ReWalk, Ekso Race to Sell Exoskeletons in Tough Rehab Market

Xconomy National — 

Every day, Ashley Barnes straps a battery-powered device onto her waist, legs, and feet, which allows the paraplegic to stand up from her wheelchair and go for walks with the help of crutches. The wearable brace has motors located at Barnes’s hip and knee joints that move the “exoskeleton,” along with her legs and feet, in a way that mimics walking.

Not only can she make meals in her kitchen and get dishes out of cabinets, but Barnes says what’s more important is that she’s reaping many health benefits. Muscle spasms in her back have decreased, she doesn’t get pressure sores from sitting all day, and her bowel function has vastly improved. The 38-year-old mother from east Texas is a passionate advocate for the exoskeleton technology, for spinal cord injury patients, and, as she puts it, for their right to get up and move around. “It’s not about replacing the wheelchair,” says Barnes, who got her injury during a botched spinal surgery in 2014. “It’s about reducing our chances of going back to the hospital [because of medical complications]. We were not made to just sit.”

Stories like Barnes’s are so compelling that several startups and even larger companies like Panasonic have jumped into the exoskeleton business over the last five years (here’s one such startup we wrote about recently). These powered, wearable robots have been designed not only for disabled people but also for able-bodied people in industrial and military settings, such as for factory workers to reduce fatigue and injury when doing difficult and repetitive tasks.

A pioneer in this area, Ekso Bionics (NASDAQ: EKSO) of Richmond, CA, has products (pictured above) for both rehabilitation and industrial applications, but is focused on the rehab market. Its competitor, ReWalk Robotics (NASDAQ: RWLK) of Marlborough, MA, sells devices for rehab for use at home and in clinics. Both companies have seen only limited adoption of their first generation of wearable robots. ReWalk has so far sold a little more than 400 units worldwide, and Ekso has sold less than 300—far from enough for a profitable business. And both companies have had financial challenges as they work to grow the market for their FDA-approved products, and develop and test next-generation ones.

Part of the difficulty is the newness of the technology. The first FDA-approved exoskeleton (made by ReWalk) got the green light in 2014 for patients with spinal cord injury. Others, from Ekso Bionics and another company, Parker Hannifin, were approved in 2016. “When I first started at Ekso seven years ago, people didn’t even know what exoskeletons were,” says Max Scheder-Bieschin, Ekso’s chief financial officer. “Now people understand it’s no longer science fiction.”

But there’s also the issue of cost. Barnes’s device, made by ReWalk, has an average price tag of $75,000-80,000, and Ekso’s device, which is targeted at rehab centers for use by multiple patients, costs $150,000. Many insurance companies have balked at covering the pricey exoskeletons, citing a lack of data on the devices’ medical benefits and concerns about whether patients would use the devices enough to really see those benefits. Barnes couldn’t get her insurance company to cover her exoskeleton—she’s instead relying on a public fundraising campaign.

Larry Jasinski, ReWalk’s CEO, says one of his company’s major goals is to convince payers to cover the devices so that people can use them at home and in the community. The company is starting to score some early wins in Germany, with two insurance groups there recently announcing that they will reimburse qualifying individuals. And the U.S. Department of Veteran Affairs agreed in late 2015 to provide qualifying veterans with spinal cord injury with access to ReWalk’s devices. Discussions between ReWalk and insurers in the U.S. are ongoing.

Scheder-Bieschin says Ekso is focused on healthcare systems and providers, making its case to hospitals and rehabilitation centers that its device can speed up the rehab process and allow patients to go home in better shape.

Building the Case

Both companies are working hard on sales and marketing—and on demonstrating the benefits of their technology. Scheder-Bieschin says Ekso’s device comes with software that allows the exoskeleton to adapt in real-time to the changing needs of the patients as they gain strength and improve their walking, or as they get tired and need more assistance. Jasinski says ReWalk’s next-generation exoskeleton, which will be tested in a clinical trial next year, will have similar capabilities.

A key part of the companies’ efforts is to generate more published clinical data showing the kinds of health benefits that Barnes reports, but across a larger number of patients. This kind of data is key to convincing payers to reimburse, says Jasinski. Although the number of studies of people using exoskeletons has increased in the last few years, more are needed, he adds. “We’re not going to grow the industry until we build a lot of data,” says Jasinski.

The first studies by ReWalk and others showed mainly that the exoskeletons were safe and could allow some paralyzed people to walk. But more recently, small studies suggest that using exoskeletons like ReWalk’s and Ekso’s can reduce body fat, pain, and improve bowel function, and more studies are underway.

Going after multiple markets in rehab will be key for the success of the companies—and to do that, exoskeleton companies are also developing new versions of their products for people with other kinds of impaired movement, like stroke patients and eventually, for those with multiple sclerosis and Parkinson’s disease.

ReWalk, for instance, is working on a lighter, cheaper, more flexible “exosuit” designed for people who can still walk, but not very well. (Ekso also recently unveiled a prototype of a lightweight, flexible exoskeleton.) ReWalk has licensed technology from Harvard University to commercialize a fabric-based device that people would put on almost like a piece of clothing. Companies will need to develop new exoskeleton technologies like this to open up new applications, especially given how similar a lot of the current exoskeletons on the market are, says Conor Walsh, the Harvard engineering professor who developed the “soft suit” technology licensed by ReWalk and is continuing to work with the company.

Walsh says his technology is particularly well suited for use in the home and out in the community, which is where he thinks the market growth opportunities are. Using an exoskeleton in a hospital with a therapist for just a few sessions a week “is not the long-term solution for the field,” says Walsh.

Jasinski says the cost of the soft suit will come in at $19,500—a quarter of the price of ReWalk’s hard exoskeleton. The Harvard-based technology works by having motors worn just on the waist, rather than along the legs like in the hard exoskeletons. The motors pull on cables that are attached to fabric wrapped around the calf and to insoles worn on the feet. Walsh’s group has shown in an early study with nine patients that the device can help people with muscle weakness and impaired coordination due to a stroke clear their feet from the ground and push forward as they walk. This reduced the amount of energy they used to walk.

ReWalk plans to start a clinical trial of its “Restore” soft exosuit by early next year, in hopes of securing FDA approval and commercializing it in the U.S. by late 2018 or early 2019—first for use in rehab centers and then, with further tweaks and tests, for home use. The success of the soft suit will be essential for the future of ReWalk, says Jasinski. “To get to the point of profitability, we’re going to need multiple products”, he says.

To do all this, ReWalk and Ekso have had to hunker down over the last couple of years, cutting operating costs by 25 to 30 percent, laying off staff, and raising money by selling shares and taking out loans to cover sales, marketing, and R&D costs. Scheder-Bieschin of Ekso says his company has raised enough funds to last for at least the next two years. Jasinski says he will need to raise more money, probably sometime next year. Profitability for ReWalk remains a few years away, Jasinski adds.

Leaders at ReWalk and Ekso also realize that a little collaboration will be needed to show the benefits of their technology. They and others are working together to reach out to medical and patient groups.

This is a step in the right direction, says Barnes. “Industry needs to come together and fight for the one thing that’s lacking, and that’s coverage.”