Bausch Health Companies Inc.
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.
View the original press release on accesswire.com
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
SK tes Announces Grand Opening of New Shannon Facility, Marking a Milestone for Sustainable Technology in Ireland22.12.2025 15:00:00 CET | Press release
SHANNON, IE / ACCESS Newswire / December 22, 2025 / SK tes, a global leader in secure technology lifecycle and IT asset disposition (ITAD) services, is delighted to announce the grand opening of its state-of-the-art facility in Shannon, County Clare. The opening event, to be held on Jan. 15, 2026, marks the culmination of a journey that began with the company's announcement in 2025 of its plans to establish a purpose-built facility in one of Ireland's fastest-growing technology regions. The grand opening will be hosted by Jin Mo Lee, SK tes Group CEO at SK tes and guest of honor, Minister Timmy Dooley will cut the ribbon to officially open the site. Minister Dooley, a Clare native, serves as Minister of State for Climate, Energy and the Environment. Minister Dooley's leadership in climate, energy, and environmental policy is especially relevant as Ireland continues to attract major global data center infrastructure and technology companies, while placing increased emphasis on sustainab
Saat & Saat Acquires Turkish Apparel Leader Aydinli Group, Expanding U.S. Polo Assn. Markets Across Turkey, the Middle East, Eastern Europe, and North Africa22.12.2025 13:00:00 CET | Press release
WEST PALM BEACH, FL AND ISTANBUL, TURKEY / ACCESS Newswire / December 22, 2025 / USPA Global is pleased to announce the acquisition of Aydinli Hazir Giyim San. Tic. A.S. (Aydinli Group) by HRK Holding A.S. (Saat & Saat). Both entities are licensing partners of U.S. Polo Assn., which is USPA Global's multi-billion-dollar sports brand and the official brand of the United States Polo Association (USPA). As one of the brand's largest partners, the acquisition of Aydinli provides access to more than 50 countries across Turkey, the Middle East, Eastern Europe, and North Africa. With this acquisition of Aydinli, Saat & Saat is expanding the company's regional portfolio alongside its very successful watch business by entering the global apparel industry. With more than nearly 450 U.S. Polo Assn. stores and multiple branded digital sites, U.S. Polo Assn. will continue its record growth. Aydinli is currently one of the leading retail powerhouses in the region, with significant growth potential a
Parallel Society Reveals Lineup for 2026 Lisbon Edition - A Cross-Genre Mashup of Cultural and Tech Pioneers22.12.2025 10:30:00 CET | Press release
Apparat (live) Kode9, Moses Boyd, Gilles Peterson and Clark head to Lisbon for new indie festival Parallel Society. LISBON, PT / ACCESS Newswire / December 22, 2025 / Parallel Society has revealed the first wave of artists for its 2026 edition in Lisbon, Portugal. The two-day event begins on 6th March, and the music starts on 7th March with a programme spanning the UK jazz revolution (Moses Boyd), experimental bass culture (Kode9, Calibre), avant-electronic (Apparat), and cultural ambassadors (Gilles Peterson), with many more acts still to be announced. A culture-first counterpoint to the corporate consolidation sweeping the global festival landscape, Parallel Society is independent, led by the community, and not for profit. With more than 60% of the lineup sourced from Lisbon's active and diverse homegrown talent pool, the event actively supports the city's underground music scenes. Ahead of Parallel Society's music and cultural programme on Day 2, Day 1, the "[un]conference", invites
Rainer Maria Morita Named "Transformational Leader of the Year 2025" at UK House of Lords22.12.2025 10:25:00 CET | Press release
Recognized for redefining executive career transition and human value creation in the AI era with his globally renowned Morita Method(R) LONDON, GB / ACCESS Newswire / December 22, 2025 / Global executive advisor and bestselling author, Rainer Maria Morita, has been awarded "Transformational Leader of the Year 2025 in the category of Global Hidden Job Market Advisory at the prestigious Global Leadership Conclave 2025, held at the iconic UK House of Lords, Parliament of the United Kingdom. The award recognizes Rainer's pioneering work in redefining leadership, employment, and human value creation in the age of artificial intelligence. With more than two decades of experience across executive search, executive career transition advisory and leadership consulting, Rainer has become a globally respected authority on the Hidden Job Market - the unadvertised ecosystem where over 90% of executive opportunities are created. As the creator of The Morita Method®, Rainer has guided thousands of s
Air T, Inc. Announces Closing of Regional Express Acquisition18.12.2025 23:10:00 CET | Press release
MINNEAPOLIS, MN / ACCESS Newswire / December 18, 2025 / Air T, Inc. (NASDAQ:AIRT) is pleased to announce the successful closing of its acquisition of Regional Express Holdings Limited (Rex), Australia's leading regional airline. Air T now owns 100% of Rex and looks forward to beginning a new chapter for Rex and the regional communities it serves across Australia. The transaction includes a comprehensive financing structure designed to support Rex's operations and future growth: Air T is providing a $50 million AUD credit facility that is funded by one of our investor partners. We anticipate that Rex will use this facility to bring its fleet fully back into service, from approximately 31 flyers currently to 45 flyers within the next two years. The Commonwealth of Australia will continue to be a secured creditor of Rex. Rex will have access to an additional undrawn $60 million AUD loan from the Commonwealth of Australia to support the overhaul of its current fleet of Saab 340s and genera
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
