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 and Boston, February 23, 2026 – 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 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.”
