Johnson & Johnson’s Auris Health has reported initial data from the ongoing BENEFIT clinical study of its robotic Monarch Platform intended for diagnostic and therapeutic bronchoscopic procedures.
The pilot study is designed to investigate the safety and feasibility of a robotic system in the diagnosis of peripheral pulmonary lesions.
So far, the study involved use of Monarch Platform in 24 subjects to localise targeted nodules by integrating direct visualisation, navigational guidance and radial endobronchial ultrasound.
The primary effectiveness endpoint of the study was successful localisation of targeted lesions confirmed with a radial endobronchial ultrasound probe. This was observed in 92% of the patients, without any significant adverse events.
Auris Health chief operating officer Josh DeFonzo said: “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.”
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Data from previous REACH and ACCESS studies showed that robotic system offers better reach than a standard thin bronchoscope and can accurately biopsy peripheral lesions in cadaveric lungs.
Cleared by the US Food and Drug Administration (FDA) in March last year, Monarch Platform is designed to combine robotics with software, data science and endoscope advancements.
The system is initially meant for precise diagnosis and treatment of even small and hard-to-reach lung nodules in cancer patients. It offers an instinctive controller interface that physicians can use to navigate the robotic endoscope to the periphery of the lung.
Auris Health, which developed the platform, was acquired by Johnson & Johnson subsidiary Ethicon.