PARIS & BOSTON & SYDNEY–(BUSINESS WIRE)–Regulatory News:
Mauna Kea Technologies (Euronext Growth: ALMKT) and Endotherapeutics, today announced that Cellvizio system has been included in the Australian Register of Therapeutic Goods (ARTG). This listing, secured by the Company’s Australian sponsor and exclusive distributor, Endotherapeutics Pty Ltd, enables the commercial launch of Cellvizio in Australia. Mauna Kea has already secured its first two system orders in Australia for use in its new CellTolerance1 indication for food intolerances.
This successful reopening of the Australian market was spearheaded by the commercial team led by Benoit Chardon. The company has also recently strengthened its ties with this experienced team to expand its global reach into other key geographies, including Europe, the Middle East and Latin America, creating a model for new market opportunities.
“We are excited to pave the way for large commercial expansion of the Cellvizio platform in Australia.” said Adam Srejber, CEO of Endotherapeutics Pty Ltd. “We are convinced that this technology can be widely adopted by a wide range of institutions here, and we are already in advanced discussions with a number of interested parties.”
Sacha Loiseau, Chairman and CEO of Mauna Kea Technologies, commented: “We are very proud to open this new market, which is full of opportunity driven by our new indication for food intolerances. In just six months, we have managed to sign an exclusive strategic agreement with a very relevant and active distributor in Australia, and secure the first sales. This is an ideal model that we intend to replicate very quickly in other high-potential territories such as Turkey, Brazil, and the UAE, where we have held regulatory clearances and commercial activity in the past, and where the market potential for Cellvizio and CellTolerance is particularly significant.”
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About Endotherapeutics Pty Ltd
Endotherapeutics is a leading Australian medical technologies company and has for over 25 years, been committed to the introduction and support of innovative medical technologies to improve healthcare in Australia and New Zealand. 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 and the safeguard plan contains forward-looking statements about Mauna Kea Technologies, its business and the progress of the safeguard proceedings initiated for the benefit of the Company. All statements other than statements of historical fact included in this press release and the safeguard plan, 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 and the safeguard plan 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.
1 See www.cell-tolerance.com for more information.
Contacts
Mauna Kea Technologies
[email protected]
NewCap – Investor Relations
Aurélie Manavarere / Thomas Grojean
+33 (0)1 44 71 94 94
[email protected]
