FDA Clears Indication for Thermage, Inc. Thermacool System

HAYWARD, Calif., June 18 /PRNewswire-FirstCall/ -- Thermage(R), Inc. today announced that the Food & Drug Administration (FDA) provided a first-time-ever 510 (k) clearance for the non-invasive treatment of periorbital wrinkles and rhytids, including upper and lower eyelids. Thermage's proprietary ThermaCool(R) system, utilizing customized ThermaTip(TM) treatment tips, is the only medical device in the non-invasive skin tightening category with this clearance.

"Thermage is the first and only company to receive FDA clearance for non-invasive eyelid treatments," said Stephen J. Fanning, president and chief executive officer at Thermage. "We believe that the clinical data supporting this milestone further defines Thermage as the gold standard in non-invasive skin tightening and contouring, differentiating our technology, safety profile and efficacy from other companies in the aesthetic market."

Eyes by Thermage(TM) is one of several treatment procedures provided by Thermage. The procedure was launched in March 2006 under the FDA general clearance for the non-invasive treatment of wrinkles and rhytids. This exclusive treatment reduces hooding, improves skin texture and tone, and smoothes the eye area. To date, more than 20,000 procedures have been completed worldwide and clinicians in 27 countries have been trained on Eyes by Thermage with approved procedure guidelines. The specific FDA clearance for eyelids is based on a multi-center clinical study conducted in the United States and Canada.

"This is a landmark event in the non-invasive aesthetics industry as no other device has a specific eyelid indication," said Brian Biesman, M.D.

Consumers are seeking cosmetic improvements but due to demanding lifestyles, downtime is often not an option. According to recent reports from the American Society for Aesthetic Plastic Surgery, non-invasive aesthetic procedures are a rapidly growing alternative to cosmetic surgery with eyelid surgery as one of the top five procedures performed during 2006. Physicians can now be assured that by offering patients Eyes by Thermage, the only FDA cleared non-invasive alternative to eyelid surgery, they are providing an effective and desired treatment for the reduction of wrinkles.

About Thermage, Inc.

Thermage's innovative technology provides a unique non-invasive procedure designed to tighten and contour skin, significantly expanding the non-invasive aesthetic applications physicians can offer to the rapidly growing "anti-aging" market. The company commercially launched its flagship ThermaCool(R) system in 2002 when it received clearance from the U.S. Food & Drug Administration. Today, the ThermaCool system is available in 80 countries; more than 400,000 patients have been treated with Thermage and approximately 2,000 dermatologists, plastic surgeons and other cosmetic physicians are using the Thermage(R) procedure worldwide. For more information about Thermage, call 1-510-259-7117 or log on to http://www.thermage.com.

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning our belief that we are the gold standard of non-invasive skin tightening and contouring and our estimate of the number of Eyes by Thermage(TM) procedures performed constitute such forward-looking statements. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause Thermage's actual results to differ materially from the statements contained herein. Actual results may be affected by a number of factors, including the introduction of other medical devices for the non-invasive treatment of eyelids. Further information on potential risk factors that could affect Thermage's business are detailed in the Company's Form 10-Q for the period ended March 31, 2007. Undue reliance should not be placed on forward-looking statements, which speaks only as of the date they are made. Thermage undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.

Thermage and ThermaCool are registered trademarks of Thermage, Inc. ThermaTip and Eyes by Thermage are trademarks of Thermage, Inc.

Thermage, Inc.

CONTACT: Media Relations, Jackie Quintanilla of Edelman, +1-323-202-1053,or Investor Relations, Jenifer Kirtland of EVC Group, +1-415-896-6820, bothfor Thermage, Inc.

Back to news