Experimental Tongue Therapy Helps Restore Brain Function

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zen2010
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Wed Dec 12, 2018 4:58 am


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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by NHE » Wed Dec 12, 2018 6:16 am

zen2010 wrote:Seems Europe is following:
https://heliusmedical.com/index.php/new ... /2018/257-
This is good news. Thanks for posting. :peace:

NEWTOWN, Pa., Dec. 12, 2018 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that its wholly owned subsidiary, NeuroHabilitation Corporation, has submitted an application for a CE Mark, the receipt of which will allow the Company to market its Portable Neuromodulation Stimulator (PoNS™) in the European Union.

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zen2010
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Thu Dec 13, 2018 2:39 am

Hi,

Just want to remind this device was validated for TBI (Traumatic Brain Injuries), not for MS.
Some studies proved it could help MSers with balance, gait and walking issues.
However, Helius company said more studies would need to be performed before sending a request to FDA.
In other words, it'll take many years before validation.

That means, even when the PoNS is on the market, we won't be able to get it.
I don't think it will be possible to purchase it on the net (medical prescription would be needed I guess).

So, I believe the only way will be to convince our GP or neurologist to help us here...

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Thu Dec 20, 2018 3:05 am

Hi,

Here is a a link to a video showing how to use the PoNS:
https://heliusmedical.com/index.php/div ... ons-device

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Thu Jan 03, 2019 4:51 am

Helius Medical Technologies, Inc. Announces Fourth Partnership to Implement Clinical Experience Programs with PoNS™ Treatment in the United States
https://heliusmedical.com/index.php/new ... /2019/260-

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by NHE » Sun Jan 06, 2019 11:29 am

Helius Medical Technologies, Inc. Announces Third Collaboration to Implement Clinical Experience Programs with PoNS™ Treatment in the United States
https://heliusmedical.com/index.php/new ... /2019/259-
NEWTOWN, Pa., Jan. 03, 2019 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that its wholly owned subsidiary, NeuroHabilitation Corporation, entered into an agreement in December 2018 to collaborate with Oregon Health & Science University (OHSU) in Portland, Oregon for launch of its third Clinical Experience Program (CEP) for its Portable Neuromodulation Stimulator (PoNS™).

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Tue Jan 08, 2019 3:36 am

Hi,
Here is an interesting study with the PoNS :
https://journals.sagepub.com/doi/pdf/10 ... 7317690561

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Fri Jan 25, 2019 4:57 am

Hi,

"Helius Medical Technologies, Inc. Provides Update on FDA’s Review of its Request for De Novo Classification and 510(k) Clearance of the PoNS™ Device"

https://heliusmedical.com/index.php/new ... /2019/261-

"FDA may request additional information in order to obtain information necessary for the agency to continue or complete its review and, in such instances, places its review on hold until the requested information is submitted."

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by NHE » Sun Feb 03, 2019 10:01 am

Here's a free book chapter from the NCBI Bookshelf discussing the PoNS.

From: Brain Neurotrauma: Molecular, Neuropsychological, and Rehabilitation Aspects. 2015

Chapter 44: Cranial Nerve Noninvasive Neuromodulation
New Approach to Neurorehabilitation
by Yuri Danilov, Kurt Kaczmarek, Kimberly Skinner and Mitchell Tyler.

https://www.ncbi.nlm.nih.gov/books/NBK299239/

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Thu Feb 07, 2019 5:54 am

Helius Medical Technologies to Release Fourth Quarter and Fiscal Year 2018 Financial Results on March 14, 2019

https://heliusmedical.com/index.php/new ... /2019/263-

"Management will host a conference call at 4:30 p.m. Eastern Time on March 14 to discuss the results of the quarter and the year. Those who would like to participate may dial 866-393-4306 (734-385-2616 for international callers) and provide access code 8929969. A live webcast of the call will also be provided on the Events section of the Company's investor relations website at https://heliusmedical.com/index.php/inv ... ing-events."

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Thu Feb 07, 2019 5:56 am

Helius Medical Technologies to Release Fourth Quarter and Fiscal Year 2018 Financial Results on March 14, 2019

https://heliusmedical.com/index.php/new ... /2019/263-
zen2010 wrote:
Thu Feb 07, 2019 5:54 am
"Management will host a conference call at 4:30 p.m. Eastern Time on March 14 to discuss the results of the quarter and the year. Those who would like to participate may dial 866-393-4306 (734-385-2616 for international callers) and provide access code 8929969. A live webcast of the call will also be provided on the Events section of the Company's investor relations website at https://heliusmedical.com/index.php/inv ... ing-events."
I'll try to attend.
In case, there would be issues regarding FDA approval, maybe they will provide explanations....

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by NHE » Mon Feb 11, 2019 7:38 am

Helius Medical Technologies CEO Phil Deschamps is interviewed by Uptick Newswire Stock Day and discusses the company's new treatment centers it's setting up across Canada utilizing the Portable Neuromodulation Stimulator (PoNS).
GlobeNewswire wrote:PHOENIX, Feb. 11, 2019 (GLOBE NEWSWIRE) -- Phoenix, Feb. 11th, 2019 (GLOBE NEWSWIRE) -- Uptick Newswire Stock Day Podcast welcomed Helius Medical Technologies, Inc. (HSDT) (HSM.TO) (the “Company”), 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. President and CEO, Phil Deschamps, joined Stock Day host Everett Jolly to discuss their clearance in Canada and share the progress of their expansion into the United States, Europe and Australia.

Jolly began the interview by asking Deschamps to share with listeners what the Company specializes in. Deschamps explained, “We are a company that is dedicated to the treatment of neurological symptoms of disease or trauma. What does that mean? We help to treat the symptoms of things like traumatic brain injury, MS, stroke, and cerebral palsy.”

Deschamps further explained that the Company is in the process of developing a technology called PoNS, which is a non-invasive medical device that, initially, aids in the treatment of traumatic brain injuries. PoNS stands for Portable Neuromodulation Stimulator, and stimulates the patient’s tongue to send impulses to the back of the brain. When paired with exercise, like physical therapy, this combination allows the brain to rehabilitate itself and ease the symptoms caused by disease or trauma.

Jolly then inquired about any recent partnerships made by the Company since their last appearance on the show. Deschamps shared that the Company has developed a clinic system throughout Canada that will allow them to offer both the medical device aspect of the treatment program, as well as the physical therapy side of the treatment. “Every time a patient gets treated, we get a transfer payment into the Company. So, that’s the business model that we are adopting in Canada.”

Deschamps then shared that after clearing Canadian regulations, they are approaching the launch of their clinics and accompanying treatments. In fact, the Company is expecting revenues for the first quarter of 2019. As a formerly pre-revenue company, this is exciting news.

Deschamps explained that the Company’s PoNS device and treatment is currently only licensed in Canada, however they are in the process of expanding into both the United States, Europe and Australia.

To close the interview, Deschamps shared that the Company is eager to expand their non-invasive technology to treat a greater number of conditions, and shared his excitement for the Company’s future.
Listen to the interview at https://upticknewswire.com/featured-int ... sdaq-hsdt/

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by NHE » Tue Mar 05, 2019 5:42 am

Helius Medical Technologies, Inc. Announces First Patients in Canada Treated with Commercially Available PoNS™ Treatment, March 05, 2019: 07:05 AM ET

https://money.cnn.com/news/newsfeeds/ar ... 553755.htm
NEWTOWN, Pa., March 05, 2019 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has begun treating patients in Canada with the Company’s Portable Neuromodulation Stimulator (PoNS™) Treatment.

“We are excited to announce the treatment of the first patients in Canada with our PoNS™ device, signifying Helius’ transition to a commercial stage company,” said Philippe Deschamps, Helius’ Chief Executive Officer. “With approximately 400,000 individuals living with chronic balance issues due to a mild to moderate traumatic brain injury (“mTBI”), Canada represents an important market opportunity for Helius. We look forward to providing our innovative PoNS Treatment to all of those suffering from this condition in Canada.”

Helius received authorization from Health Canada to market the PoNS device as an adjunct to physical therapy for chronic balance deficit in patients with mTBI in October 2018. The patients are being treated at one of two neuroplasticity clinics identified by Heuro Canada Inc., which was formed through Helius’ strategic alliance with HealthTech Connex Inc.

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Wed Apr 10, 2019 3:16 am

Hi,

U.S. Food and Drug Administration (the “FDA” or the “Agency”) has completed its review of the Company’s request for De Novo classification and 510(k) clearance of the Portable Neuromodulation Stimulator (PoNS™) device and has declined the Company’s request
https://heliusmedical.com/index.php/new ... /2019/276-

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by ElliotB » Wed Apr 10, 2019 7:41 am

It is odd that this device did not gain approval. There are numerous other similar devices that have been approved. It is likely that many could benefit from it. It all boils down to politics unfortunately. Hopefully they will try to get approval again in the future.

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