FDA Approves First LED System for Acne Treatment

IRVINE, Calif., July 4 --Alderm LLC and its exclusive manufacturing partner, Photo Therapeutics Ltd., of Manchester, England, have received marketing clearance from the US Food and Drug Administration (FDA) for the OmniLux blue light-emitting diode (LED) system for the treatment of dermatological conditions, specifically acne.

According to James Kraushaar, president of Alderm, this represents "a breakthrough in terms of making this highly-efficacious and cost-effective LED technology available to medical dermatologists as an alternative treatment for acne which has no serious negative side effects. Once acne patients become aware of this new treatment, systemic drugs will certainly become less desirable options."

Omnilux Blue uses a panel of LEDs, encased in one of several interchangeable heads driven by the OmniLux core technology platform, to deliver narrowband 415 nm visible light with high-spectral purity -- meaning that no ultraviolet, infrared or "inappropriate visible radiation" is delivered. This increases both the precision and effectiveness of the treatment, the company said. OmniLux Revive, designed for skin treatments using red light, is pending FDA clearance.

According to a New Aesthetic Technologies and Business Opportunities market study just released by Medical Insight Inc., skin rejuvenation, wrinkle removal, acne treatment and cellulite reduction are the highest-growth aesthetic device-based market segments. Over the next five years, sales of devices that perform these procedures will increase significantly as treatment volume grows, according to the report, which includes an extensive review of LED systems.

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