BOSTON — Mauna Kea Technologies reported a 21% increase in revenue to €4.4 million for the first nine months of 2026, driven by strong international sales and growing demand for its CellTolerance technology, despite a decline in third-quarter sales caused partly by temporary staffing shortages in the United States.
The medical technology company, which operates in Paris and Boston, said revenue increased 24% at constant exchange rates from €3.6 million in the same period last year.
Recurring revenue from probes, pay-per-use services and service contracts rose 17% at constant exchange rates to €2.9 million. The company sold 10 systems during the nine-month period, compared with six a year earlier.
Sales in Europe and other international markets surged 128% to €1.5 million, compared with approximately €646,000 in the first nine months of 2025. Growth was supported by expanding adoption of CellTolerance, the company’s technology for evaluating intestinal barrier function.
CellTolerance revenue increased 47% to €1.1 million, accounting for approximately 24% of total company sales. The number of paying centers using the technology increased to 27 across nine countries, up from 17 at the end of 2025.
“Over nine months our sales grew 24% at constant exchange rates with international sales up 128% and recurring revenue up 17%. In the United States we are selling at higher prices and lower discounts than at any point since 2023, and systems placed since 2025 already generate 46% of our probe sales,” said Sacha Loiseau, Ph.D., chairman and CEO of Mauna Kea Technologies.
The company’s U.S. business generated approximately €2.9 million in revenue during the first nine months, representing a 2% decline on a reported basis but a 1% increase at constant exchange rates.
Mauna Kea said its U.S. operations benefited from improved pricing, with average probe selling prices increasing 6% to $10,336. Average discounts declined to 12.8%, compared with 15.6% in 2025 and 21% in 2023.
Sales of AQ-Flex probes, used in evaluating pancreatic lesions, increased 17% by volume, while service contract revenue rose 32%.
However, third-quarter revenue declined 10% to €1.2 million, or 11% at constant exchange rates, compared with €1.3 million a year earlier.
U.S. third-quarter sales fell 14% at constant exchange rates to approximately €883,000, primarily reflecting vacancies in the company’s Northeast and Southern sales territories.
Mauna Kea said the vacancies were resolved by October, leaving all four U.S. sales territories staffed with a territory manager and clinical associate.
“The third quarter was held back by two unstaffed U.S. territories. Those roles are now filled, every territory has both a Territory Manager and a Clinical Associate, and our partnership with TaeWoong is operational,” Loiseau said.
The company also reported progress in its partnership with TaeWoong Medical, which is working to expand commercialization of Mauna Kea’s Cellvizio imaging platform in the United States.
The partnership has identified more than 200 potential customer accounts, with initial commercial efforts focused on priority targets.
Cellvizio uses probe- and needle-based confocal laser endomicroscopy technology to provide real-time microscopic imaging of tissue during medical procedures.
Mauna Kea also highlighted recent clinical research supporting its technology.
The CLIMB study, involving 526 patients across 14 U.S. medical centers, evaluated the use of Cellvizio in pancreatic cystic lesions and was presented at Digestive Disease Week 2026.
Separately, a meta-analysis involving 33 studies and 2,350 patients found that confocal laser endomicroscopy-guided targeting detected dysplasia in 28% of patients with Barrett’s esophagus, compared with 10% using standard biopsies. The analysis also reported 48.5% fewer biopsies per patient.
Looking ahead, Mauna Kea expects its traditionally stronger fourth quarter to benefit from a fully staffed U.S. commercial organization, potential system sales, international expansion and its TaeWoong partnership.
The company said it is also exploring additional partnerships to expand the commercial reach of Cellvizio across other clinical applications.
Mauna Kea reported that it expects to have sufficient financial resources to fund operations through the end of 2027, taking into account a €5 million optional shareholder financing facility provided by Vester Finance.
The company said it remains focused on controlling costs and moving toward operational self-financing.
