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 reduction of 4.0cm (1.57 inches) from the circumference measurement of the waist from the baseline measurement following the course of eight i-Lipo treatments. 79% (15 of 19 participants) of the test group achieved and surpassed this reduction, while only 6.7% (1 participant out of 15) of the control group achieved the target. This 72% difference between the two groups is more than double the percentage difference defined by the FDA as demonstrating a significant result from treatment. Comparison of the results between the mean circumference reduction from the initial baseline measurements within the two groups demonstrated a mean difference of 3.8cm (1.49 inches).
i-Lipo is the latest in non-invasive, non-surgical fat reduction, offering a solution to achieve inch loss and body contouring with no pain, no needles and no down time. i-Lipo emits low levels of laser energy, which creates a chemical signal in the fat cells, breaking down the stored triglycerides into free fatty acids and glycerol, and releasing them though channels in the cell membranes. The fatty acids and glycerol are then transported around the body to the tissues that will use them during metabolism to create energy. A period of exercise post treatment will ensure the complete metabolism and elimination from the body of the freed fatty acids.
Chromogenex Technologies LTD is the UK's leading developer and manufacturer of laser and intense pulsed light (IPL) systems. Since 1985, Chromogenex Technologies LTD has been at the forefront of laser and light technology for aesthetic applications such as hair removal, skin rejuvenation, acne and vascular lesions. In 1994, the company developed and patented the world's first Ruby laser for permanent hair reduction. In 1998, we introduced the patented Nlite laser, the first laser to receive FDA clearance for wrinkle reduction and in 2000 we were the first company to receive FDA Approval for Inflammatory acne vulgaris, working with some of the world's leading dermatologists and clinical researchers.
|SOURCE Chromogenex Technologies LTD|
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