Johnson & Johnson‘s (NYSE:JNJ) subsidiary Auris Health today released preliminary results from a first-in-human feasibility study of its Monarch robotic interventional platform, which has FDA clearance for diagnostic and therapeutic bronchoscopic procedures.
Preliminary data from the Benefit study of the Monarch platform was presented by Dr. Alexander Chen at the American Thoracic Society’s 2019 conference in Dallas, Texas.
Redwood City, Calif.-based Auris Health said that the BENEFIT study is an ongoing prospective pilot study exploring the safety and feasibility of using the Monarch system to aid in the diagnosis of peripheral pulmonary lesions.
Initial data from 24 patients indicated a 92% rate of successful localization of targeted pulmonary lesions as confirmed using a radial endobronchial ultrasound probe, which serves as the trials primary effectiveness endpoint. No significant adverse events were reported, Auris said.
“Early results from this ongoing study have shown that the Monarch Platform has the ability to successfully reach, localize and biopsy peripheral pulmonary lesions in live human subjects. These preliminary findings follow the successful REACH and ACCESS studies, which demonstrated that the platform improved reach beyond a conventional thin bronchoscope and can biopsy peripheral lesions with high accuracy in cadaveric lungs,” Dr. Chen said in a press release.
“The Monarch Platform was designed to allow physicians to diagnose small peripheral lung nodules with greater precision than ever before. We are encouraged by the initial results from the ongoing BENEFIT study which demonstrate the potential of Monarch to help diagnose these hard-to-reach lesions,” Auris COO Josh DeFonzo said in a prepared statement.
Last month, J&J said that its Ethicon biz completed its $3.4 billion acquisition of robotic surgery dev Auris Health and the $2.8 billion divestiture of its Advanced Sterilization Products to Fortive (NTSE:FTV).
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