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)

Medtronic receives FDA approval for Inceptiv closed-loop spinal cord stimulator

Closed-loop sensing capability instantly and automatically adjusts therapy while treating chronic pain

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time, keeping therapy in harmony with the motions of daily life.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Illustration of heart attack.

Investing in Cardiovascular MedTech Companies

Cardiovascular diseases remain the leading global cause of death, taking an estimated 17.9 million lives annually, based on data from the World Health Organisation. Over 80 percent of these deaths are due to heart attacks and strokes, while one-third of them occur in people under seventy years of age.

Efforts to address the core risk factors associated with cardiovascular diseases are coinciding with recent innovations in medical technology, which have been critical in not only preventing and managing them but also increasing the survival rate.

As medical technologies associated with the diagnosis and treatment of cardiovascular disease continue to evolve, medical technology companies provide an opportunity for investors to create wealth through health.

Keep reading...Show less

Thermo Fisher Scientific Reports First Quarter 2024 Results

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the first quarter ended March 30, 2024.

First Quarter 2024 Highlights

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
March Quarterly Appendix 4C

March Quarterly Appendix 4C

Cardiex Limited (ASX:CDX) (Cardiex, the Company) has released its Quarterly Cash Flow Report.


Keep reading...Show less
Cardiex March 2024 Quarter Update

Cardiex March 2024 Quarter Update

Cardiex Limited (ASX:CDX) (Cardiex, the Company) is pleased to present its Quarterly Report.
Keep reading...Show less

Latest Press Releases

Related News

×