(Information sent by the signatory company)
Laval, January 29
The approval represents an important advance in one of the largest markets for medical aesthetics
(*CORRECTION to statement previously published on January 18, 2024: The TR-4 return pad is approved for use by the US Food and Drug Administration (as part of the Thermage FLX device registration) See sentence below.*)Bausch Health Companies Inc. (NYSE/TSX:BHC) and Solta Medical, a global leader in the medical aesthetics market, have announced the approval of Thermage® FLX and the TR-4 return pad by the National Medical Products Administration of China (NMPA). [See *Prior correction: The TR-4 return pad is not approved for use by the US Food and Drug Administration.] “The approval of Thermage FLX, and the TR-4 return pad, marks a significant milestone for Solta Medical,” said Thomas J. Appio, CEO of Bausch Health. “Not only is it important for the growth of our business, but it also represents a tremendous achievement for our R&D and regulatory teams, who have worked tirelessly with the NMPA.” Thermage is a non-invasive treatment that uses radiofrequency technology to help to tighten and improve the smoothness and texture of the skin surface in order to optimize the patient’s appearance. Thermage is a versatile and effective treatment that can be used on all skin types and genders, in a wide range of areas on the face, body and around the eyes. More than two million Thermage treatments have been performed worldwide. “NMPA approval means we can continue to drive Thermage growth in China,” said Jiny Kim, Senior Vice President of Solta Medical. “Building on the legacy of Thermage CPT, which has been effectively serving Chinese institutions and consumers since 2015, we look forward to offering the proven Thermage FLX technology to the Chinese market.” Indications The Thermage® CPT and FLX system components that only supply power from radiofrequency and its accessories are indicated for use in: Non-invasive treatment of wrinkles around the eyes, including the upper and lower eyelids; Non-invasive treatment of wrinkles. The simultaneous application of radiofrequency energy and skin vibration using the Thermage® CPT and FLX system and its accessories is indicated for use in: Non-invasive treatment of wrinkles around the eyes; Non-invasive treatment of wrinkles; Temporary improvement in the appearance of cellulite.Important Safety Information “Do not undergo Thermage treatment if you have a cardiac pacemaker, cardioverter, defibrillator, or any other electrical implant. Tell your doctor if you have an electrical implant or if you have any You are unsure whether you should undergo Thermage® treatment. Solta Medical has not studied the use of the Thermage system: Fillers on the skin (lips, cheeks, facial wrinkles and skin folds); In people who are pregnant and/or breastfeeding, diabetic, with an autoimmune disease such as lupus, with cold sores, genital herpes or epilepsy; In people with permanent makeup and/or tattoos; in childrenThe most common adverse effect during treatment is mild or moderate pain in the treated area. The most frequently reported adverse effects after treatment are the following: Mild redness may occur, which usually disappears within 24 hours; Swelling may occur, which usually disappears within 5 days, but may remain for up to several weeks. The following side effects occur infrequently: The procedure may cause heating in the upper layers of the skin, causing burns and the subsequent formation of blisters and scabs. . There is a possibility of scar formation; Skin surface irregularities may appear up to 1 or more months after treatment; Numbness, tingling, or temporary paralysis may occur; it usually resolves in a short time but may persist for up to several weeks; Lumps or nodules may appear under the skin, mainly in the neck area, which usually disappear in one or two weeks without chronic complications. or long term; Skin may darken, but usually resolves within several months.More information: www.thermage.com www.solta.com
Contact Contact Name: Bausch Health Companies Inc. Contact Description: Bausch Health Companies Inc. Contact Phone: (800) 361-1448
