U.S. sales surge +31% at constant exchange rates, with continued acceleration over the year
Commercial momentum highlighted by a doubling of U.S. system sales year-to-date
Adding to U.S. commercial team to support organic demand
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 its revenue for the third quarter of 2025, up 16% at constant exchange rates (CER).
Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies, stated:"I am pleased with our significantly improved performance in the third quarter, reflecting the acceleration of our commercial momentum in the U.S., where we are benefiting from very positive clinical data presented earlier this year, strong support from a large group of leading physicians and attractive reimbursement.Responding to strengthening market demand, we have elected to expand our U.S. field organization and accelerate our conversations with potential commercial partners. In France, following the inclusion of Cellvizio for pancreatic cysts characterization in the European guidelines earlier this year, we remain cautiously optimistic about the upcoming assessment by the Haute Autorité de Santé (HAS) which would allow reimbursement. Finally, while the situation with our joint venture partner in China weighs on Asia region sales, we are evaluating other options to restart commercial activity in the region. With the unyielding support of our employees, clinical partners, debt holders and investors, I look forward to opening a new chapter of growth, based on a strengthened and solidified financial structure under the safeguard plan."
Financial Performance
Sales by geography (in €K) | Q3 2025 | Q3 2024 | Change | 9M 2025 | 9M 2024 | Change | ||
Reported | CER | Reported | CER | |||||
United States | 1,015 | 815 | +25% | +31% | 2,995 | 2,551 | +17% | +22% |
EMEA RoW | 328 | 277 | +18% | +18% | 649 | 1,359 | -52% | -52% |
Asia | 0 | 156 | -100% | -100% | 1 | 210 | -99% | -99% |
License revenue | 593 | 491 | +21% | +26% | 1,953 | 1,495 | +31% | +34% |
Total revenue | 1,935 | 1,739 | +11% | +16% | 5,599 | 5,614 | +0% | +3% |
CER: Constant Exchange Rate
Sales by category (in €K) | Q3 2025 | Q3 2024 | Change | 9M 2025 | 9M 2024 | Change | ||
Reported | CER | Reported | CER | |||||
Systems | 389 | 333 | +17% | +19% | 1,079 | 917 | +18% | +21% |
Consumables | 712 | 676 | +5% | +8% | 1,840 | 2,361 | -22% | -20% |
Services | 241 | 239 | +1% | +6% | 726 | 841 | -14% | -12% |
License revenue | 593 | 491 | +21% | +26% | 1,953 | 1,495 | +31% | +34% |
Total revenue | 1,935 | 1,739 | +11% | +16% | 5,599 | 5,614 | +0% | +3% |
CER: Constant Exchange Rate
Operational Highlights
- Strong Momentum in the U.S. Market:
This quarter, the United States has accounted for over 75% of the Group's product sales (excluding licenses). The +31% growth (CER) in Q3 marks a continuous acceleration throughout the year (following +11% in Q1 and +23% in Q2). Demand for Cellvizio systems and probes continues to accelerate, with system sales doubling compared to the same period in 2024. Four new systems were installed in 2025 in U.S. hospitals. The momentum in the pancreatic cyst application remains a key growth driver, following excellent clinical results presented at the Digestive Disease Week conference in May 2025. In fact, the Group has already received one purchase order for a Cellvizio system since the close of the third quarter.
- Continued Improvement in Pay-Per-Use (PPU) Recovery
After a low point in Q1 2025 following the Medicare reimbursement reduction in early 2024, the recovery in PPU procedure volumes that began in Q2 continued and strengthened in Q3, with 912 procedures. The strategy of targeting hospitals, which are less affected by reimbursement changes than Ambulatory Surgery Centers (ASCs), as well as reframing Cellvizio's positive economic value proposition to its customers is proving successful.
U.S. Pay-per-Use | Q1 2024 | Q2 2024 | Q3 2024 | Q4 2024 | Q1 2025 | Q2 2025 | Q3 2025 |
Procedure Volume | 1,017 | 1,062 | 888 | 831 | 802 | 823 | 912 |
- Reinforcement of the U.S. Commercial Organization:
In response to this promising momentum, the Group expanded its sales team to 6 representatives in Q2. To support the growth of the installed base and accelerate system utilization, the Group has also hired 2 clinical associates who will start in Q4 2025.
- Rebound in Europe and the Rest of the World
Business activity grew by +18% (CER), primarily driven by the international expansion of the CellTolerance® application for food intolerances. Significant sales were made in Austria and Australia, the latter having recently granted the necessary regulatory approvals.
- Situation in China
Revenue in the region remains at zero due to the lack of activity from the joint venture with Tasly in China. The Group is actively pursuing efforts to resolve the situation and restart commercial activity in this strategic region.
- Cash Position and Safeguard Proceedings
The Company's cash runway extends to the end of November 2025. As part of its draft safeguard plan, the Group is working to secure the necessary financial resources to fund its strategic roadmap until it reaches profitability and self-financing. The Company estimates at €5 million the amount it needs until the end of 2026, and €8 million to achieve profitability in 2027 and self-financing. It should be noted that this self-financing includes the repayment of financial maturities outlined in the safeguard plan.
The terms of the draft safeguard plan and the upcoming financing are detailed in the press releases previously published by the Company on its website on September 12, 2025, September 22, 2025, October 6, 2025, and October 8, 2025. The draft safeguard plan is available on the Company's website under the "Investors Safeguard Plan" section. It is reminded that the implementation of the safeguard plan remains conditional on its approval by the Paris Commercial Court. The Capital Increase is not subject to a prospectus requiring the approval of the AMF (French Financial Markets Authority).
Indicative Timeline
October 27, 2025: Hearing of the Paris Commercial Court on the safeguard plan
- First half of November 2025: Court's decision and setting of the Issue Price for the planned capital raise
- Within 2 trading days following the setting of the Issue Price: Settlement of new shares
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' 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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Contacts:
Mauna Kea Technologies
investors@maunakeatech.com
NewCap Investor Relations
Thomas Grojean
+33 (0)1 44 71 94 94
maunakea@newcap.eu
