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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 StockMarketBullon Apr 16, 2019 12:19am
125 Views
Post# 29631346

RE:HSM story/product is similiar to Wicab brainport story

RE:HSM story/product is similiar to Wicab brainport storyThere are 2 different brainport devices.

1) The first device is Brainport Vision.  This device is used as a visual aid and sends electrical impluses to the tongue to help blind people see.  The vision device received FDA approval in 2015.

2) The second device is Brainport Balance.  This device is simular to the PONS in that it sends electrical impulses to the tongue to help improve balance and gait.  It is my understanding that FDA rejected this device; and therefore, not avalible for sale in the USA.  Brainport Balance can only be purchased in Canada and Europe.  Since this device was approved in Europe, I'm speculating that PONS will also have a good chance of receiving approval in the European Union.  However, it is concerning that FDA declined both the PONS and the Brainport Balance.  I am unable to find the reason why the Brainport Balance device was rejected by the FDA.  Can someone shed some light on this?
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