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Mauna Kea Technologies Announces Joint Venture in China Obtained Class II Medical Device Business License

6 June 2024

JV now operational to start selling products in China 

Paris and Boston, June 6, 2024 – 5:45 p.m. CEST – Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announced that its joint venture with Tasly Pharmaceutical, Tasly Mauna Kea Medical Engineering Technology, has successfully obtained the Class II Medical Device Business License in China.

The Class II classification by China’s National Medical Products Administration (NMPA) applies to medical devices that require rigorous control and management to ensure safety and efficacy. This business license, issued by the Shanghai Municipal Medical Products Administration, authorizes Tasly Mauna Kea Medical Engineering Technology to engage in the wholesale distribution of Class II medical devices across China.

“The joint venture is now operational and ready to address the Chinese market, beginning with the sale of its first units of systems and probes,” stated Sacha Loiseau, Chairman and CEO of Mauna Kea Technologies. “After overcoming numerous obstacles, I am truly pleased that we have secured this license in China. This achievement paves the way for our JV’s business development and market expansion. Our ambitions in this territory are significant, reflecting the substantial size of the market. I would like to extend my gratitude to our partner Tasly for their efforts in reaching this milestone.” 

Next financial communication: 2nd Quarter and First Half 2024 Sales, on July 25, 2024, after market close

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