Bausch Health Companies Inc.
18.1.2024 22:52:24 CET | ACCESS Newswire | Press release
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
Driving the World's Leading Supply Chains: 9 OMP Customers Named to The 2026 Gartner Top 2518.6.2026 15:00:00 CEST | Press release
As global leaders move from firefighting to foresight, OMP celebrates the enterprise visionaries scaling decision-driven intelligence at the speed of change. ANTWERPEN, BE / ACCESS Newswire / June 18, 2026 / OMP, a leading AI-powered provider of supply chain planning solutions, extends its congratulations to the 9 customer organizations recognized in the newly released Gartner® Supply Chain Top 25 and Masters for 2026. Now in its 22nd year, the Gartner Supply Chain Top 25 remains the definitive benchmark for supply chain excellence, evaluating global enterprises on financial performance, ESG initiatives, and community opinion. This year's rankings point to three capabilities separating market leaders: building an autonomous workforce where people and intelligent systems collaborate on decisions, adopting network-centric strategies that treat supply chain design as a continuous, adaptive process, and orchestrating decisions end-to-end across increasingly complex ecosystems. OMP's custom
U.S. Polo Assn. Unveils Spring-Summer 2027 Collection at the 110th Edition of Pitti Immagine Uomo18.6.2026 13:00:00 CEST | Press release
Global Sports Brand Puts the Iconic Polo Shirt at the Center of its Pitti Uomo Experience FLORENCE, IT AND WEST PALM BEACH, FL / ACCESS Newswire / June 18, 2026 / U.S. Polo Assn., the official sports brand of the United States Polo Association (USPA), returned to Florence, Italy, for Pitti Immagine Uomo 110 to present The Polo Shirt: An Icon Born from the Game™ and its Spring-Summer 2027 Global Collection showcasing a modern, global expression of the sport-inspired lifestyle. The collection includes classic, sport-inspired apparel, footwear, bags, and accessories that blend authentic American-inspired sports style with European craftsmanship. 1) Polo Shirt Installation for U.S. Polo Assn. Booth at Pitti Uomo 110 in Florence, Italy 2) U.S. Polo Assn. Booth at Pitti Uomo 110 featuring The Polo Shirt: An Icon Born from the Game 3) Pitti Uomo 110 Attendees Crowd the U.S. Polo Assn. Booth U.S. Polo Assn.'s exhibit at Pitti Uomo is taking place from June 16 to 19, 2026, at Booth 32 Cavanigli
Deadline Extended for 2026 Semmelweis-Richter Journalism Award Applications18.6.2026 11:30:00 CEST | Press release
Following strong interest and numerous requests, the application deadline for the 2026 Semmelweis-Richter Journalism Award has been extended by two weeks. Submissions are now accepted until June 23, 2026, 23:59 CET. BUDAPEST, HU / ACCESS Newswire / June 18, 2026 / Building on the success of its inaugural edition, the award continues to recognise outstanding journalism that contributes to public understanding of key health issues and fosters informed discussion across Europe. The initiative is organised by Semmelweis University, Hungary's leading medical and health sciences institution, in partnership with Gedeon Richter, a Hungary-based, innovation-driven specialty pharmaceutical company. Entries are invited in two categories: Women's Health and Pharmaceutical Strategies and Innovation, the latter placing particular emphasis on cardiovascular therapies. The organisers welcome high-quality reporting that sheds light on pressing or underrepresented health topics, addresses stigma, and su
LiberNovo Announces Early Launch of Prime Sale, Featuring Limited Omni Bundle Flash Deals Starting Today18.6.2026 04:00:00 CEST | Press release
HONG KONG, HK / ACCESS Newswire / June 17, 2026 / LiberNovo today opened early access to its 2026 Prime Sale, with up to 49% off and a limited run of flash-deal bundles built around the original LiberNovo Omni. Early access is live now, and the full sale runs June 23 through July 11. LiberNovo makes dynamic ergonomic chairs, the first designed to respond to your body as it moves. Instead of locking you into one fixed posture, the dynamic support system keeps the neck support, backrest, armrests, and seat moving together as you shift, lean, and recline. Prime Sale - Omni Series Clearance Deals The original LiberNovo Omni is available at Prime Sale clearance pricing while stocks last, with prices starting as low as €939 (49% off in the EU) and £869 (46% off in the UK), representing significant savings for consumers. The original LiberNovo Omni - the first dynamic ergonomic chair - features an eight-panel Bionic FlexFit Backrest and automatic armrests that move with you through every shif
U.S. Air Force Awards GA-ASI Production Contract for FQ-42A CCA18.6.2026 00:10:00 CEST | Press release
Company Will Produce Service's New Uncrewed Combat Jets SAN DIEGO, CA / ACCESS Newswire / June 17, 2026 / General Atomics Aeronautical Systems, Inc. (GA-ASI) has received a production contract from the U.S. Air Force (USAF) for the FQ-42A Collaborative Combat Aircraft (CCA). The initial order is a significant milestone, beginning the delivery of production aircraft to the warfighter. GA-ASI designed, developed and flight-tested FQ-42A on an accelerated schedule unlike any fighter in recent history. "This is an exciting day for our company and the nation," said company President David R. Alexander. "Moving to production on FQ-42A is the result of an extraordinary partnership and many years of investments between General Atomics and the U.S. Air Force. We've been preparing for this order, and manufacturing is already well underway." The FQ-42A is a purpose-built, uncrewed fighter developed as part of ongoing investment in next-generation semi-autonomous combat aircraft. The aircraft's mo
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
