Healthcare Industry News: U.S. Food and Drug Administration
News Release - October 4, 2017
Solta Medical Receives FDA 510(k) Clearance for Thermage FLX(TM) System, Newest Generation Skin Smoothing TechnologyNew Thermage FLX™ System Reduces Treatment Time by 25 Percent and Enhances Patient Comfort
LAVAL, Quebec, Oct. 4, 2017 -- (Healthcare Sales & Marketing Network) -- Solta Medical, a division of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant"), announced today that its Thermage FLX™ System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to non-invasively smooth skin on the face, eyes and body.
Thermage FLX is the newest generation of Thermage® technologies known for non-invasively reducing the appearance of fine lines and wrinkles. The system uses patented radiofrequency technology to create a uniform heating effect in the deep collagen-rich layers of the skin. This gentle heating tightens existing collagen and stimulates the production of new collagen, all with little-to-no downtime for the patient. The Thermage FLX features a new optimized energy delivery algorithm, known as AccuREP™ technology, which automatically measures and precisely tunes the amount of energy delivered to the patient and treatment area. The system also features a new vibrating hand-piece to help enhance patient comfort, and a new, larger treatment tip that reduces treatment time by 25 percent.
"As the demand for skin tightening procedures continues to rise, we have continued to evolve and enhance our Thermage technology to meet the needs of skincare physicians and their patients who are looking for ways to achieve smoother skin with natural looking results," said Joseph C. Papa, chairman and CEO, Valeant. "With the approval of the Thermage FLX through our Solta business, a pioneer and leader in the aesthetic industry, treatments are now faster and more patient-friendly."
The non-invasive treatment of addressing the look and feel of aging skin using radiofrequency energy was first introduced by Thermage more than 15 years ago. Since that time, the technology has continued to evolve, and to date, two million Thermage treatments for women and men of all ethnicities have been performed.
"Being among the first adopters of the technology, I have confidently used the system for over a decade, as it is the center-piece of a successful skin tightening program," said Michael S. Kaminer, M.D., founding partner of SkinCare Physicians. "The Thermage system, backed by more than 50 clinical studies, is the gold standard in our practice and our most popular skin smoothing treatment. I'm excited to see what the new Thermage FLX system has to offer as each subsequent version has proven to exceed my expectations."
The new Thermage FLX system is expected to be commercially available before the end of 2017.
About Solta Medical
Solta Medical, a Valeant Pharmaceuticals International, Inc. company, is a global leader in the medical aesthetics market that helps drive revenue growth to aesthetic practices by providing innovative and effective skin rejuvenation and body contouring solutions. Solta offers seven aesthetic energy devices to address a range of skin-related concerns, including skin resurfacing and rejuvenation, body contouring, fat reduction, skin smoothing, hair removal, and acne reduction. More than five million procedures have been performed with Solta Medical's portfolio of products around the world. More information can be found at www.solta.com.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.
This press release may contain forward-looking statements which may generally be identified by the use of the words "anticipates, "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in Valeant's other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes, unless required by law.
Source: Solta Medical
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.