Mauna Kea Technologies (Euronext Growth: ALMKT) has announced two new peer-reviewed clinical studies that reinforce the diagnostic value of its Cellvizio® probe and needle-based confocal laser endomicroscopy (p/nCLE) platform for pancreatic cystic lesions (PCLs). The findings demonstrate significant improvements in diagnostic accuracy and physician agreement, addressing critical challenges in distinguishing mucinous from non-mucinous cysts and detecting high-grade dysplasia. These results support the company’s strategy to scale adoption across U.S. centers and integrate artificial intelligence into its diagnostic workflow.

The first study, published in Gastrointestinal Endoscopy, was an international interobserver assessment involving 15 independent physicians of varying experience levels. The research evaluated the reproducibility of pancreatic cyst diagnostics when Cellvizio imaging was added to standard evaluation protocols. The addition of real-time cellular imaging increased the accuracy for distinguishing mucinous versus non-mucinous cysts to 96%. Furthermore, subtype-specific accuracy rose to approximately 85%, and agreement among the independent observers improved significantly. This reproducibility across clinicians is cited as a key factor for broad clinical adoption.

The second study, published in Techniques and Innovations in Gastrointestinal Endoscopy, focused on an nCLE-guided artificial intelligence algorithm designed to detect 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, a substantial increase from the 53% accuracy rate of conventional methods. The study noted comparable sensitivity across subtypes, providing early evidence supporting the company’s roadmap to deploy AI-assisted decision support tools on the Cellvizio platform.

Clinical Impact and Expert Commentary

Dr. Somashekar (Som) Krishna, Professor of Medicine and Director of Advanced Endoscopy at The Ohio State University Wexner Medical Center, highlighted the clinical stakes of accurate diagnosis. He noted that in pancreatic cyst diagnosis, errors can lead to either unnecessary surgery for benign cysts or missed cancers. In the ongoing multicenter CLIMB study evaluating EUS-nCLE, adding real-time EUS-nCLE to standard evaluation raised diagnostic accuracy from 73% to 85%. This improvement reduced unnecessary surgery for benign cysts by more than 40% and cut missed cancers roughly six-fold. Dr. Krishna emphasized that these gains were produced by 15 international endosonographers new to the technique, demonstrating consistent performance across users.

Sacha Loiseau, Ph.D., Chairman and Chief Executive Officer of Mauna Kea Technologies, stated that the growing body of independent, peer-reviewed evidence confirms the unique value of Cellvizio in providing a window into pancreatic cysts that no other technology offers. He added that avoiding unnecessary surgeries and detecting cancers earlier strengthens the company’s conviction as it scales adoption and brings AI-assisted diagnosis to the platform.

What the Numbers Show

The data reveals a clear divergence between conventional diagnostic methods and those augmented by Cellvizio technology. While standard evaluations struggle with consistency, the integration of nCLE imaging raises overall accuracy to 96% for primary classification. More notably, the application of AI to this imaging data bridges a significant gap in detecting high-risk lesions, nearly doubling the accuracy rate from 53% to 87% in non-gastric IPMN subtypes. This suggests that the combination of hardware-based cellular imaging and software-driven analysis addresses both the reproducibility and sensitivity limitations inherent in traditional pancreatic cyst management.

Mauna Kea Technologies is listed on Euronext Growth under the ticker ALMKT. The company’s 2025 Annual Report was filed with the Autorité des marchés financiers (AMF) on April 30, 2026.

Mauna Kea Technologies reported H1 2026 sales of €3,203K, up 44% at constant exchange rates, driven by clinical adoption in the United States and rapid international expansion of CellTolerance. The company confirmed its trajectory toward profitability by year-end 2027, supported by a strengthened balance sheet and a solid systems pipeline for the second half of the year.

H1 2026 Sales Performance

Total sales for the first half reached €3,203K, compared to €2,303K in H1 2025. Growth was primarily led by the EMEA & ROW region, which surged 261% to €1,149K, while United States sales grew 10% at constant exchange rates to €2,055K. CellTolerance sales increased 142% year-over-year to €896K.

Regional and Operational Highlights

In the United States, sales growth was driven by robust probe sales, which increased 33% at constant exchange rates, and services, which rose 17%. The company noted strengthening pricing power, with average probe discounting falling from 23% in 2024 to 13% in 2026. While Q2 2026 U.S. sales declined 8% due to the phasing of system sales, the company expects a significant increase in the second half driven by pancreatic-cyst momentum and upgrade cycles.

EMEA and ROW sales grew significantly, up 261% in H1, driven by strong momentum in the CellTolerance application for food intolerances. The company successfully expanded into new territories, including the UAE, Switzerland, Australia, and Spain, and obtained regulatory approvals in the Middle East, Switzerland, and the UK.

Financial Position and Outlook

The company strengthened its financial flexibility in July 2026 with a €4 million optional shareholder loan facility from Vester Finance. This facility, drawable over 24 months, extends financial visibility beyond 2027. Combined with a €27 million debt reduction achieved through the 2025 restructuring, the company operates with an optimized cost structure.

Mauna Kea expects growth to continue in the second half of 2026, supported by increased U.S. system sales, acceleration in U.S. usage volumes, and the continued ramp-up of CellTolerance. The company confirmed its trajectory toward profitability by year-end 2027 and operational self-financing thereafter.