Mauna Kea Technologies Unveils Its Next-Generation Cellvizio® Platform

Launch of the new system is part of the company’s mission to deliver an enhanced platform combining advanced imaging, digital health informatics, and improved patient outcomes

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

Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today unveiled the next-generation Cellvizio platform, which has already received both 510(k) clearance (K193416) from the U.S. Food and Drug Administration (FDA) and CE marking. Built with enhanced capabilities, this entirely new system uses the company’s proprietary Confocal Laser Endomicroscopy (CLE) advanced imaging technology to deliver cellular and molecular imaging virtually anywhere in the human body, and will be available for purchase in the second half of 2021.

Building upon the success of the previous models, the new generation of Cellvizio equips physicians with the most advanced cellular imaging technology to improve patients’ lives. The platform includes several new features: an all-new workflow integration for endoscopic, bronchoscopic, or operating environments via integrated connectivity; enhanced capabilities enabling artificial intelligence (AI) for assisted pattern recognition; and a small footprint and slim profile allowing easy maneuverability within the procedure room.

“Our next-generation platform represents a tremendous leap forward in product innovation that significantly improves the ease of integrating Cellvizio into procedure rooms around the world,” said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. “The system readiness to host novel advanced capabilities, particularly artificial intelligence, will expand our ability to provide advanced imaging techniques and real-time digital health informatics as part of the overall delivery of patient care.”

Learn more by visiting: www.landing.maunakeatech.com/next-gen-cellvizio

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 revolutionizing the way physicians diagnose and treat patients — making a transformative change in medicine. For more information, visit www.maunakeatech.com.

Disclaimer

This press release contains forward-looking statements concerning Mauna Kea Technologies and its activities. Such forward looking statements are based on assumptions that Mauna Kea Technologies considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the Universal Registration Document of Mauna Kea Technologies registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on August 7, 2020 under number 926346434_20200807 and available on the Company’s website (www.maunakeatech.com), and to the development of economic situation, financial markets, and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this release are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Mauna Kea Technologies that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for, Mauna Kea Technologies shares in any country.

Contacts

United States
Mike Piccinino, CFA

Westwicke, an ICR Company

443-213-0500

France and Europe
NewCap – Investor Relations

Thomas Grojean

+33 (0)1 44 71 94 94

maunakea@newcap.eu