FDA Clearance for the Treatment of Acne Scars

PORTRAIT^® PLASMA RECEIVES CLEARANCE FROM THE FDA TO TREAT ACNE SCARS BY A NEW APPROACH: TREATING 100% OF THE ACNE SCAR ARCHITECTURE

Waltham, MA (April 1, 2008) Rhytec, Inc. the pioneer of plasma skin regeneration and sole provider of an aesthetic device which uses a novel thermal energy called plasma for reversing the signs of aging, today announced it has received U.S. Food and Drug Administration (FDA) clearance to market a new indication for treating acne scars. Portrait^® Plasma is already cleared by the FDA for treating facial and non-facial areas for wrinkles, superficial skin lesions, actinic keratosis, seborrhoeic keratosis and viral papillomata.

An initial single site clinical study treating acne scars was conducted using the Portrait PSR3 plasma system. D. Gault, et al, evaluated 9 patients after one Portrait Plasma treatment and found acne scarring improved by 23% at six months and sustained for two years. Although this sample size was limited, an objective evaluation method was used as compared to the subjective methods (visual observation) used in most other studies. Silicone elastomer molds were made of the skin irregularities before and after treatment and compared by measuring the depth of the defects. A 35% decrease in acne scar depth was found in this elastomer evaluation (Gault et al. Annals of Plastic Surgery. Volume 58, Number 6, June 2007).

Rhytec then conducted a multi-center IRB clinical study at three sites evaluating Portrait Plasma treatment of areas of sunken, atrophic, post acne scars (G. Lask/P. Yamauchi, J.F. Tremblay & N. Uebelhoer). Twenty-nine patients completed the one treatment protocol with physicians reporting a mean improvement of 29% in acne scar appearance at 6 months. Patient self assessment was 35% average improvement and seventy-one percent (71%) of patients would recommend the procedure to a friend. These results were obtained after a single Portrait® Plasma treatment compared to the six treatments patients endure with the 1320nm Nd:Yag and up to 5 treatments with fractional lasers.

Portrait Plasma is a one of its kind - novel, non-invasive, in-office technology clinically proven to treat unhealthy signs of aging often accelerated by sun exposure. Plasma treats 100% of the skin; it stimulates a natural response producing healthier regeneration of the skin. Different from lasers which only target specific components of the skin, physicians and patients feel that with plasma’s unique approach results are maximized. This is especially important when treating acne scars, all wrinkles, skin laxity and pre-cancerous lesions, such as actinic keratosis. Further, unlike other procedures on the market, like CO2, erbium, or fractionated lasers, Portrait Plasma offers less downtime and little to no risk of hypopigmentation, scarring or discoloration as seen in this clinical study.

About Portrait Plasma:
Portrait^® PSR³ harnesses the power of plasma to deliver dramatic skincare results without the risk or down time associated with laser procedures. The hand-piece delivers nitrogen plasma energy that works both at and below the surface of the skin to modify its architecture and generate new collagen for up to two years. Portrait Plasma has been proven to treat fine lines and deep wrinkles, sun damage, pre-cancerous lesions, dyschromia and tighten skin. It also improves pore size, elasticity, and tone and texture of the face and body.

About Rhytec – The Makers of Portrait Plasma:
Rhytec develops innovative plasma technologies based on sound scientific and clinical research for the dermatological, plastic and cosmetic surgery markets. Plasma energy stimulates a true, natural skin regenerative process that is supported by over 30 completed and ongoing clinical trials. Founded in 2004, Rhytec works with leading dermatologists, plastic surgeons, and cosmetic physicians to develop new technologies that enhance the skin’s appearance and function, improving the quality of life for patients seeking treatment. Rhytec, Inc. is privately held, based in Waltham, MA (US), and is a subsidiary of Rhytec, Ltd. in Berkshire (UK).