Mauna Kea Technologies Receives NMPA Regulatory Approval in China
for its Next-Generation Cellvizio® Platform

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


Paris and Boston, November 20, 2025 – 5:45 p.m. CET – 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.


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Mauna Kea Technologies NewCap - Investor Relations
investors@maunakeatech.com Thomas Grojean
+33 (0)1 44 71 94 94
maunakea@newcap.eu


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
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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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