18th June 2019- Helius Medical Technologies, Inc. issued an announcement, which is summarized as follows：
Helius Medical Technologies, Inc. is providing an update on its strategy to resubmit an application for De Novo clearance of PoNS device with the U.S. FDA.
The Company recognizes the importance of generating new clinical data demonstrating the independent contribution of physical therapy alone in its treatment protocol in order to demonstrate the overall impact of the PoNS Treatment on participants.
The Company has concluded that, while it will not finalize its resubmission protocol until after it engages with the FDA in its pre-submission meeting, such a protocol will, at a minimum, need to include analyzing the effect of physical therapy alone, without use of the PoNS device.Accordingly, the Company proactively has decided to initiate a study to generate the physical therapy alone data. It has completed its new study protocol using the same design as its TBI 001 study including a 5-week treatment period and the same inclusion/exclusion requirements. In addition, the Company has identified sites at which to conduct this study and expects to be prepared to enroll participants by the end of July 2019.
The Company is also in the process of drafting its pre-submission letter to the FDA requesting a pre-submission meeting. Following the pre-submission meeting, the Company expects to finalize its resubmission strategy and looks forward to reporting on that when completed.
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