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

JV now operational to start selling products in China

PARIS & BOSTON–(BUSINESS WIRE)–Regulatory News:

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

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About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio® platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit www.maunakeatech.com.

Disclaimer

This press release contains forward-looking statements about Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Mauna Kea Technologies’ financial condition, business, strategies, plans and objectives for future operations are forward-looking statements. Mauna Kea Technologies believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements are subject to numerous risks and uncertainties, including those described in Chapter 2 of Mauna Kea Technologies’ 2023 Annual Report filed with the Autorité des marchés financiers (AMF) on April 30, 2024, which is available on the Company’s website (www.maunakeatech.fr), as well as the risks associated with changes in economic conditions, financial markets and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Mauna Kea Technologies to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, or the solicitation of an order to buy or subscribe for, shares of Mauna Kea Technologies in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.

Contacts

Mauna Kea Technologies
investors@maunakeatech.com

NewCap – Investor Relations
Aurélie Manavarere / Thomas Grojean

+33 (0)1 44 71 94 94

maunakea@newcap.eu