The FDA has rejected Helius Medical Technologies' (NASDAQ:HSDT) application for De Novo status and 510(k) clearance of its Portable Neuromodulation Stimulator (PoNS). The agency cited the lack of sufficient information to determine the relative contributions of the PoNS device and physical therapy in its clinical trials.
The FDA stated that the company may refile its application after generating additional data.
CEO Philippe Deschamps says, “We are understandably disappointed by the Agency’s decision to decline our request for [approval], but Helius remains committed to generating the data [to support approval] of our PoNS device in the future for the treatment of patients with chronic balance deficit due to mmTBI, in order to bring our innovative therapy to more than 1.5 million Americans suffering from this condition. In addition to working on generating this new data, we will continue to focus on expanding our commercial efforts and treating patients in Canada, where we do currently have regulatory clearance."
Shares, currently halted, will resume trading at 7:35 am ET.
Update: Shares are down 57% premarket on light volume.
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