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All-in-one lung cancer diagnostic, treatment

By Liz Hollis

Staff Writer

With the field of robotic surgery continuing to heat up, Auris Health Inc. has entered a cooperative development and commercialization agreement with Neuwave Medical Inc., a subsidiary of Johnson & Johnson's (J&J) Ethicon Inc., focused on robotically assisted bronchoscopic ablation of lesions in the lung.

The agreement revolves around the development of systems for robotic control, navigation and application of microwave ablation delivered by bronchoscopes. A bronchoscope with a small camera and an accessory channel would permit tools to enter the lungs through the mouth. The co-development agreement also covers technology optimization and procedure development.

"From the beginning, our vision has been to create a platform capable of enabling advanced diagnosis and therapy for a spectrum of disease, using the least-invasive approach," said Frederic Moll, co-founder and CEO of Redwood City, Calif.-based Auris. "Through this collaboration, we believe we are taking a significant first step together toward making the goal of diagnosing and treating lung cancer, all through the body's natural openings, an eventual reality."

Word of the deal comes about two months after the company reported that the FDA had cleared its Monarch robotic platform for diagnostic and therapeutic bronchoscopic procedures. (See BioWorld MedTech, March 27, 2018.) The platform has an interface that is managed with a gaming-like controller. It is accompanied by a computer-aided navigation program that uses 3D modeling of an individual lung.

Ethicon's Neuwave Flex microwave ablation system, the only FDA-cleared flexible microwave ablation probe, builds on the Neuwave percutaneous microwave ablation system. The Flex system is indicated for soft tissue ablation in percutaneous procedures, open surgical procedures, as well as in procedures in which the target tissue is accessed by a lumen or scope, such as an endoscope.

"For those treating people with suspicious nodules in the lung, the holy grail is to one day be able to detect and treat the disease in a single procedure," said Kazuhiro Yasufuku, associate professor of surgery at the University of Toronto. "When this option becomes a reality, we may see many patients seek early screening and minimally invasive treatment."

Lung cancer is the leading cause of cancer deaths worldwide. "Four hundred and fifty people die every day in the U.S. due to lung cancer. It is the number one cancer killer of both men and women in the world. Lung cancer screening has given us an opportunity to save some of these people by diagnosing the cancer early, while we have a chance to cure it. Despite the benefit, we still are limited by the current technology in making a diagnosis," said Michael Simoff, director of Interventional Pulmonology at Henry Ford Health System in Detroit, at the time of the FDA clearance of the Monarch platform. "The development of new advanced technology, like the Monarch platform, could allow us the opportunity to make the diagnosis early, which translates directly to saving lives."

Timelines, future plans

In terms of timelines, Josh DeFonzo, chief strategy officer at Auris, told BioWorld MedTech that development will start in the coming months. "[O]nce we begin collaborating, we will have a better sense of timelines." He added that no financial details were being disclosed.

"We are open to partnerships that help us advance our goal of addressing a spectrum of disease in a minimally invasive manner," DeFonzo said when asked about potentially linking up with other companies. He added that no additional details about plans for future applications with Monarch were being shared.

Competitive landscape

Formerly named Auris Surgical Robotics Inc., the company is in a competitive field led by Intuitive Surgical Inc. Intuitive has more than 4,000 systems for use in laproscopic hernia repair, colon, gynecology, urology, thoracic and general surgeries. Moll helped co-found Intuitive.

In addition, Mazor Robotics Ltd., which has teamed up with Medtronic plc, is developing a robotic surgical system for brain and spinal procedures. On Monday, the company posted first quarter results. Wells Fargo analysts noted that systems revenue of $6.6 million missed their estimates by about $2 million, due in part to lower net systems being place in the quarter than what was modeled.

"The company will no longer provide a breakdown of system placements for competitive reasons, but noted that the installed base stood at over 200 as of the end of Q1," the analysts noted. "By our math, Mazor likely placed 15 net systems in 1Q18, up from 10 in 1Q17 and 16 in 4Q17, which is four systems shy of our estimate." Overall, revenue of $15.5 million exceeded the analysts' estimates.

Globus Medical offers a range of products for spinal surgery. It jumped into this field with its Excelsius GPS, a robotic guidance and navigation system – a move that appears to have boosted the company's revenues. It disclosed first quarter revenues of $174.4 million, above the consensus of $167.9 million. Analysts from William Blair noted that the results, which were discussed May 2, were driven in part by interest in the Excelsius GPS.

"We remain compelled particularly by the company's emerging technologies opportunity and believe that management has been putting in place the proper foundation to accelerate growth from here, though we acknowledge that the growth required to meet the company's goal of $1 billion in sales by 2020 is still fairly aggressive," wrote William Blair analysts.

The company reported the first spine surgeries with the platform Oct. 10, 2017, after noting it had received clearance for it two months earlier.

U.K.-based startup CMR Surgical, which changed its name in Cambridge Medical Robotics Ltd. in February, is planning to launch its next-generation universal surgical robotic system, Versius, later in the year. It closed a $46 million series A funding last fall to help with this effort. (See BioWorld MedTech, Sept. 20, 2017.) Its robotic surgical system, aims to replicate the actions of a human wrist movement in holding a surgical instrument. The system could be applicable in a range of minimal access surgeries, as well as offering a less expensive treatment option.

Published  May 17, 2018

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