Lerner Medical Devices, Inc.'s Levia(R) for Personal Targeted Phototherapy(TM) Treatment of Psoriasis Receives FDA 510 (k) Clearance

January 5, 2010 |

2 min read

LOS ANGELES, CA--(Marketwire - January 05, 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.”

About Lerner Medical Devices, Inc.

Lerner Medical Devices is focused on the use of ultraviolet B phototherapy for self-treatment of psoriasis and other photo-responsive skin conditions. Levia® is the first of their Personal Targeted Phototherapy™ products; it is designed to facilitate safe and effective management of psoriasis in a home environment and incorporates:

-- Proprietary beam delivery attachments to direct UVB light precisely to the affected areas of skin and scalp. -- Touch screen interface for maximum control by patients in accordance with preset instructions from the prescribing physician.

To learn more about Levia® and Lerner Medical, please visit www.mylevia.com.

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