24thOct 2019- Helius Medical Technologies, Inc. issued an announcement, which is summarized as follows：
Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today is providing an update outlining the Company’s US regulatory strategy following its pre-submission meeting with the U.S. Food and Drug Administration (“FDA”).
“The pre-submission meeting was built upon Helius’ prior clinical work and experience gained through ongoing interactions with FDA,” said Philippe Deschamps, Chief Executive Officer of Helius. “The discussion during the course of the meeting focused on supporting FDA’s request for a study that demonstrates the benefit of PoNS Treatment® compared to physical therapy alone in a way that can be generalized to the intended population of patients with balance deficits following mild-to-moderate traumatic brain injury. FDA indicated that additional data are required to support the new de novo submission. Study design, endpoints, eligible patient population and the duration of the investigation were discussed. Two analysis methods were proposed and will be implemented to maximize the information gained in the study while allowing for efficient enrollment and study execution. Overall, the meeting provided the information needed to help finalize the design of the new study in accordance with FDA’s current recommendations. Helius has already incorporated FDA’s new feedback in its plans, and estimates that it will be able to submit a new request for de novo classification based on the results of our new study in the third quarter of 2020.”
Mr. Deschamps continued, “We thank FDA for their feedback on our plans during the recent pre-submission meeting and look forward to further collaboration with the Agency as we prepare our new de novo submission. We intend to provide further updates on our US regulatory strategy during our third quarter earnings call on November 12, 2019.”
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