Navigation Links
Syneron Medical Completes and Summarizes the Multi-site Clinical Study Agreed Upon with FDA for the UltraShape Contour I
Date:10/21/2013

IRVINE, California, October 21, 2013 /PRNewswire/ --

Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device marketplace, announced that it has completed the multi-site clinical study for the UltraShape Contour I System for non-invasive abdominal circumferential reduction.

     (Logo: http://photos.prnewswire.com/prnh/20120528/535447)

The Contour I is designed to use the mechanical effects of ultrasound to disrupt fat cells non-invasively. It achieves this effect without any significant heating of the target or adjacent tissue, minimizing any impact on blood vessels, nerves, and muscle tissue outside the target area. The Contour I also provides an automatic guidance system that adjusts for patient movement for enhanced user convenience and for a high degree of safety.  

In the randomized, controlled clinical study of the Contour I, which was performed in 3 clinical sites in the U.S. and one site outside the U.S., a total of 150 subjects were treated and followed-up for up to 4 months. In this multi-site study, an average abdominal circumference reduction of 2.4-3.5 cm was demonstrated. The results successfully met the primary hypothesis for clinically significant circumference reduction. Furthermore, the results demonstrated progressive improvement over time in circumference reduction, beginning after the first treatment session. No serious adverse events related to the device were reported. The treatment was administered without the need for anesthetic and was well tolerated by patients.

The Contour I received the CE mark in 2005 and is marketed in European countries, Canada, Australia, Israel, Mexico, Brazil, Uruguay, Hong Kong, Korea, Russia, Ukraine, Singapore, Taiwan, South Africa and Thailand. The Contour I has been used in 220,000 procedures worldwide, with a positive safety and effectiveness profile.

"In our practice, we found significant abdominal circumference reduction following treatment with the Contour I. The treatment was easy to perform and no serious adverse events occurred," stated William Coleman M.D., Clinical Professor of Dermatology, Adjunct Professor of Surgery (Plastic Surgery), Tulane University Health Sciences Center and a principal investigator in the study. "We are looking forward to incorporating this effective and safe non-invasive treatment into our practice."

Robert Weiss, M.D., Vice President of the American Society of Laser Medicine and Surgery, who was also a principal investigator in the study, stated, "The treatment was well tolerated and our patients were very satisfied with the treatment and with the results they achieved. The automated tracking feature ensures safe, effective and homogeneous treatments."

Dr. Shimon Eckhouse, CEO of Syneron, commented: "The highly successful completion of the large UltraShape FDA clinical study is an extremely important milestone for Syneron. Syneron's UltraShape technology presents a safe and effective non-invasive alternative for the destruction of fat cells and abdominal circumferential reduction. This is one of the largest studies ever performed in the area of non-invasive aesthetic medicine and it clearly demonstrates Syneron's commitment to body shaping and to bringing to the market the most advanced technology for this important aesthetic application."

About Syneron

Syneron Medical Ltd. is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. The Company's technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic applications including body contouring, hair removal, wrinkle reduction, improving the skin's appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. The Company sells its products under two distinct brands, Syneron and Candela.  

Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Medical Ltd. are located in Israel. Syneron also has R&D and manufacturing operations in the U.S. The company markets, services and supports its products in 86 countries. It has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, China, Japan, and Hong Kong and distributors worldwide.

For additional information, please visit http://www.syneron-candela.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Company's most recent Annual Report on Form 20-F, and the other factors described in the filings that Syneron Medical makes with the SEC. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contacts:

Zack Kubow
The Ruth Group
646-536-7020
zkubow@theruthgroup.com

Hugo Goldman
Chief Financial Officer
Hugo.Goldman@syneron.com
Syneron Medical - Public Relations
pr@syneron.com


'/>"/>
SOURCE Syneron Medical Ltd.
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Global Medical Imaging Reagents Market 2012 - 2016: Worldwide Industry Latest Market Share, Investment Trends, Growth, Size, Trends, Strategy And Forecast Research Report
2. Cedars-Sinai Medical Center to Use Exosome Diagnostics Exosome RNA Biofluid Kits in Neo-Natal Setting and Cancer for Development of Personalized Medicine Diagnostics
3. Dr. Szczepan Baran Appointed to Board of Directors at Americans for Medical Progress
4. Global Medical Experts to Discuss Knowledge Translation for Integration of Complementary Therapies in Cancer Treatment at Vancouver, BC Conference
5. Global 3D Medical Imaging Industry
6. Portland Medical Marijuana Clinic - The Aurora Clinic - Now Offering Complimentary Telephone Consultations for Washington and Oregon Medical Marijuana Cards
7. V. Suzanne Klimberg, M.D. Appointed Medical Director of Ascendant Diagnostics™
8. Miami’s Preferred Cord Blood Laboratory, GeneCell International, Partakes in North Shore Medical Center and Hialeah Hospital’s OB/GYN Symposium
9. Young scientists receive NSBRI space biomedical research fellowships
10. Avon Foundation for Women, NIH, and the Center for Advancing Innovation Launch Start-Up Challenge to Advance Breast Cancer Biomedical Invention
11. VIVEX BIOMEDICAL Successfully Completes $7.6 Million Round of Financing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... June 24, 2016 , ... Researchers at the Universita Politecnica delle Marche ... with peritoneal or pleural mesothelioma. Their findings are the subject of a new article ... Diagnostic biomarkers are signposts in the blood, lung fluid or tissue of mesothelioma patients ...
(Date:6/23/2016)... 23, 2016 A person commits a crime, and ... to track the criminal down. An outbreak of ... Drug Administration (FDA) uses DNA evidence to track down the ... Sound far-fetched? It,s not. The FDA has increasingly used a ... of foodborne illnesses. Put as simply as possible, whole genome ...
(Date:6/23/2016)... SAN FRANCISCO , June 23, 2016   ... it has secured $1 million in debt financing from ... to ramp up automation and to advance its drug ... for its new facility. "SVB has been ... goes beyond the services a traditional bank would provide," ...
(Date:6/23/2016)... NEWPORT BEACH, Calif. , June 23, 2016 /PRNewswire/ ... offering new biological discoveries to the medical community, has ... and co-founder Matthew Nunez . "We ... provide us with the capital we need to meet ... funding will essentially provide us the runway to complete ...
Breaking Biology Technology:
(Date:6/22/2016)... 2016   Acuant , the leading ... has partnered with RightCrowd ® to ... Management, Self-Service Kiosks and Continuous Workforce Assurance. ... functional enhancements to existing physical access control ... with an automated ID verification and authentication ...
(Date:6/20/2016)... , June 20, 2016 Securus Technologies, ... technology solutions for public safety, investigation, corrections and ... prisons involved, it has secured the final acceptance ... facilities for Managed Access Systems (MAS) installed. Furthermore, ... facilities to be installed by October, 2016. MAS ...
(Date:6/9/2016)... 9, 2016  Perkotek an innovation leader in attendance control systems is proud to ... hours, for employers to make sure the right employees are actually signing in, and ... ... ... ...
Breaking Biology News(10 mins):