Leveraging strong momentum for the CellTolerance® application, Mauna Kea Technologies is expanding into new geographies with high growth potential
Regulatory clearance in Australia (TGA) expected in the coming months
Paris and Boston, July 24, 2025 – 5:45 p.m. CEST – Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces its entry into the Australian market by signing a new exclusive distribution agreement with Endotherapeutics Pty Ltd, a leading Australia-based distributor of cutting-edge medical devices, to bring the Cellvizio platform to Australian physicians.
This strategic expansion comes as Mauna Kea experiences growing momentum for its CellTolerance application, prompting the company to open new geographic markets with strong growth potential.
The three-year agreement grants Endotherapeutics the exclusive rights to distribute and promote the Cellvizio platform in Australia. As part of the market entry, a submission for Therapeutic Goods Administration (TGA) approval for the latest generation of Cellvizio products is underway. Mauna Kea Technologies has already been granted TGA clearance in the past and does not anticipate any hurdles in obtaining it again.
The partnership will leverage the upcoming launch of the CellTolerance program with Professor Gerald Holtmann, MD, PhD, MBA, a leading Australian physician at Princess Alexandra Hospital in Brisbane, who is planning to acquire one Cellvizio for food intolerance applications.
“This technology brings hope of change for millions of patients suffering from food-related IBS symptoms,” commented Professor Holtmann. “Cellvizio is truly unique in its ability to help identify the root causes of patient symptoms, enabling the creation of tailored diets. My entire team is excited to explore its full potential and improve the lives of our patients.”
“We’re very pleased to partner with Mauna Kea Technologies to introduce Cellvizio to the vibrant Australian GI market”, stated Rob Curtin, Business Manager for GI at Endotherapeutics. “The potential for Cellvizio and its key indications, particularly pancreatic cyst characterization and food intolerance detection is very significant.”
Sacha Loiseau, Chairman and CEO of Mauna Kea Technologies, added: “We are thrilled to partner with Endotherapeutics, a premier distributor of cutting-edge medical devices and a trusted partner with deep roots in the Australian healthcare system. This partnership marks a key milestone in our international expansion strategy. As we see good momentum in the adoption of our platform, particularly for CellTolerance, we are taking key initiatives to expand our market reach in territories with strong growth potential.”
