Press Release
12.03.2008
biolitec AG receives FDA approval in the US for its improved ELVeS™ laser system
Approval by the Food and Drug Administration opens up the US market for the improved, innovative ELVeS™ vein treatment system by biolitec AG
Jena, March 12, 2008—biolitec AG (ISIN DE0005213409) in Jena, which is listed in the Prime Standard of the Frankfurt stock exchange, received FDA approval in the US for an improved version of its innovative ELVeS™ vein treatment system. This will allow biolitec AG to expand its role as a technology leader in the largest and most important market in the world for endovenous laser therapy. "In recent months, we have already successfully established BPH treatment in the US using biolitec’s LIFE™ laser therapy. Well-known US urologist David S. Turk, MD, just received the 2007 Thirlby Award, presented by the American Urological Association (AUA) for his work in the area of out-patient BPH treatment using the EVOLVE™ laser system. The FDA approval in the US for the optimized ELVeS™ system is another milestone in our international expansion strategy“, said Dr. Neuberger, CEO of biolitec AG.
The ELVeS™ system, proven in Europe, is being sold in the US under the name ELVeS™ PL. At the 33rd SIR Annual Scientific Meeting in Washington D.C. from March 15 to 19, 2008, ELVeS™ PL will be presented to a broad specialist public for the first time. A number of American vein specialists were already trained beforehand at European ELVeS™ treatment centers. "We think the ELVeS™ PL laser will quickly penetrate the US market. In the area of laser medicine, the name biolitec AG stands for state-of-the-art technology and for safety", explains Dr. Neuberger, "therefore, we place a lot of emphasis on the standardization of treatment and training of physicians who work with the ELVeS™ system.“
In Germany, approximately 22 million people are affected by venous diseases. Primarily, these involve varicose veins, the cause of which is insufficiency in the venous valves . In the US, this number is several times higher. In contrast to Germany, every other treatment in the US is done on an out-patient basis.
With ELVeS™ PL, biolitec AG, located in Jena, has created a revolutionary, minimally invasive treatment through the synergy of clinical know-how, reliable laser technology, specific treatment kits and worldwide reference centers, and has set new standards for patients and users. biolitec's new generation of diode lasers, together with the ELVeS™ treatment kits, is based on a technology that facilitates a high absorption in water - the critical step in painless post-operative recovery and excellent medical-cosmetic results. Moreover, ELVeS™ PL enables a rapid return to normal activities, resulting in maximum patient satisfaction.
About biolitec
biolitec is the only supplier for photodynamic therapy worldwide that offers all relevant core competencies – photosensitizers, lasers and optical fibers. Besides minimal invasive laser treatments and the oncology business, biolitec has successfully developed competencies in the field of aesthetics. biolitec is listed in the Prime Standard under ISIN DE0005213409. For more information: www. biolitec.com.
