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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 Dec 19, 2019 2:35pm
217 Views
Post# 30473650

RE:Independent research

RE:Independent researchI read the study and it conclusions were as follows:

Conclusions

Both the HFP+PT and LFP+PT groups had significantly improved balance scores, and outcomes were sustained for 12 weeks after discontinuing TLNS treatment. Results between arms did not significantly differ from each other. Whether the 2 dosages are equally effective or whether improvements are because of provision of PT cannot be conclusively established at this time.

We have seen these results before - is this information important only because its in a peer reviewed publication? The FDA rejected the device because of the uncertainty: was the improvement attibutable to the device or the physical therapy? Also, how effective was the device compared to the sham?

Any ideas? 

notafinger wrote:

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 - GlobeNewswire

19-Dec-2019 04:30:44 AM

To view this story on Eikon, click here

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-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.

PoNS Treatment is exclusively offered by authorized clinics, with multiple locations across Canada. To learn more about PoNS Treatment and to book a 15-minute consultation with an authorized PoNS Treatment clinic, visit ponstreatment.ca.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness.  The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.  

About the PoNS™ Device and PoNS Treatment™

The PoNS is an authorized class II, non-implantable, medical device in Canada intended for use as a short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”), and it is currently under review for clearance by the AUS Therapeutic Goods Administration. PoNS Treatment is currently not commercially available in the United States, the European Union or Australia.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
443-213-0500
investorrelations@heliusmedical.com

 

 

 


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