Solta Medical's Thermage FLX And TR-4 Return Pad Receive Registration Certifications In China

Author: Benzinga Newsdesk | January 18, 2024 09:06am

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and Solta Medical, a global leader in the medical aesthetics market, today announced the approval of Thermage® FLX and the TR-4 Return Pad by China's National Medical Products Administration (NMPA). The TR-4 Return Pad is not approved for use by the U.S. Food & Drug Administration.

"The approval of Thermage FLX, and the TR-4 return pad, marks a significant milestone for Solta Medical," Thomas J. Appio, Bausch Health Chief Executive Officer, said. "Not only is this important for growing our business, but it also represents an enormous achievement for our R&D and Regulatory Teams, who worked tirelessly with the NMPA."

Thermage is a non-invasive treatment that uses radiofrequency technology to help tighten and improve the smoothness and texture of the skin's surface to optimize a patient's appearance. Thermage is a versatile and effective treatment that can be used on all skin types and genders, on a wide range of areas on the face, body and around the eyes. Globally, more than two million Thermage treatments have been performed.

"The approval from NMPA means we are able to continue the momentum of the growth of Thermage in China," Jiny Kim, Senior Vice President, Solta Medical, said. "Building on the legacy of Thermage CPT, which has been serving Chinese institutions and consumers effectively since 2015, we look forward to delivering the Thermage FLX proven technology to the Chinese market."

Indications

• The radiofrequency energy only delivery components of the Thermage® [CPT] [FLX] system and accessories are indicated for use in:
  • Non-invasive treatment of wrinkles around the eyes, including upper and lower eyelids
  • Non-invasive treatment of wrinkles
• The simultaneous application of radiofrequency energy and skin vibration by the Thermage® CPT and FLX systems and accessories are indicated for use in:
  • Non-invasive treatment of wrinkles around the eye
  • 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, a cardioverter, a defibrillator, or any other electrical implant. Let your doctor know if you have an electrical implant or if you have any questions about whether you should undergo a Thermage® treatment.
• Solta Medical has not studied the use of the Thermage system:
• Over skin fillers (lips, cheeks, facial wrinkles and skin folds)
• In people who are pregnant and/or breast feeding, diabetic, have an auto-immune disease such as lupus, have cold sores, have genital herpes, or have epilepsy
• In people who have permanent make-up and/or tattoos
• In children
• Mild redness may occur and typically resolves within 24 hours.
• Swelling may occur and typically resolves within 5 days, but can remain up to several weeks.
• The following adverse effects occur infrequently:
• The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation. There is a possibility of scar formation.
• Skin surface irregularities may appear up to 1 or more months post-treatment.
• Numbness, tingling" or temporary paralysis may occur; typically resolves in a short period of time but may persist up to several weeks.
• Lumps or nodules may occur under the skin primarily in the neck area, and usually resolve within 1 or 2 weeks without chronic or long-term complications.
• Skin may darken, but normally resolves within several months.
• The most commonly reported adverse effect during treatment is mild to moderate pain in the area being treated.
• The most commonly reported adverse effects after treatment include the following:

Ask your doctor for more information about Thermage FLX and see www.thermage.com for additional details.

Posted In: BHC TSX:BHC