PhotoMedex's XTRAC Velocity laser gets FDA clearance
May 20, 2008 -- PhotoMedex, Inc. has received U.S. Food and Drug Administration 510k clearance to market its XTRAC Velocity excimer laser system to treat psoriasis, vitiligo, atopic dermatitis and leukoderma. According to the company, XTRAC Velocity delivers the highest UV power of any medical excimer laser on the market today, and is up to three times faster per treatment.
May 20, 2008 -- PhotoMedex, Inc. (Montgomeryville, PA) developer of proprietary excimer laser and fiber optic systems and dermatological techniques, has received U.S. Food and Drug Administration 510k clearance to market its new, more powerful, faster XTRAC Velocity excimer laser system to treat psoriasis, vitiligo, atopic dermatitis and leukoderma.
According to the company, XTRAC Velocity delivers the highest UV power of any medical excimer laser on the market today, while retaining all the reliability and clinical efficacy of its predecessor, the XTRAC Ultra. As a result, the Velocity is up to three times faster per treatment, creating a viable alternative to many of the current and costly psoriasis therapies, including therapies involving biologics, systemics and a combination of psoralen and UVA light ("PUVA"), but without any of the potential systemic side effects. The enhanced laser speed decreases patient and office staff treatment time while allowing for the practical treatment of moderate to severe patients. The BlueCross BlueShield Association in February 2007 issued a national reference policy stating that targeted phototherapy [including the XTRAC] may be considered medically necessary for the treatment of moderate to severe psoriasis comprising less than 20% body area for which NB-UVB or PUVA are indicated.
Earlier this Spring, PhotoMedex announced the results of a pilot study indicating that the company's XTRAC Excimer Laser is effective in treating patients with moderate to severe cases of psoriasis.
PhotoMedex President and CEO Jeff O'Donnell, commented, "I am very proud of the PhotoMedex Product Development Team. When our Scientific Advisory Board requested a more powerful laser, they came through. They delivered the new power standard for excimer laser treatment for psoriasis. Dr. John Koo has already reported on the effectiveness of the XTRAC Ultra in treating moderate to severe psoriasis, and given the widespread coverage already in place for treatment by the XTRAC laser for mild to moderate psoriasis and the Blue Cross national reference policy for severe psoriasis of less than 20% body area, we anticipate that coverage for such people suffering from moderate to severe psoriasis will increase. The Velocity is the ideal, practical and affordable means to treat those patients suffering from moderate to severe psoriasis."
The Company's original excimer laser system generating 308-nm UV-B energy was the first FDA-approved laser treatment for psoriasis, which is the second most common skin disorder in the U.S. The National Psoriasis Foundation estimates that psoriasis afflicts more than 7 million Americans and that between 150,000 and 260,000 new cases are diagnosed each year.
PhotoMedex provides contract medical procedures to hospitals, surgi-centers and doctors' offices, offering a wide range of products and services across multiple specialty areas, including dermatology, urology, gynecology, orthopedics, and other surgical specialties. The Company is a leader in the development, manufacturing and marketing of medical laser products and services.