솔타 메디컬의 써마지(R) FLX 및 TR-4 리턴 패드, 중국에서 등록 인증 획득

LAVAL, QC, Jan 23, 2024 – (ACN Newswire) – 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). [위의 *수정 사항 참조: TR-4 리턴 패드는 미국 식품의약국(FDA)의 사용 승인을 받지 않았습니다.]

“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.”

표시

• Thermage® CPT 및 FLX 시스템의 무선 주파수 에너지 전달 구성 요소와 액세서리는 다음 용도로 사용됩니다.

o 위 눈꺼풀과 아래 눈꺼풀을 포함한 눈 주위의 주름을 비침습적으로 치료합니다.

o 주름의 비침습적 치료

• Thermage® CPT 및 FLX 시스템과 액세서리를 통한 고주파 에너지와 피부 진동의 동시 적용은 다음과 같은 용도로 사용됩니다.

o 눈 주위 주름의 비침습적 치료

o 주름의 비침습적 치료

o 셀룰라이트의 일시적인 개선

중요한 안전 정보

심장박동기, 심장율동전환기, 제세동기 또는 기타 전기 이식 장치를 장착한 경우에는 써마지 치료를 받지 마십시오. 전기 임플란트를 시술받았거나 써마지(Thermage®) 치료를 받아야 하는지에 관해 질문이 있는 경우 담당 의사에게 알리십시오.

Solta Medical은 써마지 시스템의 사용을 연구하지 않았습니다.

– 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

치료 중 가장 흔하게 보고되는 부작용은 치료 부위의 경미~중등도 통증입니다.

치료 후 가장 흔히 보고되는 부작용은 다음과 같습니다.

– 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.

다음과 같은 부작용이 드물게 발생합니다.

– 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.

Thermage FLX에 대한 자세한 내용은 의사에게 문의하고 다음을 참조하세요. www.thermage.com 자세한 내용은.

솔타메디칼 소개

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.

Bausch Health 소개

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.

미래 예측 진술

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.

주제 : 보도 자료 요약

출처: Bausch 건강 회사 Inc
분야 : 생명공학, 의료 및 제약

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