Radiancy Receives FDA Clearance For The Psoriasis Light Unit Assembly
Published: Feb 15, 2006
ORANGEBURG, N.Y., Feb. 15 /PRNewswire/ -- Radiancy, Inc., the global leader in light-based skin therapies, announced today it has received U.S. Food and Drug Administration (FDA) 510(K) clearance to market the company's Psoriasis Light Unit Assembly (LUA) to treat psoriasis. The company's proprietary Light Heat Energy (LHE(R)) technology is already being used successfully in Europe, Asia and other countries to treat this chronic condition.
Results of clinical studies showed LHE phototherapy to be a safe and effective treatment for mild to moderate plaque and guttate psoriases. Patients in the study showed an average reduction of 65 percent on the Psoriasis Severity Index (PSI).
Radiancy's LHE based phototherapy systems have previously been cleared by the FDA for hair removal and the treatment of acne vulgaris and pigmented and vascular lesions on all skin types. Like Radiancy's other LUAs, the modular psoriasis LUA attaches quickly to Radiancy's LHE phototherapy systems, including the SkinStation(R), the company's leading product in the United States. SkinStation incorporates today's most sought after applications in one user-friendly system.
"We are delighted to have received FDA approval to market our Psoriasis LUA in the US," says Fabian Tenenbaum, vice president of marketing and sales for Radiancy. "This new indication provides additional treatment benefits to patients and physicians and is testament to our ongoing commitment in improving the lives of skin sufferers around the world."
Radiancy's LHE technology combines special wavelengths of pulsed light with direct heat to treat psoriasis from the inside out. The psoriasis LUA delivers green-yellow light that penetrates below the epidermis and through the plaque to the blood vessels that feed the plaque, explained Amos Leviav, M.D., head of plastic surgery at Kaplan Hospital, Rehovot, Israel, and lead investigator of the LHE psoriasis study.
The blood vessels are coagulated and destroyed via selective photothermolysis, resulting in eventual destruction of the plaque and its replacement by healthy tissue. The LUA also delivers red light and direct heat into the lesion to reduce swelling and inflammation and relieve itching.
"The LHE selective photothermolysis system delivers controlled heat simultaneously with the light pulse. It covers a wide area and relieves itching after one week of treatment," said Dr. Leviav. "The system is very safe and efficient and sufficiently cost-effective for practical widespread use."
Founded in 1998, Radiancy, Inc., develops unique professional and consumer medical products employing its proprietary Light Heat Energy (LHE(R)) and Extended Ablation Laser technologies. The company's mission is to deliver light-based therapeutic systems that improve the lives of people while enhancing clinical practice. Radiancy serves a worldwide clinical community from its offices in New York, Europe, Asia and Latin America.Radiancy, Inc.
CONTACT: Fabian Tenenbaum, Radiancy, Inc., +1-845-398-1647
Web site: http://www.radiancy.com/