Aufrufe: 42
Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies, commented:
"Our Q1 2026 performance confirms the robust growth trajectory initiated in the U.S. in 2025, which is now expanding internationally. This momentum reinforces the growing evidence of clinical and commercial adoption of Cellvizio, as the standard of care for the evaluation of pancreatic cysts and subsequent management of patients at risk for pancreatic cancer. In addition, our investments in CellTolerance are yielding tangible results, including the U.S. launch of a premier food intolerance reference center in Southern California and the signing of two new U.S. pay-per-use accounts in the Midwest and East Coast. Likewise, we are gratified with the international response to this significant unmet medical need, including an additional CellTolerance-dedicated site in Germany. As we progress through 2026, the entire Mauna Kea organization remains laser-focused on operational discipline, balance sheet management, and scaling our commercial activity to ensure this strong start translates into sustained, profitable, long-term growth.”
First Quarter 2026 Operational Highlights
1. United States: Continued Growth Trajectory
The United States continued its strong growth momentum in Q1 2026, driven by robust capital sales in both systems and probes:
2. International (EMEA & RoW): Accelerated momentum
International sales growth accelerated to 326% in Q1 2026, building on the rebound initiated in H2 2025 and driven primarily by the CellTolerance indication.
During the quarter, the Company sold 2 systems in Germany (versus 0 in Q1 2025), including one dedicated to CellTolerance. Probe sales surged +176%, supported by increased activity from newly installed accounts.
3. Outlook
The Company significantly expanded its pipeline of new opportunities during the quarter, particularly for the CellTolerance application.
Financial Performance
| Sales by geography (in €K) | Q1 2026 | Q1 2025 | Change | |
| Reported | CER | |||
| United States | 1,032 | 850 | +21% | +34% |
| Systems | 347 | 206 | +68% | +85% |
| Probes | 248 | 148 | +68% | +84% |
| PPU | 260 | 318 | -18% | -10% |
| Services | 177 | 179 | -1% | +9% |
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| EMEA & ROW | 495 | 116 | +326% | +326% |
| Systems | 286 | - | - | |
| Probes | 170 | 61 | +176% | +176% |
| Services | 40 | 55 | -28% | -28% |
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| Asia | - | 4 | -100% | -100% |
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| Total Sales | 1,527 | 970 | +57% | +68% |
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| License revenue | - | 514 | -100% | -100% |
| Total revenue | 1,527 | 1,484 | +3% | +10% |
| CER: Constant Exchange Rates | ||||
Total revenue (including licensing) amounted to €1,527K (+10% CER), successfully absorbing the anticipated end of the 3-year non-cash recognition of the 2023 Tasly licensing payment. As a reminder, this relates to a $6.5 million payment received in 2023 for a licensing agreement with Tasly JV, which was being recognized quarterly over three years (2023–2025) at $0.5 million per quarter.
Upcoming events:
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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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