|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 (212) 661-8030
For Analyst Info: Nicole Salas (212) 661-8030
For Media Info: Deanne Eagle (212) 661-8030
FOR IMMEDIATE RELEASE: January 30, 1998
FDA ADVISORY PANEL RECOMMENDS APPROVAL OF CLOSURE MEDICAL CORPORATION’S DERMABOND TOPICAL SKIN COHESIVE
Raleigh, NC, January 30, 1998-- CLOSURE Medical Corporation (Nasdaq: CLSR) today announced that the General and Plastic Surgery Devices Panel, a Food and Drug Administration advisory committee, unanimously recommended approval of DERMABOND* as a wound closure device. DERMABOND is a topical skin cohesive based on CLOSURE’s proprietary cyanoacrylate technology.
The Advisory Panel reviewed CLOSURE’s PMA, including the 818 patient ten-center clinical study designed to demonstrate that DERMABOND is a safe and effective alternative to topical sutures used in the closure of many incisions and lacerations. The clinical trials demonstrated DERMABOND to be at least equivalent to nonabsorbable 5.0 or smaller diameter sutures, staples or adhesive strips/tapes in wound closure, wound healing, cosmetic outcome and infection rate and also demonstrated that the use of DERMABOND substantially reduced procedure time. Procedures performed included emergency lacerations, minimally invasive puncture sites, plastic and reconstructive surgeries, and general surgical incisions.
"We are very pleased with the Panel’s recommendation, especially since DERMABOND is the only skin cohesive for topical wound closure that has advanced this far in the U.S. regulatory approval process," said Mr. Robert V. Toni, President and Chief Executive Officer. In December 1996, the FDA advised CLOSURE that it would review it’s DERMABOND PMA submission under expedited processing because of the potential of DERMABOND to benefit the public health. "We have enjoyed a fine working relationship with the FDA as they demonstrated consistent and prompt follow through on this expedited processing review."
Prior to final approval from the FDA, the company must demonstrate to the FDA adequate control and complete validation of its manufacturing processes and agree to final package labeling.
In March 1996, the Company entered into a marketing agreement with Ethicon, Inc., a subsidiary of Johnson & Johnson, for exclusive worldwide marketing and distribution of DERMABOND. Ethicon is currently marketing and distributing DERMABOND in several countries in the European Union.
CLOSURE Medical develops, commercializes and manufactures medical cohesive products 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 OctyldentÒ , used in conjunction with antibiotics to treat adult periodontal disease, NexabandÒ , a line of topical cohesives used in veterinary wound closure and management, and DERMABOND, CLOSURE’s non-absorbable cohesive used for certain topical wound closure applications.
* 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, the early stage of commercialization of the Company’s products; scale-up of manufacturing processes; the need for regulatory approval and effects of governmental regulation; technological uncertainties; 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, 1996 and filed with the Securities and Exchange Commission.