PhotoMedex Receives FDA Clearance to Utilize the XTRAC-TM- laser System for Treatment of Atopic Dermatitis -Eczema-.Business Editors/Biotechnology Writers RADNOR, Pa.--(BUSINESS WIRE)--Aug. 14, 2001 PhotoMedex, Inc. (Nasdaq: PHMD) 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. ) clearance to market the XTRAC(TM) laser system to treat atopic dermatitis Atopic Dermatitis Definition Eczema is a general term used to describe a variety of conditions that cause an itchy, inflamed skin rash. Atopic dermatitis, a form of eczema, is a non-contagious disorder characterized by chronically inflamed skin and . Atopic dermatitis, or eczema, is a chronic inflammation chronic inflammation n. Inflammation that may have a rapid or slow onset but is characterized primarily by its persistence and lack of clear resolution; it occurs when the tissues are unable to overcome the effects of the injuring agent. of the skin that can afflict persons of any age, but is considered to be the most common skin disease in children under the age of 11. It is a common, potentially debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction disease that can severely compromise quality of life. According to an 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). (AAD AAD American Academy of Dermatology. AAD American Association of Dermatology ) press release entitled "Eczema on the Rise", more than 15 million Americans suffer from eczema, and more than 10% of children worldwide. According to the same AAD release, scientist's estimate that sixty-five percent of children diagnosed with eczema contracted the disease in the first year of life. The disease is characterized by inflamed, dry, scaling, and itchy skin. The itching is so intense that many patients, especially children, will scratch or rub themselves until they bleed, increasing the risk of secondary infection. It is estimated that, in the U.S., more than $365 million is spent annually on treatment, which typically involves a regimen of lubricants, tar-based gels, antihistamines Antihistamines Definition Antihistamines are drugs that block the action of histamine (a compound released in allergic inflammatory reactions) at the H1 , antibiotics, topical corticosteriods, and ultraviolet light therapy for severe cases. Although the symptoms of eczema typically dissipate by adolescence in 50% of affected children, the condition can persist into adulthood, with no known cure. It is estimated that eczema accounts for approximately 20 percent of all patient referrals to a dermatologist. As in psoriasis and 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. , eczema frequently occurs in the hinged areas of the body, which the XTRAC(TM) laser system is particularly effective in treating. Generally, current treatments for chronic eczema are a reimbursable medical expense by private insurers and government health programs. Jeff O'Donnell, 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. , commented, "We are very pleased to have received approval from the FDA so quickly. With 15 million Americans suffering from the disease, the ability to now treat eczema is another significant opportunity to expand the treatment platform for our XTRAC(TM) laser." 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, and eczema. 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 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. 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 |
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