First LED device to receive approval for a medical claim associated with cosmetic improvement of aging and sun-damaged skin

Jan 5 2005

Light BioScience announced today that the U.S. Food and Drug Administration (FDA) cleared GentleWaves Light Emitting Diode (LED) Photomodulation System for the non-invasive treatment of periorbital (eye area) wrinkles and rhytids.

GentleWaves is the first and only LED device to receive marketing approval for a medical claim associated with cosmetic improvement of aging and sun-damaged skin, further validating the science of LED Photomodulation for skin rejuvenation.

"GentleWaves LED Photomodulation is a fundamentally new approach to improving photoaging and environmentally damaged skin that does not rely on high-energy sources and heat damage to photoactivate collagen genes," said Robert A. Weiss, MD, associate professor of dermatology at Johns Hopkins University School of Medicine in Baltimore, Maryland. "For the first time, we are both slowing down collagen breakdown and building up new collagen with no pain, no redness and no serious side effects. GentleWaves' unique ability to stimulate and/or inhibit cell signaling pathways for skin rejuvenation truly represents the next frontier in anti-aging medicine," added Dr. Weiss.

GentleWaves uses specially coded arrays of light emitting diodes to modulate the activity of living cells. Unlike other laser, pulsed light or radiofrequency techniques used today for skin rejuvenation, GentleWaves' exclusive core technology delivers very low-intensity, non-thermal light energy to stimulate collagen and reverse the appearance of photoaging. With its proprietary and predetermined energy sequencing, the easy-to-use device poses no learning curve or risk of complications. A patient simply sits with his/her face exposed to two panels of over 2,000 yellow cascading LED lights for less than one minute. The device can also be adjusted to treat the neck and chest areas. And, for patients seeking a full program of skin fitness, GentleWaves treatment is complemented by a scientifically developed line of cosmeceutical products.

According to lead researcher David H. McDaniel, MD, the FDA clearance of GentleWaves marks the culmination of years of rigorous scientific investigation and successful clinical practice by renowned aesthetic physicians nationwide. "We are proud that we adhered to the scientific standards the FDA applies to guarantee the efficacy of a new anti-wrinkle device introduced to today's appearance-conscious consumers," said Dr. McDaniel, the director of the Institute of Anti-Aging Research in Virginia Beach, VA.

Recognizing the capabilities and benefits of the GentleWaves System, Rick Krupnick, CEO of Light BioScience, enthusiastically announced his excitement regarding the regulatory clearance: "The FDA clearance distinguishes GentleWaves as the first and only LED device to effectively treat periorbital wrinkles. Today's announcement of medical marketing claims allows us to meet a growing demand from patients who have been waiting for a gentle, pain-free skin fitness regime without side effects, downtime or a huge investment."

To assess the safety and efficacy of GentleWaves, the FDA reviewed data from a multi-center clinical study of 54 patients. After 8 GentleWaves treatments, over 50% of all patients showed measurable improvement in periorbital wrinkle reduction. Further, of those with more severe wrinkles (category 6-8), 94% exhibited measurable improvement.