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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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