These clearances enable the commercialization of Cellvizio in two major markets and accelerate the Group's international expansion
First order for the next-generation Cellvizio (Gen 3) platform received from Bern University Hospital, dedicated to functional intestinal barrier disorders
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 it has obtained the regulatory registrations and approvals required to commercialize its Cellvizio system in Switzerland and the United Kingdom.
These approvals provide access to two strategic European markets recognized for their excellence in interventional gastroenterology. They are fully aligned with the new commercial organization announced on February 4, 2026, which aims to accelerate growth outside the United States by structuring the international expansion of both Cellvizio and CellTolerance.
At the same time, Mauna Kea Technologies has already received an order from Bern University Hospital (Inselspital), one of Switzerland's leading gastroenterology centers. The institution will receive its new Cellvizio Gen3 system dedicated to applications in functional disorders related to intestinal barrier dysfunction.
The opening of these territories enables Mauna Kea to address a dense network of specialized healthcare institutions:
- In the United Kingdom: the country includes approximately 200 NHS Trusts and several hundred accredited endoscopy sites (the majority within the public sector), representing significant potential for the deployment of Cellvizio and CellTolerance assessments;
- In Switzerland: the hospital landscape includes approximately 275 institutions, including five world-renowned university hospitals. Centers performing advanced interventional digestive endoscopy are concentrated around these hubs of excellence and specialized private clinics, offering an ideal environment for rapid adoption, with pricing levels often higher than those observed elsewhere in Europe.
Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies, commented: "Obtaining these approvals in Switzerland and the United Kingdom shortly after our CE MDR certification marks an important milestone in our expansion strategy beyond the United States. These markets represent an immediate opportunity for both Cellvizio and CellTolerance. The installation of the new Cellvizio Gen3 system at Bern University Hospital is a first concrete validation of this momentum and reflects the confidence of leading European clinicians in our technology. We are encouraged by our commercial momentum at the start of 2026, both in the United States and internationally, and we are entering this year with determination."
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
The present press release, together with the safeguard plan, contains forward-looking statements relating to Mauna Kea Technologies, its business and the course 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 Mauna Kea Technologies' financial position, business, strategies, plans and management objectives for future operations, are forward-looking statements. Mauna Kea Technologies believes that such forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the projections set forth in such forward-looking statements will be achieved, as they 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 relating to changes in economic conditions, 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 material as of the date hereof. The occurrence of all or part of such risks could cause Mauna Kea Technologies' actual results, financial condition, performance or achievements to differ materially from those expressed in such forward-looking statements. This press release, the safeguard plan 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, Mauna Kea Technologies shares in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. Likewise, they do not constitute and should not be treated as investment advice. They do not take into account the investment objectives, financial situation or particular needs of any recipient. No representation or warranty, express or implied, is made as to the accuracy, completeness or reliability of the information contained in these documents. Readers should not regard them as a substitute for the exercise of their own judgment. All opinions expressed in these documents are subject to change without notice. This document does not constitute an offer to sell or the solicitation of an order to buy or subscribe for the Company's securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration of the relevant securities or any other qualification under the securities regulations of such country or jurisdiction.
The distribution of this document may be subject to specific regulations in certain countries. Persons who come into possession of this document should inform themselves about, and comply with, any applicable local restrictions.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260223552044/en/
Contacts:
Mauna Kea Technologies
investors@maunakeatech.com
NewCap Investor Relations
Thomas Grojean
+33 (0)1 44 71 94 94
maunakea@newcap.eu
