Product and service revenue of EUR3.2 million, up 37% driven by strong CellTolerance(R) momentum in Europe and new international markets
Gross margin on product and service revenue of 65%, up 2 points
Operating expenses(1) of EUR5.9 million, with R&D and G&A slightly down
Financial visibility extended to the end of 2027 with the renewed support of long-term shareholder and partner Vester Finance
PARIS & BOSTON--(BUSINESS WIRE)--October 08, 2026--
Regulatory News:
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio(R), the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today reports its consolidated results for the first half of 2026, as approved by the Board of Directors on September 28, 2026. The half-year financial report will be available on the Company's website.
Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies, commented: "The first half of 2026 was consistent with our roadmap. Growth was driven by CellTolerance(R), with dynamic sales in Europe, notably in Germany and Switzerland, and first sales in new markets such as the United Arab Emirates, Australia and Spain, while we maintained strict cost discipline. In the United States, we have evolved our commercial model with a dedicated Clinical Associates team focused on providing clinical support and driving Cellvizio usage. Completed in June, this organization is ramping up and lays the foundations for healthy, sustainable growth.
At the same time, the clinical foundations of Cellvizio continue to strengthen, with results confirmed both in Barrett's esophagus, through the large independent meta-analysis conducted in South Korea, and in pancreatic cysts, with the CLIMB study and associated ancillary studies. Cellvizio is becoming established in interventional endoscopy. Finally, thanks to the renewed commitment of our long-term shareholder and partner, Vester Finance, our financial visibility now extends to the end of 2027, giving us the means to execute our plan."
H1 2026 highlights
Confirmatory clinical data
-- Pancreatic cysts: the CLIMB study was selected for the ASGE
Presidential Plenary Session at Digestive Disease Week 2026, where ten
Cellvizio abstracts were accepted. The Ohio State University Annual
Pancreatic Cyst Consortium Meeting brought together more than 100
interventional endoscopists, reflecting the growing recognition of
Cellvizio in pancreatic cyst risk stratification.
-- Barrett's esophagus: an independent systematic review and meta-analysis
led by NECA, South Korea's National Health Technology Assessment agency,
covering 33 studies and 2,350 patients, concluded that adding Cellvizio
to standard endoscopy nearly tripled the dysplasia detection rate (from
10% to 28% of patients) while reducing the average number of biopsies by
48.5%.
-- Inflammatory bowel disease: a prospective study published in the UEG
Journal showed that all ulcerative colitis patients (29 out of 29) who
achieved "triple healing" assessed by Cellvizio remained relapse-free
over 24 months, compared with a 33% relapse rate in those who did not.
Strengthened U.S. commercial organization
-- The U.S. commercial model evolved with a dedicated Clinical Associates
team, completed in June 2026 with two new hires bringing the team to
four. Working alongside the Territory Managers, they provide clinical
support and drive Cellvizio usage within existing accounts. Given the
time needed for training and ramp-up, this new organization is not yet
reflected in H1 figures.
-- Four new CellTolerance accounts were added in the United States,
including a large hospital system, with first clinical use initiated at
the end of the second quarter.
International expansion of CellTolerance
-- Dynamic CellTolerance sales in Europe, notably in Germany and
Switzerland, with Europe and Rest of World revenue up from EUR0.3 million
to EUR1.1 million.
-- Regulatory clearances obtained in the UAE, Turkey, Switzerland and the
United Kingdom, opening new addressable markets.
-- First sales in four new markets: the United Arab Emirates, Switzerland,
Australia and Spain.
-- Establishment of a dedicated commercial organization led by Benoît
Chardon, supported by a network of specialized agents, enabling rapid
entry into new territories.
Consolidated financial statements
The Board of Directors approved the consolidated financial statements on September 28, 2026. The complete unaudited financial statements of Mauna Kea will be available on the website www.maunakeatech.com.
Details of the First Half 2026 Results
Consolidated Income Statement for the First Half of 2026
(in EURk) -- IFRS H1 2026 H1 2025 Change
------------------------------------- --------- --------- -----------------
EURk %
------------------------------------- --------- --------- --------- ------
Product and service revenue 3,197 2,331 +866 +37%
------------------------------------- --------- --------- --------- ------
License revenue (non-cash item)* - 1,361 (1,361) -100%
------------------------------------- --------- --------- --------- ------
Total revenue 3,197 3,692 (495) -13%
------------------------------------- --------- --------- --------- ------
Other income 301 339 (38) -11%
------------------------------------- --------- --------- --------- ------
Total income 3,498 4,031 (533) -13%
------------------------------------- --------- --------- --------- ------
Cost of goods sold (1,109) (865) (244) +28%
------------------------------------- --------- --------- --------- ------
Research & Development expenses (1,605) (1,655) +50 -3%
------------------------------------- --------- --------- --------- ------
Sales & Marketing expenses (2,344) (1,883) (461) +24%
------------------------------------- --------- --------- --------- ------
General & Administrative expenses (1,968) (1,999) +31 -2%
------------------------------------- --------- --------- --------- ------
Share-based payments (631) (421) (210) +50%
------------------------------------- --------- --------- --------- ------
Current operating income (loss) (4,159) (2,792) (1,367) +49%
------------------------------------- --------- --------- --------- ------
Non-current operating income (loss) - (212) +212 -100%
------------------------------------- --------- --------- --------- ------
Operating income (loss) (4,159) (3,004) (1,155) +38%
------------------------------------- --------- --------- --------- ------
Share of equity affiliates - (685) +685 -100%
------------------------------------- --------- --------- --------- ------
Financial result (656) (924) +268 -29%
------------------------------------- --------- --------- --------- ------
Income tax - (56) +56 -100%
------------------------------------- --------- --------- --------- ------
Net Profit (loss) (4,815) (4,669) (146) +3%
------------------------------------- --------- --------- --------- ------
* Non-cash revenue corresponding to the recognition over three years
(2023--2025) of the $9 million licensing payment received from Tasly in 2023.
Recognition ended as scheduled at the end of 2025.
Revenue
Product and service revenue amounted to EUR3.2 million, up 37% compared with H1 2025. By category, systems sales rose 73% to EUR1.2 million, consumables 27% to EUR1.5 million and services 12% to EUR0.5 million. By geography, revenue in Europe and the Rest of the World increased to EUR1.1 million (EUR0.3 million in H1 2025), driven by the deployment of CellTolerance in food intolerance. The United States remained stable at EUR2.0 million, as the new commercial organization ramps up.
Total revenue amounted to EUR3.2 million, down 13% compared with EUR3.7 million in H1 2025. This anticipated decrease is non-cash in nature: it reflects the scheduled end, at the end of 2025, of the three-year recognition of the $9 million licensing payment received from Tasly in 2023.
Gross margin
Cost of goods sold increased by 28% to EUR1.1 million, alongside growth in product and service revenue. Gross margin on product and service revenue improved to 65%, compared with 63% in H1 2025.
Operating expenses
R&D expenses decreased 3% to EUR1.6 million. Sales and marketing expenses increased 24% to EUR2.3 million, reflecting the strengthening of the commercial organization: in the United States, the recruitment in 2025 of two Territory Managers at the end of H1 and two Clinical Associates in H2, dedicated to clinical support and to driving Cellvizio usage within existing accounts; in Europe and Rest of World, the set-up of a dedicated outsourced sales network for CellTolerance. General and administrative expenses decreased 2% to EUR2.0 million, reflecting the sustained cost savings implemented in 2025. Share-based payments, a non-cash expense, amounted to EUR0.6 million, reflecting the employee plan granted in the second half of 2025.
Operating loss