Parker Hannifin says that its FDA clearance will give 270,000 people with severe spinal cord injuries the opportunity to walk again. Convincing payors to cover the device, however, could be a challenge.

Brian Buntz

Parker Hannifin Corp. has convinced FDA to clear its 26-lb. exoskeleton, which could be used to treat up to 1.7 million people in the United States--including more than a quarter-million people with severe spinal cord injuries. There are roughly 12,500 new cases of severe spinal injury each year according to the National Spinal Cord Injury Statistical Center.

It is the second exoskeleton after the ReWalk won FDA clearance in 2014 to be sold to both for home and clinical use.

It remains to be seen what kind of traction the technology, which costs $80,000 per unit, will have with insurers. "That will take time. We're not claiming this business will be hundreds of millions of dollars a year," Achilleas Dorotheou, head of Parker's Human Motion & Control unit, admitted to the Wall Street Journal.

The company hopes to produce substantial evidence that the technology helps improve expensive medical conditions encountered by patients with severe spinal cord injuries. This evidence could be used to sway payers to cover the technology. Parker Hannifin announced last October that it will work with the U.S. Department of Defense to determine the economic and rehabilitation benefits of the technology.

The company began working on exoskeletons after the company decided to look for new applications for its robotics and motion control technology. The exoskeleton technology has also given the company a dedicated medical device business, which could help offset the cyclical nature of its other business segments, which include aviation and automotive. 

In 2015, Parker Hannifin had received the regulatory green light to market the technology in Europe.

Paralyzed Veterans of America (Paralyzed Veterans) recently released a statement applauding the availability of the second exoskeleton in the United States.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.