Lerner Medical Devices' Levia receives FDA clearance

Jan 6 2010

Lerner Medical Devices, Inc. announced today that Levia®, a novel, in-home, ultraviolet B (UVB) phototherapy device, has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for treatment of psoriasis and certain other skin conditions such as vitiligo. Under the direction of a physician, Levia enables patients to treat privately their chronic scalp and small area psoriasis with a convenient, safe and effective non-drug option: Personal Targeted Phototherapy™.

Levia is purpose-designed to facilitate personal treatment of scalp and small area psoriasis flare-ups in the home environment, with physician control and oversight. Levia's proprietary touch-screen user interface permits the patient to manage the delivery of a physician-prescribed treatment regimen with appropriate flexibility. Levia's proprietary beam delivery attachments, Lite-Brush™ and Lite-Spot™, direct UVB light to the affected areas of scalp and skin. This precise targeting minimizes exposure of uninvolved areas and ensures controlled and rapid treatment.

John R. Lyon, CEO of Lerner Medical, said: "UVB phototherapy is a proven, non-systemic treatment for psoriasis which is under-utilized, because, as a cumulative therapy, it requires multiple office visits, with attendant multiple co-pays. Levia and Personal Targeted Phototherapy™ now offer psoriasis patients and their physicians the ability to utilize the non-drug option of UVB light in a private home environment, with a highly efficient treatment regimen and built-in safeguards. We believe that Personal Targeted Phototherapy with Levia represents a new standard of therapeutic effectiveness, convenience and control in the treatment of psoriasis. We expect Levia to be available to patients in the first quarter of 2010."