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
Paris and Boston, June 3rd, 2026 – 5:45 p.m. CEST – 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.
Together, this body of work, spanning more than 430 patients across independent cohorts in Mainz, Sydney, Erlangen and Iași, 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” commented Sacha 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.”
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.
