Healthcare Industry News:  Thermage 

Devices FDA Dermatology

 News Release - January 16, 2006

Thermage(R) Is Granted Regulatory Clearance for New Off-Face Indication

Clinicians Can Now Perform Thermage Procedures Off-Face for Non-Invasive Treatment of Wrinkles

HAYWARD, Calif., Jan. 16 (HSMN NewsFeed) -- Thermage today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) for a new indication of the ThermaCool(TM) system that enables clinicians to perform Thermage procedures off-face for the non-invasive treatment of wrinkles and rhytids. Until now, the ThermaCool system was indicated for use in the United States for periorbital region (forehead and area around the eyes) and the mid/lower face (cheeks, area around the mouth, chin, jowls, and jaw line).

"This regulatory clearance from the FDA begins a whole new chapter for Thermage where we can now start educating our customers on how to perform off- face Thermage procedures," said Stephen J. Fanning, President and Chief Executive Officer at Thermage. "This clearance, along with our current clearances and the recent FDA approval to begin an Investigational Device Exemption (IDE) study to evaluate the use of Thermage technology to treat the upper arms, demonstrates our commitment to developing new off-face protocols and further expanding our technology based on strong, scientific support."

Similar to the Multi-Specialty Consensus Treatment Guidelines created for the face indication, Thermage is developing treatment protocols for different off-face procedures, including thighs, abdomen, buttocks, and hands. The company is also creating opportunities for clinicians to share their experience with off-face procedures through educational forums, webinars, user workshops and speaking opportunities at various industry trade shows and conferences.

"This new clearance is very exciting for me as I see using Thermage non-invasive, no downtime procedures for off-face applications as a big opportunity in the aesthetic marketplace" said Flor A. Mayoral, M.D. "My patients are looking for alternatives to tighten loose skin on various areas of their bodies -- such as arms, abdomens, and thighs -- without having to undergo surgery. Thermage continues to fulfill its commitment to its customers by introducing and supporting new applications that my patients are asking for."

In addition to leveraging this new indication to educate and train clinicians on off-face procedures, Thermage is unveiling a new brand for its Thermage procedures, called Body by Thermage(TM), to reflect the company's direction and encompass a full suite of procedures.

"We expect that, in addition to the current Face by Thermage(TM) procedures, ultimately Body by Thermage will include procedures for the treatment of arms, thighs, buttocks, eyes, abdomen, legs, and hands," said Sherree Lucas, Vice President of Marketing at Thermage. "This new brand more accurately communicates our expanding suite of procedure offerings."

Thermage is a safe, non-invasive aesthetic procedure which is administered by a qualified medical practitioner. It is clinically proven to tighten, contour, and rejuvenate skin by utilizing proprietary capacitive radio frequency (CRF) technology to help naturally restore a younger appearance.

About Thermage

Located in Hayward, Calif., Thermage, Inc. is a medical device company dedicated to the development of unique capacitive radio frequency technologies. Its science and technology provide the first non-invasive procedure to tighten and contour skin, greatly expanding the aesthetic applications physicians can offer to the booming "anti-aging" market. Its flagship ThermaCool system is available in over 50 countries. To date, more than 190,000 patients have been treated with Thermage and approximately 2,000 dermatologists, plastic surgeons and other cosmetic physicians are using the Thermage procedure worldwide. For more information about Thermage, log on to www.Thermage.com.


Source: Thermage

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