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FDA Grants Over-The-Counter Clearance to GentleWaves(R) for the First Home Use Light-Based Device to Treat Wrinkles
Date:2/25/2008

Clearance Opens Door For Home Use In The Anti-Aging Market

VIRGINIA BEACH, Va., Feb. 25 /PRNewswire-USNewswire/ -- Light BioScience(R), LLC, the leader in the science of LED (light emitting diode) Photomodulation, announced today that it has become the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for the treatment of periorbital wrinkles. This clearance paves the way for future development of a new anti-aging device to deliver the GentleWaves LED Photomodulation(R) technology directly to the consumer marketplace without a prescription.

Currently used by physicians around the world, GentleWaves has been scientifically proven to reduce the appearance of fine lines and wrinkles through the use of a patented system of pulsating amber-colored LEDs. These LEDs are specifically coded to stimulate collagen production while slowing down collagen breakdown(1). Invented by David H. McDaniel, M.D., director of the Institute of Anti-Aging Research and Assistant Professor of Clinical Dermatology and Plastic Surgery, Eastern Virginia Medical School, Virginia Beach, Va., the GentleWaves LED Photomodulation technology is a novel approach to provide skin rejuvenation without injuring the skin. GentleWaves is non-thermal, non-ablative and has no pain, side effects, or downtime.

"This clearance marks a significant milestone for our company as we continue to demonstrate our leadership in light-based science and break new ground in the medical professional and home use markets," comments Rick Krupnick, Chief Executive Officer of Light BioScience. "The opportunity to develop the first FDA cleared at-home, light-based device to treat wrinkles is just the first step in making this exciting technology more accessible to the public."

The future of GentleWaves is even more promising as its benefits expand beyond the anti-aging arena. Currently the Company is investigating new treatments for wound healing, radiation dermatitis, acne, thinning hair, and ophthalmic disorders.

"Our on-going research reveals that the platform GentleWaves technology has the potential to treat or prevent a wide variety of medical conditions," adds Krupnick. "Light BioScience is committed to investing in research and development so that we can bring these expanded applications to the medical community as well as to the consumer marketplace."

In 2003, Light BioScience created a new way for dermatologists and plastic surgeons to approach anti-aging and skin rejuvenation with the introduction of its flagship product, the GentleWaves LED Photomodulation System. Today, LED technology has become one of the most popular cosmetic treatments offered by doctors and estheticians worldwide.

"GentleWaves LED Photomodulation is a very useful new tool for cosmetic surgeons to reduce wrinkles in a rapid, safe and truly painless manner," explains Dr. McDaniel. "The ability to extend this therapy for use in the home without a reduction in benefits is a significant advancement in treating aging skin. The most exciting part of this development may ultimately be the interest that has been stimulated by the science and theory of Photomodulation discovered during the research and development of the GentleWaves device. Physicians and scientists worldwide are now exploring how very low energy light interacts with not just skin, but all living cells in the body. I expect many new applications for the GentleWaves technology in the future - this is only the beginning of what will be possible for both home and medical light therapies."

Tina Alster, M.D., director of the Washington Institute of Dermatologic and Laser Surgery in Washington, D.C. comments, "GentleWaves(R) offers superior rejuvenation compared to applying Retinoic Acid, but without the potential irritation."

About GentleWaves LED Photomodulation

Quick and convenient for today's fast-paced world, GentleWaves has been clinically proven to reduce fine lines and wrinkles without pain, redness, peeling or downtime. Users spend less than one minute sitting in front of a cascading array of amber colored pulsating lights. Because LED Photomodulation is a non-thermal, photo-biochemical process, it is one of the only technologies now available to safely treat all skin types resulting in noticeably softer, smoother and healthier-looking skin.

About Light BioScience, LLC

Light BioScience, LLC is the leader in the science of Light-Emitting Diodes (LED) Photomodulation, a groundbreaking light-based technology for medical and aesthetic applications. Its flagship product, the GentleWaves LED Photomodulation System, provides a safe and effective nonablative solution to photoaging. This non-thermal, non-invasive technology uses low intensity LEDs at specially calibrated energies to reduce the visible signs of aging and sun-damaged skin.

The company is actively researching other applications of the unique GentleWaves platform technology, including treatment protocols for the control of radiation dermatitis, the treatment of acne, thinning hair, and ophthalmic disorders. Based in Virginia Beach, VA, Light BioScience was founded in 2002 and now has more than 17 issued patents and 60 pending in the U.S.A. and worldwide. GentleWaves is currently used in hundreds of physician offices and medi-spas worldwide and has been clinically tested and shown to be safe and effective.

Dedicated to science and research, the company is continuing it's testing of a variety of new technologies to expand offerings to the medical and consumer markets.

For more information on Light BioScience and its products, visit Light BioScience's website at http://www.lightbioscience.com .

(1) Robert A. Weiss M.D., David H. McDaniel, M.D. Roy G. Geronemus, M.D., Margaret A. Weiss M.D, "Clinical Trial of A Novel Non-Thermal LED Array for Reversal of Photoaging: Clinical, Histologic, and Surface Profilometric Results," Lasers in Surgery Medicine, 2005 and Robert A. Weiss M.D., David H. McDaniel, M.D., Margaret A. Weiss M.D., Roy G. Geronemus, M.D., Karen L. Beasley, Girish M. Munavalli, M.D., Supriya G. Bellew, M.D., "Clinical Experience With Light-Emitting Diode (LED) Photomodulation(R)," The American Society for Dermatologic Surgery, 2005.


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SOURCE Light BioScience, LLC
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