World's Smallest Flexible Microscope Targets Biopsies

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. Its diagnosis remains challenging, despite significant advancements in diagnostic and treatment technologies. The number of lung nodules identified on chest CTs continues to rise. Determining if a suspicious pulmonary nodule is malignant or benign can be challenging and time-consuming, often requiring multiple biopsy attempts and/or invasive procedures that can result in inconclusive results and complications. Now, the rapidly growing field of molecular imaging aims to improve the detection of cancer cells through easier and more precise visualization.

Cellvizio from Mauna Kea Technologies (Allston, MA, USA) is a breakthrough imaging platform making biopsies more targeted and more accessible. Cellvizio advanced technology helps target biopsies using the world's smallest flexible microscope, providing clinicians with microscopic images of tissue instantaneously and in a minimally-invasive manner. Mauna Kea has received a new U.S. FDA 510(k) clearance for the use of the Cellvizio 100 Series platform with a molecular imaging agent, the first of its kind, for real-time in vivo visualization during endoscopic, laparoscopic, and needle-based procedures.

The pioneering category of medical procedures expanded through this new clearance – Molecular Image-guided Procedures (MIP) – is designed to provide Cellvizio the unique clinical ability to visualize tissues to which molecular agents bind, allowing the potential for real-time visualization of cancer at the cellular level during minimally invasive interventions. The use of MIP during bronchoscopic lung biopsy may improve the diagnostic accuracy of biopsies while reducing the number of procedures, time, and complications associated with obtaining a diagnosis.

Thanks to its Confocal Miniprobes, Cellvizio is compatible with all types of flexible endoscopes and when placed in direct contact with the mucosa, it provides real-time in vivo video sequences of the cellular and vascular microarchitecture of internal human tissue structure. Treatment decisions can be made in a minimally invasive and in an instantaneous manner, as opposed to traditional method of taking “blind biopsies”. Targeted biopsies are digital microscopic video sequences displayed live on a monitor during the endoscopic evaluation. Cellvizio has been proven to help physicians secure their decisions, reduce indetermination and improve patient outcomes. It reduces the number of biopsies needed while increasing diagnostic yield by providing real-time vision at the cellular level.

“While the suite of tools to diagnose and treat lung cancer has evolved over the past few decades, there remains a significant unmet need to improve how early and how accurately patients can be staged and treated after lung nodule detection,” said Nicolas Bouvier, Interim Chief Executive Officer of Mauna Kea Technologies.

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