|AT CLOSURE MEDICAL CORP.||AT GOLIN/HARRIS INTERNATIONAL|
|Robert V. Toni, President & CEO
J. Blount Swain, CFO
CLOSURE Medical Corporation
|For Media Info: Julie Gilman: (312) 729-4216|
|AT THE FINANCIAL RELATIONS BOARD|
|For General Info: Paul G. Henning
For Analyst Info: Brian Gill (212) 661-8030
FOR IMMEDIATE RELEASE: November 23, 1998
FOLLOW-UP HIGHLIGHTS EXCELLENT COSMETIC RESULTS
WITH DERMABOND* TOPICAL SKIN ADHESIVE
Raleigh, N.C., November 23, 1998 — A study appearing this month in Plastic and Reconstructive Surgery highlights findings from a one-year period that shows patients treated with DERMABOND* (2-Octyl Cyanoacrylate) Topical Skin Adhesive experience superior cosmetic outcomes compared to patients treated with sutures. DERMABOND Adhesive, which can be 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 Food and Drug Administration for the U.S. market.
One hundred and eleven patients participated in the trial, which was conducted in a facial plastic and reconstructive surgery setting. Patients were assigned to two groups: those with wounds requiring subcutaneous sutures or wounds without subcutaneous sutures. These groups were then randomized to receive treatment with either DERMABOND Adhesive or sutures.
At one year, photos of the healed wounds were given to two independent facial plastic surgeons who were unfamiliar with the study design to rate the appearance of the healed incisions. Each surgeon was asked to rate the cosmetic result using a visual analog scale, which is more specific than the scale used at 90 days during clinical study submitted to the Food and Drug Administration.
At one-year post-treatment, the facial plastic surgeons’ evaluation of the photos revealed the group that received treatment with DERMABOND Adhesive received cosmetic outcome ratings superior to the group treated with sutures. In addition, there were no instances of wound dehiscence, hematoma or infection.
"The advantages of tissue adhesive in skin closure are significant to both patients and physicians, providing faster, relatively painless closure as compared to sutures," says Dean M. Toriumi, MD, Associate Professor, Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology -- Head and Neck Surgery, University of Illinois at Chicago, and lead author of the study. "Our study finds that in certain applications and with proper wound management, tissue adhesive also provides a better cosmetic result than sutures. This is particularly important for use in surgical procedures on the head or face where scarring is an important consideration."
DERMABOND adhesive is intended for topical application to close easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. DERMABOND adhesive should be used in conjunction with, but not in place of, subcuticular sutures, when they are required.
DERMABOND adhesive must not get into the wound or be used below the skin. It should not be used across areas of skin tension, such as knuckles, elbows or knees, unless the joint will be immobilized during the wound healing process. DERMABOND adhesive also should not be used on patients with a known hypersensitivity to cyanoacrylate or formaldehyde, or on any wounds with visual evidence of active infection, gangrenous wounds or wounds from decubitus ulcers. It should not be used on mucosal surfaces or internally. Physicians should consult the package insert for full information on use.
DERMABOND Topical Skin Adhesive competes in a worldwide market of approximately 90 million procedures and annual suture and staple sales of $2.6 billion. In 1996, CLOSURE Medical licensed exclusive worldwide marketing and distribution rights for DERMABOND Topical Skin Adhesive to ETHICON, INC., a subsidiary of Johnson & Johnson.
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.