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Diomed’s
EVLT® Approved for Treatment of Varicose
Veins in the UK
Diomed Press
Release - 25th March 2004
Investor Relations
ANDOVER, MA. March 25, 2004Diomed
Holdings, Inc. (AMEX: DIO), a leading
developer and marketer of minimally
invasive medical technologies, including
EVLT® for the laser treatment
of varicose veins, today announced
that the National Institute for Clinical
Excellence in London (NICE)
has issued guidance documents for
users and patients indicating "that
the procedure is safe enough and works
well enough for use in the National
Health Service."
"Receipt of the NICE Guidance
document provides Diomed with a solid
platform from which to accelerate
the use of EVLT® for treatment
of the long saphenous vein, the most
common form of venous insufficiency
or varicose veins, in public and private
hospitals throughout England and Wales,
commented Kevin Stearn, Director of
Diomed, Ltd (Cambridge, England),
a subsidiary of Diomed Holdings, Inc.
Most importantly, the issuance
of the NICE Guidance document is based
on a long and thorough evaluation
of the safety and efficacy of EVLT®
clinical data spanning more than three
years of patient evaluation.
It is estimated that more than 5
million people in the UK suffer from
venous insufficiency. The Company
expects to see widespread adoption
of the EVLT® procedure in the
UK now that reimbursement for the
procedure in public and private hospital
settings is likely.
About Diomed
Diomed develops and commercializes
minimally-invasive medical procedures
that use its proprietary laser technologies
and disposable products. Diomed focuses
on Endovenous Laser Treatment (EVLT®)
for use in varicose vein treatments,
photodynamic therapy (PDT) for use
in cancer treatments, and dental and
general surgical applications. The
EVLT® procedure and the Companys
related products were cleared by the
United States FDA in January of 2002.
Along with lasers and single-use procedure
kits for EVLT®, the Company provides
its customers with state of the art
physician training and practice development
support. Additional information is
available on the Companys website,
www.evlt.com.
EVLT® is a registered trademark
of Diomed Inc. Andover, MA.
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. These statements relate
to our future plans, objectives, expectations
and intentions. These statements may
be identified by the use of words
such as "may," "will,"
"should," "potential,"
"expects," "anticipates,"
"intends," "plans,"
"believes" and similar expressions.
These statements are based on our
current beliefs, expectations and
assumptions and are subject to a number
of risks and uncertainties. Our actual
results could differ materially from
those discussed in these statements.
Our Annual Report on SEC Form 10-KSB/A
(the "Annual Report") contains
a discussion of certain of the risks
and uncertainties that affect our
business. We refer you to the "Risk
Factors" on pages 5 through 16
of the Annual Report for a discussion
of certain risks, including those
relating to our business as a medical
device company without a significant
operating record and with operating
losses, our risks relating to our
commercialization of our current and
future products and applications and
risks relating to our common stock
and its market value. Diomed disclaims
any obligation or duty to update or
correct any of its forward-looking
statements.
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