Approval Represents an Important Breakthrough in One of the Largest Medical Aesthetics Markets
(*CORRECTION to the release that was posted earlier on January 18, 2024: The TR-4 Return Pad is approved for use by the U.S. Food & Drug Administration (as part of the Thermage FLX device registration) See sentence below.*)
LAVAL, QC / ACCESSWIRE / January 18, 2024 / Bausch Health Companies Inc. (NYSE/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). [See *Correction above: 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 and FLX system and accessories are indicated for use in:
o Non-invasive treatment of wrinkles around the eyes, including upper and lower eyelids
o Non-invasive treatment of wrinkles
• The simultaneous application of radiofrequency energy and skin vibration by the Thermage® CPT and FLX system and accessories are indicated for use in:
o Non-invasive treatment of wrinkles around the eye
o Non-invasive treatment of wrinkles
o 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
- 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:
- 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.
Ask your doctor for more information about Thermage FLX and see www.thermage.com for additional details.
About Solta Medical
Solta Medical, a business unit of Bausch Health, is a global leader in the medical aesthetics market. Our vision at Solta is to develop and support trusted aesthetic brands that provide value to our customers and their patients. The Thermage® RF systems, Fraxel® laser, Clear + Brilliant® laser, and VASER® ultrasonic system provide exceptional results for patients and lasting growth to physicians due to our foundation of brands that have stood the test of time. 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.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch +Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the expected results of, and market for, the Company's Thermage® treatment. 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. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
SOURCE: Bausch Health Companies Inc.
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