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Reliant Technologies Announces FDA Clearance of the Fraxel(R) Laser for the Treatment of Acne and Surgical Scars


MOUNTAIN VIEW, Calif.--March 27, 2006--Reliant Technologies today announced that it has received U.S. Food and Drug Administration (FDA) clearance to market a new indication for its breakthrough Fraxel(R) Laser that enables physicians to treat acne scars and surgical scars. Until now, facial scarring has been difficult to treat with even the most aggressive topical and abrasive therapies. This has been a major disappointment to adult patients who must carry the stigma of adolescent acne long after their skin is free of active acne, or to those individuals who are left with a permanent reminder of a past surgery.

Scars are depressions or indentations that occur from the skin's natural healing process following surgery or a medical condition, such as acne. Like photodamaged skin, scars contain reduced amounts of collagen, have irregularly structured dermal fibers and usually lack elasticity. There are several types of scars caused by acne - including deep "ice-pick" scars that are the hallmark of acne scarring; "box car" scars that usually occur on the cheek or forehead and resemble chickenpox marks; and "rolling" scars that give the skin a wavy appearance. A surgical scar is scar tissue that forms and leaves a mark in response to skin healing after a surgical incision.

According to Zakia Rahman, M.D., clinical instructor of dermatology at Stanford University in Palo Alto, CA and medical director of the Fraxel Laser Clinic in Mountain View, CA, "a successful treatment outcome requires both the removal of damaged epidermal (surface) tissue and the stimulation of collagen remodeling in the dermal component of acne and surgical scars in order to improve collagen fiber reorganization, surface texture and skin tone.

"Only the proprietary Fraxel laser with its unique science of fractional resurfacing provides a comprehensive treatment approach that gently repairs the epidermal abnormalities and also reaches deep into the dermis to induce new collagen formation without compromising patient safety," continues Dr. Rahman, who was the principal investigator of the clinical study that Reliant presented to the FDA for 510(k) clearance.

The study enrolled 40 subjects who had 53 scars that were treated with the Fraxel laser. Clinical outcomes were reviewed after three to five treatments at one- and three-month follow-ups. Independent investigator evaluation indicated that 92% of all subjects treated sustained statistically significant improvement in overall scar severity at the three-month follow-up visit. Treatments were safe and well-tolerated with no serious adverse events observed.

"The beauty of the Fraxel laser is its unrivalled ability to repair a range of facial scars and promote collagen growth in patients of all skin types," says dermatology laser expert Vic Narurkar, M.D., founder of the Bay Area Laser Institute of San Francisco, CA.

Dr. Narukar adds, "Using millions of tiny microscopic laser spots surrounded by islands of healthy tissue, the new Fraxel laser produces optimal results without the downtime and complications associated with ablative lasers and other destructive techniques. Our patients are thrilled because they can see and feel a noticeable improvement in the surface texture, skin color and the topography of the scar after only one to two treatments."

The latest FDA approval for the Fraxel laser extends clearances obtained in 2003 for soft tissue coagulation; in 2004 for skin resurfacing and for correction of periorbital wrinkles and pigmented lesions, including age spots, sun spots and skin discoloration; and in 2005 for the treatment of melasma.

Reliant Technologies is a leading manufacturer of medical laser technology for aesthetic applications. The Company's laser device is used primarily by aesthetic physicians to treat periorbital wrinkles, pigmented lesions and photo-damaged skin of the face and body. Reliant pioneered the development of the Fraxel laser which relies on new-generation fractional resurfacing with a million points of light to produce safe and effective results with minimal recovery time. Reliant employs more than 100 people and is headquartered in Mountain View, California.