CLOSURE Medical Receives European Approval for OMNEX(TM) Surgical Sealant, Its First Internal Product
February 22 2005 - 10:33AM
PR Newswire (US)
CLOSURE Medical Receives European Approval for OMNEX(TM) Surgical
Sealant, Its First Internal Product RALEIGH, N.C., Feb. 22
/PRNewswire-FirstCall/ -- CLOSURE Medical Corporation
(NASDAQ:CLSR), a global leader in biomaterial-based medical
devices, today announced that it has received the European Union's
CE Mark approval for its proprietary OMNEX(TM) Surgical Sealant,
the Company's first product indicated for use inside the body. The
CE Mark approval will allow the Company to market and distribute
the product in EU countries and was based primarily on the positive
results of the product's biocompatibility, laboratory, animal and
human clinical use data. OMNEX(TM) sealant is a synthetic,
biodegradable material that mechanically seals the surfaces of
blood vessels and artificial grafts to prevent blood leakage after
traditional suturing. The product's clinical application under the
CE Mark allows for its use as an adjunct to sutures to achieve
hemostasis in peripheral vascular reconstructions, such as when
bypassing an occluded blood vessel or to create a shunt for
hemodialysis access in diabetic patients. OMNEX(TM) sealant was
developed from CLOSURE's core cyanoacrylate technology.
Cyanoacrylates have proven to be very strong bonding agents and
OMNEX(TM) sealant will allow physicians in Europe the ability to
use this technology during surgery. Notably, most internal sealants
other than OMNEX(TM) are derived from human or animal blood
products; CLOSURE's OMNEX(TM) sealant is entirely synthetic and
will not expose patients to the risks of blood borne illness. Dr.
Alan B. Lumsden, principal investigator for the OMNEX(TM) U. S.
clinical study, stated, "I believe CLOSURE Medical's OMNEX Surgical
Sealant has the opportunity to change vascular surgery. Bleeding is
a byproduct of the surgeries we perform and we have found that this
product controls bleeding reliably and simply, before it has a
chance to begin. I do not believe there is anything else like it in
terms of its effectiveness or its ease of use. I believe this
sealant has the opportunity to be an enabling technology for such
procedures as minimally invasive laparoscopic vascular surgery
since the difficulty in suturing is currently the limiting path."
Dr. Lumsden holds positions at Baylor College of Medicine and the
Methodist DeBakey Heart Center of The Methodist Hospital in
Houston, Texas. Daniel A. Pelak, President and CEO, commented, "The
approval of the OMNEX Surgical Sealant is a major milestone for
CLOSURE, and we believe it is the first in a series for our
surgical sealant platform. Given the feedback from surgeons
regarding OMNEX and the worldwide market potential for tissue
sealants, we believe our unique technology will have applications
in many other surgical specialties. We are encouraged by the
opportunities offered by the commercialization of our technology
inside the body." In the United States, the Company plans to seek
approval for OMNEX(TM) sealant from the U.S. Food and Drug
Administration during 2005. The Company has completed the
enrollment phase of its 150-patient pivotal study for OMNEX(TM)
sealant, which was initiated in March 2004. The study assessed the
ability of the sealant to prevent leakage following reconstruction
of vascular structures in patients receiving femoral bypass or
arteriovenous shunt procedures for hemodialysis access. Patients
were enrolled at 13 medical institutions in the U.S. and Europe
with follow-up visits at four and twelve weeks. 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 Company's
success in securing a marketing and distribution partner for its
OMNEX(TM) product; the ability of the Company to increase the
efficiencies in its manufacturing processes; the effectiveness of
initiatives launched in response to the Company's competitors'
product introductions; the progress and success of its research and
development programs for future products; the success of its
clinical study for its OMNEX(TM) 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 inventory
management policies adopted by the Company's marketing partners;
end-user growth for the products sold by the Company's marketing
partners; 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: media, Len Hall, +1-949-474-4300, , or
investors, Joe Allen, +1-212-691-8087, , 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.allencaron.com/
Web site: http://www.closuremed.com/
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