NEWS RELEASE for September 25, 2008 FOR IMMEDIATE RELEASE
Contacts: Branden Morris
Integrated Marketing Manager
Palomar Medical Technologies, Inc.
Palomar Receives FDA Clearance for the Treatment of Scars
with the Lux1540 Fractional Non-Ablative Laser Handpiece
BURLINGTON, MA (September 25, 2008) … Palomar Medical Technologies, Inc. (Nasdaq: PMTI), a leading researcher and developer of light-based systems for cosmetic treatments, today announced that it has received clearance from the FDA for the treatment of scars with the Palomar Lux1540™ Fractional Non-Ablative Laser Handpiece, including those from surgical procedures and acne. The Lux1540 is an attachment to the StarLux® and StarLux 500® Laser and Pulsed-Light Systems.
The Lux1540 has been shown to be effective in treating both atrophic (depressed) and hypertrophic (raised) scars by creating micro-columns of coagulated tissue in the skin. This process results in significant improvement in the appearance of scars, offers short recovery times, and allows doctors to tailor the treatment for each patient's individual skin type and scar. Until now, other light-based scar treatments have offered either modest results or undesirable side effects and healing time.
"The laser uses fractional, non-ablative technology, which maximizes the efficacy of the treatment while avoiding some of the side effects associated with full-surface ablative therapy," said David B. Vasily, MD, Medical Director of the Aesthetica Cosmetic and Laser Center in Bethlehem, Pennsylvania. "Treatment with the Palomar Lux1540 fractional technology has the potential to become the gold standard for scar treatment."
This latest FDA clearance for the Lux1540 expands its approvals to melasma, soft tissue coagulation and non-ablative skin resurfacing in addition to the new scar approvals.
"Scars can have negative effects on patients both physically and psychologically," said Gregory Altshuler, Ph.D., Senior Vice President of Research at Palomar. "We are pleased to offer an effective treatment that works on surgical scars, such as those from caesarian sections, mastectomies or other cancer surgeries, as well as those caused by acne."
Leading scar treatment experts Dr. Vasily and Vic A. Narurkar, MD, Assistant Professor of Dermatology at UC Davis Medical School, will demonstrate the Lux1540 and scar treatment procedure in a Web seminar on October 9, 2008 at 8:00pm EST. The seminar can be accessed from www.palomarmedical.com.
ABOUT PALOMAR MEDICAL TECHNOLOGIES Palomar is a leading researcher and developer of light-based systems for cosmetic treatments. Palomar pioneered the optical hair removal field, when, in 1997, it introduced the first high-powered laser hair removal system. Since then, many of the major advances in light-based hair removal have been based on Palomar technology. In December 2006, Palomar became the first company to receive a 510(k) over-the- counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home use, light-based hair removal device. OTC clearance allows the product to be marketed and sold directly to consumers without a prescription. There are now millions of light-based cosmetic procedures performed around the world every year in physician offices, clinics, spas and salons. Palomar is testing many new and exciting applications to further advance the hair removal market and other cosmetic applications. Palomar is focused on developing proprietary light-based technology for introduction to the mass markets. In addition to the non- exclusive License Agreement with Proctor &Gamble, Palomar also has an agreement with Johnson & Johnson Consumer Companies to develop and potentially commercialize home-use, light-based devices for reducing or reshaping body fat including cellulite, reducing the appearance of skin aging, and reducing or preventing acne.
For more information on Palomar and its products, visit Palomar's website at www.palomarmedical.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current expectations, plans, intentions, beliefs or predictions. These forward-looking statements are neither promises nor guarantees, but involve risk and uncertainties that may individually or mutually impact the matters herein, and cause actual results, events and performance to differ materially from such forward-looking statements. These risk factors include, but are not limited to, results of future operations, technological difficulties in developing or introducing new products, the results of future research, lack of product demand and market acceptance for current and future products, the effect of economic conditions, challenges in managing joint ventures and research with third parties and government contracts, the impact of competitive products and pricing, governmental regulations with respect to medical devices, including whether FDA clearance will be obtained for future products and additional applications, the results of litigation, including patent infringement lawsuits, difficulties in collecting royalties, potential infringement of third-party intellectual property rights, factors affecting the Company's future income and resulting ability to utilize its NOLs, and/or other factors, which are detailed from time to time in the Company's SEC reports, including the report on Form 10-K for the year ended December 31, 2007 and the Company's quarterly reports on Form 10-Q. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to release publicly the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.