NMPA approval obtained following a 3-year certification process
Mauna Kea is now evaluating options to commercialize Cellvizio Gen 3 in China independently of the JV with Tasly
Regulatory News:
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces that it has obtained approval from the National Medical Products Administration (NMPA) in China for the import and commercialization of its next-generation Cellvizio (Gen 3) platform.
This registration was processed and obtained directly by Mauna Kea Technologies S.A. and is valid for five years until November 2030. It authorizes the use in China of the Gen 3 platform in conjunction with the Company's full range of confocal probes (GastroFlex N, ColoFlex N, CholangioFlex N, AlveoFlex N, AQ-Flex 19 N).
The Cellvizio Gen 3 system is the Company's most advanced platform and is a distinct asset not included in the previous agreements under the Joint Venture with Tasly. By securing this approval directly, Mauna Kea reinforces its portfolio of proprietary assets in China.
China represents an important market for interventional endoscopy, with strong demand for precision diagnostic technologies. With this essential regulatory authorization now in place, Mauna Kea is currently evaluating its options for the commercialization of the next-generation Cellvizio platform to Chinese hospitals, aiming to make this cutting-edge technology available to practitioners and patients as effectively as possible.
Sacha Loiseau, Chairman, CEO, and founder of Mauna Kea Technologies,commented "The approval of our Cellvizio Gen 3 in China is excellent news as it reopens the Chinese market, a very important territory for endoscopy where we historically have had significant activity. This approval positions us as the most advanced technology relative to the competition that exists specifically in this market. We will move quickly to evaluate and identify the best options that will allow us to commercialize our new platform as soon as possible, which would represent upside revenue compared to our current business plan."
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 and the safeguard plan contain forward-looking statements relating to Mauna Kea Technologies, its activities, and the progress of the safeguard proceedings opened for the benefit of the Company. All statements other than statements of historical fact included in this press release and in the safeguard plan, including, without limitation, those regarding the financial position, business, strategies, plans, and objectives of Mauna Kea Technologies' management 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 as to the achievement of the forecasts expressed in these forward-looking statements, which are subject to numerous risks and uncertainties, including those described in Chapter 2 of Mauna Kea Technologies' 2024 Annual Report filed with the Autorité des marchés financiers (AMF) on April 30, 2025, available on the Company's website (www.maunakeatech.fr), as well as risks related to changes in the economic environment, financial markets, and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release and in the safeguard plan are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider significant at this date. The occurrence of some or all of these risks could cause the actual results, financial conditions, performance, or achievements of Mauna Kea Technologies to differ significantly from the results, financial conditions, performance, or achievements expressed in these forward-looking statements. This press release, the safeguard plan, and the information they contain do not constitute an offer to sell or subscribe, 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 said jurisdiction. Likewise, they do not constitute and should not be treated as investment advice. They do not have regard to the investment objectives, financial situation, or particular needs of any recipient. No representation or warranty, express or implied, is given as to the accuracy, completeness, or reliability of the information contained in these documents. They should not be considered by recipients as a substitute for the exercise of their own judgment. All opinions expressed in these documents are subject to change without notice. This press release has been prepared in French and English. In the event of any discrepancy between the two versions of the press release, the French version shall prevail
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Contacts:
Mauna Kea Technologies
investors@maunakeatech.com
NewCap Investor Relations
Thomas Grojean
+33 (0)1 44 71 94 94
maunakea@newcap.eu
