Photomedex Receives FDA Approval to Utilize the XTRAC--TM-- Laser for Treatment of Vitiligo.Business Editors RADNOR, Pa.--(BUSINESS WIRE)--March 2, 2001 PhotoMedex, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : PHMD) today announced that it has received U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approval to market the XTRAC(TM) laser system to treat vitiligo vitiligo or leukoderma Skin disorder manifested by smooth, white spots on various parts of the body. Though the pigment-making cells of the skin, or melanocytes, are structurally intact, they have lost the ability to synthesize the pigment. . The XTRAC(TM) laser system is the first FDA-approved excimer laser system to treat vitiligo, a skin disease that, according to the National Vitiligo Foundation, afflicts approximately 1-2% of Americans (2-4 million). The disease causes losses of pigmentation pigmentation, name for the coloring matter found in certain plant and animal cells and for the color produced thereby. Pigmentation occurs in nearly all living organisms. in which patients develop white spots in the skin that vary in size and location. The spots occur when pigment cells, or melanocytes Melanocytes Skin cells derived from the neural crest that produce the protein pigment melanin. Mentioned in: Malignant Melanoma, Skin Pigmentation Disorders melanocytes , are destroyed and the pigment melanin melanin (mĕl`ənĭn), water-insoluble polymer of various compounds derived from the amino acid tyrosine. It is one of two pigments found in human skin and hair and adds brown to skin color; the other pigment is carotene, which contributes can no longer be produced. Up until now, there has been no known cure or effective treatment for vitiligo. The Company believes that, based on clinical trials conducted to date, that the XTRAC(TM) laser system can effectively re-pigment a patient's skin, essentially eradicating the white spots that had developed as a result of vitilgo, and restoring the patient's skin to the same condition that existed prior to the onset of the disease. The Company's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Jeff O'Donnell, commented, "The FDA approval for vitiligo is a monumental step towards expanding the treatment capabilities of our excimer laser platform technology and a testament to our belief in its potential effectiveness in the treatment of other skin diseases. This FDA approval will enable our doctors to offer an efficacious treatment to a patient population that, up to now, has had few options and is largely under served. We believe that this recent development moves us closer to having our technology universally recognized as an indispensable tool in the dermatology suite." Jeff O'Donnell further commented, "This approval comes at a very important time. We are showcasing the XTRAC(TM) laser system at the American Academy of Dermatology The American Academy of Dermatology (AAD) is the largest organization of dermatologists in the world. The Academy grants Fellowships and Associate Memberships, as well as Fellowships for Nonresidents (of the United States of America or Canada). Conference in Washington, D.C., March 2-7, and as the conference begins today, we can initiate physician awareness for using the XTRAC(TM) to treat vitiligo in addition to psoriasis." The Company's excimer laser system generating 308-nm UV-B UV-B or UVB Noun ultraviolet radiation with a range of 280-320 nanometres radiation is also the first FDA-approved laser treatment for psoriasis, which is the second most common skin disorder in the U.S. The National Psoriasis Foundation The National Psoriasis Foundation is a patient-driven, non-profit US-based psoriasis education and advocacy group. The National Psoriasis Foundation's mission is to improve the quality of life of the millions of Americans with psoriasis and/or psoriatic arthritis by promoting estimates that psoriasis afflicts more than 7 million Americans and that between 150,000 and 260,000 new cases are diagnosed each year. 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 and vitiligo. 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 the subsidiary companies 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 |
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