CLOSURE Medical Corporation Initiates Patient Enrollment in Pilot Study for Its Vascular Sealant Product
05 November 2003 - 4:25AM
PR Newswire (US)
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/
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