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:6/23/2016)... -- Any dentist who has made an implant supported denture ... of them do not even offer this as a viable ... costs involved. And those who ARE able to offer that ... cost that the majority of today,s patients would not be ... , founder of Dental Evolutions Inc. and inventor of Implanova ...
(Date:6/23/2016)...  In a startling report released today, National Safety Council ... a comprehensive, proven plan to eliminate prescription opioid overdoses. ... states are tackling the worst drug crisis in recorded U.S. history, ... Kentucky , New Mexico , ... the 28 failing states, three – Michigan , ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... Market Analysis 2016 - Forecast to 2022" report to ... report contains up to date financial data derived from varied ... major trends with potential impact on the market during the ... segmentation which comprises of sub markets, regional and country level ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... was developed to enhance the health of felines. The formula is all-natural and is ... herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library ... City Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ... for fumigation is not a common occurrence, but a necessary one in the event that ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... ... ... crisis. Her son James, eight, was out of control. Prone to extreme mood shifts and ... him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife on ... say he was going to kill them. If we were driving on the freeway, ...
(Date:6/24/2016)... ... ... of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum Wage’ ... 2020 and then adjusting it yearly to increase at the same rate as the median ... floor does not erode again, and make future increases more predictable. , The company is ...
Breaking Medicine News(10 mins):