Closure Medical (NASDAQ:CLSR)
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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/