100% of patients achieving Cellvizio-assessed triple healing remained relapse-free over 24 months (0 of 29), versus a ~33% relapse rate among those who did not
A decade of converging, multi-center evidence positions Cellvizio as a differentiated tool to predict outcomes across inflammatory bowel disease (IBD), a therapeutic market with significant potential exceeding $25 billion
Regulatory News:
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today highlighted the publication of a prospective study in the United European Gastroenterology Journal (Minea et al.1) that strengthens the case for Cellvizio as a differentiated tool to predict relapse in ulcerative colitis (UC). The study introduces "triple healing" as a new therapeutic target, adding to more than a decade of independent research pointing in the same clinical direction.
The prospective study followed 81 UC patients in clinical and endoscopic remission over 24 months, with Cellvizio assessment at baseline. Among them, 29 patients achieved "triple healing", defined as histological healing combined with intact intestinal permeability in both the terminal ileum and colon. None of these 29 patients relapsed during the 24-month follow-up, compared with a 33% relapse rate among those who did not reach this state. Assessed in vivo through probe-based confocal laser endomicroscopy, "triple healing" represents a potential new therapeutic target that could refine ulcerative colitis management beyond conventional mucosal healing.
This new publication is the latest in a consistent line of prospective studies, conducted across independent academic centers in Germany, the UK, Australia, France and Romania, all reaching a common conclusion: confocal endomicroscopic imaging of the intestinal barrier reflects disease outcomes more accurately than conventional endoscopy and/or histology, across both ulcerative colitis and Crohn's disease.
Study | Cohort | Key finding (confocal laser endomicroscopy, CLE) |
Kiesslich et al., Gut (2012)2 | 58 IBD patients (47 UC, 11 CD) in clinical remission | First demonstration that barrier dysfunction fluorescein leakage on CLE predicts relapse within 12 months (p 0.001); specificity 90%, accuracy 79% |
Chang et al., Gastroenterology (2017)3 | 110 subjects (57 CD, 31 UC, 22 controls) | CLE-measured Confocal Leak Score identified barrier-driven bowel symptoms despite mucosal healing with 95.2% sensitivity and 97.6% specificity (AUROC 0.88) |
ERIca Trial Rath et al., Gastroenterology (2023)4 | 181 IBD patients (100 CD, 81 UC) in clinical remission | Barrier healing by CLE was superior to endoscopic and histologic remission for predicting major adverse outcomes; colonic barrier healing specificity 92.7% (vs 62.5% for endoscopic remission) |
Rath et al., Frontiers in Medicine (2023)5 | Same UC cohort as ERIca (81 UC enrolled) | Intact ileal barrier predicted low risk of adverse events: PPV 90.9%, NPV 92.2%, accuracy 91.8% |
Minea et al., UEG Journal (2026) | 81 UC patients in clinical and endoscopic remission | Defines "triple healing"; 0 of 29 triple-healing patients relapsed over 24 months; CLE parameters outperformed calprotectin and CRP as independent predictors |
Together, this body of work, spanning more than 430 patients across independent cohorts in Mainz, Sydney, Erlangen and Ia?i, establishes a reproducible scientific foundation. This accumulated peer-reviewed evidence base underpins Cellvizio's differentiated value proposition across the IBD market.
Even with a therapeutic market exceeding $25 billion annually, roughly one in three IBD patients relapses despite apparent clinical remission, because conventional endoscopy cannot reliably detect the two drivers of relapse: residual microscopic inflammation and barrier dysfunction. Precise assessment of subclinical activity can help clinicians personalize treatment, avoid costly escalation to biologics, and identify at-risk patients earlier. Beyond clinical practice, this capability may also be of interest to therapeutic developers seeking precise endpoints for patient stratification, a potential avenue the Company intends to explore actively.
Building on the reimbursement strategy that supported adoption in Barrett's Esophagus and pancreatic cyst diagnosis, where Cellvizio secured a dedicated CPT code, the Company intends to engage with medical societies and payers to explore a dedicated reimbursement pathway for IBD monitoring within an established, reimbursed therapeutic ecosystem.
"This new study reinforces a decade of clinical evidence around Cellvizio-assessed barrier integrity in IBD: it predicts relapse and sustained remission more reliably than conventional endoscopy, histology or standard biomarkers. The fact that not a single one of the 29 patients achieving triple healing relapsed over 24 months is an outstanding result," commentedSacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies. "IBD has become one of the most dynamic markets in healthcare, but the bottleneck is no longer the availability of drugs, it is knowing whether a patient is truly in remission. That is exactly the question Cellvizio answers, and triple healing turns it into a concrete target clinicians can treat toward. Our priority now is to bring this advance into routine practice including engaging payers on a dedicated reimbursement pathway so that measuring deep, durable remission becomes the standard of care in IBD, with Cellvizio as its reference tool."
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.
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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' 2025 Annual Report filed with the Autorité des marchés financiers (AMF) on April 30, 2026, 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.
1Minea H. et al. Integrated Assessment of Intestinal Barrier Function and Microscopic Inflammation Using Confocal Laser Endomicroscopy for Relapse Prediction in Ulcerative Colitis. United European Gastroenterology Journal, 2026.
2Kiesslich R., et al., Gut, 2012. https://doi.org/10.1136/gutjnl-2011-300695
3Chang J., et al., Gastroenterology, 2017;153:723-731. https://doi.org/10.1053/j.gastro.2017.05.056
4Rath T., et al. (Essai ERIca), Gastroenterology, 2023;164:241-255. https://doi.org/10.1053/j.gastro.2022.10.014
5Rath T., et al., Frontiers in Medicine, 2023;10:1221449. https://doi.org/10.3389/fmed.2023.1221449
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Mauna Kea Technologies
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Thomas Grojean
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