Study Shows Thermage, Inc. Procedure Can Be Used Safely Over Fillers

HAYWARD, Calif., Dec. 19 /PRNewswire/ -- Thermage(R) today announced the results of a study that showed that the Thermage procedure can be used safely over soft-tissue fillers. The study, which was published in the December 2005 issue of Lasers in Surgery and Medicine, is the first part of a two-part study that evaluated the tissue interactions of monopolar capacitive radiofrequency (CRF) with five commonly injected fillers in an animal model.

"This is the first study ever conducted that suggests that the Thermage procedure and fillers can be used as a combination therapy to improve skin laxity and volume," said Peter R. Shumaker, M.D. from the Naval Medical Center in San Diego, Calif., and a lead investigator in the study. "The results are significant for physicians who have patients that have or want filler injections, and would like to receive the Thermage procedure at the same time."

The Thermage monopolar CRF treatment is used by physicians to tighten and contour the skin of their patients. Soft tissue filler augmentation, one of the fastest growing aesthetic procedures, is a treatment modality widely used for aesthetic improvement of deep facial lines and wrinkles. Since many people seeking aesthetic procedures may have had previous filler injections or may desire filler treatment and concurrent Thermage skin tightening and contouring, Thermage initiated a study to examine the safety and interaction of Thermage radiofrequency treatment over five commonly injected soft-tissue fillers.

"Filler injections are one of the most popular non-surgical procedures that we perform in my practice and I feel comfortable using Thermage over these fillers," said Dr. Jeffrey Dover, Associate Clinical Professor, Department of Dermatology, Yale School of Medicine. "Using procedures in combination, like the use of fillers and Thermage, we are able to achieve wonderful results with no downtime."

In this animal study, the filled tissue areas were treated with the Thermage procedure immediately or one month following injections of fillers. Filler-injected skin was examined over a period of four months. Results showed no increase in the incidence of local side effects, and no negative impact on filler longevity or persistence in the tissue. In addition, an increase in collagen deposition with fillers and monopolar CRF treatment was observed with certain filler types.

"Publication of this study in peer-reviewed literature is a significant milestone for Thermage as the scientific literature documents that the Thermage procedure, when used as a complementary treatment with fillers, has the potential to be the only treatment available to restore tissue volume and improve facial laxity," said Stephen J. Fanning, president and chief executive officer at Thermage. "We are dedicated to safety and we now have evidence to communicate to our physician base that Thermage can be used safely over fillers in combination therapy or in patients previously injected with fillers."

Thermage is a safe, non-invasive cosmetic procedure performed in a single treatment with no downtime. It is clinically proven to tighten, contour and rejuvenate facial skin to help naturally restore a more youthful appearance. The Thermage procedure is administered in a doctor's office using the ThermaCool(TM) system that utilizes a unique form of capacitive radiofrequency technology to tighten existing collagen and stimulate new natural collagen growth.

About Thermage

Located in Hayward, Calif., Thermage, Inc. is a medical device company dedicated to the development of unique radiofrequency-based 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.

Thermage, Inc.

CONTACT: Lisa Waters of Thermage, Inc., +1-323-202-1051, orlisa.waters@thermage.com

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