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Chromogenex Receives FDA Clearance for Circumferential Reduction for i-Lipo Body Contouring System
Date:4/13/2012

NEW YORK, April 13, 2012 /PRNewswire/ -- Chromogenex announced today that they have received FDA clearance to market the i-Lipo low-level laser diode device for circumferential reduction. i-Lipo is the first direct skin contact laser device designed for fat reduction and body contouring to receive FDA clearance for circumferential reduction. Based on results from a recent double-blind, placebo-controlled, randomized study of 34 volunteers, the FDA found that over 70% of participants experienced significant inch loss, thus validating the use of i-Lipo to target specifically chosen anatomical areas for fat reduction. The results represented more than double the percentage difference for meeting significant results as defined by the FDA.

"This study supports previous studies completed in France and the UK and from results experienced by current i-Lipo devices already placed in over 1000 commercial clinics worldwide," stated Peter McGuinness, CEO of Chromogenex Technologies LTD. "This result from the FDA is extremely statistically significant and gives confidence of 99.99% that a participant undertaking i-Lipo will achieve a greater circumference reduction than a participant undertaking exercise alone in a three to four week period."

Data Demonstrated Significant, Measurable Results

Of the 34 male and female participants recruited for the study, 19 were randomly selected for the treatment group and 15 for the control group. The treatment group received eight 20-minute laser treatment sessions, scheduled over a three to four week period, which were immediately followed by a period of post-treatment exercise. The control group undertook an identical treatment and exercise program using a placebo light diode device. Participants were unaware of their group allocations until after completion of the study.

The individual success criteria for the study participants was to achieve a minimum reductio
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SOURCE Chromogenex Technologies LTD
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