Auris Health presented late-breaking data tracking its Monarch robotic bronchoscopy system in real-world settings showing it was able to successfully target hard-to-reach lung nodules and biopsy the undiagnosed tissue to check for possible cancers.
The data are from the company’s first study in live human subjects since the system’s FDA clearance and commercial launch last year; two previous studies had operated on cadavers.
The minimally invasive Monarch system snakes an articulated tube down the patient’s throat and into the lungs, navigating the tight airway passages to reach deeper peripheral lesions. Guided by a surgeon using a video-game-like controller, it can deliver a biopsy needle and retrieve samples once it reaches its destination.
Early results from the first-in-human study were presented in May—the system was able to localize lesions in 92% of cases among 24 patients using a combination of direct visualization from the internal probe’s eye plus endobronchial ultrasound and navigational guidance.
The new, late-breaking data included 54 patients with peripheral lesions 1 cm to 5 cm in size and demonstrated that the robotic platform was similarly successful in 96.3% of procedures. Two cases of pneumothorax occurred, one of which required the placement of a tube to drain air or fluid from the chest. The study was presented at the CHEST 2019 Conference in New Orleans.
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“This is the first prospective, multicenter study of robot-assisted bronchoscopy in patients with undiagnosed lung lesions,” said trial investigator Gerard Silvestri, the Hillenbrand Professor of Thoracic Oncology and a lung cancer pulmonologist at the Medical University of South Carolina.
“This data suggests robot-assisted bronchoscopy is feasible and may improve the bronchoscopists' ability to effectively localize peripheral lesions,” said Silvestri, who is also a paid consultant for Auris. “The promising results of this study warrant further evaluation in additional prospective studies where yield can be better assessed.”
The company said that more than 1,000 procedures have been performed in the U.S. since the commercial launch of its Monarch platform last year. Meanwhile, Auris itself—along with its founder, Frederic Moll—were added to Johnson & Johnson’s pantheon of medical device companies in a $3.4 billion deal completed this past April.
“The rapid adoption of the technology demonstrates that Monarch helps overcome the limitations of current, manual bronchoscopic technology in the diagnosis of lung disease,” said Eric Davidson, Auris’ vice president of marketing and sales.
Auris also said it plans to continue building clinical evidence to support the Monarch platform’s use in interventional pulmonology.
Prior to its acquisition, Auris had launched a project with NeuWave Medical—a subsidiary of J&J’s Ethicon unit—to add microwave ablation instruments to the end of Monarch’s robotic bronchoscope, with the potential goal of localizing and treating lung tumors during the same procedure.