Monarch, a first-of-its-kind robotic technology, was cleared by the FDA in March 2018 for diagnostic and therapeutic bronchoscopies. In May, Auris touted interim results from an independent feasibility study designed to assess the platform. In that study, in 82 procedures, researchers reported that although most of the lesions were less than 3cm in size the outer third of the lung, they were able to reach them in 94% of cases.
Auris published the results of its Benefit study to evaluate the safety and feasibility of the Monarch platform, led by Dr. Alexander Chen (St. Louis, Mo.) and Dr. Gerard Silvestri (Charleston, S.C.) in CHEST.
The trial enrolled 55 patients across five leading institutions: Washington University (St. Louis), Medical University of South Carolina, the Cleveland Clinic, Henry Ford Hospital and Inova Fairfax Hospital. The Monarch platform was used to localize targeted nodules using direct visualization, navigational guidance and radial endobronchial ultrasound.
Results demonstrated safety, as pneumothorax occurred in two out of 54 procedures (3.7%) and placement of a chest tube happened once (1.9%). No serious adverse events were reported, while, in 96.2% of cases, the pre-planned target area was reached and localized as confirmed by ultrasound imaging, according to a news release.
“We are thrilled to be making a meaningful impact on the diagnosis of lung conditions, particularly in patients with small and difficult to reach nodules that may progress to something more serious,” Auris Health president of flexible robotics Eric Davidson said in the release. “Physicians in the study, using our first-generation Monarch software, were able to localize and diagnose the most difficult-to-reach nodules at a higher rate than was previously possible. Since then, we have continued to improve the platform, delivering a higher level of accuracy and ease of use.
“We continue to build robust clinical evidence in support of the Monarch platform and work with our colleagues at the Lung Cancer Initiative at Johnson & Johnson with the goal of transforming the standard of care for this devastating disease.”
This is the second positive outcome for the Benefit trial after, in October 2019, Auris reported that the device reached its primary effectiveness endpoint in nearly all procedures.
The company is continuing to make strides in the robotic surgery space, having finally announced in November 2020 further details on its Ottava surgical robotic platform that it says offers unrivaled flexibility and control compared to the rest of the market.