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

SMBs Attract Talent with AI Upskilling as Large Firms Cut Jobs and Benefits, Study Finds18.8.2026 12:00:00 CEST | Press release

General Assembly study finds role-specific AI training is the most effective approach for SMBs NEW YORK CITY, NY / ACCESS Newswire / August 18, 2026 / Small-to-medium employers (SMBs) see their human talent as a key area of investment for the AI era and are seeing strong impact from role-specific AI training, according to new research from General Assembly, a global leader in practical AI skills training. Layoff and benefit reductions at larger companies have made it easier for SMBs to recruit and retain top talent, say 81% of human resources (HR) leaders at SMBs, while nearly half (47%) of SMBs have already hired from larger firms in the past year. "Growth-stage companies see AI adoption as a catalyst, not a cost-cutting exercise," said Daniele Grassi, CEO of General Assembly. "They're able to move faster to implement AI and scale it quickly, and they're upskilling their workforces accordingly. As talent sees daily headlines around layoffs and benefit reductions, they're increasingly

LiberNovo Previews Support Week 2026, Putting Better Ergonomic Support Within Reach18.8.2026 10:00:00 CEST | Press release

Support Week starts August 25. We've got your back. HONG KONG, HK / ACCESS Newswire / August 18, 2026 / One size does not fit all. Yet most ergonomic chairs are still built around a standard frame, leaving taller, broader, and heavier users adapting to the chair instead of the chair adapting to them. LiberNovo is addressing that gap with the Maxis Series, the lead range for LiberNovo Support Week 2026, opening August 25 across the European Union and United Kingdom. Built for Bigger Builds Maxis was engineered at full scale, not adapted from a standard chair platform. A 52 cm seat depth provides greater thigh support, while a wider seat cushion gives users more room to shift naturally. Its reinforced frame supports up to 181 kg. Maxis also features a five-stage recline control system from 105° to 160°, supported by a Segmented Support System using progressive springs. This provides controlled, consistent support throughout the recline range, even under heavier loads. Three configuration

IFS Softeon Announces Successful First Go-Live with BF Global Group in Europe13.8.2026 14:00:00 CEST | Press release

First deployment marks a major milestone in strategic multi-site warehouse modernisation initiative. RESTON, VA / ACCESS Newswire / August 13, 2026 / IFS Softeon, the warehouse management system (WMS) provider delivering visibility from the boardroom to the warehouse floor, today announced the successful go-live of its warehouse management system at the first BF Global Group distribution centre, marking a significant milestone in the companies' strategic partnership announced earlier this year. The first deployment supports a leading premium stroller and baby products brand and represents the initial phase of BF Global Group's broader rollout of IFS Softeon Warehouse Management System across facilities throughout Europe in partnership with Lanark. The implementation was completed through a carefully coordinated weekend cutover, with operations transitioning successfully to the new platform. Since go-live, the facility has successfully processed and shipped both B2B and B2C customer ord

U.S. Polo Assn. Takes No. 1 Spot for All Sports Brands and Climbs to No. 22 Overall on License Global's 2026 'Top Global Licensors' Ranking13.8.2026 13:00:00 CEST | Press release

WEST PALM BEACH, FL / ACCESS Newswire / August 13, 2026 / U.S. Polo Assn.®, the official sports brand of the United States Polo Association (USPA), was named the highest-ranking sports brand on License Global's annual Top Global Licensor list for the second consecutive year, surpassing the NFL Players Association, PGA Tour, and Formula 1. Marking another milestone, U.S. Polo Assn. climbs to No. 22 overall on the global licensor list spanning the entertainment, fashion, lifestyle, and sports industries. This achievement reflects the continued expansion of the multi-billion-dollar brand globally as it delivered a record year on all fronts with $2.7B in retail sales in 2025. U.S. Polo Assn.®, the official sports brand of the United States Polo Association (USPA), ranked the No. 1 Sports Licensor on License Global's annual Top Global Licensor list. This achievement reflects the continued expansion of the multi-billion-dollar sport brand globally as it delivered a record year on all fronts

Fermi Announces Second Quarter 2026 Results and Delivers on All Five 90-Day Objectives13.8.2026 13:00:00 CEST | Press release

Company Signed Its First Anchor Customer, Named a CEO, Added a Strategic Alliance and Premier Contractors, Received Three F-Series Turbines and Raised More Than $431 Million of Shareholder-Friendly Capital DALLAS, TX / ACCESS Newswire / August 13, 2026 / Fermi Inc. (NASDAQ:FRMI)(LSE:FRMI), operating as Fermi America™ ("Fermi" or the "Company"), today announced full execution of the 90-day plan provided in May. The Company established significant momentum and took a major step toward delivering its large-scale, reliable private power grid for AI and advanced computing. The Company also reported second quarter 2026 financial results. A conference call is scheduled for 9 a.m. Eastern Time / 2 p.m. British Time today, August 13, 2026. Accompanying slides and prepared remarks can be found at https://investor.fermiamerica.com. Participation details are included in this release. Delivering on Commitments "Roughly 90 days ago, we put ourselves on the clock with a clear set of aggressive object

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