Mauna Kea Technologies announces that initial enrollment of patients has begun in a prospective, randomized, two-arm, multi-site clinical study sponsored by Mayo Clinic and financially supported by Mauna Kea Technologies. The study will combine nCLE and robotic-assisted bronchoscopy, using both Cellvizio and the Ion platform for minimally invasive peripheral lung biopsy from Intuitive Surgical Inc., to assess the capability of nCLE to enhance the physician's ability to quickly and accurately position a biopsy tool in the center of peripheral lung nodules (Clinicaltrials.gov: NCT05556525). The primary objective of this study is to evaluate the ability of nCLE to further improve the diagnostic yield and accuracy of confirming successful targeting of the lesion (“tool-in-lesion”) and definitive diagnostic sampling of the lesion (“lesion-in-tool”) during robotic-assisted bronchoscopy procedures.

The secondary objectives are to evaluate the reproducibility of using nCLE across multiple facilities and to evaluate the ability of nCLE to diagnose malignancy vs. non-malignancy, including exploring diagnostic yield at the index procedure. This study will include 118 patients with peripheral lung nodules in two U.S. sites, Mayo Clinic's campus in Jacksonville, Florida and Mayo Clinic's campus in Rochester, Minnesota.