Mauna Kea Technologies Announces Joint Venture in China Obtained Class II Medical Device Business License
June 06 2024 - 11:45AM
Business Wire
JV now operational to start selling products
in China
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: 2nd Quarter and First Half
2024 Sales, on July 25, 2024, after market close
***
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.
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Mauna Kea Technologies investors@maunakeatech.com
NewCap - Investor Relations Aurélie Manavarere / Thomas
Grojean +33 (0)1 44 71 94 94 maunakea@newcap.eu
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