ReWalk fails to report FDA rebuke

ReWalk management

The FDA is demanding that the Israeli medical device company conduct a post-market study plan.

Getting a warning letter from the US Food and Drug Administration (FDA) is one of the risks for medical device and pharmaceutical companies. ReWalk Robotics Ltd.(Nasdaq:RWLK), which has developed a robot device that serves as a skeleton to replace a wheelchair in movement by paralyzed patients, noted this risk as one of its risk factors in its recently published annual financial statements, as required. The company did not mention, however, that it had received just such a warning letter.

According to an update published a week ago by the FDA, the US agency sent ReWalk a warning letter in September 2015 saying that when the FDA had approved ReWalk's device for marketing (when the company's name was Argo), it had demanded that the company implement a post-market study plan .

The warning letter was sent because failure by the device to prevent the patient from falling is liable to cause him serious injury (including death) and complications from the fall, such as brain or spinal cord damage.

The FDA said that it had notified ReWalk in September 2014 that the post-market study plan it had proposed was defective, and the required information had to be completed within 30 days, which did not happen. After ReWalk's answer arrived late, the FDA notified the company that particulars were still lacking, and this sequence of events later repeated itself.

"The FDA tried many times to coordinate a conference call in order to solve the problem," the letter stated. ReWalk was given 15 months from last September to carry out the post-market study plan as required, following its approval by the FDA. It is possible that the problem has already been solved, at least partially, but ReWalk has not mentioned the issue at all. ReWalk's market cap is $105 million, following a 28% slide in its share price since the company's IPO 18 months ago. The company's CEO is Larry Jasinski.

ReWalk stated, "ReWalk Robotics responded within 15 business days to the FDA warning letter dated September 30, 2015, and the company has been in regular communication with the FDA in the intervening months to resolve all issues tied to the post-market study. Restructuring the format of the study has raised additional conversations, and ReWalk is confident we will be able to reach a resolution that meets the requirements of the FDA 522 order."

Published by Globes [online], Israel business news - www.globes-online.com - on March 9, 2016

© Copyright of Globes Publisher Itonut (1983) Ltd. 2016

ReWalk management
ReWalk management
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