Diomed Receives FDA Clearance for New EVLT Applications; EndoVenous Laser Treatment Expands Beyond the GSV.ANDOVER, Mass. -- Diomed Holdings, Inc. (AMEX AMEX See: American Stock Exchange : DIO DIO Diode DIO Digital Input/Output DIO Defence Intelligence Organisation (Australia) DIO Designated Institutional Official DIO Days Inventory Outstanding DIO Data Input-Output DIO Defence Industries Organisation ), a leading developer and marketer of minimally invasive medical technologies, announced today that the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has granted 510k clearance for the expanded use of its patented EVLT EVLT Endovenous Laser Treatment (R) procedure. Since initial FDA clearance in January of 2002, the Company has been marketing EVLT(R) for the treatment of venous reflux in the Great Saphenous Vein great saphenous vein n. A vein formed by the union of the dorsal vein of the big toe and the dorsal venous arch of the foot and empties into the femoral vein in the upper part of the femoral triangle. (GSV GSV Greater Saphenous Vein GSV Genealogical Society of Victoria (Australia) GSV Garnisonen I Sør-Varanger (Norway military Garrison of Sør-Varanger) GSV General Systems Vehicle GSV Gross Standard Volume ) associated with varicose veins. The new FDA clearance authorizes the use of Diomed's 810nm D15 Plus and D30 Plus laser systems and associated procedure kits for treatment of venous incompetence and reflux of other superficial veins in the lower extremity. Lower extremity venous insufficiency is a common medical condition afflicting 20% to 25% of women and 10% to 15% of men. Although GSV reflux is the most common underlying cause of significant varicose veins, the impact of other "truncal truncal /trun·cal/ (trung´k'l) pertaining to the trunk. trun·cal adj. 1. Of or relating to the trunk of the body. 2. Of or relating to an arterial or nerve trunk. " veins such as the small saphenous vein small saphenous vein n. A vein that arises from the union of the dorsal vein of the little toe with the dorsal venous arch and ascends through the middle of the calf to the lower portion of the popliteal space where it empties into the popliteal vein. system (SSV SSV Surface Safety Valve SSV Specialty Sports Venture LLC (Denver, CO) SSV Simian Sarcoma Viral SSV Soldier Survivability SSV Sommer Schluss Verkauf (German: Summer Season Low Price) ) is also very significant. According to Robert Min MD, Vice Chairman of Radiology and Director at Cornell Vascular and one of the developers of the EVLT(R) procedure, "It has been a challenge handling non-GSV sources of reflux without surgery, but advances in duplex ultrasound imaging and the versatility of the EVLT(R) procedure have made safe and effective minimally invasive treatment possible. In our experience, more than 95% of small saphenous veins, accessory saphenous veins and posterior thigh circumflex veins have remained closed after initial EVLT(R) treatment." According to an independent study published in the November 2000 issue of Journal of Vascular Surgery, "Isolated SSV system incompetence can cause the entire range of signs and symptoms of chronic venous disease." Of the 2,254 limbs with chronic venous disease in the study, 10% had SSV incompetence as the primary cause of reflux, with another 5.6% having combined GSV and SSV reflux. Diomed's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. James A. Wylie concluded, "Our FDA clearance represents another first for Diomed. Once again, we have reinforced our position as the leader in the field of endovenous laser treatment Endovenous Laser Treatment is a minimally invasive image-guided technique in which a catheter bearing a laser fibre is inserted under ultrasound guidance into the great saphenous vein (GSV)[1] or small saphenous vein (SSV) through a small puncture. of varicose veins. We view this as a further growth opportunity and we plan to actively promote use of EVLT(R) treatment in this market segment." 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(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.diomedinc.com or www.evlt.com. Safe Harbor statements under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Form SEC 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 19 through 32 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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