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Third party validation is crucial IMO, and this

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Helius Medical Technologies, Inc. Announces FDA Has Granted the PoNS Device Breakthrough Device Designation for the Treatment... GlobeNewswire Inc. - 5/12/2020 7:05:10 AM
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UPDATE -- Helius Medical Technologies, Inc. Announces Publication of its PoNS™ Registrational Clinical Trial (TBI-001) in T... GlobeNewswire Inc. - 4/30/2020 12:02:09 PM
tykundegex Member Level  Thursday, 12/19/19 01:00:40 PM
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Third party validation is crucial IMO, and this study echoes the findings of previous studies. But it does not draw a comparison between PoNS with PT and PT alone. However I find this requirement (imposed by FDA for before granting 510k for PoNS) to be superfluous given that both this and prior studies clearly stated that all participants "had seen little progress or had plateaued in their recovery with PT", implying that PT alone will not benefit the patients further.

Here is the partial PR, with emphasis added.

Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (the “Company”), a neurotech company focused on neurological wellness, announced today that the results from independent research conducted at the University of Wisconsin-Madison on translingual neurostimulation for the treatment of chronic symptoms due to mild-to moderate traumatic brain injury (“mmTBI”) have been published in the December 2019 issue of the Archives of Rehabilitation Research and Clinical Translation. For more information on the trial and its results, see the published journal article.
The newly published results from the double-blind randomized clinical trial which paired translingual neurostimulation using the Portable Neuromodulation Stimulator (PoNS™) device with therapeutic activities, showed significantly improved balance and gait scores over the 14-week treatment period and the outcomes were sustained for 12 weeks after discontinuing the treatment.

“Traumatic brain injuries are rising steadily in North America and whether these injuries are mild or moderate, the effects can last a lifetime,” said Philippe Deschamps, Chief Executive Officer of Helius Medical Technologies. “The results from this independent clinical trial provide clinical support for the PoNS Treatment™ as an effective treatment option for patients suffering from the effects of mmTBI and we are excited to have the validation of the data in a peer reviewed publication.”

The trial evaluated 43 participants who had experienced an mmTBI at least one year prior to receiving the PoNS Treatment and had seen little progress or had plateaued in their recovery with physical therapy. Researchers found that approximately 74 percent of the participants who completed the 14 weeks of PoNS Treatment experienced significant improvements in their balance. Patients also showed meaningful improvements in their gait and walking endurance.

Exploratory endpoints, such as headache burden and sleep quality, were also observed as part of the trial. While further analysis and research is needed, there was an indication of improvement in these exploratory endpoints. The demonstrated improvements in balance and gait, coupled with potential improvements in the exploratory endpoints may allow treated individuals to experience a better quality of life.

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