Auris Health Announces Early Results from First-In-Human Study of Monarch™ Platform

Ongoing BENEFIT Study of Monarch Platform Indicates Safety, Feasibility and Successful Localization of Lung Nodules in 92% of Cases

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Johnson & Johnson Medical Devices Companies

May 20, 2019, 08:30 ET

DALLAS, May 20, 2019 /PRNewswire/ -- Auris Health, Inc., part of Johnson & Johnson Medical Devices Companies,* today announced early positive results from an ongoing study designed to evaluate the safety and feasibility of the Monarch Platform, a first-of-its-kind robotic technology cleared by the U.S. Food and Drug Administration (FDA) for diagnostic and therapeutic bronchoscopic procedures. Preliminary data from the study was presented by Alexander C. Chen, M.D., of St. Louis, Mo., at the American Thoracic Society (ATS) 2019 Conference in Dallas.

The BENEFIT study is an ongoing prospective, multicenter pilot study to assess the safety and feasibility of utilizing a robotic system to aid in the diagnosis of peripheral pulmonary lesions. In the study thus far, the robotic system has been used in 24 patients to localize targeted nodules using a combination of direct visualization, navigational guidance and radial endobronchial ultrasound. The primary effectiveness endpoint, successful localization of targeted pulmonary lesions confirmed using a radial endobronchial ultrasound probe, has been reported in 92% of cases, with no significant adverse events.

"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," said Dr. Chen. "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."

"The Monarch Platform was designed to allow physicians to diagnose small peripheral lung nodules with greater precision than ever before," said Josh DeFonzo, Chief Operating Officer of Auris Health. "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."

Lung cancer is the number one cancer killer of both men and women in the world.ⁱ In the United States, approximately 400 people die daily due to the diseaseⁱⁱ. The development of new advanced technologies, like the Monarch Platform, could allow the opportunity to make an earlier diagnosis, potentially saving many lives as a result.

AURIS and MONARCH are trademarks and/or registered trademarks of Auris Health, Inc. in the United States and in other countries. All other trademarks and product names used herein are the property of their respective owners.

About Auris Health, Inc.
Auris Health is pioneering the next era of medical intervention by developing platforms that enhance physician capabilities, evolve minimally invasive techniques, and create new categories of care that redefine optimal patient outcomes. The company is committed to transforming medical intervention by integrating robotics, micro-instrumentation, endoscope design, sensing, and data science into one platform. Every element of our technology is driven by patient-specific design aimed at maintaining the integrity of the human body. Learn more at www.aurishealth.com.

About Johnson & Johnson Medical Devices Companies
As the world's most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopaedics, vision and interventional solutions, we're working to profoundly change the way care is delivered. We are in this for life.

*Comprising the surgery, orthopaedics, vision and interventional businesses within the Johnson & Johnson's Medical Devices segment

Dr. Chen is a paid consultant to Auris Health, Inc.

ⁱ World Health Organization: https://www.who.int/cancer/PRGlobocanFinal.pdf

ⁱⁱ National Cancer Institute https://seer.cancer.gov/statfacts/html/lungb.html

SOURCE Johnson & Johnson Medical Devices Companies