Mauna Kea Technologies Accelerates International Expansion with New Regulatory Clearances in Switzerland and the United Kingdom

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

PARIS & BOSTON--(BUSINESS WIRE)--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

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