Ongoing Strategic Negotiations Towards a Licensing Agreement
Strong Momentum for CellTolerance: Over 1,500 Procedures Completed, New Centers of Excellence Adopting the Technology, Including a Leading U.S. Institution
Regulatory News:
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, provides an update on the safeguard proceedings initiated on March 31, 20251, as well as on the progress of its strategic discussions and operational developments. This announcement is part of the Company's commitment to maintaining ongoing transparency with its shareholders and partners during the ongoing process.
Since the initiation of this safeguard proceedings, the Company has engaged in constructive discussions with its financial partners to identify the most appropriate options for achieving a sustainable solution to the current situation.
In parallel, the Company is actively pursuing the exclusive negotiations announced on April 1st, 2025, with a major healthcare player, aiming to finalize a licensing agreement for Cellvizio® technology in a high-potential therapeutic area. These discussions are progressing constructively and could represent a major strategic milestone for the Company's clinical and commercial development.
On the operational front, Mauna Kea Technologies is experiencing strong momentum with its CellTolerance franchise. The symbolic milestone of 1,500 procedures has been surpassed, demonstrating the growing adoption of the technology. Several new accounts have recently been onboarded, including prestigious institutions that form a solid foundation for future growth. Among them, a leading center in the United States has already performed over 100 procedures in just a few months and continues to show an upward trend in usage. The Company plans to continue updating on these clinical and commercial advancements in the coming weeks.
Finally, Mauna Kea Technologies is actively engaged with several investors to secure the financial visibility required for the safeguard proceedings and the finalization of licensing agreement. These discussions aim to provide the Company with the resources required to execute its long-term growth strategy.
Sacha Loiseau, Ph.D., Chairman and Chief Executive Officer of Mauna Kea Technologies, stated: "We are navigating this transition period with full determination and remain strongly committed to equipping the Company for future growth. Our commercial outlook is becoming more tangible each day, both for CellTolerance and our pancreatic cyst application, which are increasingly supported by clinical data and a clear enthusiasm among physicians and patients. The safeguard proceedings provide us with a protective framework ideal for negotiating with our stakeholders and preparing for the Company's redeployment on solid foundations. I am very pleased with the dedication of our teams and am fully committed to shaping a new chapter of strong value creation for the Company. Cellvizio is proving its relevance more than ever today, offering a unique opportunity to improve care for millions of patients while reducing healthcare system costs."
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.
1 Press release dated March 31, 2025: "Mauna Kea Technologies announces the opening of a safeguard proceeding to restructure its financial liabilities"
View source version on businesswire.com: https://www.businesswire.com/news/home/20250521798502/en/
Contacts:
Mauna Kea Technologies
investors@maunakeatech.com
NewCap Investor Relations
Aurélie Manavarere Thomas Grojean
+33 (0)1 44 71 94 94
maunakea@newcap.eu
