Thermi™ Announces New FDA Clearance for Thermi250® to Provide Temporary Reduction of Cellulite

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Thermi™ Announces New FDA Clearance for Thermi250® to Provide Temporary Reduction of Cellulite

Thermi™, a world leader in thermistor-regulated energy solutions for plastic surgery and dermatology, is proud to announce the FDA (Food and Drug Administration) clearance of Thermi250® for the temporary reduction of cellulite. Thermi250® represents a high-powered addition to the company’s portfolio of temperature controlled radio frequency devices, providing a myriad of solutions to the aesthetic medical marketplace.

The Thermi250® is a high powered, thermistor-regulated radio frequency system designed with a wide array of electrodes and user-friendly graphic interface. Treatments performed with Thermi250® will be named ThermiSmooth®. ThermiSmooth® treatments benefit from the device’s versatility - targeting a wide variety of conditions from skin laxity, localized unwanted fat as associated with cellulite. Thermi250® promises to meet the needs of patients seeking solutions in the vast non-surgical body contouring market.

A multi-site IRB approved clinical study was conducted in more than 90 sites across the USA to determine the range of efficacy and safety for a range of conditions such as wrinkles, skin laxity, body slimming and cellulite. The first data from the study appeared in the November 2015 issue of the Journal of Drugs in Dermatology. The study entitled “A Preliminary Study of a Transdermal Radiofrequency Device for Body Slimming” (author, Douglas Key, MD) documented the positive results of 14 patients presenting with abdominal laxity who received 4 treatments at two week intervals, and concluded that the device “is a safe and effective modality for non-invasive body slimming.” The company plans to conduct further studies related to the reduction of unwanted localized fat (“body slimming”) and other skin conditions.

According to company President, Kevin O’Brien, “ThermiSmooth® is expected to become a ‘go to’ solution for patients who are seeking non-surgical solutions to common aesthetic problems. The versatility of the Thermi250® device will ensure that ThermiSmooth® treatments will produce predictable results and a high profit revenue source for plastic surgeons and dermatologists.”

About Thermi™:
Thermi™ is a leading manufacturer of thermistor-regulated solutions for the aesthetic and gynecologic markets. With three platforms – ThermiRF®, ThermiVa® and Thermi250®, plastic surgeons, dermatologists and cosmetic physicians offer a wide array of solutions for patients using “the science of heat” where temperature is the clinical endpoint. The company’s products are distributed worldwide.

For more information please visit: http://www.thermi.com/
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EDITOR'S NOTE: For more information about Thermi250™ and to arrange to speak with a company spokesperson, please contact Nancy Trent or Pamela Wadler at 212-966-0024 or pam@trentandcompany.com.

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Pamela Wadler