Helius Medical Technologies, Inc. announced that the U.S. FDA has completed its review of the Company’s request for De Novo classification and 510(k) clearance of the Portable Neuromodulation Stimulator (PoNS?) device and has declined the Company’s request. In reaching its conclusion, the FDA 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, 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.
“We are understandably disappointed by the FDA’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” said Philippe Deschamps, Chief Executive Officer of Helius. “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.” added Mr. Deschamps.
The original website link：https://heliusmedical.com/index.php/newsroom/news-release/2019/276-