|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: Brian Gill (212) 661-8030
For Media Info: Deanne Eagle (212) 661-8030
FOR IMMEDIATE RELEASE: June 3, 1998
COMPLETES PILOT CLINICAL
STUDY FOR TREATMENT OF ORAL ULCERS
Raleigh, NC, June 3, 1998-- CLOSURE Medical Corporation (Nasdaq: CLSR) at today’s annual Stockholders Meeting announced the key findings of a pilot clinical study conducted at the University of North Carolina — Chapel Hill Hospitals and School of Dentistry. The purpose of this study was to evaluate the potential of several of CLOSURE’s proprietary cohesive formulations to reduce oral ulcer pain and reduce ulcer healing time.
The pilot study demonstrated that one of CLOSURE’s proprietary non-absorbable formulations, when applied to oral ulcers, reduced both short-term and longer-term pain when compared to the pain experienced by patients in a control group who were not treated with the device. The study further demonstrated that CLOSURE’s proprietary formulation significantly reduced the time required for the ulcer to heal completely when compared to ulcers which were not treated by CLOSURE’s device. At day seven, 77% of patients treated with CLOSURE’s proprietary formulation experienced complete healing of their oral ulcer compared to only 21% of patients who did not receive treatment.
"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. "CLOSURE’s formulation may be able to offer many of these patients reduced time to complete ulcer healing and relief from the discomfort associated with these oral ulcers."
The 42 patient single-center, single-blinded, randomized, controlled, pilot outpatient clinical trial was conducted at the University of North Carolina under the direction of Drs. Mark Kutcher, John Ludlow and Allen Samuelson as approved by the University Investigational Review Board (IRB) and the General Chemical Research Clinics (GCRC) Committee.
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 cohesive used for certain topical wound closure applications marketed and distributed exclusively by Ethicon, Inc., a subsidiary of Johnson & Johnson, OctyldentÒ , used in conjunction with antibiotics to treat adult periodontal disease and, NexabandÒ , 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, future studies may not yield comparable results 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, 1997 and filed with the Securities and Exchange Commission.