Diomed’s EVLT Approved for Treatment of Varicose Veins in the UK
ANDOVER, Mass.–(BUSINESS WIRE)–March 25, 2004
Diomed Holdings, Inc. (AMEX: DIO), a leading developer and marketer of minimally invasive medical technologies, including EVLT(R) 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(R) 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(R) 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(R) procedure in the UK now that reimbursement for the procedure in public and private hospital settings is likely.
Diomed develops and commercializes minimally-invasive medical procedures that use its proprietary laser technologies and disposable products. Diomed focuses on EndoVenous Laser Treatment (EVLT(R)) for use in varicose vein treatments, photodynamic therapy (PDT) for use in cancer treatments, and dental and general surgical applications. The EVLT(R) procedure and the Company’s related products were cleared by the United States FDA in January of 2002. Along with lasers and single-use procedure kits for EVLT(R), the Company provides its customers with state of the art physician training and practice development support. Additional information is available on the Company’s website, www.evlt.com.
EVLT(R) 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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