CLOSURE Medical's DERMABOND Shown to be a Barrier to Common Microbial
Organisms that Cause Infection
RALEIGH, N.C., Jan. 16 /PRNewswire-FirstCall/ -- CLOSURE Medical
Corporation (the "Company") (Nasdaq: CLSR), a medical tissue adhesive products
company, today announced it has received FDA approval to include in its device
labeling that DERMABOND adhesive acts as a barrier to microbial penetration.
Clinically, this provides for the potential reduction of infection rates, as
long as the adhesive remains intact, when closing incisions and lacerations
with DERMABOND adhesive versus the traditional use of sutures and staples
which have not been shown to protect against microbial penetration.
Originally approved in 1998 for use in hospitals as an alternative to sutures
and staples, DERMABOND adhesive is currently distributed in 37 countries and
regions by ETHICON, Inc., a division of Johnson & Johnson, the leading
worldwide distributor of suture products and suture technology.
"The expansion of the product labeling to include such a benefit as the
microbial barrier substantiates DERMABOND adhesive's versatility as being not
only a wound closure device but also a sealant which protects incisions and
lacerations from infection. Additionally, results from other product studies
have also shown that our cyanoacrylate technology provides superior barrier
attributes to bacteria that cause infections versus traditional wound care
technologies," said Robert V. Toni, President and CEO.
The data collected and submitted to the FDA in support of this claim
include in vitro microbial penetration studies using five common bacteria that
cause infection, including E. coli and certain staph and pseudomonas bacteria.
During the studies, DERMABOND adhesive was 99 percent effective at preventing
the penetration of the microbial organisms.
Mr. Toni added, "Preventing infection will not only provide greater
benefits to patients but can also represent significant cost savings to
healthcare providers by alleviating treatment cost and subsequent
complications."
About CLOSURE Medical
CLOSURE Medical Corporation, headquartered in Raleigh, North Carolina,
develops, manufactures, and commercializes medical tissue adhesive products
based on its proprietary cyanoacrylate technology. CLOSURE's proprietary
technology has customized the physical and chemical properties of
cyanoacrylates to develop medical adhesive formulations to close and seal
topical skin wounds and incisions. In addition, CLOSURE is currently
developing internal adhesive formulations to close or seal internal wounds and
an adhesive formulation for the possible treatment of emphysema.
DERMABOND Topical Skin Adhesive is a topical tissue adhesive used to close
wounds from skin lacerations and incisions, minimally invasive surgery and
plastic surgery. DERMABOND adhesive can be used as a replacement for topical
sutures or staples and is marketed and distributed by ETHICON, Inc., a Johnson
& Johnson company and the world leader in wound closure products.
LIQUIDERM(TM) adhesive is the first and only cyanoacrylate medical device
approved by the FDA for the over-the-counter ("OTC") adhesive bandage market.
LIQUIDERM(TM) adhesive is painted on the wound, sealing it from dirt and germs
and creating a healing environment which allows natural healing to take place
quickly. As the wound heals, the adhesive sloughs off naturally. CLOSURE has
signed a worldwide supply, distribution and development rights agreement with
Johnson & Johnson Consumer Products Company which includes rights to its
LIQUIDERM(TM) adhesive and its overall OTC wound care platform, including
distribution rights to all present and future OTC products, except for SOOTHE-
N-SEAL(R) adhesive. Distribution of LIQUIDERM(TM) adhesive by Johnson &
Johnson Consumer Products Company is expected to begin in early 2002.
SOOTHE-N-SEAL(R) adhesive is indicated for the treatment of oral ulcers
and mouth sores. It forms a protective barrier that shields oral ulcers from
irritation due to eating and drinking while providing immediate and long-term
pain relief. SOOTHE-N-SEAL(R) adhesive is distributed to the professional and
consumer markets by Colgate Oral Pharmaceuticals, Inc.
The NEXABAND(R) liquid adhesive line consists of two products used in
veterinary wound closure and wound care. The adhesives are used in cat declaw
procedures as well as spay and neuter procedures. In July 2001, the Company
entered into an agreement providing Abbott Laboratories with worldwide supply,
distribution and development rights to the NEXABAND(R) product line. In
accordance with the agreement, Abbott has been granted immediate worldwide
distribution rights of NEXABAND(R) adhesives excluding the United States and
Canada. Upon the expiration of the Company's prior distribution arrangement
in the second quarter of 2002, Abbott can begin the distribution of
NEXABAND(R) products in the United States and Canada.
In November 2001, the Company entered into an agreement providing Johnson
& Johnson Wound Management, a division of ETHICON, Inc., a Johnson & Johnson
company, with worldwide supply, distribution and development rights to the
Company's professional wound management platform, including the novel Liquid
Occlusive Dressing ("LOD"). The agreement is in the form of an amendment to
the terms of its existing licensing and development agreement with ETHICON,
Inc.
For additional information related to DERMABOND adhesive visit
http://www.dermabond.com .
DERMABOND adhesive is a registered trademark of ETHICON, Inc.; SOOTHE-N-
SEAL(R) is a registered trademark of Colgate Oral Pharmaceuticals, Inc.;
LIQUIDERM(TM) is a trademark of CLOSURE Medical Corporation; and NEXABAND(R)
is a registered trademark of CLOSURE Medical Corporation.
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 products; the need for regulatory approval and effects of governmental
regulation; technological uncertainties; the satisfactory conclusion of
negotiations with, and 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, 2000 filed with the
Securities and Exchange Commission.
SOURCE CLOSURE Medical Corporation
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Related links:
http://www.dermabond.com
CONTACT:
Robert V. Toni, President & CEO, Benny Ward,
CFO, both of CLOSURE Medical Corporation, +1-919-876-7800, or
General, Alison Ziegler, Analysts, Julie Tu, Media, Judith
Sylk-Siegel, of FRB Weber Shandwick, +1-212-445-8400
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