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Pelleve Receives FDA Clearance for the Treatment of Mild to Moderate Facial Wrinkles
Date:5/18/2009

Ellman International launches next-generation aesthetic skin tightening technology

OCEANSIDE, N.Y., May 18 /PRNewswire/ -- Ellman International, Inc. announced today that the Food and Drug Administration (FDA) has granted clearance to Pelleve(TM), a skin tightening system for the non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV. The clearance was granted based on clinical data demonstrating that a single treatment with the high frequency radiowave device can safely and effectively tighten and improve the appearance of skin on the face through six months.

"Today's FDA clearance of the Pelleve system represents a very exciting step in the introduction of next-generation high frequency radiowave technology to physicians and patients in the United States," said Rick Epstein, CEO of Ellman International, Inc. "Pelleve offers safe, non-invasive facial rejuvenation with no need for a local anesthetic and minimal discomfort -- a significant evolution from previous-generation technologies in this class."

Pelleve uses the advanced radiowave technology of the Ellman International Surgitron(R) Dual RF(TM) S5 and a proprietary Pelleve handpiece to precisely deliver energy through the skin to the dermal tissue beneath without damaging the epidermis. This gentle heating of the deeper dermal tissue induces collagen denaturization and contraction. As the dermal tissue recovers, new collagen synthesis occurs, which creates a tightening effect. The result is a noticeable improvement in skin quality and appearance with minimal side effects and healing time for patients.

In a clinical trial conducted to determine the effectiveness of the Pelleve system, 83 women and 10 men were given a single treatment with the Pelleve handpiece. The procedure was performed in an ambulatory (outpatient) setting with no need for skin cooling products or anesthesia and took an
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SOURCE Ellman International, Inc.
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