ReWalk’s clearance puts exoskeleton technology in forefront of med-tech
August 20, 2014
Part one of three
Prior to 2009, exoskeletons and therapies for paralyzed patients were probably the last things on Stephanie Souza’s mind. That changed suddenly and the California resident’s life was turned upside down, when she discovered she was suffering from transverse myelitis, a neurological condition consisting of an inflammatory process of the spinal cord.
“I woke up one morning and I had back pain and tingling toes, and within a week I was paralyzed from the rib cage down,” Souza, told Medical Device Daily. “I will never be able to walk again.”
But Souza was able to get some small measure of freedom by participating in EKSO Bionics (Richmond, California) clinical trial for its exoskeleton in 2011. Souza would be able to walk and stand up for the first time in two years. The ordeal greatly empowered the former dance instructor, who up until that time had been mostly confined to a wheelchair.
“I’m used to rolling everywhere [in a wheel chair],” she said. “Being able to use the [exoskeleton] does empower you and it makes you feel normal again. It was really cool to be able to see myself walking. It was pretty emotional to be able to look at my family members face to face, without them having to bend down to look at me.”
Exoskeletons are being called the next big advancement that have the potential to take patients beyond normal wheelchair use.
“Your body and your mind remembers [walking)], said Paul Thacker, a patient who used EKSO Bionics’ technology. “It’s like, hey I remember how this works. This is the way it’s supposed to go.”
But although the technology has been around for years (there’s even a research paper dating back to the 1950s that discusses the exoskeletons), the devices have mostly been in the background and used in rehabilitation centers.
This changed in June, when the devices received worldwide media attention and were rocketed into the spotlight. The migration from relative obscurity came when ReWalk Robotics (Marlborough, Massachusetts), a public med-tech firm, gained FDA clearance for community use of its exoskeleton (Medical Device Daily, June 30, 2014). Companies in the space already had approval in Europe and had clearance in the U.S. for use of exoskeletons in the rehabilitation environment, but this was the first time a firm gained the FDA nod for individual use of the device.
At the time of the clearance the company called the clearance a ‘historic moment’ in the space.
“The actual structure of the [FDA] clearance is the biggest factor,” Larry Jasinski, ReWalk Robotics CEO, told MDD. “FDA has made the entire category of Exoskeletons class II, and what that means for any of us now is that we have a reasonably good definition of what we have to do to bring a product to market. It has removed a lot of the uncertainty we faced on what was required. Other companies now know what they need to do to sell a product in the U.S.
ReWalk’s exoskeleton consists of a fitted, metal brace that supports the legs and part of the upper body; motors that supply movement at the hips, knees, and ankles; a tilt sensor; and a backpack that contains the computer and power supply. Crutches provide the user with additional stability when walking, standing, and rising up from a chair. Using a wireless remote control worn on the wrist, the user commands ReWalk to stand up, sit down or walk.
The exoskeleton is for people with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra) when accompanied by a specially trained caregiver. It is also for people with spinal cord injuries at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra) where the device is limited to use in rehabilitation institutions.
The four year path to approval in the U.S. wasn’t an easy one according to the company. Part of the reason was that there were questions from all parties on just what device category the technology would fall under.
“Early on it was such a new and different technology that [FDA] couldn’t figure out what to do with it, and that left some confusion quite frankly on what the regulatory technology path could or should be and they gave us different directions at different times,” Jasinki said. “But what I would give as a positive note for the FDA here is that they looked at the risk benefit of this and they did a pretty good job after the first year of educating and learning about the technology and they were pretty good through the clinical study period. The agency did a pretty good job in this area in establishing this new category for the industry.”
Others in the space seem enthusiastic about the clearance and the possibilities it could provide. But some are cautiously optimistic about the technology being available for individual use – especially since the technology can cost up to $70,000 and up. EKSO Bionics, which develops the EKSO GT commented on the clearance and said that more work needs to be done before it can be a viable market for at home use.
“ReWalk’s clearance is exciting because it makes it really easy for people like us to do that when the time comes,” Nathan Harding Co-Founder and CEO of Ekso Bionics, told MDD. “But the funny thing about it is this, at the current technology level and the current price points people are selling them at, there isn’t really a compelling value proposition for these independent users.”
Ekso Bionics has FDA clearance for its device for use under the supervision of an EKSO Certified physical therapist, for the purposes of providing functional based rehabilitation, over ground gait training, and upright, weight bearing exercise in a clinical environment. In addition we have CE mark Class 2a, Health Canada approval and BSI certification as an ISO Certified medical device.
“We put feelers into that market and we tried various price points, then we decided to double down in rehab, where the tools can offer a really fantastic rehabilitation experience right now,” Harding said. “I believe that to get into the individual market it’s really going to take a lot more than the FDA to say okay. It’s going to take some more groundbreaking technology that we’re working on that’s going to make the trade off between the incentive level people get and the price.”
Ultimately, the clearance helps clear up any perceptions or misconceptions about the technology.
“There was clear entrance prior to the clearance, but exoskeletons were still viewed by many as experimental technology,” Jasinski said. “I think the clearance gave us validation that this product is a safe technology to use in rehab centers as well as a safe technology that can be used outside of rehab centers. I think that validation as we’re seeing from a field and customer response is very strong. There is a higher degree of faith and [people are seeing] that this is something that’s not the stuff of science fiction anymore. This is real.”
– Coming tomorrow in MDD, a look at the top players in the exoskeleton space. //