Medical Corporation, headquartered in Raleigh, North Carolina,
develops, manufactures and commercializes 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 tissue cohesives for internal
wound closure and management. Currently marketed nonabsorbable tissue
cohesive products include DERMABOND* Topical Skin Adhesive, which is used to
replace sutures and staples for closure of certain lacerations and incisions,
OCTYLDENT(R) cohesive, which is used as an adjunct in the treatment of adult
periodontal disease; and NEXABAND(R) topical cohesives, a family of products
used in veterinary wound closure and management.
* DERMABOND is a trademark of Ethicon, Inc.; SOOTHE-N-SEAL, OCTYLDENT and
NEXABAND are all trademarks of CLOSURE Medical Corporation.
To receive CLOSURE's latest news release and other corporate documents via
fax, at no cost, call 1-800-PRO-INFO. Use the Company's ticker, CLSR. Or visit
the Financial Relations Board's website at http://www.frbinc.com .
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 progress of its research and development programs for
future nonabsorbable and over-the-counter 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, 1998 filed with the Securities and Exchange
Commission.
SOURCE CLOSURE Medical Corporation
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Related links:
http://www.frbinc.com
CONTACT:
Robert V. Toni, President & CEO or J. Blount
Swain, CFO of CLOSURE Medical Corporation, 919-876-7800, General
Info, Paul G. Henning, Analysts, Nicole Salas, Media, Deanne
Eagle 212-661-8030, all of The Financial Relations Board for
Closure Medical Corporation
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