|AT THE COMPANY||AT THE FINANCIAL RELATIONS BOARD|
|Robert V. Toni, President & CEO
Benny Ward, CFO
CLOSURE Medical Corporation (919) 876-7800
|For General Info: Stuart Levine (212) 661-8030
For Analyst Info: Cecelia Heer (212) 661-8030
For Media Info: Deanne Eagle (212) 661-8030
FOR IMMEDIATE RELEASE: August 1, 2000
CLOSURE MEDICAL CORPORATION FILES A 510(K) APPLICATION
FOR U.S. MARKETING CLEARANCE OF ITS
LIQUIDERM™ LIQUID ADHESIVE BANDAGE
Raleigh, NC, August 1, 2000 -- CLOSURE Medical Corporation (Nasdaq: CLSR), a medical tissue adhesive products company, today announced its filing of a 510(k) premarket notification with the FDA, seeking marketing clearance for its LIQUIDERM™ liquid adhesive bandage ("LIQUIDERM"). LIQUIDERM's indication for use is the treatment of minor cuts, abrasions, burns, minor irritations and help protect them from infection. The filing is based in part on the findings of a 162 patient multi-center clinical study conducted at the University of Miami, the Orlando Regional Healthcare System and the Palm Beach Research Center.
In the multi-center study, LIQUIDERM™ liquid adhesive bandage was found to: (1) stay on wounds better and longer than traditional adhesive bandages, (2) seal wounds from dirt and germs, (3) minimize pain better than adhesive bandages, (4) stop bleeding of minor cuts and abrasions and (5) require only one application per treatment.
LIQUIDERM™ liquid adhesive bandage utilizes the same proprietary technology as the Company's professional product DERMABOND® Topical Skin Adhesive ("DERMABOND"). DERMABOND is used in hospitals as an alternative to sutures and staples in closing incisions and lacerations. LIQUIDERM is simply painted on the wound, sealing it from dirt and germs, creating a healing environment, which allows natural healing to take place quickly. As the wound heals, the adhesive sloughs off naturally.
"For over 75 years, the adhesive bandage category, a $1 billion worldwide category, has seen limited major innovations with no new alternatives," said Robert V. Toni, President and CEO. "LIQUIDERM™ liquid adhesive bandage represents a transformational innovation with superior product benefits versus traditional adhesive bandages. LIQUIDERM is more than just a covering for wounds."
Mr. Toni continued, "LIQUIDERM™ liquid adhesive bandage is unlike existing adhesive bandages, because it conforms to any wound size, stays on bending and moving parts of the body and will not fall off when wet."
CLOSURE is currently in discussions with several top tier OTC marketing companies with respect to the worldwide marketing rights to LIQUIDERM™ liquid adhesive bandage, which is its second over-the-counter product.
CLOSURE Medical Corporation, headquartered in Raleigh, North Carolina, develops, manufactures and commercializes medical tissue adhesive products based on its proprietary cyanoacrylate technology. CLOSURE's nonabsorbable tissue adhesive products may be used to replace sutures and staples for certain topical wound closure applications, while its internal tissue adhesive products can potentially be used for internal wound closure and management. Currently marketed nonabsorbable tissue adhesive products include DERMABOND®* Topical Skin Adhesive, which is used to replace sutures and staples for closure of certain lacerations and incisions, OCTYLDENT®* adhesive, which is used as an adjunct in the treatment of adult periodontal disease; and the NEXABAND®* line of topical adhesives, which are used in veterinary wound closure and management.
* DERMABOND® adhesive is a trademark of Ethicon, Inc.; SOOTHE-N-SEAL™ canker sore relief and LIQUIDERM™ adhesive are trademarks of CLOSURE Medical Corporation. OCTYLDENT® adhesive and NEXABAND® adhsives are federally registered 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 symbol CLSR. Or visit the Financial Relations Board's website at 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 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, 1999 filed with the Securities and Exchange Commission.