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
Regulatory News:
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."
About Endotherapeutics Pty Ltd
Endotherapeutics is a leading Healthcare Technologies distributor serving customers across Australia and New Zealand, headquartered in Sydney, Australia. Endotherapeutics' mission is to improve healthcare and achieves this by supplying innovative healthcare solutions with the highest levels of service and support. To find out more, visit www.endotx.com.au
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
This press release contains forward-looking statements about Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Mauna Kea Technologies' financial condition, business, strategies, plans and objectives for future operations are forward-looking statements. Mauna Kea Technologies believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements 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, which is available on the Company's website (www.maunakeatech.fr), as well as the risks associated with changes in economic conditions, financial markets and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Mauna Kea Technologies to differ materially from those expressed in the forward-looking statements. This press release 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, shares of Mauna Kea Technologies in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.
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Contacts:
Mauna Kea Technologies
investors@maunakeatech.com
NewCap Investor Relations
Aurélie Manavarere Thomas Grojean
+33 (0)1 44 71 94 94
maunakea@newcap.eu
