Bausch Health Companies Inc.
18.1.2024 22:52:24 CET | ACCESS Newswire | Press release
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
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
Loar Holdings Inc. Announces Date and Time for First Quarter 2026 Earnings and Conference Call17.4.2026 15:15:00 CEST | Press release
WHITE PLAINS, NY / ACCESS Newswire / April 17, 2026 / Loar Holdings Inc. (NYSE:LOAR), will report Q1 2026 earnings before the market opens on Thursday, May 7, 2026. A conference call will follow at 10:30a.m., Eastern Time. To participate in the call telephonically please dial +1 877-407-0670/+1 215-268-9902. International participants can find a list of toll-free numbers here. A live audio webcast will also be available at the following link as well as through the Investor section of Loar Holdings website; https://ir.loargroup.com The webcast will be archived and available for replay later in the day. About Loar Holdings Inc. Loar Holdings Inc. is a diversified manufacturer and supplier of niche aerospace and defense components that are essential for today's aircraft and aerospace and defense systems. Loar has established relationships across leading aerospace and defense original equipment manufacturers and Tier Ones worldwide. Contact: Ian McKillop Loar Holdings Inc. Investor Relatio
Loar Holdings Inc. Announces Date and Time for First Quarter 2026 Earnings and Conference Call17.4.2026 15:15:00 CEST | Press release
WHITE PLAINS, NY / ACCESS Newswire / April 17, 2026 / Loar Holdings Inc. (NYSE:LOAR), will report Q1 2026 earnings before the market opens on Thursday, May 7, 2026. A conference call will follow at 10:30a.m., Eastern Time. To participate in the call telephonically please dial +1 877-407-0670/+1 215-268-9902. International participants can find a list of toll-free numbers here. A live audio webcast will also be available at the following link as well as through the Investor section of Loar Holdings website; https://ir.loargroup.com The webcast will be archived and available for replay later in the day. About Loar Holdings Inc. Loar Holdings Inc. is a diversified manufacturer and supplier of niche aerospace and defense components that are essential for today's aircraft and aerospace and defense systems. Loar has established relationships across leading aerospace and defense original equipment manufacturers and Tier Ones worldwide. Contact: Ian McKillop Loar Holdings Inc. Investor Relatio
Karbon-X Launches SkyXero, a New App for Flight Emissions Tracking as Travelers Seek Trusted Climate Solutions17.4.2026 15:00:00 CEST | Press release
New mobile app enables real-time flight emissions tracking and access to verified climate projects worldwide, launching during Earth Month. CALGARY, AB / ACCESS Newswire / April 17, 2026 / Karbon-X Corp. (OTCQX:KARX) ("Karbon-X" or the "Company"), a vertically integrated climate solutions provider operating across compliance and voluntary carbon markets, today announced the launch of SkyXero, a new mobile application that enables travelers to measure and balance the emissions of their flights in a few taps. Launching during Earth Month, a period of heightened global focus on environmental impact, SkyXero is now available globally and is designed to meet the growing demand from travelers seeking practical, trusted ways to incorporate climate considerations into their travel decisions. SkyXero allows users to enter flight details, instantly calculate associated emissions, and contribute to a curated portfolio of high-integrity, third-party verified climate projects, including those certi
Karbon-X Launches SkyXero, a New App for Flight Emissions Tracking as Travelers Seek Trusted Climate Solutions17.4.2026 15:00:00 CEST | Press release
New mobile app enables real-time flight emissions tracking and access to verified climate projects worldwide, launching during Earth Month. CALGARY, AB / ACCESS Newswire / April 17, 2026 / Karbon-X Corp. (OTCQX:KARX) ("Karbon-X" or the "Company"), a vertically integrated climate solutions provider operating across compliance and voluntary carbon markets, today announced the launch of SkyXero, a new mobile application that enables travelers to measure and balance the emissions of their flights in a few taps. Launching during Earth Month, a period of heightened global focus on environmental impact, SkyXero is now available globally and is designed to meet the growing demand from travelers seeking practical, trusted ways to incorporate climate considerations into their travel decisions. SkyXero allows users to enter flight details, instantly calculate associated emissions, and contribute to a curated portfolio of high-integrity, third-party verified climate projects, including those certi
Maxon Announces Free Tools and Mobile Expansion of ZBrush and Cinema 4D16.4.2026 16:55:00 CEST | Press release
Cinema 4D brings professional 3D workflows to iPad. The return of Autograph - now free for individual users. ZBrush expands to Windows on Arm. See it all at NAB 2026. BAD HOMBURG, GERMANY / ACCESS Newswire / April 16, 2026 / Maxon, a leading developer of powerful and intuitive 2D and 3D software and complete graphic design workflows, today announced a major step forward in its mission to make professional creative tools more accessible to artists everywhere. With the debut of Cinema 4D on iPad, the return of the Autograph motion graphics application, and the expansion of Maxon tools to Windows on Arm (WoA) tablet devices, Maxon is lowering the barrier to entry while empowering artists to work where they want, how they want. Visitors to NAB 2026 can see it all at the Maxon booth (N2741). Professional Tools, Broader Access As demand for 3D and motion content accelerates across social media, streaming, gaming, and immersive media, creators are seeking flexible and affordable entry points
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
