Contact: Allen & Caron Inc CLOSURE Medical Corp
Joe Allen (investors) Len Hall (media) Benny Ward, CFO
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CLOSURE MEDICAL CORPORATION ANNOUNCES FDA APPROVAL TO BEGIN PIVOTAL CLINICAL STUDY FOR ITS VASCULAR SEALANT PRODUCT
RALEIGH, NC (March 18, 2004) … CLOSURE Medical Corporation (Nasdaq:CLSR), a global leader in biomaterial-based medical devices, announced today that it has received approval from the U. S. Food and Drug Administration (FDA) to initiate a pivotal clinical study to support
U.S. Premarket Approval for its vascular sealant product, the Company’s first product to be used inside the body. The approval was based on the positive results of a ten-patient pilot study that completed enrollment last December.
The randomized pivotal study will enroll 150 patients, with four- and twelve-week follow-up visits, at approximately 14 medical institutions in the United States and Europe.
Dr. Alan B. Lumsden of Baylor College of Medicine and the Methodist DeBakey Heart Center, The Methodist Hospital, Houston, Texas will act as the principal investigator of the study. The study will assess the ability of CLOSURE’s vascular sealant to prevent leakage following reconstruction of vascular structures in patients receiving femoral-popliteal bypass or arteriovenous access grafting.
Daniel A. Pelak, President and CEO, commented, “Attaining FDA approval to initiate the pivotal clinical study is a major milestone for the Company. We are encouraged by the positive results of our pilot study and plan to enroll the first patient in the pivotal study within the next few weeks. We expect to complete the study by the end of 2004 and if all goes according to plan, we anticipate commencing commercialization of the product outside the U.S., upon receipt of European CE Mark approval, in 2005.”
The vascular sealant is intended to be used in vascular procedures such as reconstructive grafts and dialysis-access procedures. The product is biodegradable and designed to seal the surfaces of veins, arteries and artificial grafts that can leak after suturing. The formulation is synthetic thereby eliminating the risk of infection transmission and immune response disorders associated with animal-derived or human blood-based products. In addition, the vascular sealant is transparent, allowing physicians to determine that the seal at the surgical site is complete.
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CLOSURE MEDICAL CORPORATION ANNOUNCES FDA APPROVAL OF PIVOTAL CLINICAL STUDY
About CLOSURE Medical Corporation
CLOSURE Medical Corporation is a global leader in the development and manufacture of innovative biomaterial-based medical devices that fulfill the needs of healthcare practitioners, patients and consumers.
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; the progress and success of its research and development programs for future products; the success of its pivotal study for is vascular sealant product and future clinical studies; the successful enrollment of current and future clinical studies; the need for regulatory approval and effects of governmental regulation; technological uncertainties; the Company’s success in securing marketing partners for future products; the satisfactory conclusion of negotiations with, and 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, 2003, filed with the Securities and Exchange Commission. Although the Company believes that the expectations in the forward-looking statements are reasonable, the Company cannot guarantee such results. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.
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