News - Cellvizio - Feb 25, 2019

510(k) Clearance for the Cellvizio® Needle-Based AQ-Flex 19 Confocal Miniprobe Enabling Peripheral Lung Nodule Targeting and Imaging

The Cellvizio® AQ-Flex probe is cleared for use with transbronchial needles through existing bronchoscopes and bronchoscopic accessories

Mauna Kea Technologies today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the use of the Cellvizio AQ-FlexTM 19 Confocal MiniprobeTM through existing bronchoscopes, transbronchial needles and other bronchoscopic accessories. This marks the 16th U.S. FDA 510(k) clearance of the Cellvizio® p/nCLE platform.

“Our pioneering team has demonstrated that real-time imaging and identification of benign and malignant cellular structures inside pulmonary nodules and lymph nodes with needle-based Confocal Laser Endomicroscopy is not only feasible but highly reproducible.” said Pr. J. T. Annema, M.D., Ph.D., chairman of the Department of Respiratory Medicine, Amsterdam University Medical Centers. “The availability of nCLE inside the lungs has clear potential to have a major impact on the diagnostic accuracy for peripheral nodules, one of the most elusive challenges in the battle against lung cancer.”

Current navigation products provide advanced minimally invasive access to peripheral nodules but with limited ability to achieve direct visualization outside the airways. The Cellvizio AQ-FlexTM 19 Confocal MiniprobeTM can be used through the working channel of existing navigation products to provide direct “through the needle” visualization inside peripheral lesions.

“This is an important regulatory milestone for the Company and, more importantly, we believe this clearance formalizes our market development strategy: to evaluate the potential commercial opportunity for our Cellvizio technology in the interventional pulmonology market,” said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. “We believe our Cellvizio AQ-FlexTM 19 Confocal MiniprobeTM unlocks a new era in interventional pulmonology, paving the way toward more precise guidance to identify the optimal area for sampling, and potentially as a real-time feedback technique for diagnostic, staging and treatment procedures in lung lesions.”

Mr. Gershon continued: “We have an established presence in the U.S. GI market, and expect our commercial strategy in the U.S. GI market to be the primary driver of revenue growth in 2019. With more than 240,000 annual lung biopsy procedures in the U.S. alone1, interventional pulmonology represents a compelling market opportunity for Mauna Kea’s next clinical indication for commercial focus. We look forward to sharing our plans to evaluate this opportunity on our 2018 full year results conference call on March 20, 2019.”


1 Source: American Cancer Society Cancer Facts & Figures 2018, internal analysis