PhotoMedex Receives FDA Approval For The Treatment of Leukoderma.

Business Editors/Health & Medical Writers

RADNOR, Pa.--(BW HealthWire)--May 17, 2002

PhotoMedex, Inc. (Nasdaq:PHMD) today announced that it has received U.S. Food and Drug Administration (FDA) clearance to market the XTRAC(TM) laser system to treat leukoderma (the loss of skin pigmentation often as a complication of injury to the skin from trauma, surgery, laser therapy and burns).

The Archives of Dermatology recently reported that the key to the effectiveness of the XTRAC(TM) excimer laser is that it stimulates melanocyte migration and proliferation by the release of cytokines and inflammatory mediators in the skin, which lead to re-pigmentation. PhotoMedex has experienced very promising results with its clinical studies on some of the more common types of leukoderma.

David J. Goldberg, MD, Skin Laser and Surgery Specialists of New York and New Jersey and Director of Laser Research in the Department of Dermatology at New York's Mount Sinai School of Medicine, reported on his pioneering efforts using the XTRAC(TM) laser on stretch marks.

Dr. Goldberg, in his recent interview with CNN (which will air on Friday May 17) noted, "the excimer laser targets the pigment cells in the white scar and causes them to produce more pigment, thereby improving the quality of the scar's color." He further commented, "Stretch marks are one of the biggest cosmetic concerns I hear among women, but overweight men are also susceptible."

Dr. Goldberg's research followed the progress of 10 subjects treated for stretch marks at weekly intervals over a five week period. The results show that within 6 to 9 treatments the stretch marks re-pigmented, making them less noticeable.

Stretch marks commonly occur from pregnancy and substantial weight gain, when the skin is stretched beyond its elastic limits and actually thins out. This thinned out skin initially appears red from inflammation, but eventually turns white, leaving a mature stretch scar.

Dr. Roy G. Geronemus of the Laser & Skin Surgery Center of New York, a pioneer in this field, stated in an interview with FOX News, "the use of the 308-nm excimer laser for the treatment of post-surgical scars and CO2 skin-resurfacing induced leukoderma is the first truly effective therapeutic option that we have seen that will be effective for millions of patients. It is a safe, painless, and effective treatment for the re-pigmentation of scars from surgery, as well as scars from previous traumatic injury, including burns. Though the treatment frequency varies from patient to patient, we have seen some remarkable results in as little as 2 treatments. The treatment sessions do not injure the skin, there is no patient downtime and the potential for success is high, making this an ideal cosmetic treatment."

Jeff O'Donnell commented, "We are pleased with this recent approval from the FDA for leukoderma, and are continuing to expand the applications for use of the XTRAC(TM) in the dermatological suite. We were delighted to learn that Dr. Goldberg will be featured on CNN on Friday, where he will be interviewed by Paula Zahn with respect to his recent pioneering efforts in the use of the XTRAC(TM) on stretch marks. 1 in 5 Americans suffer from either leukoderma, psoriasis, vitiligo, or atopic dermatitis. With the addition of this recent FDA approval, PhotoMedex can now provide effective remedial therapy for this group of patients. We will continue to expand the clinical applications of XTRAC(TM) to address the various other skin disorders that could be positively impacted by the XTRAC(TM) laser."

About PhotoMedex:

PhotoMedex is engaged in the development of proprietary excimer laser and fiber optic systems and techniques directed toward dermatological applications, with FDA approval to market the XTRAC(TM) laser system for the treatment of psoriasis, vitiligo, eczema and leukoderma.

The Company's excimer laser system generating 308-nm UV-B radiation is the first FDA-approved laser treatment for psoriasis, which is the second most common skin disorder in the U.S. The National Psoriasis Foundation estimates that psoriasis afflicts more than 7 million Americans and that between 150,000 and 260,000 new cases are diagnosed each year.

The XTRAC(TM) laser system is also the first FDA approved excimer laser system to treat vitiligo, a skin disease that, according to the National Vitiligo Foundation, afflicts approximately 1 to 2% of Americans, and eczema, a skin disease that is estimated to afflict 15 million Americans.

Some paragraphs of this press release, particularly those describing PhotoMedex' strategies, operating expense reductions and business plans, contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1993, as amended and Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. While PhotoMedex is working to achieve those goals, actual results could differ materially from those projected in the forward-looking statements as a result of a number of factors, including difficulties in marketing its products and services, need for capital, competition from other companies and other factors, any of which could have an adverse effect on the business plans of PhotoMedex, its reputation in the industry or its expected financial return from operations. Factors such as these could have an adverse effect on PhotoMedex' results of operations. In light of significant uncertainties inherent in forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by PhotoMedex and its subsidiaries that it will be achieved.