J&J’s Auris Has Solid Data to Support Monarch

Johnson & Johnson’s Auris Health revealed late-breaking data from the BENEFIT study during the CHEST 2019 Conference in New Orleans last week. BENEFIT is a study of the Monarch Platform, a robotic technology indicated for the use in diagnostic and therapeutic bronchoscopic procedures.

BENEFIT assessed the safety and feasibility of using a robotic system to aid in the diagnosis of peripheral pulmonary lesions 1cm to 5 cm in size. During the study, investigators performed robotic-assisted bronchoscopy using the Monarch Platform on 55 patients across five study sites.

The Monarch Platform localized targeted nodules using a combination of direct visualization, navigational guidance and radial endobronchial ultrasound (R-EBUS).

The primary effectiveness endpoint, successful localization of targeted pulmonary lesions, was reported in 52/54 (96.3%) of procedures. Pneumothorax occurred in 2/55 (3.6%) of procedures and required tube thoracostomy in 1/55 (1.8%) procedure. No additional serious adverse events were reported.

"The results from the BENEFIT study demonstrate the potential of Monarch to help physicians diagnose these hard-to-reach lesions," said Josh DeFonzo, COO of Auris Health, said in a release. "We are very encouraged by the results of the BENEFIT study and are thrilled to be making a positive impact on the diagnosis of lung conditions. We will continue to build robust clinical evidence around the Monarch Platform to support its use in interventional pulmonology."

Johnson & Johnson’s $3.4 billion-plus milestone acquisition of Auris Health was one of the largest medtech deals of the year. Christopher Velis, a co-founder of Auris recently spoke during a keynote session at MD&M Minneapolis. Before the session, Velis spoke to MD+DI about the benefits of J&J acquiring Auris.

“Johnson & Johnson and Auris are a great fit for many reasons,” Velis told MD+DI in an earlier interview. “J&J has a global network to support sales, distribution and, importantly, physician, and surgical team training. The company also understands the many different applications of which the Monarch Platform is capable including a variety of surgical specialties and interventions.”