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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 miningfundion Nov 12, 2017 4:13pm
177 Views
Post# 26948029

RE:Further pondering on PoNS

RE:Further pondering on PoNSRichyboy is not easily impressed: "Reading between the lines on the press release, and the webcast, is that they are taking a positive spin on this. Essentially, we are told, all of the data combined will be enough to get approval. That doesn’t impress me."

The Q3 2017 report stated that: "On November 9, 2017, we announced positive results from our registrational clinical trial evaluating the safety and effectiveness of the  PoNS device for the treatment of subjects with chronic balance deficits due to mild-to-moderate TBI." Richyboy is accusing the Board of Directors (and the Advisory Board?) of "spin" i.e. deception - serious stuff.

A Y2016's Risk Factor stated that: "If we are unable to complete clinical trials, or are unsuccessful in doing so, we will be unable to advance the PoNS device to regulatory authorization and commericalization ..." This risk was not highlighted in the Q3 report.
It did, however, include mention that funding would be required before 12/31/17 - keep you powder dry.



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