06/18/2019 | Press release | Distributed by Public on 06/18/2019 05:41
Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) ('Helius' or the 'Company'), a neurotech company focused on neurological wellness, today is providing an update on its strategy to resubmit an application for De Novo clearance of its Portable Neuromodulation Stimulator (PoNS™) device with the U.S. Food and Drug Administration (the 'FDA').
Since the Company received the letter from the FDA in April denying its submission for De Novo clearance of the PoNS device, it has been developing a strategy to resubmit an application to the FDA. As part of that strategy, members of the Company's management participated in an informational discussion with the FDA on June 3rd regarding the issues the FDA raised in its April response letter. The FDA indicated that it denied the Company's request for clearance primarily because it was unable to ascertain the relative independent contributions of physical therapy and the PoNS device to the observed improvements in the balance of the Company's trial participants.
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.
'We are pleased with our progress in resubmitting for FDA clearance. It is important to note that until we complete our pre-submission meeting with the FDA, we will not have a clear understanding and agreement from the FDA on full path forward,' said Phillipe Deschamps, Chief Executive Officer of Helius.
'Meanwhile, we remain focused on our Canadian commercialization and are pleased with the initial results we have achieved thus far in Canada. I look forward to updating our investors on such progress during our Q2 earnings call on August 8, 2019,' continued Mr. Deschamps.