Following significant U.S. commercial restructuring in early 2025, which delivered sustained sales acceleration throughout the year, Mauna Kea is now sharpening its international strategy outside the United States. The organizational changes aim to capitalize on proven clinical momentum in pancreatic cyst characterization and unlock the high-potential market for CellTolerance® in Europe, the Middle East, Australia, and beyond.
Benoit Chardon, who has served as Senior Strategic Advisor since 2024 and played a pivotal role in shaping CellTolerance®'s value proposition, branding, go-to-market strategy, and initial commercial rollout (Europe, Australia, and other regions), is appointed Fractional Chief Commercial Officer dedicated to CellTolerance®. With over 20 years of proven leadership in healthcare, weight loss, and medical aesthetics, Benoit Chardon has developed scalable playbooks for revenue development and value creation.
Under his leadership, a dedicated, outsourced commercial and marketing team will drive CellTolerance® scaling with the following key priorities for 2026:
“CellTolerance® has proven strong clinical relevance and market traction globally, reaching €1 million in sales in 2025,” said Benoit Chardon. “We are now entering the execution phase to replicate proven scalable models I have successfully deployed before. Our goal is disciplined, high-quality scaling to make CellTolerance the go-to solution for food intolerance diagnosis in Europe and key international markets, targeting significant growth in the coming years through disciplined expansion and partnerships. With current users already describing CellTolerance as an ‘essential technology’ for their patients, we see a compelling and immediate opportunity to address a large, underserved market.”
In addition to CellTolerance®, the commercial efforts will prioritize pancreatic cyst characterization outside the U.S., an indication with strong clinical momentum. This leverages landmark achievements including positive CLIMB study results, the recent inclusion of Cellvizio® in the European Society of Gastrointestinal Endoscopy (ESGE) technical guidelines, and an ongoing review by the French National Authority for Health (Haute Autorité de Santé) that could unlock reimbursement in France.
Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies, commented: “2025 marked a turning point with record U.S. momentum in pancreatic cysts and CellTolerance emerging as a true second pillar. To seize the international opportunity ahead, we are adapting our organization with clear focus and the right expertise. Benoit’s proven track record in scaling high-growth healthcare businesses makes him the right leader to structure and accelerate CellTolerance globally. 2026 will be the year we move from the CellTolerance pilot phase into meaningful, recurring growth alongside building pancreatic cyst momentum outside the U.S.”
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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.
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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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