March 25, 2003
ANDOVER, Mass.--(BUSINESS WIRE)--March 25, 2003
Diomed Holdings, Inc (AMEX: DIO) announced today
that it has received regulatory approval from
Health Canada for its EndoVenous Laser Treatment
(EVLT(TM)) laser system to treat varicose veins,
enabling Diomed to expand its promotion of EVLT(TM)
into Canada. Diomed also announced that it has
engaged Sigmacon Health Products Corporation of
Toronto, Ontario as its exclusive Canadian distributor
for the sale of Diomed's EVLT(TM) lasers and EVLT(TM)
optical fiber kits to physicians who treat varicose
veins.
Diomed is the first endovenous laser to receive
approval by the U.S. Food and Drug Administration
for expanded indications for treatment of varicose
veins and varicosities associated with the superficial
vein reflux of the greater saphenous vein. EVLT(TM)
is a non-surgical treatment that can be performed
under local anesthetic in a doctor's office to
treat the medical cause of varicose veins at its
source.
"Thousands of U.S. patients have benefited
from EVLT(TM) by being able to walk out of their
physician's office and resume normal activity
quickly without any lasting side effects,"
said James A. Wylie, Jr., President & CEO
of Diomed. "Canadian approval of EVLT(TM)
is both a milestone for Diomed and an important
validation of EVLT(TM) in the treatment of varicose
veins. Now, Canadians who suffer from varicose
veins don't have to live with the chronic and
debilitating conditions of the disease. And, they
have a better alternative that cures the disease,
not just slows its progression."
According to Jay Herman, Sr. Vice President at
Sigmacon, "The Health Canada Approval means
we can now offer the minimally invasive EVLT(TM)
technique to both the public and physicians. As
a distributor with a 20 year history we do the
same due diligence on companies and procedures
as any medical practitioner would - selecting
on the best of breed. Diomed is the innovator
of this technique and has devoted its resources
to continually perfecting it, and we believe that
Diomed will be the leader in providing products
for endovenous laser treatment of varicose veins."
About Varicose Veins
The most common medical origin of varicose veins
is known as "reflux of the greater saphenous
vein," the major vessel in the superficial
venous system, running from the groin to the ankle.
Within all veins there are a series of one-way
valves that assure blood flow in the direction
of the heart. "Reflux" relates to a
failure of these valves that causes blood to flow
backwards, pool and stretch the walls of veins
in the lower leg causing the unsightly blue, bulging
and painful veins known as varicose veins. Heredity
is the most important factor, followed by gender
and age. Women have a higher incidence of varicose
vein disease, due in part to the female hormones
affecting the vein walls, especially during pregnancy
when there is also a temporary increase in blood
pressure and volume in the veins. Age is a factor
because vein walls loose elasticity, causing the
valve system in veins to work less effectively.
Up to 25 of all women and 18 of all men will suffer
from vein reflux disease to some degree.
About Diomed
Diomed specializes in developing and commercializing
minimal and micro-invasive medical procedures
that use its laser technologies and disposable
products. In developing and marketing its innovative
clinical solutions, it uses proprietary technology
and aims to secure strong commercial advantages
over its competitors by gaining governmental approvals
in advance of others and through exclusive commercial
arrangements. To participate in the rapidly growing,
minimal and micro-invasive medical procedure industry,
Diomed integrates disposables into its product
lines. Diomed holds proprietary technology in
certain methods of synchronizing diode light sources
and in certain optical fibers. Diomed focuses
on photodynamic therapy (PDT) for use in cancer
treatments, EndoVenous Laser Treatment (EVLT(TM))
for use in varicose vein treatments, and dental
and general surgical applications.
Safe Harbor statements under the Private Securities
Litigation Reform Act of 1995: Statements in this
news release looking forward in time involve risks
and uncertainties, including the risks associated
with trends in the products markets, reliance
on third party distributors in various countries
outside the United States, reoccurring orders
under OEM contracts, market acceptance risks,
technical development risks and other risk factors
detailed in the company's Securities and Exchange
Commission filings.
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