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 prokofievon Nov 05, 2018 10:08pm

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Post# 28928297

RE:Just Curious

The way I would think about this where the stock was trading prior to the release of its results in November 2017. At this point, investors were expecting the mTBI registrational trial to meet its primary endpoint which combined with the safety profile of the PoNS device would bode well for the FDA approval. At that point the stock was trading between US$15-20. Assuming the primary endpoint had been met and the FDA would have cleared the device, the stock would probably be trading north of US$30.

While the primary endpoint wasn’t reached, we all know the device works, and actually worked too well during the trial so that the control arm (supposed placebo) saw significant improvements. But the market didn’t care and sold off the stock to US$10-12.

The company needed money, so investors shorted it ahead of the raise explaining why it briefly traded below US$8.

Fast forward to today, the stock is trading at US$10, Health Canada has approved the PoNS device and the commercialization continues to progress ahead of the FDA approval with the launch of Heuro Canada and the Clinical Experience Programs with some of the best neurological clinics in North America.

As such, I highly doubt the FDA approval is “baked in”. Some institutions have made limited investments in Helius medical so far (including the clinic in Surrey, BC which has treated patients), but this is still an under the radar and under-owned stock.

Furthermore, if you believe they will be generating revenues in 1Q19, which will be reported sometimes in April/May of 2019, this will be a huge catalyst for the stock. Essentially, you have 6-9 months full of expected positive news flow and a “cheap” stock relative to where it has traded before and versus the overall addressable market and opportunity.

Prokofiev

ShakesPeer wrote: Can anyone speculate as to whether or not an FDA approval is ‘baked in’ to the current price of this stock? I’m sure there are institutions, that would not gamble on a pre-rev, pre approval company, that will start to get in at the bottom after FDA approval?

This ‘company in the making’ stuff is a little new
to me. I’m holding on for this ride though.

Thanks all.