CLARO Receives FDA-Clearance for Treatment of Acne |
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By: CLRS Technology Posted: 2008-10-29 05:54:51 |
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CLRS Technology today announced the CLARO acne-clearing device received marketing clearance by the US Food & Drug Administration (FDA) for treatment of mild to moderate inflammatory acne. CLARO, the first hand-held device to use Intense Pulsed Light (IPL) for treatment of acne, will be available by prescription January 2009 from medical professionals, including dermatologists, family practitioners and pediatricians.
"CLARO represents a new option for women and men of all ages who suffer from inflammatory acne," said Richard Oberreiter, CEO and Founder, CLRS Technology. "Unlike other at-home devices on the market for acne treatment, CLARO uses clinically proven Intense Pulsed Light (IPL) technology, combining heat and light to clear acne fast." CLARO is the company's first entry into the $225 million home device category, a dynamic part of the personal care market. According to Medical Insight Inc., the category is anticipated to grow to $1 billion in sales by 2012 as major corporations enter the field, including Palomar with Gillette, Syneron and Procter & Gamble and Light BioScience with L'Oreal. "I am very impressed with the science and engineering behind CLARO and believe it will be an important tool for anyone who struggles to clear their chronic or stubborn acne," said Dr. Ronald Moy Former Co-Chief of the Department of Dermatology and Chief of Dermatologic Surgery, UCLA and the lead investigator for CLARO clinical studies. "As physicians, we prescribe a variety of topical and oral treatments to fight acne, but people still experience the frustrations of flare-ups that wreck havoc on their self-esteem and their social life. My patients will be thrilled to have the efficacy of professional IPL technology in treating acne safely at their own convenience, whenever they need to." Using proprietary technology, CLARO delivers a series of light pulses in 6 seconds that safely penetrate the skin to eliminate the bacteria that cause acne and reduce inflammation. Clinical studies demonstrate a 94.8% decrease in p. acnes bacteria after just one treatment. CLRS Technology also announced the appointment of industry veteran Philip Charlton as Senior Vice President for International Distribution. As the founder of Photo Therapeutics Limited (PTL) Charlton led a pre-IPO financing round for that company that raised $25 million from institutional investors. He was also responsible for establishing and developing the Omnilux light therapy technology to a pre-eminent position throughout Europe, SE Asia and Australia. Charlton's role at CLRS Technology will be to drive product penetration in key global markets. In fact, the company already has a signed letter of intent from Paragon Global Marketing for distribution in South Korea, and is in final talks with multiple strategic and distribution partners both abroad and in the United States CLARO will be available in three colors, Onyx Black, Hot Pink and Cobalt Blue. The lightweight unit is battery-operated and portable. The suggested price will be $275. For more information, visit http://www.myclaro.com. CLRS Technology will be a participant in the 3rd Annual California Medical Device Forum, a "who's who" of medical device innovation nationwide, October 29-30 in Orange Country, CA (http://www.camedicaldeviceforum.com). About CLRS Technology Established in 2007, CLRS Technology is a manufacturing company that specializes in development of innovative and clinically proven consumer hand-held medical devices that deliver at-home solutions for common skin and allergy problems that were previously only available at a medical or aesthetic professional's office. |
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