|Contacts at CLOSURE Medical||At FRB | Weber Shandwick|
|Robert V. Toni, President & CEO||For General Info: Alison Ziegler|
|Benny Ward, CFO||For Analyst Info: Julie Tu|
|(919) 876-7800||For Media Info: Judith Sylk-Siegel|
FOR IMMEDIATE RELEASE: January 16, 2002
DERMABOND ADHESIVE RECEIVES FDA APPROVAL
FOR ENHANCED DEVICE LABELING
CLOSURE MEDICAL'S DERMABOND Shown to be a Barrier to Common Microbial Organisms that Cause Infection
Raleigh, N.C., January 16, 2002 - 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™ adhesive is the first and only cyanoacrylate medical device approved by the FDA for the over-the-counter ("OTC") adhesive bandage market. LIQUIDERM™ 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™ adhesive and its overall OTC wound care platform, including distribution rights to all present and future OTC products, except for SOOTHE-N-SEAL® adhesive. Distribution of LIQUIDERM™ adhesive by Johnson & Johnson Consumer Products Company is expected to begin in early 2002.
SOOTHE-N-SEAL® 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® adhesive is distributed to the professional and consumer markets by Colgate Oral Pharmaceuticals, Inc.
The NEXABAND® 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® product line. In accordance with
the agreement, Abbott has been granted immediate worldwide distribution rights
of NEXABAND® 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® 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 www.dermabond.com.
DERMABOND adhesive is a registered trademark of ETHICON, Inc.; SOOTHE-N-SEAL® is a registered trademark of Colgate Oral Pharmaceuticals, Inc.; LIQUIDERM™ is a trademark of CLOSURE Medical Corporation; and NEXABANDÒ 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.