Helius Medical Technologies Inc HSDT

Healthcare Medical Devices

Helius Medical Technologies, Inc. is a neurotech company in the medical device field. It is focused on neurologic deficits using orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms enhancing the lives of people dealing with neurologic diseases. It develops, licenses, or acquires non-implantable technologies targeted at reducing symptoms of neurological disease or trauma. Its product Portable Neuromodulation Stimulator (PoNS) is a non-implantable medical device, inclusive of a controller and mouthpiece, which delivers mild electrical stimulation to the surface of the tongue to provide treatment of gait deficit and chronic balance deficit. PoNS Therapy is integral to the overall PoNS solution and is the physical therapy applied by patients during use of the PoNS neuromodulation stimulator. PoNS is used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.

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Helius Medical Technologies Inc

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Comment by miningfundion Dec 11, 2017 2:48pm

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Post# 27132372

RE:RE:RE:Similar study

Thanks Zane777. Based on the trial, the effectiveness of the PoNS is extraordinary and indisputable when compared to the baseline i.e. plateaued physical therapy. But, considering the similarities of the two devices, why was there no sham for the TDU but an "intended sham" for the PoNS that has caused a great deal of confusion and concern?

Zane777 wrote:
https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN130039.pdf

Page 10 shows how they evaluated effectiveness. There was no sham device.

One could draw parallels in that all participants were completely blind to begin with and patients in the Helius study all having plateaued with physical therapy prior to the trial.

And yes, they received FDA (which I'm sure you knew.)

Safety in de novo applications appears to be paramount. Meeting un-met need, begin safe, and showing positive results through their many studies will all help greatly with the Helius FDA application.