Helius Medical Technologies Inc (HSDT)

[cash_cow1]

The New Da Novo submission is....Coming

[cash_cow1]

This PoNS Neurostimulation Device is going to pass the FDA submission.

[cash_cow1]

So what are they trying to say, the patients were reaching some of these goals without the use of the PoNS neurostimulation device. The difference is that all of these patients didn't start the PoNS neurostimulation not until after 12 months after their brain injuries, then they started the program. IMO, I guess the FDA wanted half in the study to be treated with the PoNS neurostimulator device and the other half to be treated with Physical Therapy sections not using the PoNS Device. Make sense. Next complete a trial study of Patients whom have completed Physical Therapy and enroll them into the PoNS neurostimulator device Clinical study and see how well they benefited from using the PoNS device after going thru PT. What percentage of patients benefited from the PoNS Device, and what percentage of patients did not benefit from the device.

Then on the other hand I can see while Helius Medical Technologies Inc sent in their NDA for PoNS Device because they use Patients 12 months after their injuries and not before. IMO the reason why the FDA did not have enough evidence to support Helius study of the PoNS. Maybe if they would've started the study from start of traumatic injuries mild to moderate injuries, in both physical therapeutic to using the PoNS Device and a study of Patient using PT without PoNS device. Helius Medical Technologies inc would probably have an FDA Approval for the PoNS neurostimulation Device.

Please, Correct me if I'am wrong.

[tykundegex]

The third-party study is definitely helping IMO, though that particular study did also have a statement in the conclusion that they could not rule out that the improvements were not related to the PT alone. This was FDA's main gripe, but given that all these patients had been doing PT before and were no longer improving, I find it hard to imagine PT (or placebo effect) was the sole reason for the dramatic improvements.

With the existing Canadian clinics alone, by their own estimates, they should achieve annual revenues of $7MM. If traction continues and they get more clinics and actual results yield the same outcomes as the studies, then an FDA approval would be huge. But Canada alone can easily make this a profitable business. Time will tell .. so far not much press out of the Canadian clinics...

[cash_cow1]

That is a huge bid that show up at .965 share price should start soaring back over $1 and back to $2 on Next Physical therapy new release from Mild to moderate patients whom suffered from traumatic brain injure. Last week release news from study shown 73% of patients who had traumatic brain injuries show a difference in balance when walking and gait after use of PoNS Device the Neurostimulation. This was just one study report taking from Winconsin Madison University. Helius Medical Technologies Inc will be releasing more studies of Patients receiving the PoNS Treatment to stimulate their nerves from mild to moderate brain injuries to support the the Physical and therapy each patients received from the neurostimulation device. Evidence the FDA board is looking for as address in the CRL the physical and therapy.

[jonnyvs]

Huge bids just showed up at .965

[jonnyvs]

It’ll hit 2.00 this week imo

[Big bucks]

150 k in revenue and losing millions every qtr..

[Big bucks]

Going back to
.50 range last week pump and dump...imho

[Neweconomy]

DANGER AHEAD.. read the financials and look at their burn and what they pay themselves after their failure! ridiculous financing at 35 cents when the market was 75...just so bad! Far more dilution on the horizon when they run out of money in 3-6 months and the approval will now take TWO YEARS!!!!!! Don't think they can keep a hype going for that long without money. Do your due diligence unless this is a day trade then go for it lol

[hedge_fun]

My guess is that it's a medical device play......

MB*T has gone ballistic of late. I figure it's just a momo play?

But what do I know?

GL

[Scandle34]

So, is this getting primed for a promotion or does someone know news that isn't released yet? Rising like this on no news *during an S3 public offering* suggests something is going on.

[Lenard]

Saw it in the 70's range wonder if this will continue Thursday had nice after hours today

[ClayTrader]

* * $HSDT Video Chart 12-24-2019 * *

Link to Video - click here to watch the technical chart video

[reconranger]

Pay f=day

[reconranger]

sHOW ME THE MONEY

[reconranger]

aWESOME

[reconranger]

looking to make new HOD

[ALERTS100%to10000%GAIN]

could HSDT go to $9.00 PPS AGAIN? very interesting here Clinical Trials https://heliusmedical.com/index.php/our-research/clinical-trials

[ALERTS100%to10000%GAIN]

Helius Medical Technologies Inc (TSE:HSM) CEO on Treating Traumatic Brain Injuries with PoNS Device https://midasletter.com/2019/03/helius-medical-technologies-inc-tsehsm-ceo-treating-traumatic-brain-injuries-pons-device/

[ALERTS100%to10000%GAIN]

read the website ,huge info https://heliusmedical.com/index.php/about/overview

[ALERTS100%to10000%GAIN]

on L2 very ,very thin now to.99

[ALERTS100%to10000%GAIN]

will be good here

[Tobster3344]

A Lot of Dumping now.....

[Tobster3344]

A Lot of Dumping now.....

[ALERTS100%to10000%GAIN]

Helius Medical Technologies shares are trading higher after the company announced results from an independent research study showed positive results on translingual neurostimulation plus physical therapy with significant improvement in balance and gait.

Dec 19, 2019 11:03a ETBenzinga Stock Analysis

[ALERTS100%to10000%GAIN]

today is the highest volume for HSDT https://finance.yahoo.com/quote/HSDT/history?p=HSDT

[ALERTS100%to10000%GAIN]

.685 wall fall and run after

[ALERTS100%to10000%GAIN]

looking close to .80

[ALERTS100%to10000%GAIN]

.5731 low of the day,holding great and breakout ahead

[ALERTS100%to10000%GAIN]

holding my for dollars,great inside info

[Tobster3344]

I am new at this stock as of today. Kinda nervous getting in late after the spike. Where do you guys this this will end up today? Just a one day run or is there something here worth staying?

[ALERTS100%to10000%GAIN]

will be a nice close

[ALERTS100%to10000%GAIN]

loaded at .64 again

[tykundegex]

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.

[420man]

Bull up on news...Bear back down to support...Bull back up to test resistance... Clockwork :)

[whytestocks]

News: $HSDT Independent Research Published Show Positive Results on Translingual Neurostimulation Plus Physical Therapy With Statistically Significant Improvement in Balance and Gait Scores and the Outcomes Were Sustained for 12 Weeks After Discontinuing Treatment

NEWTOWN, Pa., Dec. 19, 2019 (GLOBE NEWSWIRE) -- 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-...

Read the whole news HSDT - Independent Research Published Show Positive Results on Translingual Neurostimulation Plus Physical Therapy With Statistically Significant Improvement in Balance and Gait Scores and the Outcomes Were Sustained for 12 Weeks After Discontinuing Treatment

[yankees18]

Squeeze

[420man]

Stopped out on that dip. Waiting for direction

[420man]

Peeps are still playing with naked pics... LOL

[ALERTS100%to10000%GAIN]

will see,we need green here

[420man]

Opening bell should be very interesting.

[ALERTS100%to10000%GAIN]

HSDT~~could be a crazy run,bottom chart
https://www.stockscores.com/charts/charts/?ticker=hsdt

[420man]

Agreed. Will add on any significant dip. GL

[ALERTS100%to10000%GAIN]

342k volume,very thin low shares left

[ALERTS100%to10000%GAIN]

great news here Helius Medical Technologies Inc. (HSDT) shares more than doubled premarket to 88 cents.
The neurotech company said 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 were published in the December 2019 issue of the Archives of Rehabilitation Research and Clinical Translation.
The newly-published results from the double-blind randomized clinical trial which paired translingual neurostimulation using the Portable Neuromodulation Stimulator 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, the company said.
The trial evaluated 43 participants. Researchers found about 74% of the participants who completed the 14 weeks of PoNS Treatment experienced significant improvements in their balance, the company said. Patients also showed meaningful improvements in their gait and walking endurance.

Write to Michael Dabaie at [e-mail]

[420man]

Bounce from here. Almost a Milly short. That's 600K left to cover on buying pressure

[ALERTS100%to10000%GAIN]

very violative

[420man]

Reloaded a few @ .76. Only 250k shares traded so far...expecting more momo as news spreads.

[ALERTS100%to10000%GAIN]

will be hart to buy again if does't go down