|AT THE COMPANY||
| Robert V. Toni, President & CEO
J. Blount Swain, CFO
CLOSURE Medical Corporation
|For Media Info: Barbara Box: (312) 729-4143|
|AT THE FINANCIAL RELATIONS BOARD|
|For General Info: Paul G. Henning
For Analyst Info: Brian Gill (212) 661-8030
FOR IMMEDIATE RELEASE: August 27, 1998
CLOSURE MEDICAL ANNOUNCES FDA APPROVAL OF DERMABOND
Raleigh, NC, August 27, 1998-- CLOSURE Medical Corporation (Nasdaq: CLSR) announced that it has received U.S. Food and Drug Administration (FDA) approval for market release of its DERMABOND* Topical Skin Adhesive.
DERMABOND Topical Skin Adhesive, which is used to replace sutures, staples, and adhesive strips for closing certain topical incisions and lacerations, is the first such product to be approved by the FDA for the U.S. market. CLOSURE Medical filed the pre-market approval application (PMA) with the FDA in December 1996 whereupon the application was granted "expedited processing" because of the potential public health benefit of DERMABOND Topical Skin Adhesive to reduce patient pain and anxiety. An FDA panel unanimously recommended approval of DERMABOND adhesive on January 30, 1998.
DERMABOND Topical Skin Adhesive will compete in a worldwide market of approximately 90 million procedures and annual suture and staple sales of $2.6 billion.
In March 1996, CLOSURE Medical licensed exclusive worldwide marketing and distribution rights for DERMABOND Topical Skin Adhesive to ETHICON, INC., a subsidiary of Johnson & Johnson. "The FDA approval of DERMABOND Topical Skin Adhesive represents a major milestone for CLOSURE Medical Corporation and our vision to develop products that will change the face of wound care," said Robert V. Toni, president and CEO of CLOSURE MedicalCorporation. "We also believe that ETHICON, the leader in suture sales, is well positioned to bring DERMABOND adhesive to U.S. physicians, surgeons and other health care providers."
In August 1997, CLOSURE received CE Mark approval allowing the company to ship DERMABOND Topical Skin Adhesive to ETHICON to support its launch in European Union countries. DERMABOND adhesive is currently marketed by ETHICON in over 23 countries outside the U.S.
CLOSURE Medical ( ) develops, commercializes and manufactures medical cohesive products for wound closure based on its proprietary cyanoacrylate technology. CLOSURE’s nonabsorbable products may be used to replace sutures and staples for certain topical wound closure applications, while its absorbable products can potentially be used as surgical sealants and cohesives for internal wound closure and management. Currently marketed products include: DERMABOND, CLOSURE’s non-absorbable adhesive used for certain topical wound closure applications marketed and distributed exclusively by ETHICON, INC., a subsidiary of Johnson & Johnson; Octyldent‚, used in conjunction with antibiotics to treat adult periodontal disease; and, Nexaband‚, a line of topical cohesives used in veterinary wound closure and management.
* DERMABOND is a trademark of ETHICON, INC., a subsidiary of Johnson & Johnson.
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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, scale-up of manufacturing processes; technological uncertainties; competition from other products; 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, 1997 and filed with the Securities and Exchange Commission.