Pomerantz LLP is investigating claims on behalf of investors of ReWalk Robotics Ltd. ("ReWalk" or the "Company") (NASDAQ: RWLK) (ISIN: IL0011331076). Investors are advised to contact Robert S. Willoughby at email@example.com or 888-476-6529, ext. 9980.
The investigation concerns whether ReWalk and certain of its officers and/or directors have violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
On or about September 17, 2014, ReWalk announced the closing of its initial public offering ("IPO") of 3,450,000 ordinary shares to the public, through which the Company raised approximately $41.4 million. The IPO's registration statement stated that the U.S. Food and Drug Administration ("FDA") had classified ReWalk as subject to special controls, which included 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. In September 2015, ReWalk received a Warning Letter from the FDA, outlining ReWalk's substantial failures to propose and commence an adequate post-market surveillance plan.
On February 25, 2016, ReWalk disclosed receipt of the FDA's warning letter. On this news, the Company's share price fell $1.24, or 10.64%, to close at $10.41 on February 25, 2016.
On May 10, 2016, ReWalk revealed that at the time of the IPO, the Company had been unable to comply with the FDA's special controls due to inadequate staffing.