No Pain, More Gain — Restore Skin's Youthful Look with Aesthera's PPx Therapy

Business Wire,  May 3, 2005  

• E-mail
• Print
• Link

LIVERMORE, Calif. -- FDA Clears Way for First Painless Light-Based Therapy for Treatment of Vascular and Pigmented Lesions and Permanent Hair Reduction; Safer, Faster Than Current Laser Methods

Aesthera Corp. announced today that the U.S. Food and Drug Administration has cleared its Aesthera Photopneumatic (PPx)(TM) System, for the treatment of vascular and pigmented lesions and permanent hair reduction. Photopneumatic Therapy (PPx) is the first no pain and safer light based therapy to treat sun damaged and aging skin, including brown spots, redness and broken capillaries, as well as unwanted hair and unsightly veins.

PPx Therapy is a combination of pneumatic energy (pressure) and broadband light. It is a safer alternative to other laser and light-based treatments but with the same effectiveness, or better than, traditional therapies. This highly efficient delivery of energy greatly reduces the possibility of side-effects such as redness, burning, and scarring. PPx Therapy is also a more hygienic procedure thanks to a personalized single-use disposable tip, which is customized per treatment area. Unlike existing treatment alternatives, patients do not need to undergo time consuming pre-treatment procedures such as applying topical numbing agents or cooling gels. Immediately after the procedure, patients are ready to resume their normal activities.

Vic Narurkar, M.D., director and founder of the Bay Area Laser Institute in San Francisco and an initial investigator for PPx Therapy, recently completed a clinical study using the Aesthera PPx system. "One hundred percent of patients in the study reported no pain or burning sensation when treated with PPx therapy," said Dr. Narurkar. "This opens the door to many other patients who may have been unwilling or apprehensive to try traditional technologies for the treatment of sun damaged and aging skin, hair removal and the removal of unwanted veins."

How it Works:

Photopneumatic Therapy gently changes the optical characteristics of the skin.

--The handpiece is placed on the area of the body to be treated, and the patient's skin is stretched and thinned by gentle suction

--Targets, such as hair follicles, are elevated closer to the skin's surface

--Blood vessels are immediately compressed and blanched

--Light is applied

--Highly efficient photons reach the target at four to five times the standard rate but at lower energies, making the overall procedure safer, painless and five times faster

According to the American Society for Aesthetic Plastic Surgery, 11.9 million cosmetic surgical and non-surgical procedures were performed on Americans in 2004 to combat the appearance of aging.

"FDA clearance of PPx Therapy is a significant milestone for the nearly $25.5 billion U.S. cosmetic procedure market because it is the first treatment that is actually no pain, more gain," said Alon Maor, president and CEO of Aesthera Corp. "Our goal was to create a pain-free, safer treatment, and through the PPx development process, we were also able to make the treatment faster and more effective."

PPx Therapy provides clear benefits to both patients and physicians, including substantial time savings. It takes only 20 minutes for one PPx hair removal session for either both legs or the back versus up to 120 minutes using other laser or light-based technologies. Since PPx Therapy takes substantially less time to complete, clinicians can perform treatments on more patients each day with a significantly positive impact on revenues. With FDA clearance, Aesthera will begin taking orders for the PPx System from qualified physicians immediately.

About Dr. Narurkar

Dr. Vic Narurkar is Associate Professor of Dermatology at the University of California, Davis and founder of the Bay Area Laser Institute in San Francisco where he has conducted clinical trials and pioneered the use of lasers for cutting edge aesthetic applications. Dr. Narurkar is a graduate of Brown University and of Stanford University Medical School and is a member of Aesthera's Medical Advisory Board.

About Aesthera Corporation

Aesthera (www.aesthera.com) develops, manufactures and markets light-based aesthetic treatment systems based on proprietary Photopneumatic Technology. PPx more effectively delivers energy to dermal targets than currently available methods for hair removal, and the treatment of vascular and pigmented lesions. Found in trial research to be pain-free and up to seven times faster, Aesthera's revolutionary aesthetic system combines the proven properties of therapeutic light with gentle pneumatic energy that creates an unprecedented efficiency of photons delivered to the target. Now Aesthera allows physicians to provide high technology aesthetic treatments in a system with very low cost-to-own and near-immediate profitability -- finally freeing the practice from dependence upon high patient volume to achieve a favorable return on investment.

COPYRIGHT 2005 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning