|CONTACTS AT THE COMPANY||AT THE FINANCIAL RELATIONS BOARD|
|Robert V. Toni, President & CEO
J. Blount Swain, CFO
CLOSURE Medical Corporation
|For General Info: Paul G. Henning
For Analyst Info: Nicole Salas (212) 661-8030
For Media Info: Deanne Eagle (212) 661-8030
FOR IMMEDIATE RELEASE: June 8, 1999
CORPORATION ANNOUNCES FILING OF 510(K)
FOR SOOTHE-N-SEAL™ CANKER SORE RELIEF
Raleigh, NC, June 8, 1999-- CLOSURE Medical Corporation (Nasdaq: CLSR), a medical tissue cohesive products company, today announced its filing of a 510(k) with the FDA, seeking marketing clearance for its SOOTHE-N-SEAL™ canker sore relief. The filing is based in part on the findings of a sponsored 155-patient multi-center clinical study conducted at Brigham & Women's Hospital, the School of Dentistry at UNC-Chapel Hill, and the Forsyth Dental Center.
In the multi-center study, SOOTHE-N-SEAL™ canker sore relief was found to provide immediate and long-lasting pain relief. In addition, SOOTHE-N-SEAL™ canker sore relief provided a protective barrier that reduced the pain associated with the irritation of eating and drinking.
"Based upon primary market research we believe that there are about 40 million households within the U.S. 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. "SOOTHE-N-SEAL™ canker sore relief may provide immediate and long-lasting pain relief from the discomfort associated with these oral ulcers."
CLOSURE Medical Corporation is currently seeking a well-positioned OTC consumer marketing partner for SOOTHE-N-SEAL™ canker sore relief. SOOTHE-N-SEAL™ canker sore relief is the first step in developing what CLOSURE Medical Corporation believes to be a significant platform of OTC consumer products.
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® cohesive, which is used as an adjunct in the treatment of adult periodontal disease; and NEXABAND® 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 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 deveopment programs for future nonabsorbable and absorbable 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.