After obtaining "China-US dual certification," Peninsula Medical plans to cover the top 300 medical institutions across the United States.

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As competition in the domestic medical aesthetics market intensifies,"going abroad" is becoming an important theme for the industry.

Recently, Peninsula Medical's radio frequency skin treatment device"Peninsula Anti-clockwise" was officially granted the Class III medical device registration certificate by the National Medical Products Administration, making it the first domestic gold microneedle device to obtain the "Class III certificate".

Prior to this, Peninsula Anti-clockwise was the first to obtain the USFDA 510(k) registration certificate.

With the issuance of the domestic license,"Peninsula Anti-clockwise" has now officially established the compliance barrier of "dual certification" with bothNMPAandFDA, which provides key support for its further penetration into high-end markets abroad such as the United States.

According to Peninsula Medical founder Lei Xiaobin in an interview with Xin Feng,"Peninsula Anti-clockwise" underwent three and a half years of clinical trials in China, and is the first gold microneedle device to complete Class III medical device clinical certification domestically.

Clinical data has become the accelerator for Peninsula Medical to conquer overseas markets.

"FDAofficials looked at the data and said it was sufficient to prove efficacy, so the registration was quickly approved," Lei Xiaobin said.

With access to both the Chinese and US markets, Peninsula Medical is now"expanding its territory" in the United States.

According to Lei Xiaobin in his interview with Xin Feng, Anti-clockwise has now entered the US top30and plans to cover the top300medical institutions nationwide by2026.

Specifically, Peninsula Medical mainly promotes its device by collaborating on research projects with institutions such as Harvard University Massachusetts General Hospital, Boston Lab,UCI, and others.

This is also one of the main strategies for many medical device companies adopting a "high-profile, strong approach" to entering the US market. For example, when the medical imaging equipment company United Imaging was expanding into the US, it also established research cooperation with top local universities and research institutions.

Regarding the capitalization process of concern to the outside world, Lei Xiaobin told Xin Feng that due to the current external environment, there are no plans to list in the short term. At this stage, the focus will continue to be on technology development, aiming to push its devices to make breakthroughs in global markets.

Whether Peninsula Medical can successfully capture more market share in the US market is attracting attention.

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