Shares in Helius Medical Technologies fell as much as 57 percent on Wednesday after the company announced that the FDA declined its request for de novo classification and 510(k) clearance of its portable neuromodulation stimulator (PoNS) device. According to the company, the agency said it "did not have sufficient information to discern the relative independent contributions" of the device and physical therapy on improvements from baseline in the effectiveness endpoints observed in clinical trials. However, the FDA indicated that Helius Medical could generate additional data and resubmit its application.
CEO Philippe Deschamps remarked that the company "remains committed to generating the data to pursue a de novo classification and 510(k) clearance of our PoNS device…for the treatment of patients with chronic balance deficit" due to mild-to-moderate traumatic brain injury.
Helius Medical noted that the FDA found no device-related serious adverse events in either of the company's two clinical trials, and that patients in both the treatment and placebo control arms showed improvements from baseline for all the pre-specified clinical endpoints, "including the primary endpoint of responder rate based on sensory organisation test score."
Helius Medical submitted  its request to the FDA last September for de novo classification and 510(k) clearance of the PoNS device. Earlier this year, the company was asked  to submit additional information to the FDA in order for the agency to complete its review.
The PoNS device is approved for use in Canada  for the treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury when used with physical therapy. Helius Medical submitted a CE mark application  for the device last December.