Mauna Kea Technologies (Euronext Growth: ALMKT) highlighted a landmark independent systematic review and meta-analysis published in Endoscopy International Open, which reinforces the diagnostic accuracy of its Cellvizio platform in upper gastrointestinal cancer.

The study, conducted and funded by Korea’s National Evidence-Based Healthcare Collaborating Agency (NECA), pooled data from 33 studies involving 2,350 patients. The authors concluded that probe-based confocal laser endomicroscopy (pCLE) is a safe and accurate adjunct to standard upper gastrointestinal endoscopy.

Enhanced Lesion Detection

The meta-analysis documented significant improvements in diagnostic yield when pCLE was added to high-definition white-light endoscopy. In Barrett’s esophagus surveillance, per-patient dysplasia detection rose to 28% (14 of 50 patients) from 10% (5 of 50 patients).

In cases of poorly cohesive gastric adenocarcinoma, pCLE-guided biopsies identified malignant tissue in 65% of patients (19 of 29), compared to 30% (10 of 32) with standard white-light-directed biopsies. A randomized trial in suspected gastric precancerous lesions showed a diagnostic yield per biopsy of 75.1% with pCLE combined with flexible spectral imaging color enhancement (FICE), versus 31.5% with FICE alone.

Reduced Biopsy Burden

The data indicates that targeted biopsy strategies reduce procedural burden. The same randomized study found that pCLE-guided targeting reduced the mean number of biopsies per patient by 48.5%, from 6.8 to 3.5.

In a cohort of 13 patients with Barrett’s esophagus and subtle mucosal irregularities, adjunctive pCLE altered real-time therapeutic management in 69.2% of cases (9 of 13), either prompting endoscopic resection or avoiding unnecessary procedures.

Diagnostic Performance Metrics

Pooled sensitivity for both esophageal and gastric neoplasia was 89%, while specificity was 79% for esophageal lesions and 95% for gastric lesions. For high-grade dysplasia and overtly neoplastic lesions, pooled sensitivity was 88% and specificity was 87%. The authors noted that these estimates should be interpreted with caution given potential small-study effects and the reliance on high-volume academic centers.

Regulatory and Reimbursement Context

Confocal laser endomicroscopy is already established in the indications covered by this review. In Korea, NECA issued a positive health technology assessment in 2018, and coverage was ratified by the Ministry of Health and Welfare in February 2020. In the United States, optical endomicroscopy is performed under dedicated Category I CPT codes, representing the core of the company’s recurring per-procedure revenue.

Sacha Loiseau, Ph.D., Chairman and Chief Executive Officer of Mauna Kea Technologies, stated that the independent review reinforces the value proposition of Cellvizio and may help broaden reimbursement coverage and clinical adoption in the United States, the company’s primary market.

What the Numbers Show

The divergence between sensitivity (89%) and specificity (95% for gastric lesions) suggests that while the technology effectively captures most true positives, it is particularly strong at ruling out false positives in gastric applications. This high specificity, combined with a 48.5% reduction in biopsy count, indicates a shift toward more efficient diagnostic workflows where fewer samples are required to achieve higher confidence in malignant tissue identification.

Mauna Kea Technologies reported its monthly share capital data for July 2026, disclosing 195,296,487 shares comprising the capital in circulation as of July 31, 2026. The medical device company, listed on Euronext Growth Paris under ticker ALMKT (ISIN: FR0010609263), also confirmed that both its gross total voting rights and net total voting rights stand at 196,383,354. This disclosure ensures transparency regarding ownership structure and voting power distribution for investors monitoring the firm’s equity base.

The filing was made in accordance with Article L233-8-II of the Commercial Code and Article 223-16 of the General Regulations of the AMF. These regulatory requirements mandate regular updates on share capital composition to maintain market integrity and inform stakeholders of any changes in voting rights thresholds.

Share Capital Breakdown

The following table details the share capital and voting rights figures as reported by Mauna Kea Technologies:

The gross number of voting rights serves as the basis for calculating regulatory thresholds. In line with Article 223-11 of the General Regulations of the AMF, this figure includes all shares carrying voting rights, even those without active voting privileges. The net number of voting rights excludes shares with suspended voting rights and reflects the count exercisable in general meetings, published per the AMF recommendation of July 17, 2007.

What the Numbers Show

The alignment between gross and net voting rights at 196,383,354 indicates that no voting rights were suspended during the reporting period. This parity suggests a stable shareholder base without temporary restrictions on voting power, which can sometimes occur due to legal disputes or specific corporate governance actions. For investors tracking control dynamics, this consistency implies that all theoretical voting power is currently actionable in shareholder meetings.

Mauna Kea Technologies manufactures and sells Cellvizio®, a real-time in vivo cellular imaging platform used globally across various medical specialties. The technology enables physicians to monitor disease progression, assess reactions in real time, and guide surgical interventions. For further details, investors may visit www.maunakeatech.com or contact investor relations at investors@maunakeatech.com .