ReStore Exo-Suit by ReWalk Robotics Cleared by FDA for Sale to Rehabilitation Centers in the U.S.

The ReWalk Robotics stroke rehabilitation exosuit, ReStore Exo-Suit, has been cleared by the U.S. Food and Drug Administration (FDA) for sale to rehabilitation centers across the United States, reports PR Newswire.  This announcement comes on the heels of the ReStore Exo-Suit receiving the CE Mark for sale in Europe at the end of May.  This has been a very good week for ReWalk Robotics indeed!

The ReStore Exo-Suit becomes the first soft powered exoskeleton to be cleared by the FDA.  This is a significant win for the company which has invested heavily in bringing the device to market which was originally developed at the Wyss Institute at Harvard.

The FDA approval is based on a multi-center clinical study, with the data generated used for the successful 510(k) submission.  The company expects to publish these results sometime later within the year.

When the ReStore Exo-Suit goes on sale it will join the company’s sister product, the ReWalk 6.0 exoskeleton.  According to ReWalk’s self-reported numbers, it has placed 550 ReWalk exoskeletons in 26 countries and over 270 rehabilitation centers to date.

Reportedly, the ReStore will retail for $28,900 and will include leasing options as well.  This is a significantly lower price point than any lower body powered exoskeleton currently on the market.

In after-hours trading, the company stock value (Nasdaq:RWLK) increased by 166%.  Compared to the initial 37% jump after the device’s CE approval, it appears that investors are a lot more excited about the sales potential in the U.S. over the EU.

What’s next for ReWalk?

Now that the company has successfully executed its vision of gaining regulatory clearance before it needs a new round of funding what’s next on the horizon?  The ReStore is based on exosuit technology from the Wyss Institute and there are multiple images showing the lab working on upper body powered exosuits.  It is possible that these prototypes can become the next products in the near future.

Equally plausible, the company could return its attention to hard frame exoskeletons and develop a new version of the ReWalk (ReWalk 7.0 anyone)?

ReWalk has been a pioneer in rehabilitation technology with the promise of bringing, accurate,  reproducible, and measurable physical rehabilitation to thousands of people all over the world.

References:

FDA Issues Clearance for the ReStore™ Exo-Suit, the First Soft Robotic System for Stroke Therapy, PR Newswire, Jun 4, 2019, https://www.prnewswire.com/news-releases/fda-issues-clearance-for-the-restore-exo-suit-the-first-soft-robotic-system-for-stroke-therapy-300861824.html