Closure Medical (NASDAQ:CLSR)
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CLOSURE Medical Corporation Initiates Patient Enrollment in Pilot Study for Its
Vascular Sealant Product
RALEIGH, N.C., Nov. 4 /PRNewswire-FirstCall/ -- CLOSURE Medical Corporation , 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.
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
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.
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; or Benny Ward, CFO of CLOSURE Medical Corp,
+1-919-876-7800
Web site: http://www.allencaron.com/
Web site: http://www.closuremed.com/