US FDA clearance for Rewalk Robotics’ second powered exosuit, ReStore, will have come as a relief to the group’s investors after the troubles that have dogged the company’s first system. The group’s stock closed up 122% yesterday.
Analysts had not expected the approval until the second half, so Rewalk is ahead of schedule. But this is a new kind of technology in an unproven market, and early adoption of the system will be closely watched.
ReStore is designed to help in the rehabilitation of stroke survivors with mobility problems. The battery and motor part of the system is worn on the waist, and transmits power to a fabric leg brace and a foot plate under the shoe. This helps the patient lift their feet and move their legs. It also includes sensors worn on both shoes to enable the movements to be synchronised with the patient’s natural gait.
The system also tracks the patient’s performance, and rehab therapists can analyse the data to monitor improvements, tweaking the settings as necessary.
The company says this is the first soft exosuit approved in the US, as indeed it was in Europe when it was CE marked at the end of last month. The device will be priced at $28,900, and the company believes that it will fall into existing gait training reimbursement codes.
In Europe ReStore will cost €28,500 and it is set to be launched this month. Rewalk plans to use its own sales force in Germany and the UK as these two countries have reimbursement policies in place for post-stroke rehabilitation. The group is expected to sign up distributors for France and Italy.
As well as selling the suit outright, the company intends to offer a leasing option, potentially allowing rehabilitation centres to limit their up-front capital investment. Investors will now want to see decent early adoption rates.
The company already sells the ReWalk exoskeleton for personal use by patients with spinal cord injury; it also sells the system to rehabilitation centres. ReWalk Personal reached the US five years ago, but was the subject of FDA warnings and skated close to being withdrawn from market (Rewalk draws the FDA’s ire, March 3, 2016).
Rewalk placed 85 of these systems in 2018, giving total revenues of $6.5m. But sales seem to be falling; in 2017 it had sales of $7.8m from 107 systems. Perhaps ReStore’s market debut will help reverse this apparent decline.