FDA denies Helius Medical request for clearance, de novo classification of PoNs

Helius Medical announced that the FDA has completed its review of the company’s request for de novo classification and 510 clearance of the Portable Neuromodulation Stimulator, or PoNS, device and has declined the company’s request. In reaching its conclusion, the agency noted that it did not have sufficient information to discern the relative independent contributions of the PoNS device and physical therapy on the improvements from baseline in the effectiveness endpoints observed in the company’s clinical studies. The FDA noted that the company could generate additional data to address its concerns and resubmit its application. In the course of its review of the company’s submission, the FDA recognized that there were no device-related serious adverse events in either of the company’s two clinical trials, and that patients in both the treatment and the sham control arms demonstrated improvements from baseline for all the pre-specified clinical endpoints, including the primary endpoint of responder rate based on Sensory Organization Test score.

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