ReWalk Robotics, Yokneam Ilit, Israel, and Marlborough, Massachusetts, is the subject of a class action lawsuit related to its initial public offering (IPO) in September 2014. The suit was filed with the Superior Court of California, County of San Mateo, by the law firm of Levi & Korsinsky, headquartered in New York. The complaint alleges that while the registration statement filed pursuant to the IPO stated that the U.S. Food and Drug Administration (FDA) had classified ReWalk as subject to special controls, including compliance with medical device consensus standards, performance of a post-market surveillance clinical study demonstrating a reasonable assurance of safety and effectiveness in urban terrain, and a training program, among other things, the company failed to disclose that it was unable to comply with the special controls. The lawsuit also states that ReWalk omitted that it had received a warning letter from the FDA in September 2015, in which the FDA outlined the company’s failures to propose and commence an adequate post-market surveillance plan. On May 10, ReWalk revealed that at the time of the IPO, it had been unable to comply with the FDA’s special controls due to inadequate staffing.
ReWalk Robotics did not respond to our request for a comment.
