Solta Medical's Thermage FLX and TR-4 Return Pad Receive Registration Certifications in China

Approval Represents an Important Breakthrough in One of the Largest Medical Aesthetics Markets

Bausch Health Companies Inc. (NYSE:BHC)(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). 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] [FLX] system and accessories are indicated for use in:
    • Non-invasive treatment of wrinkles around the eyes, including upper and lower eyelids
    • Non-invasive treatment of wrinkles
  • The simultaneous application of radiofrequency energy and skin vibration by the Thermage® CPT and FLX systems and accessories are indicated for use in:
    • Non-invasive treatment of wrinkles around the eye
    • Non-invasive treatment of wrinkles
    • 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
  • 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.
  • 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:

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.

###

Investor Contact:
ir@bauschhealth.com
(877) 281-6642 (toll free)

Media Contact:
Kevin Wiggins
corporate.communications@bauschhealth.com
(848) 541-3785

SOURCE: Bausch Health Companies Inc.



View the original press release on accesswire.com

News Provided by ACCESSWIRE via QuoteMedia

BHC:CA,BHC
The Conversation (0)
Salix to Present Late-Breaking Data from Phase 2 Trial of Amiselimod in Active Ulcerative Colitis at Digestive Disease Week 2024

Salix to Present Late-Breaking Data from Phase 2 Trial of Amiselimod in Active Ulcerative Colitis at Digestive Disease Week 2024

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals, today announced that they will be presenting data from its Phase 2 trial evaluating Amiselimod as treatment for active ulcerative colitis (UC). The data will be presented at Digestive Disease Week (DDW) 2024 during the IMIBD Late Breakers and Innovations in IBD session on Sunday, May 19, 2024, in Washington, D.C

"We are pleased to present late-breaking data on Amiselimod, our investigational, oral, sphingosine 1-phosphate (S1P) receptor modulator as a potential treatment for the induction of remission in UC," said Tage Ramakrishna, M.D., Chief Medical Officer and President of Research & Development, Bausch Health. "The abstract underscores our steadfast commitment to developing new and innovative therapies for patients with UC."

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
Bausch Health Announces Updates Related to Norwich XIFAXAN Matters

Bausch Health Announces Updates Related to Norwich XIFAXAN Matters

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology business Salix Pharmaceuticals, today announced certain updates related to its litigation with Norwich Pharmaceuticals, Inc

With respect to the April 11, 2024, decision of the US Court of Appeals for the Federal Circuit, both Bausch Health and Norwich have filed petitions for panel rehearing or rehearing en banc. The Company anticipates a decision on whether a rehearing will be granted within the next three months.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Thermo Fisher Scientific Elects New Director to Board

Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, today announced Karen S. Lynch has been elected to its board of directors, effective February 19, 2025. The appointment brings the total number of Thermo Fisher board members to 12.

Ms. Lynch is a seasoned health care executive with over three decades of experience in the industry. As the former president and chief executive officer of CVS Health Corporation (NYSE: CVS), a leading health solutions company, she was responsible for leading more than 300,000 employees. Under Ms. Lynch's leadership, CVS Health touched the lives of more than 120 million consumers through its health care benefits and pharmacy benefits management businesses, and presence in over 9,000 community health destinations across the U.S. Prior to her service as president and CEO of CVS Health, Ms. Lynch served as an Executive Vice President of CVS Health and President of Aetna, and prior to that, Ms. Lynch held a number of executive positions at Aetna Inc., a health insurance company, Magellan Health Services, a health care management company, and at Cigna Corporation, a global health insurance company. Ms. Lynch began her career as a Certified Public Accountant at the auditing firm Ernst & Young LLP, and has previously served as a board member of CVS Health and U.S. Bancorp.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Medtronic reports third quarter fiscal 2025 financial results

Delivering durable revenue growth with strong earnings power; strength in Pulsed Field Ablation, Pacing, Structural Heart, Diabetes, and Neuromodulation

Medtronic plc (NYSE: MDT) today announced financial results for its third quarter (Q3) of fiscal year 2025 (FY25), which ended January 24, 2025 .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic reports third quarter fiscal 2025 financial results

Delivering durable revenue growth with strong earnings power; strength in Pulsed Field Ablation, Pacing, Structural Heart, Diabetes, and Neuromodulation

Medtronic plc (NYSE: MDT) today announced financial results for its third quarter (Q3) of fiscal year 2025 (FY25), which ended January 24, 2025 .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic reports third quarter fiscal 2025 financial results

Delivering durable revenue growth with strong earnings power; strength in Pulsed Field Ablation, Pacing, Structural Heart, Diabetes, and Neuromodulation

Medtronic plc (NYSE: MDT) today announced financial results for its third quarter (Q3) of fiscal year 2025 (FY25), which ended January 24, 2025 .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic reports third quarter fiscal 2025 financial results

Delivering durable revenue growth with strong earnings power; strength in Pulsed Field Ablation, Pacing, Structural Heart, Diabetes, and Neuromodulation

Medtronic plc (NYSE: MDT) today announced financial results for its third quarter (Q3) of fiscal year 2025 (FY25), which ended January 24, 2025 .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic reports third quarter fiscal 2025 financial results

Delivering durable revenue growth with strong earnings power; strength in Pulsed Field Ablation, Pacing, Structural Heart, Diabetes, and Neuromodulation

Medtronic plc (NYSE: MDT) today announced financial results for its third quarter (Q3) of fiscal year 2025 (FY25), which ended January 24, 2025 .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×