Israeli company ReWalk Robotics Ltd. (Nasdaq: RWLK) has announced that the FDA has granted marketing approval in the US for its product for treatment of stroke victims, one week after approval of the same product in Europe.
The company's share jumped 5% yesterday, and was up 170% at the beginning of today's trading on Wall Street. ReWalk's market cap is only $15 million, but the gains in its share price will boost this to $41.5 million if they are maintained in trading.
ReWalk received a great deal of favorable coverage by bringing to market a product enabling people with lower limb paralysis to walk using an external robot skeleton, but revenue from this product was lower than expected, and the company's share plunged as a result. ReWalk hopes that through its new product, it will be able to recover its status.
ReWalk's ReStore Exo-Suit enables people paralyzed by stroke to practice walking during the rehabilitative process. This product differs from the company's first product, both because it is also suitable for elderly patients with less than optimal upper body functioning and because it is designed for walking practice, not daily use.
ReWalk's first product was designed for people paralyzed by injury whose upper body is strong and functional, but whose lower limbs are permanently paralyzed. The objective was to use it as an accessory for daily use instead of a wheelchair, not merely as a training device. The first product was therefore sold to patients (insurance reimbursement was inadequate, which is one of the reasons that it achieved only limited success), while the new product will be sold to rehabilitation clinics.
The ReStore product is not a hard inflexible skeleton; it anchors the body with textiles and flexible soft components that facilitate a variety of movements. Among other things, it helps move the foot sole for bending the ankle. The device studies the patient's movements and synchronizes itself with the patient's natural stride in order to improve his or her practice walking.
In contrast to ReWalk's product for people with paralysis created by injury, which was the first of its kind in the market, the current product competes against other "walking" products in rehabilitation clinics. ReWalk says, however, that its product creates new capabilities.
ReWalk announced that the price of its ReStore suits would be substantially lower than that of the first generation of inflexible external skeleton technologies, and that the suits could be used for a broad range of patients in need of rehabilitation from stroke. The company will offer its suits for direct sale and also under a rental model through a third party.
"The reasonable price of the device and the multiple uses that it offers make it an attractive solution for wider variety of rehabilitation uses than previous technologies," said ReWalk CEO Larry Jasinski last week at the product's launch in Europe. "Given the high frequency of stroke and the need for more effective and economical clinical solutions, the market for ReStore is substantial, with enormous potential for continual innovation in rehabilitative treatment."
ReWalk plans to use its existing sales, training, and service teams to commercialize the ReStore Exo-Suit. The stroke rehabilitation market is huge, and the company believes that success in this market could also lead to use of this product, with appropriate adjustment, for multiple sclerosis and Parkinson's Disease patients.
ReWalk has installed nearly 550 external skeletons to date in 26 countries, and has given training in over 270 rehabilitation clinics worldwide in the use of its external skeletons. The company had only $1.1 million in revenue in the first quarter of 2019, and posted a $4 million loss. Its market cap fell 88% last year, after it emerged that its leading product probably could not be made profitable. If the rise in its share price is maintained, ReWalk will be able to raise the capital needed to market its new product.
Published by Globes, Israel business news - en.globes.co.il - on June 5, 2019
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