CLOSURE Medical Corporation Announces FDA Approval to Begin Pivotal Clinical Study for Its Vascular Sealant Product
19 March 2004 - 2:48AM
PR Newswire (US)
CLOSURE Medical Corporation Announces FDA Approval to Begin Pivotal
Clinical Study for Its Vascular Sealant Product RALEIGH, N.C.,
March 18 /PRNewswire-FirstCall/ -- CLOSURE Medical Corporation , 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 completethe 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. 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. For additional information on CLOSURE Medical visit its
website at http://www.closuremed.com/ or visit the "Clients"
section of the Allen & Caron website at
http://www.allencaron.com/. 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 expectationsimplied 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. DATASOURCE:
CLOSURE Medical Corporation CONTACT: investors, Joe Allen,
+1-212-691-8087, , or media, Len Hall, +1-949-474-4300, , both of
Allen & Caron Inc, for CLOSURE Medical Corp; or Benny Ward, CFO
of CLOSURE Medical Corp, +1-919-876-7800 Web site:
http://www.closuremed.com/
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