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CoolTouch Endovenous Laser Ablation (CTEV)

COOLTOUCH® 1320NM LASER SYSTEM GETS FDA NOD FOR TREATMENT OF ACNE AND ACNE SCARS

 

Roseville, Calif - May 28, 2003. As many as four out of five people between the ages of 11 and 30 now have a cool treatment option to erase acne and the devastating scars left behind. CoolTouch Inc. announced today that its flagship CoolTouch 1320nm laser system received 510(k) clearance from the U.S. Food and Drug Administration for treatment of unsightly whiteheads, blackheads, red pustules and depressed scars that are the hallmarks of active acne.

"Cool Touch is an exciting new weapon in our acne-fighting armory, especially for three patient groups: young people who fail to respond to traditional acne treatments; patients who simply don't want to take pills; and those who demand active therapy with a device," said laser expert Dr. Jeffrey Dover, associate clinical professor of dermatology at Yale University School of Medicine. "Our acne patients are delighted with the dramatic improvements they see with as few as two CoolTouch treatments."

Unlike resurfacing lasers that remove the top layers of skin, CoolTouch's non-ablative technology reaches deep down to alter the sebaceous glands where acne lesions occur without affecting the skin surface. By using CoolTouch's infrared light energy to heat the layer of the sebaceous glands to therapeutic levels, clinical studies show the number of active acne lesions is significantly reduced. In contrast to other high-tech devices for acne treatment, CoolTouch laser technology effectively works for all skin types, requires no downtime and is well tolerated. Its powerful cryogen cooling mechanism further protects the epidermis and minimizes the risk of hyperpigmentation.

Dr. Dover noted that "we also find the new CoolTouch CT3 to be a stellar therapy for patients with acne scarring and are very encouraged by our early results." In fact, Dr. Dover just completed a clinical study using CoolTouch for acne scars on 60 male and female patients of all skin types, including skin of color. Each patient underwent a series of six CoolTouch treatments at monthly intervals. Patients found treatment to be virtually pain-free, and all but two expressed high satisfaction with their results. No adverse effects were reported.

According to dermatologic laser experts, it makes perfect clinical sense that CoolTouch technology would be a home run for acne scars since the device was the first non-ablative laser system to demonstrate collagen remodeling for wrinkle treatment. "By stimulating fibroblasts to produce collagen in the dermis, we see a tightening of the skin around a scar that gradually smoothes and evens out the atrophic acne scar, similar to the softening we see when wrinkled skin is pulled taut," explains Dr. Dover. "Thus, we can expect CoolTouch to offer safe, rapid clearance of active acne, improve acne scarring and provide cosmetic enhancement all in one treatment regime."

About CoolTouch
CoolTouch N.I.C.E.T (Non-Invasive Collagen Enhancement) Skin Treatments are the first non-invasive process to stimulate the production of new collagen to reduce fine lines and wrinkles and combat the visible signs of aging with no downtime.
Launched in 1996, the first CoolTouch laser incorporated proprietary non-ablative technology with pulsed cryogen cooling and a unique thermal feedback mechanism to provide a process for selectively targeting and stimulating collagen-producing fibroblasts in the upper dermis. The end result is a softening of wrinkles and a healthier, refreshed appearance.

For more information, please visit our Web site at www.cooltouch.com