NEWS RELEASE for November 4, 2003
Contact: Allen & Caron Inc CLOSURE Medical Corp
Joe Allen (investors) Len Hall (media) Benny Ward, CFO
(212) 691-8087 (949) 474-4300 (919) 876-7800
CLOSURE MEDICAL CORPORATION INITIATES PATIENT ENROLLMENT IN PILOT STUDY FOR ITS VASCULAR SEALANT PRODUCT
RALEIGH, NC (November 4, 2003) … CLOSURE Medical Corporation (Nasdaq:CLSR), a global leader in biomaterial-based medical devices, announced the first use in humans of its synthetic vascular sealant product under the Company’s FDA-approved clinical trial. The first patient received the product at the University of Virginia Medical Center while undergoing an arteriovenous shunt procedure to insert an artificial graft for dialysis access. The current trial is a non-randomized, ten-patient pilot study with four- and twelve-week follow-ups.
The vascular sealant, the Company’s first product to be used inside the body, is biodegradable and is designed to seal the surfaces of veins, arteries and artificial grafts which can leak after suturing. In addition to dialysis access procedures, the product will also be used for other peripheral vascular procedures such as reconstructive grafts.
Daniel A. Pelak, President and CEO, commented, “The initiation of this study is a milestone for CLOSURE. Being able to treat indications inside the human body requires a much more advanced formulation, the development of which demonstrates the breadth of our core competence. Based on other research, we believe the vascular sealant is the first of multiple indications within the body that our technology may be used for.”
The Company believes its vascular sealant product offers advantages over other internal adhesives currently being used. 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 thus allowing physicians to be confident that the seal at the surgical site is complete.
Upon completion of the pilot study, the Company anticipates the initiation of a pivotal study to support U.S. Premarket Approval and European CE Mark approval. Current plans are to enroll patients at multiple centers in the United States and Europe for treatment to be conducted in a hospital setting, with four- and twelve-week follow-up visits. The end-point of the study will assess the ability of CLOSURE’s vascular sealant to prevent leakage in the reconstruction of vascular structures.
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 pilot 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, 2002, 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.