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 Apr 12, 2019 2:56pm

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Post# 29620301

RE:Next Catalyst CE Marking In Europe

Thanks - interesting analysis. However, I don't think that it addresses the fact that the FDA has already rejected the effectiveness of the device. So even though Europe may approve it, it seems likely that European (or Canadian?) physicians and insurers would not recommend or cover it? I suggest that FDA approval is essential without it, the company will struggle to survive.

Speaking of HSM's new business plan, I believe that it is not enough for management to disclose the FDA rejection, it is also required to disclose how it will respond to the material change resulting from that material fact. It's not enough to hear tidbits from Oppenheimer.

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