FDA Clears GentleWaves® -- The First and Only Light Emitting Diode Device for the Treatment of Periorbital Wrinkles and Rhytids
GentleWaves® LED Photomodulation® proven effective for cosmetic skin fitness.
Virginia Beach, VA (PRWEB via PR Web
Direct) January 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.
About Light
BioScience
Light BioScience, LLC is the leader in the science of LED
Photomodulation, a groundbreaking light-based technology for medical and
aesthetic applications. Its flagship GentleWaves LED Photomodulation System
provides a safe and effective non-invasive and non-ablative solution to
photoaging and includes a complete skin care regimen featuring cosmeceuticals
that are dermatologist-tested and intended for all skin types. The Company is
actively researching other clinical uses of the GentleWaves platform technology,
including applications to improve acne, sunburn and wound
healing.
Based in Virginia Beach, VA, Light BioScience
was established in 2002 and now has over 11 patents issued or pending worldwide.
For more information, please visit www.lightbioscience.com.
For more information,
contact:
Nadine Tosk
504.483.6957
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Source : http://www.prweb.com/releases/2005/1/prweb194647.htm