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Thermacool TCTM Thermage System Receives FDA Clearance for Treatment of Periorbital Wrinkles and Rhytids

Hayward, CA - November 13, 2002 - Thermage, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted clearance to its ThermaCool TC^TM Thermage System for the non-invasive treatment of wrinkles and rhytids in the periorbital area. The new cosmetic use clearance is based on clinical data showing that a single non-ablative treatment with the new radio frequency device can safely improve the appearance of skin around the eye area, such as smoothing crow's feet at the corners of the eyes.

"The recent FDA clearance marks our first corporate milestone for an aesthetic application of the ThermaCool TC technology in the United States," said Edward A. Ebbers, Vice President of Thermage, noting that U.S. regulatory clearance was preceded earlier this year by Canadian HPB approval for non-surgical brow lift and non-surgical tightening of periorbital and facial tissue, including rhytids. "We are very pleased by the impressive clinical results of our investigators and the growing body of scientific knowledge about the potential capabilities of our new radio frequency system."

The Thermage procedure works by delivering a volumetric and uniform heating effect to the deep dermis via a unique form of radio frequency energy. The procedure is intended to cause immediate collagen contraction followed by gradual collagen tightening to lift skin without wounding the epidermis (top skin layer). Simultaneously a cryogen spray cools the skin's surface before, during and after each radio frequency pulse to further protect the epidermis.

In clinical trials to evaluate the facial tissue effects of the ThermaCool TC System, six prominent researchers enrolled 79 females and 7 males who were given a single treatment on the forehead with a standardized algorithm devised to "brighten" the eye area and soften periorbital wrinkles. Performed in an outpatient setting using a topical anesthetic, the procedure typically lasted about 25 minutes, and patients were able to resume routine activities immediately following treatment. About 80% of patients demonstrated a significant improvement in an objective assessment of their wrinkle severity, with progressive improvements noted up to six months after a single treatment. Five patients experienced a very small burn in the treatment area, which resolved without incident.

"Based on the pattern of continued improvement we are seeing over time from a single treatment session, Thermage radio frequency technology appears to create a uniquely powerful tissue heating effect that complements the more superficial effects of non-ablative laser/light-based systems," stated study investigator Michael Kaminer, M.D., Assistant Professor of Dermatology at Dartmouth Medical School in New Hampshire and Yale Medical School in New Haven, CT. "While further research is in progress to confirm these remarkable findings, the clinical results suggest that some patients will experience cosmetic improvements previously available only with invasive procedures."

According to Mr. Ebbers, the ThermaCool TC System will be introduced for commercial use to a limited number of dermatologists, plastic surgeons and other cosmetic surgery specialists. He added that "research to evaluate the effects of Thermage technology for other clinical applications is underway."

Thermage was founded in 1995 to build a foundation of patents and technologies based on the hypothesis that radio frequency energy could be used to achieve a desired cosmetic or therapeutic effect on the skin without damaging the skin surface. The Company is headquartered in Hayward, California in the Silicon Valley area between San Jose, San Francisco and Oakland.

For more information about Thermage, ThermaCool TC System or radio frequency technology, log on to www.thermage.com.