ACCESS Newswire

Bausch Health Companies Inc.

18.1.2024 22:52:24 CET | ACCESS Newswire | Press release

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

Fermi Signs Credit Support Agreement with AMD and Announces Partnership13.10.2026 14:00:00 CEST | Press release

DALLAS, TX / ACCESS Newswire / October 13, 2026 / Fermi Inc. (Nasdaq:FRMI)(LSE:FRMI), operating as Fermi America™ ("Fermi" or the "Company"), today announced that it has signed a credit support agreement with AMD, the high performance and adaptive computing leader, supporting a lease for phase one of Fermi's Project Matador energy and AI buildout in Carson County, Texas, with 222 megawatts (MW) of gross power capacity in line with Fermi's first customer lease as announced on August 10, 2026. The agreement represents a key milestone toward securing project financing. The companies have also signed an agreement outlining a partnership and framework for future expansion of up to 650 MW of gross power capacity. Lee McIntire, Fermi Chief Executive Officer said, "We are thrilled to partner with AMD as we advance development at Project Matador. Our strategic partnership establishes a framework for phases two and three. We have the land, the permits, the water, the power equipment, and the fib

Digi Power X Announces $200 Million Debt Financing Commitment to Support Completion of Alabama AI Data Center and Provides Expansion Update13.10.2026 13:30:00 CEST | Press release

MIAMI BEACH, FL / ACCESS Newswire / October 13, 2026 / Digi Power X Inc. (Nasdaq:DGXX)(Cboe Canada:DGX) ("Digi Power X" or the "Company"), an AI data center infrastructure operator, today announced that it has received a commitment letter from a major lending institution for US$200 million in debt financing to support the development of its 40 MW AI data center in Columbiana, Alabama. The financing, syndicated by Goldman Sachs, is expected to close within 90 days, subject to definitive documentation and satisfaction of various conditions, including the lender's completion of its diligence efforts. The financing is to be structured at a project special purpose vehicle ("SPV") level, with an unsecured Company guarantee through project completion and other limited matters. Proceeds are intended to support completion of the Alabama project and related project costs, helping preserve corporate liquidity, mitigate shareholder dilution and position the Company to pursue additional customer co

Akkodis Brings Multilingual Intelligence to Mercedes-AMG PETRONAS Formula One Team races13.10.2026 06:45:00 CEST | Press release

ZURICH / ACCESS Newswire / October 13, 2026 / Akkodis, a global leader in digital engineering consulting and part of the Adecco Group, today announced the deployment of a multilingual AI solution that enables international guests in the Mercedes-AMG PETRONAS Formula One Team Viewing Gallery to access real-time translated team radio and race commentary, event information and Formula 1 (F1) communications in their preferred language. Built using Akkodis' AI-Core system, the solution processes information directly at the circuit, delivering responsive, low-latency real-time transcription and translation services. The deployment highlights a growing shift in how organizations operate, bringing intelligence closer to where information is generated and decisions are made. Debuting at the Formula 1 Italian Grand Prix in Monza, the solution demonstrates how such systems can enhance real-world experiences in demanding, fast-paced and information-rich environments. For international guests in th

Fermi Announces Third Quarter 2026 Earnings Release and Call Date12.10.2026 22:01:00 CEST | Press release

DALLAS, TX / ACCESS Newswire / October 12, 2026 / Fermi Inc. (NASDAQ:FRMI)(LSE:FRMI), operating as Fermi America™ ("Fermi" or the "Company"), today announced that it plans to release third quarter 2026 financial results at 7 a.m. Eastern Time / 12 p.m. British Time on Thursday, November 12, 2026. This announcement will be followed by an earnings conference call at 9 a.m. Eastern Time / 2 p.m. British Time. The Company's earnings release and supplemental information will be posted to the Investors section of the Company's website prior to the conference call. To join the live conference call, dial 888-506-0062 in the U.S. or +1 973-528-0011 internationally approximately 15 minutes prior to the scheduled start time and refer to conference code 176575. The call will also be webcast in a listen-only mode and can be accessed through the Investor Relations Events & Presentations page of Fermi's website. A replay of the webcast will be available for a period of one year. Investor Contact Barr

Chervon Names Charlie Harte Director of Field Sales & Recruiting - Canada12.10.2026 16:00:00 CEST | Press release

NAPERVILLE, IL / ACCESS Newswire / October 12, 2026 / Charlie Harte joins Chervon as Director of Field Sales and Recruiting - Canada, effective Monday, October 12, 2026, reporting to Neil Harrison, VP/MD Sales and Marketing - Canada. Harte brings 15+ years of experience in the Canadian power tools, outdoor power equipment, and hand tool market. Additionally, he has 6+ years of experience selling into the commercial plumbing arena. Early in his career, Harte spent six years at Black and Decker growing into the National Sales and Marketing Manager position for B&D Canada. He subsequently became Director of Sales for Irwin Industrial Tools and then became a Director of Sales for Milwaukee Canada. Harte moved into the VP Sales position for Uponor Advanced Plumbing Solutions. Harte has an impressive track record in field sales leadership and strategic account development. He is known for his ability to build and manage high-performance sales teams throughout Canada. "Charlie brings an outst

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