AT THE COMPANY
Robert V. Toni, President & CEO
J. Blount Swain, CFO
CLOSURE Medical Corporation
AT THE FINANCIAL RELATIONS BOARD
For General Info: Paul G. Henning (212) 661-8030
For Analyst Info: Nicole Salas (212) 661-8030
For Media Info: Deanne Eagle (212) 661-8030
FOR IMMEDIATE RELEASE:
September 7, 1999
CLOSURE MEDICAL CORPORATION ANNOUNCES FDA APPROVAL OF SOOTHE-N-SEAL™ CANKER SORE RELIEF
Raleigh, NC, September 7, 1999-- CLOSURE Medical Corporation (Nasdaq: CLSR), a medical tissue cohesive products company, today announced it has received FDA clearance to market its SOOTHE-N-SEAL™ Canker Sore Relief product.
"SOOTHE-N-SEAL™ 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 Dental Center. In the multi-center study, SOOTHE-N-SEAL™ Canker Sore Relief was found to provide relief of pain associated with oral ulcers. In addition, SOOTHE-N-SEAL™ 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™ Canker Sore Relief. CLOSURE believes SOOTHE-N-SEAL™ 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® 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 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.
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