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Helius Medical Technologies Inc HSDT

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.


NDAQ:HSDT - Post by User

Comment by wetcoastdaveon Nov 23, 2017 11:12am
219 Views
Post# 27018977

RE:News Release Interpretation

RE:News Release InterpretationIt was implied (but not clearly stated) in the presentation of the registrational trial that the FDA was involved in how to design a sham device that could hide from the participants whether their device was active or not. 

The way to handle the statistics of the so-called sham device (LFP) group, namely combining it's results with the active (HFP) group, if a P<0.05 was not achieved, may have had informal FDA input as well.

These are conjectures which I have asked IR about but with no response. I suspect that Helius would be loath to elaborate on the degree of FDA input in the study design as it could complicate the relationship Helius has with the FDA. Nonetheless, FDA involvement must be common in many study design approvals to avoid wasting time and money on a reviewing a poorly designed study.

Does anyone have more colour on this aspect?

I added shares on the post-presentation dip as I believe the study clearly shows an improvement that far exceeds that of physical therapy alone.
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