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Thermage(R) Receives Regulatory Clearance in Canada for Off-Face Procedures
 

New Larger ThermaTip(TM) Increases Procedure Appeal for Off-Face Indications

(press release from Thermage, Inc.)

HAYWARD, Calif., Feb. 22 -- Thermage today announced that it has received regulatory clearance from Health Canada to market a new indication for its non-invasive, skin tightening ThermaCool(TM) system in Canada. The new indication states that the Thermage ThermaCool system is cleared for the non-surgical tightening of lax and/or redundant tissue of the torso and extremities. Previously, Thermage had been cleared in Canada for non-surgical brow lift and non-surgical tightening of periorbital and facial tissue, including rhytids. This new indication gives clinicians regulatory clearance to treat off-face, an area in high demand from consumers who are looking for younger-looking and tighter skin on their arms, abdomen, thighs, and buttocks.

This regulatory clearance by Health Canada enables us to better serve the Canadian market with an expanded suite of Thermage procedures," said Stephen J. Fanning, President and Chief Executive Officer at Thermage. "We are committed to developing off-face protocols and leveraging this new indication to educate and train clinicians on off-face procedures through Coherent-AMT, our marketing and distribution partner in Canada."

The Thermage ThermaCool system was recently cleared in the United States by the Food and Drug Administration for the non-invasive treatment of wrinkles and rhytids, expanding its indication and giving physicians in the U.S. the clearance to treat off-face.

To reflect the company's direction and the expanding suite of procedure offerings, Thermage is unveiling a new brand called Body by Thermage(TM). "As Thermage develops guidelines for treatment of specific body parts, new sub-brands will be launched under the Body by Thermage umbrella," said Sherree Lucas, Vice President of Marketing at Thermage. "Arms by Thermage(TM), Thighs by Thermage(TM), and Abdomen by Thermage(TM) are examples of new brands that will be launched when guidelines are developed for these body parts. Face by Thermage(TM) and Eyes by Thermage(TM) have already been launched behind current regulatory clearances in Canada."

Thermage also recently received Canadian clearance to market its new 3.0cm(2) ThermaTip(TM). This new tip is twice as large as the current 1.50cm(2) ThermaTip enabling physicians to treat larger areas in less time. The new tip also has an expanded treatment range allowing Thermage procedures to be performed on the most sensitive patients. The 3.0cm(2) was introduced in the U.S. in November 2005 with extremely positive reviews from physicians and patients, and will now be available to customers in Canada; distribution began earlier this month.

"Combined, the expanded indication and availability of the larger treatment tip represents a major innovation in the field of non-invasive aesthetic procedures," said Sheetal Sapra, M.D., a dermatologist in Oakville, Ontario. "This technology will benefit my patients looking for a single, non-invasive procedure to tighten loose skin on areas in addition to the face."

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-info.com

About Coherent-AMT

Coherent-AMT is a medical distributor of innovative technology solutions. Over the past 16 years, the company has gained a superior reputation for its dedication to the Canadian healthcare community (hospitals and clinics) within the aesthetic, ophthalmic and surgical marketplaces. It is the largest independent medical device distributor in Canada, offering both comprehensive national clinical and technical support.


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