Navigation Links
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 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).

About i-Lipo

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.

About Chromogenex

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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Qualitest Pharmaceuticals Receives FDA Approval for Levetiracetam Oral Solution, 100 mg/mL
2. American Oriental Bioengineering Inc. Receives NYSE Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard
3. Labcon Receives Renewal of Quality Certification
4. Roche Receives FDA Approval for cobas p 630 Pre-analytical Solution for Automated Molecular Testing Platform
5. MAP Pharmaceuticals Receives Complete Response Letter from FDA for LEVADEX® (dihydroergotamine) NDA
6. Heraeus Venus® Bulk Fill Composite Receives 4-Star Rating from REALITY
7. Inovio Receives U.S. Patent for SynCon® H1N1 Influenza Universal Vaccine
8. Accuray Receives Microsoft Dynamics® Customer Excellence Award
9. HeartWare Receives 54-Patient Allotment From FDA Under Continued Access Protocol for Pivotal U.S. Bridge-to-Transplant Clinical Trial
10. Mylan Canada Receives Health Canada Approval for Generic Version of Crestor®
11. New Nail Fungus Approach Receives FDA Clearance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/23/2017)... HORSHAM, Pa. , Sept. 22, 2017 ... received a complete response letter from the U.S. Food ... (BLA) seeking approval of sirukumab for the treatment of ... response letter indicates additional clinical data are needed to ... of moderately to severely active RA. ...
(Date:9/22/2017)... -- AVACEN Medical (AVACEN) announced that its CE-Marked AVACEN ... with the widespread pain associated with fibromyalgia in the ... Essex, England commented, "I had difficulty ... sleep at all, tremendous pain, with every movement sending ... AVACEN 100] enough, how this has and is helping ...
(Date:9/19/2017)... , Sept. 19, 2017   ZirMed Inc ., ... analytics, today announced that it has been ranked #1 by ... Black Book™ Rankings 2017 User Survey. ZirMed was recognized ... for large hospitals and medical centers over 200 beds and ... Book,s healthcare technology user survey history. ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... 12, 2017 , ... Asante, a nationally recognized health system ... their existing home health joint venture through an agreement, effective October 1, 2017, ... venture home health company with Asante, delivering clinically integrated care, for the past ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, ... a medical article to the newly revamped Cosmetic Town journal section, ... hair transplant procedure known as Follicular Unit Extraction (FUE). , Dr. ...
(Date:10/12/2017)... ... 2017 , ... Leading pediatric oncology experts at Children’s National Health System ... Congress of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired by ... and Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., Chief of ...
(Date:10/12/2017)... RAPIDS, Mich. (PRWEB) , ... October 12, 2017 ... ... Wellness, has been named one of Michigan’s 2017 Best and Brightest in Wellness® ... and Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. ...
(Date:10/12/2017)... ... October 12, 2017 , ... In the ... a year. In some states—like New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, ... retirement havens have extremely low property-tax rates, which contributes to the relatively lower ...
Breaking Medicine News(10 mins):