Mauna Kea Technologies announced the first patient enrollment in the multi-center randomized controlled trial (RCT) entitled "Confocal Laser Endomicroscopy VERification" (CLEVER, NCT06079970)1 in collaboration with the Amsterdam University Medical Centers (UMC) for the diagnosis and management of peripheral lung lesions. In the framework of this trial, over 200 patients will be enrolled across 7 sites in Europe and the U.S. until end of second quarter 2025. Lung cancer is the world's leading cause of cancer deaths claiming over 1.8 million lives every year - more than colorectal, breast, and prostate cancers combined.

The rise in lung cancer screening and the increased use of chest-computed tomography (CT) has generated a surge in the detection of suspected malignant lung lesions globally, increasing the need for more effective and efficient diagnostic methods. Over 80% of these incidental lesions develop in the peripheral bronchi and are not easily visualized or accessed during conventional bronchoscopy. Adding nCLE as an adjunctive technique offers a potential solution by providing real-time feedback on the correct positioning of biopsy twazers or needles (tool-in-lesion) and collecting the right cells samples (lesion-in-tool).