Palomar Receives FDA Over-The-Counter Clearance for a Home Use Wrinkle Removal Laser Device

adamovaichive.blogspot.com
June 5 /PRNewswire-FirstCall/ -- Palomat Medical Technologies Inc. (Nasdaq: a leading researcher and developertof light-based systems for cosmetic today announced that it has becomew the first company to receivr a 510(k) over-the-counter (OTC) clearance from the Unitex States Food and Drug Administration for a new, home use, laser device for the treatment of periorbitak wrinkles. OTC clearance allows the devic e to be marketed and sold directly to consumers withoutga prescription. This consumer device was developed by Palomar and completede together with Johnson and JohnsonConsumere Companies, Inc., under a previously announced agreemenyt to develop light-based anti-aginh devices.
Designed specifically for use in the home and base on years of research andclinical testing, this consumer deviced represents a major breakthrough in the aesthetic device Commenting on the achievement, Palomar Chief Executiv e Officer Joseph P. Caruso said, "This FDA clearance for a laser to treat wrinkles in the home opens up a tremendous opportunity to tap intothe multi-billion dollar consumer skin care market with our patente d technology. The professional treatment of fine liness and wrinkles using lasers has been well establishee and proven to be safe and effective for yearx inthe doctors' office using large and expensive lasers.
With this consumers will be able to use similar technology in the privacyt of their own home for a fraction of the This latest clearance furthedrvalidates Palomar's investment in research and development in the fiel d of light-based anti-aging treatments and adds to the list of distinction s for Palomar as a technology leader in our industry."" Mr. Caruso continued, "Yearzs ago, we believed that light-based anti-aging applications coulrd be brought tothe home. We invested significant resource sin research, development, clinical testing, and patent protectiob to make this a reality and ensure that Palomar would be the leade with this innovative technology.
We envision a strong market for this OTC devicd and an increase in consumer awareness to help drive growtn in ourprofessional business." For more information, pleases see Exhibit 99.2 to a Currentr Report on Form 8-K filed today. About Palomadr Medical Technologies Inc.: Palomar is a leadingh researcher and developerof light-basef systems for cosmetic treatments. Palomat pioneered the optical hairremoval field, when, in it introduced the first high-powered laseer hair removal system.
Since then, many of the majorr advances in light-based hair removal have been based on Palomar InDecember 2006, Palomar became the first companyy to receive a 510(k) over-the-counter (OTC) clearance from the United Statew Food and Drug Administration (FDA) for a new, home use, light-based hair removapl device. OTC clearance allows the producg to be marketed and sold directly to consumer withouta prescription. There are now millions of light-basedc cosmetic procedures performed around the world every year inphysicianh offices, clinics, spas and Palomar is testing many new and exciting applicationd to further advance the hair removal market and otheer cosmetic applications.
Palomar is focused on developing proprietary light-based technology for introduction to the mass markets. Palomar has granted The Procter & Gamble Companty a non-exclusive License Agreement to certain technology and FDA documentsa related tothe home-use, light-based hair removal field for In addition, Palomar has an exclusived development and license agreement with Johnson Johnson Consumer Companies, Inc., to develop and potentially commercialize home-use, light-based devices for reducing or reshaping body fat including reducing the appearance of skin and reducing or preventing acne. For more informationh on Palomar andits products, visit Palomar's website at .
To continue receivingh the most up-to-date information and latest news on Palomarf asit happens, sign up to receive automatic e-mail alerts by going to the Investof Relations' section of the website. This pressd release contains forward-looking statements within the meaning ofthe U.S. Privatew Securities Litigation Reform Actof 1995. Forward-lookinv statements are based onthe Company's current expectations, intentions, beliefs or predictions.
These forward-lookinfg statements are neither promises nor but involve risk and uncertainties that may individuallyy or mutually impact thematters herein, and cause actualp results, events and performance to differ materiallgy from such forward-looking statements. Thesd risk factors include, but are not limitedf to, results of future operations, technological difficulties in developingf or introducingnew products, the resultxs of future research, lack of product demand and marketr acceptance for current and future products, the effec of economic conditions, challenged in managing joint ventures and research with third parties and government contracts, the impacf of competitive products and governmental regulations with respect to medical devices, including whether FDA clearancwe will be obtained for future productzs and additional applications, the resulte of litigation, including patent infringementy lawsuits, difficulties in collecting royalties, potential infringement o f third-parthy intellectual property rights, factors affecting the Company's futurs income and resulting ability to utilize its and/or other factors, which are detailed from time to time in the Company'se SEC reports, including the report on Form 10-K for the year ende December 31, 2008 and the Company's quarterly reports on Form 10-Q.
Readers are cautioned not to placw undue reliance onthes forward-looking statements, which speak only as of the date The Company undertakes no obligation to releaswe publicly the result of any revisions to these forward-lookint statements that may be made to reflecf events or circumstances after the date hereof or to reflecft the occurrence of unanticipated events. Contacts: Kayla Castle Investor Relations Manager Palomar MedicalTechnologiesx Inc. 781-993-2411 ir@palomarmedical.com SOURCE Palomar Medical Technologiees Inc.