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Mauna Kea miniprobe receives FDA approval

06 Mar 2019

Addition to Cellvizio platform will assist imaging of peripheral lung nodules.

Mauna Kea has announced the granting of FDA approval for use of its Cellvizio AQ-FlexTM 19 confocal miniprobe through existing bronchoscopes and broncoscopic accessories in the US, paving the way for wider use of the company's technology in the imaging of lung disease.

Cellvizio is the Paris-based company's confocal laser endomicroscopy platform, targeted at a variety of surgical applications in both probe-based and needle-based versions, and designed to deliver minimally invasive microscopic images of tissues in real-time.

Since its initial development in 2011, the Cellvizio technology has been employed to spot early signs of cancers in the esophagus, pancreas, and urinary tract, and played a part in the development of optical biopsy methods allowing surgeons to assess the condition of tissues without needed to excise samples and await their examination.

In 2018 Cellvizio images of the bile duct adjacent to the liver played a part in analysis of the interstitium, a fluid-filled interstitial space characterized as an organ of the body in its own right.

The latest FDA approval relates specifically to the identification of peripheral pulmonary lesions. These lesions are positioned in the smaller sub-divisions of the bronchus away from the main tracheobronchial tree, and imaging of them is challenging with a conventional fiber-optic bronchoscope.

According to Mauna Kea, current navigation products provide access to these peripheral nodules but with limited ability to achieve direct visualization outside the airways. The Cellvizio miniprobe has now been approved for use through the working channel of existing navigation products, to provide direct "through-the-needle" visualization inside peripheral lesions.

Compelling market opportunity

"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," commented Robert Gershon, CEO.

"We believe our 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."

Mauna Kea's development of Cellvizio has been associated with some financial pressures on the company, which has struggled to generate a consistent revenue stream and been hindered by the lag between system placements and regular sale of consumables, such as the miniprobes. In 2018 it adopted a new pay-per-use model for the US market to address some of these issues.

Full-year results for 2018 showed that the company's figures improved substantially since the pay-per-use model was introduced, with sales for the fourth quarter of the year reaching €2.1 million, up 37 percent year-on-year.

Discussing the new FDA approval, Gershon noted that he expected the gastrointestinal market to remain the primary driver of revenue growth in 2019, but characterized lung biopsy procedures and interventional pulmonology as a compelling market opportunity for Mauna Kea’s future commercial focus.

"We look forward to sharing our plans to evaluate this opportunity on our 2018 full-year results conference call on March 20th 2019," he said.

SPECTROGON ABOmicron-Laserage Laserprodukte GmbHAVANTES BVEKSMA OPTICSEaling UGBRD Optical Co., LtdDiffraction International
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