Laserscope Announces FDA Clearance for Innovative New Acne Laser Treatment
11/25/03
SAN JOSE, Calif., Nov 25, 2003 /PRNewswire-FirstCall via Comtex/ --
Laserscope (Nasdaq: LSCP), a pioneer in the development and commercialization of medical lasers and advanced fiber-optic devices, today reported that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Aura(TM) laser for the treatment of acne.
'We are very excited about receiving this clearance for our Aura laser,' said Eric Reuter, Laserscope's President and CEO. 'According to the American Academy of Dermatology, nearly 80% of the world's population is affected by acne at some point in their lifetime and close to 40% of adolescents have acne severe enough to require some treatment by a physician. Additionally, many of the existing treatment solutions for acne, such as oral antibiotics, topical retinoids and topical antibiotics, can be ineffective and, in some cases, have been associated with significant health risks. By contrast, the Aura laser treatment is fast, virtually painless and efficacious.'
Clinical data was obtained from initial research conducted at the Wellman Laboratories of Photomedicine at Harvard Medical School, Massachusetts General Hospital by Dr. Ledya Elizabeth Bowes, Dr. Dieter Manstein and Dr. R. Rox Anderson of the Department of Dermatology and by Dr. William Baugh, a dermatologist from Fullerton, California and a Fellow of both the American Academy of Dermatology and the American Society of Laser Medicine and Surgery.
'Treatment of facial acne with the 532-nanometer, KTP Aura laser twice weekly for two weeks resulted in a marked reduction of the acne lesion counts, which was maintained for at least 3 months after exposure. A reduction in sebum production was also noted, as well as an attenuation of the fluorescence attributable to P. acnes,'said Dr. Bowes.
'The Aura laser is a safe and highly effective device for the treatment of acne vulgaris,'said Dr. Baugh. 'Our patients have been uniformly impressed with the ease of treatments and the outstanding results. This laser not only makes my patients look good but their great results make me look good too! I highly recommend it to any physician who treats acne.'
<snip> |
