Sunday, 23 March 2008 00:00
Orangeburg, NY: 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 Skin Station phototherapy system to treat psoriasis. The company’s proprietary Light Heat Energy (LHE®) 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. Radiancy’s modular platform allows the psoriasis handpiece kit to attach quickly to Radiancy’s SkinStation®, the company’s leading product. SkinStation incorporates today’s most sought after applications in one user-friendly system.
“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."
“We are delighted to have received FDA approval to market our Psoriasis technology 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 device 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 device also delivers red light and direct heat into the lesion to reduce swelling and inflammation and relieve itching.