No longer will surgeons be flying blind while performing biopsies of peripheral lung nodules—at least, not if Mauna Kea Technologies and Johnson & Johnson’s Lung Cancer Initiative have anything to say about it.
While central lung tumors can be easily sampled and diagnosed using traditional bronchoscopies, those located in the outer third of the lung are much more difficult to spot, with diagnostic yields dropping the smaller the nodule.
Mauna Kea’s Cellvizio technology is designed to make up for that loss. By adding what the company claims is the world’s smallest flexible microscope to the end of a standard endoscope, surgeons can receive real-time video guidance through the peripheral lung. Once the miniprobe has reached an area of interest, it can generate microscopic cellular images delving up to 150 micrometers into the mucosa, the inner lining of the lung where many cancerous tumors reside.
Under a new research collaboration with J&J’s Lung Cancer Initiative, the French company is launching a single-arm clinical trial of the technology to further validate Cellvizio’s ability to improve needle placement during biopsies of peripheral lung nodules.
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The study will pair Cellvizio with the Monarch robotic-assisted bronchoscopy platform from Auris Health, acquired by J&J in 2019. The Monarch platform is designed to help surgeons snake deeper into the lungs and improve their navigation through the organ using robotic controls and an integrated camera.
J&J’s Lung Cancer Initiative will fund and sponsor the study. It will also allot a total of €978,375, or about $1.15 million, to Mauna Kea, a portion of which will be withheld until certain undisclosed milestones are achieved in the study.
The research collaboration also gives J&J a right of first refusal should Mauna Kea seek out any transaction relating to Cellvizio’s use in lung-related endoluminal robotic procedures, in intra-tumoral drug delivery procedures or in the creation of artificial intelligence-based models to diagnose and treat lung disease.
Alongside the news of its partnership with J&J, Mauna Kea also outlined a proposed €12.5 million ($14.67 million) share capital increase funded in part by J&J’s venture arm, Johnson & Johnson Innovation. The €11.5 million in net proceeds from the capital increase will be used to continue developing and commercializing the Cellvizio platform in the U.S., with the funds expected to support those efforts through the third quarter of next year.
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The Cellvizio technology has received a long list of FDA 510(k) clearances since its first regulatory green light in 2005. The platform is now used not only in endoscopies, but also in laparoscopic and robotic-assisted surgeries, spanning pulmonology, gastroenterology and urology.
The most recent of these—the company’s 19th—cleared the platform in August for use in combination with the fluorescent dye fluorescein to help visualize blood flow in the microvasculature and capillaries.