Mauna Kea Technologies Announces Two New Peer-Reviewed Clinical Studies Confirming the Clinical Value of Cellvizio® and Its Combination with AI for the Diagnosis of Pancreatic Cysts

International interobserver study confirms increase of diagnostic accuracy to 96% for mucinous vs. non-mucinous, and higher physician agreement with Cellvizio

AI + Cellvizio increases accuracy in detecting high-risk lesions from 53% to 87%

PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News:

Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announced that two new peer-reviewed studies published across leading gastroenterology journals reinforce the growing body of evidence supporting needle-based confocal laser endomicroscopy (nCLE) for the diagnosis of pancreatic cystic lesions (PCLs).

A new international interobserver study — Proven reproducibility across physicians

An international study, published in Gastrointestinal Endoscopy¹, assessed how consistently physicians of differing experience interpret pancreatic cyst diagnostics. Adding Cellvizio imaging to standard evaluation increased mucinous-vs. non-mucinous accuracy to 96%, raised subtype-specific accuracy to approximately 85%, and significantly improved agreement among 15 independent observers. Reproducibility across clinicians is one of the keys to broad adoption.

A groundbreaking artificial intelligence (AI) study — Increasing accuracy in high-risk lesions

A clinical study, published in Techniques and Innovations in Gastrointestinal Endoscopy², evaluated an nCLE-guided artificial intelligence algorithm for detecting high-grade dysplasia or early cancer within intraductal papillary mucinous neoplasms (IPMNs). In higher-risk, non-gastric IPMN subtypes, the AI algorithm achieved 87% accuracy versus 53% for conventional methods with comparable sensitivity across subtypes — early evidence supporting the Company's roadmap to bring AI-assisted decision support to the Cellvizio platform.

Dr. Somashekar (Som) Krishna, Professor of Medicine and Director of Advanced Endoscopy at The Ohio State University Wexner Medical Center, commented: "In pancreatic cyst diagnosis, the cost of being wrong is enormous in either direction — we over-resect benign cysts and still miss cancers. In the ongoing multicenter CLIMB study evaluating EUS-nCLE, adding real-time EUS-nCLE to the standard evaluation raised diagnostic accuracy from 73% to 85%, reduced unnecessary surgery for benign cysts by more than 40%, and cut missed cancers roughly six-fold. What makes that compelling is who produced it: 15 international endosonographers new to the technique, with the gains holding across all of them. And we can now build on it, applying artificial intelligence to nCLE video detected high-grade dysplasia and cancer with 87% accuracy in the non-gastric IPMN subtypes that carry the highest risk of progression. Used within a multimodal, size-based approach, nCLE, which is now included in the ESGE guidelines, is becoming a key piece in solving the pancreatic cyst puzzle.”

Sacha Loiseau, Ph.D., Chairman and Chief Executive Officer of Mauna Kea Technologies, concluded: “This growing body of independent, peer-reviewed evidence confirms what physicians are seeing in practice: Cellvizio gives them a unique window into pancreatic cysts that no other technology offers. Every unnecessary surgery avoided and every cancer detected earlier give meaning to what we do. It also strengthens our conviction as we scale adoption across U.S. centers and bring AI-assisted diagnosis to the platform.”

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' 2025 Annual Report filed with the Autorité des marchés financiers (AMF) on April 30, 2026, 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 The Impact of Confocal Endomicroscopy Combined with Standard Diagnostics in Evaluating Large Pancreatic Cystic Lesions: An International Interobserver Study, https://doi.org/10.1016/j.gie.2026.06.067
² Preoperative Prediction of Subtype and Artificial Intelligence–Driven Endomicroscopy Detection of Advanced Neoplasia in Intraductal Papillary Mucinous Neoplasms. https://doi.org/10.1016/j.tige.2025.250956