DALLAS, Aug 20, 2002/ FW/ --- Lumenis Ltd. (Nasdaq: LUME) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to the first acne treatment device for moderate inflammatory acne vulgaris.

The ClearLight system uses high-intensity, narrow-band phototherapeutic light to destroy the bacteria that cause acne.

Acne, a disease involving the sebaceous glands of the skin, is estimated to affect more than 80% of the world's population at some time during their life.

More than 30% of all dermatologist visits each year are for acne-related causes and, in the U.S., more than $1.4 billion is spent on anti-acne medications and treatments.

"Studies indicate about 40% of acne bacteria are resistant to antibiotics," according to Alon Maor, executive vice president of Lumenis' Aesthetic Division.

"And some treatments are now associated with very severe side effects. The ClearLight solution is designed as an attractive alternative to acne sufferers."

"Acne often causes social withdrawal, depression and embarrassment, which can have a devastating effect on self-esteem and self-confidence," says dermatologist A. R. Shalita, M.D. of SUNY Downstate Medical Center in Brooklyn, NY, one of the world's leading acne experts, who led the multi-center ClearLight clinical trials.

"ClearLight is an important new treatment for acne. It's effective, painless and, most importantly, has no known side effects."

About the ClearLight Acne PhotoClearing System

Representing a new paradigm in acne therapy, the ClearLight treatment penetrates just deeply enough into the skin's tissue to safely and effectively destroy Propionibacterium acnes bacteria, or P. acnes, the primary cause of acne.

The clinical data submitted to the FDA examined the effects of high-intensity, narrow-band light on P. acnes bacteria and the studies concluded that ClearLight was "a promising non-invasive, non-systemic alternative to current anti-acne remedies for moderate inflammatory acne."

The ClearLight technology, developed and manufactured by CureLight Ltd., treats acne at its source in a very natural way. P. acnes bacteria produce porphyrins as part of their normal metabolism.

The device's high-intensity light excites the porphyrins, resulting in photodestruction of the acne bacteria without damaging the surrounding tissue or skin. "Just exposing the patient's skin to this high-intensity light for 15 minutes will result in the elimination of bacteria that cause acne," said Macrene Alexiades-Armenakas M.D., a New York City-based dermatologist who has been using the ClearLight device.

ClearLight treatments are quick, easy and painless, and patients have no disruption of their normal activities - an important factor for today's busy teens and young adults.

Patients lie comfortably on a bed in their dermatologist's office for 15 minutes during each treatment session.

The typical ClearLight treatment regimen consists of eight visits over a period of four weeks. While any area of the body that has moderate inflammatory acne can be treated, the most common areas are the face, neck, chest and back.

The ClearLight system works equally well on patients of all skin colors.

Study Details

In the clinical validation study, researchers found the ClearLight Acne PhotoClearing System to be an effective method of reducing moderate inflammatory acne lesions.

All patients were treated twice a week for four weeks, then followed monthly for an additional three months. Clearing of inflammatory acne was observed to continue throughout the follow-up period.

After eight semi-weekly treatments, patients with moderate inflammatory acne showed significant improvement and no side effects were noted.

"Study participants were very satisfied with the clarity of their skin after undergoing ClearLight therapy," said Dr. Shalita.

"ClearLight is a non-drug alternative that's easy and effective, and, with no known side effects, this treatment device will surely allow more acne sufferers to enjoy the benefits of clear skin," said Maor of Lumenis. "ClearLight was launched in Canada, Europe and Japan last year, and has already caused a great deal of excitement among both dermatologists and acne sufferers."