Mauna Kea Technologies Announces New Clinical Study and Research Collaboration Agreement with the Lung Cancer Initiative at Johnson & Johnson

Mauna Kea Technologies (the “Company”), inventor of Cellvizio^®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (“pCLE” and “nCLE”) platform, today announced that it has entered into a new research collaboration agreement with the Lung Cancer Initiative (“LCI”) at Johnson & Johnson¹ to advance the validation of Cellvizio as a real-time biopsy guidance tool during robotic-assisted bronchoscopy to potentially reduce the near-miss rate of peripheral lung cancer. 

Under the terms of the agreement, Mauna Kea Technologies will participate in a prospective, multi-center, open-label, single-arm clinical feasibility study (the “Study”) led by LCI. The Study will combine nCLE and robotic-assisted bronchoscopy, using both Cellvizio and the Monarch^® Platform from Auris Health, Inc., part of the Johnson & Johnson Medical Devices Companies, to assess the capability of nCLE to accurately confirm needle position for the diagnosis of peripheral lung nodules. LCI will sponsor and fund the Study. In consideration of the Company’s resources and support to the Study, pursuant to the terms of the Agreement, LCI will provide total funding to the Company of 978,375 euros, a portion of which is contingent upon the successful completion of certain Study activities under the Agreement.

In addition, pursuant to the Agreement, the Company granted a right of first refusal (“ROFR”) to LCI (through JJEI) with respect to any transaction relating to Mauna Kea Technologies’ nCLE variant (i) for use in endoluminal robotic procedures for any lung applications, (ii) for the application of machine learning, artificial intelligence solutions and learning models for diagnosis, risk stratification, and treatment associated with lung disease and (iii) for use for endoluminal or  transthoracic intra-tumoral drug delivery procedures for lung.  The ROFR is effective for the term of the Study plus an additional four months thereafter.

"We are pleased to announce this important clinical study and expanded agreement as part of our collaboration with the Lung Cancer Initiative at Johnson & Johnson," said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. "We are also pleased with the progress we have made in our strategic collaboration with LCI and the potential impact of real-time in vivo cellular imaging with Cellvizio, combined with the Monarch Platform, particularly as it relates to using Cellvizio for real-time tool-in-lesion confirmation during robotic-assisted bronchoscopy procedures."