ACCESS Newswire

Bausch Health Companies Inc.

Share
CORRECTION BY SOURCE: Solta Medical's Thermage(R) FLX and TR-4 Return Pad Receive Registration Certifications in China

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

DK

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

TruMerit Adds Two More Global Credentials for Rehabilitation Care Workers16.9.2025 20:00:00 CEST | Press release

PHILADELPHIA, PA / ACCESS Newswire / September 16, 2025 / TruMerit, a global leader in healthcare workforce development, today launched two new global credentials for healthcare workers specializing in rehabilitation, habilitation, and restorative care. The Certified Global Health Worker-Rehabilitation (CGHW-R) and the Certified Global Health Worker-Rehabilitation Advanced (CGHW-RA) have been developed specifically for eligible health workers worldwide who wish to have their applied experience and competencies in rehab care recognized and verified by passing a certification examination. These credentials, along with the Certified Global Nurse-Rehabilitation (CGN-R) that TruMerit established last year, are intended to advance and improve services for the more than two billion people worldwide who need this care. The CGHW-RA credential was developed for those with a degree or diploma in a rehabilitation field. These include clinicians, educators, and instructors with physiotherapy, occup

Second Blue Magic Netherlands Event Set for November 1816.9.2025 18:30:00 CEST | Press release

Registration Site Is Open and Dutch Innovators Are Encouraged to Attend and Apply to Present Capabilities SAN DIEGO, CALIFORNIA / ACCESS Newswire / September 16, 2025 / General Atomics Aeronautical Systems, Inc. (GA-ASI), in collaboration with the Dutch Ministry of Defence and the Dutch Ministry of Economic Affairs, will host its second Blue Magic Netherlands (BMNL) event on November 18, 2025. BMNL 2025 follows the successful first event in 2024 and will take place at the MELT at Avular building, a world-class venue for technology interchange near Brainport Eindhoven, the center of the Dutch high-technology manufacturing industry. The registration site can be accessed at www.ga-asi.com/blue-magic-netherlands-2025. "The first BMNL event was a huge success for Dutch industry," said Brad Lunn, managing director for GA-ASI. "We've built strong investment opportunities with Dutch companies - including Arceon, Emergent Swarm Solutions, and Saluqi Motors - and now we're looking to build on th

U.S. Polo Assn. Celebrates Sport and Style as Official Apparel Sponsor of the 2025 Engel & Völkers Berlin Maifeld Polo Cup16.9.2025 13:00:00 CEST | Press release

Sports Brand Supports Germany's High-Goal Polo Event for Sixth Consecutive Year BERLIN, GERMANY AND WEST PALM BEACH, FL / ACCESS Newswire / September 16, 2025 / U.S. Polo Assn., the official sports brand of the United States Polo Association (USPA), proudly partnered as the Official Jersey and Apparel Sponsor of the Engel & Völkers Berlin Maifeld Polo Cup, also known as the German High-Goal Championship 2025, held August 22-31, 2025, in Berlin. This prestigious tournament is the pinnacle of the polo season in Germany and is one of the most celebrated events in European polo.Engel & Völkers Berlin Maifeld Polo Cup Winners Photo Credit: Guadalupe Aizaga The finals weekend for the Engel & Völkers Berlin Maifeld Polo Cup took place at the iconic Maifeld Stadium, the same historic venue where the sport of polo was last played in the 1936 Olympic Games. Qualifying matches were held August 21-28 at the Prussian Polo and Country Club, leading to a thrilling finale that showcased the very best

Case IQ Introduces Clairia: AI Assistant for Compliance, Workplace Investigations and Case Management16.9.2025 11:00:00 CEST | Press release

Transforming how ethics, compliance, and HR teams across Europe resolve cases with speed, intelligence and confidence. LONDON, GB / ACCESS Newswire / September 16, 2025 / Case IQ has announced the launch of Clairia, an AI assistant designed to simplify case management and provide clarity at every step. Clairia empowers European organizations, HR teams, and compliance officers to manage cases with efficiency, speed and confidence from the initial complaint or report to case resolution. Clairia is built into Case IQ's case management solution and is designed for ethics, compliance, HR, and investigations teams who require accuracy, consistency, and accountability. It delivers clear and context-aware suggestions on how to proceed that draw on uploaded documents such as internal codes of conduct and applicable regulatory frameworks like the EU Whistleblower Directive, and most recently in the UK, the new corporate criminal offence of "Failure to Prevent Fraud" under the Economic Crime and

Clean Air Metals Announces Appointment of John Mason as Director15.9.2025 13:00:00 CEST | Press release

THUNDER BAY, ON / ACCESS Newswire / September 15, 2025 / Clean Air Metals Inc. ("Clean Air Metals" or the "Company") (TSX.V:AIR)(FRA:CKU)(OTCQB: CLRMF) is pleased to announce the appointment of John Mason, D.Sc., P.Geo., as Director of the Company effective immediately. John Mason is a professional geoscientist with 49 years of experience in mineral exploration and mining in Northern Ontario. Mr. Mason's work experience includes management positions with the Ontario Ministry of Northern Development and Mines (NDMNRF) and Thunder Bay Community Economic Development Commission, before starting John Mason and Associates. John Mason has worked with all mines and major exploration projects in Northwestern Ontario, specific to supply and service, workforce, energy, and transportation access needs. John has worked with many of the indigenous communities, MNO and municipalities to maximize economic development opportunities related to exploration and mining and balance environmental/ESG require

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye