Mauna Kea Technologies has signed a research collaboration agreement with the Johnson & Johnson (J&J) Lung Cancer Initiative (LCI) to validate its biopsy guidance tool, named Cellvizio.
Cellvizio is a probe and needle-based confocal laser endomicroscopy (pCLE and nCLE) platform.
The new partnership is intended to establish the use of the platform as a real-time guidance tool for biopsies, which could potentially aid in lowering the near-miss rate of peripheral lung cancer during robotic-assisted bronchoscopy operations.
According to the agreement terms, Mauna Kea will be part of a prospective, multi-centre, open-label, single-arm clinical feasibility study led, sponsored and funded by the LCI at J&J.
The study will integrate nCLE with robotic-assisted bronchoscopy, using Cellvizio and the Monarch Platform of Auris Health, which is part of the J&J Medical Devices Companies.
It aims to analyse the ability of nCLE to precisely confirm needle position and diagnose peripheral lung nodules.
Mauna Kea Technologies CEO Robert Gershon said: “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.”
Considering Mauna Kea’s resources and support for the study, LCI agreed to provide funding of €978,375 to the company. The funding is partly subject to the conclusion of some study activities covered by the agreement.
Under the deal, the company provided LCI with a right of first refusal in connection with any transaction associated with the nCLE variant.
This includes the variant’s use in endoluminal robotic procedures for all lung applications as well as the use of machine learning, artificial intelligence solutions and learning models to diagnose, stratify risk and treat lung disease.
In addition, the terms cover the use of the technology for endoluminal or transthoracic intra-tumoral drug delivery procedures for the lung.
The right of first refusal is effective during the study period as well as the four months immediately following it.