Thermage® Receives FDA Clearance for Full Face Treatment
Hayward, Calif - June 22, 2004 - Thermage, Inc. announced today that the U.S. Food & Drug Administration (FDA) cleared its radiofrequency ThermaCool™ device for the non-invasive treatment of facial wrinkles and rhytids. Previously cleared for the treatment of periorbital (around the eyes) wrinkles and rhytids, the ThermaCool system is the only technology proven to tighten and contour skin and it's underlying tissue structures without incisional surgery.
For the majority of people who prefer a more natural, tightened look and don't have the time, money and interest for major plastic surgery, the Thermage procedure is a welcome and more subtle alternative.
This non-invasive choice is particularly attractive for the many patients with only mild symptoms of loose skin and are not yet ready - mentally or physically - for the more drastic effects of a facelift and its associated recovery period.
Bob Byrnes, President and CEO of Thermage stated: "We are very pleased to receive FDA clearance for treatment of the full-face with the Thermage procedure. With the market potential for cosmetic treatments of the mid and lower face estimated to be at least four to five times greater than the demand for periorbital procedures, this additional regulatory clearance presents a tremendous growth opportunity for our company."
The Thermage patented capacitive radiofrequency (RF) technology deploys deep, uniform and volumetric heating to tighten both skin and underlying tissue, while protecting the skin's outer layer with a cooling cryogen spray. The deep heating action promotes immediate collagen contraction beneath the skin surface and generates new collagen growth over time.
The new regulatory clearance for the full-face indication was based on a submission of clinical data from 48 patients who received Thermage treatment on facial skin. The multi-site study was conducted by leading dermatologic surgeons Dr. Roy Geronemus of New York City, Dr. Tina Alster of Washington, DC, and Dr. Michael Kaminer of Boston, MA.
Summarizing the research findings, Dr. Kaminer commented: "When treating the cheeks, jawline and chin areas using a multiple-pass approach, we observed a substantial reduction in laxity with just one treatment session in most cases. Further, there were no reports of adverse events. And although pain medications were used, most patients found the treatment to be quite tolerable."
In addition, Dr. Alster noted that "these study findings of facial skin treatment validate what researchers at our clinical center have long considered to be one of the most useful applications of Thermage technology - sagging and drooping of the mid and lower facial region. Laxity reduction, particularly in the area just underneath the chin and along the jawline, is a frequent request from cosmetic patients. The Thermage procedure is the only proven non-invasive choice for tightening skin in this region."
Dr. Alster cited similar evidence from her peer-reviewed clinical study published in the April 2004 issue of Dermatologic Surgery. Based on long-term results, Drs. Alster and Tanzi demonstrated that improvement from a single Thermage treatment was sustained for at least the 12-month post treatment evaluation period, with the greatest improvement observed at three to six months post-treatment.
Thermage is a leading medical device company developing innovative aesthetic technologies, including its patented capacitive radiofrequency device, to achieve a desired cosmetic or therapeutic effect on and under the skin surface. Its flagship ThermaCool TC System is currently installed in more than 1,000 dermatology, plastic surgery and other cosmetic surgery practices worldwide. Founded in 1996, the Company's headquarters are located in Hayward, California, proximate to the San Francisco Bay Area and the Silicon Valley.
For more information about Thermage and its ThermaCool system, or to locate physicians using its exclusive radiofrequency technology, log on to www.thermage.com.