Mauna Kea Technologies has received FDA 510(k) clearance for its Cellvizio AQ-Flex 19 Confocal Miniprobe.
The device was cleared for use through the company’s existing bronchoscopes, transbronchial needles and other bronchoscopic accessories.
“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,” Pr. J. T. Annema, chairman of the department of respiratory medicine at Amsterdam University, said in a press release. “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.”
Mauna Kea Technologies’s Cellvizio system can be used through a working channel of existing navigation products to give a 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 pulmonary market,” Robert Gershon, CEO of Mauna Kea Technologies, said. “We believe our Cellvizio AQ-Flex 19 Confocal Miniprobe 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.”
The company’s flagship Cellvizio has received clearance and approval for a number of applications in more than 40 countries.
“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,” said Gershon. “With more than 240,000 annual lung biopsy procedures in the U.S. alone, 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.”
