The US Food and Drug Administration (FDA) has rejected Helius Medical Technologies’ premarket submission for the Portable Neuromodulation Stimulator (PoNS) device due to a lack of data.
Designed to be used in conjunction with physical therapy, PoNS is intended for the treatment of chronic balance deficit caused by mild-to-moderate traumatic brain injury.
Treatment involves the delivery of neuromodulation to stimulate cranial nerves, which is claimed to restore neurological function.
The company filed a submission to the FDA in September last year. Its application included findings from two double-blind, randomised, controlled clinical trials that evaluated the safety and efficacy of PoNS in a total of 163 participants.
The regulator has rejected the application stating that it does not have enough evidence that the effects observed in the clinical trials were due to the independent effects of the medical device.
The FDA noted that patients in both the treatment and control arms experienced improvements from baseline for all of the clinical endpoints.
The agency added that the neurotech company can resubmit its application in the future with additional data.
In a press release, Helius Medical said that the FDA’s review did not identify any device-related serious adverse events in the clinical trials.
Helius Medical Technologies CEO Philippe Deschamps said: “We are understandably disappointed by the agency’s decision to decline our request for de novo classification and 510(k) clearance, but Helius remains committed to generating the data to pursue a de novo classification and 510(k) clearance 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.”
PoNS currently holds regulatory approval in Canada and is being reviewed in the European Union (EU).