Experimental Tongue Therapy Helps Restore Brain Function

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby NHE » Sat Sep 08, 2018 5:26 pm

zen2010 wrote:
NHE wrote:The following website claims that the average time for FDA 510(k) clearance is around 6 months.
https://www.emergobyul.com/resources/re ... s-research


From the above website: "The 15,000+ device clearances we analyzed in March 2017"

15,000+ in a month?!?!?
Seriously?That's 500+ per day!

They were just looking at the clearances and not the actual devices. It's likely that they just did an analysis based off a spreadsheet and did some data plots or other data summaries.

Did you read their report on 510(k) clearance?

https://www.emergogroup.com/sites/defau ... s-2017.pdf
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Mon Sep 10, 2018 10:58 pm

Hi NHE,

OK, I misunderstood.
After reading the report it's more clear

In 2016 they gave the green light to around 8 requests/day.

Only 8, seriously?!?
lol

Just kidding:)
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Tue Sep 11, 2018 12:24 pm

Bad news for us (MSers)

Here is a message I received from Helius (I sent few questions...):

Hello ***,

Thank you for your interest in Helius Medical Technologies and the PoNS (Portable Neuromodulation Stimulator) device. The PoNS is an experimental device which is going through the clinical trial development process.

Helius submitted our request for clearance with the FDA and Health Canada with the hope of receiving approval for the device by the end of the year.

The FDA will limit the use of the device to people with TBI at first because that is the study we have submitted for clearance. For use in other neurological conditions, other studies will need to be done. Due to the highly regulated industry that we are in, there are several details that we are not able to finalize until the device is cleared.

Information such as how and where to purchase the device will be announced as soon as they are available as well as additional clinical trials for other uses of the device.

To ensure you are always up to date with Helius, we encourage you to sign up for our newsletter. You can do so by visiting our website at http://heliusmedical.com/index.php/cont ... ny-updates.

Kind regards,
Lori
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Tue Sep 11, 2018 12:49 pm

After reading again Lori's answer, I am a bit confused.

I mentionned in my information request that I had ms. What I understand from Lori's answer is that the PoNS will be first available to people with TBI (Traumatic Brain Injuries), not other pathologies.

BUT...TBI can sometimes be part of MS...

So I guess MSers who have only spinal lesions won't be able to use the PoNS before completion of other studies .
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby NHE » Tue Sep 11, 2018 9:46 pm

zen2010 wrote:The FDA will limit the use of the device to people with TBI at first because that is the study we have submitted for clearance. For use in other neurological conditions, other studies will need to be done. Due to the highly regulated industry that we are in, there are several details that we are not able to finalize until the device is cleared.

They ran a small trial in MS. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5466147/ There were just 7 treated patients and 7 controls. It seems like they might need a larger trial for FDA approval. It does bring up the question if off label device prescriptions work the same way as off label medicine prescriptions, i.e., it's up to an individual doctor to prescribe the device?
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Wed Sep 12, 2018 6:02 am

Hi,

when I suggested to Helius people that "TBI (Traumatic Brain Injury) was also part of Multiple Sclerosis (Extreme fatigue, cognitive issues, cerebellum lesions etc…) + it would be up to doctors to prescribe the device + it would be really unfair to suffer from TBI without being able to benefit from the PoNS cause we are labelled MS…"

I received the following answer "In order to qualify for an “Early Access Program” there must be a serious or life-threatening disease or condition as defined by FDA. In the absence of a serious or life- threatening condition, the patient has time to wait for definitive data to emerge regarding safety and efficacy. Due to the guidelines provided by FDA and our regulatory attorneys, we believe that our technology does not qualify for this program."

So that means:
-We can forget about this device at the moment
-MS will never get qualified for an “Early Access Program”
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby NHE » Wed Sep 12, 2018 2:31 pm

zen2010 wrote:when I suggested to Helius people that "TBI (Traumatic Brain Injury) was also part of Multiple Sclerosis (Extreme fatigue, cognitive issues, cerebellum lesions etc…) + it would be up to doctors to prescribe the device + it would be really unfair to suffer from TBI without being able to benefit from the PoNS cause we are labelled MS…"

I received the following answer "In order to qualify for an “Early Access Program” there must be a serious or life-threatening disease or condition as defined by FDA. In the absence of a serious or life- threatening condition, the patient has time to wait for definitive data to emerge regarding safety and efficacy. Due to the guidelines provided by FDA and our regulatory attorneys, we believe that our technology does not qualify for this program."

So that means:
-We can forget about this device at the moment
-MS will never get qualified for an “Early Access Program”

Helius also appears to be saying that they, as well as the FDA, don't think MS is serious. WTF! :wtf:
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby NHE » Thu Sep 13, 2018 11:42 pm

NHE wrote:
zen2010 wrote:The FDA will limit the use of the device to people with TBI at first because that is the study we have submitted for clearance. For use in other neurological conditions, other studies will need to be done. Due to the highly regulated industry that we are in, there are several details that we are not able to finalize until the device is cleared.

They ran a small trial in MS. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5466147/ There were just 7 treated patients and 7 controls. It seems like they might need a larger trial for FDA approval. It does bring up the question if off label device prescriptions work the same way as off label medicine prescriptions, i.e., it's up to an individual doctor to prescribe the device?

Here's another small study with MS patients from 2014. There were 10 treated and 10 controls. The results were positive for improving gait in MS patients.

https://jneuroengrehab.biomedcentral.co ... 0003-11-79

Full free text.
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Fri Sep 14, 2018 5:58 am

NHE wrote:Here's another small study with MS patients from 2014.



2014....
We're almost in 2019 and no phase2 study was performed :cry:
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Fri Sep 28, 2018 12:38 am

Hi,

Helius Medical Technologies Submits Medical Device License Application to Health Canada for PoNS™:
https://heliusmedical.com/index.php/new ... /2018/241-

I am happy to see this as I fell in love with the west part of Canada (British Columbia). I spent one year there, few years ago.

About Helius: you can register for updates at https://heliusmedical.com/index.php/con ... ny-updates

Cheers
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby NHE » Sat Sep 29, 2018 10:12 pm

It looks like some folks will get access to the PoNS at neurorehab centers even before FDA approval.


Helius Announces First Partnership to Implement Clinical Experience Programs With the Investigational PoNS™ Therapy in the United States
https://money.cnn.com/news/newsfeeds/ar ... 379685.htm

NEWTOWN, Pa., Sept. 19, 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 it has partnered with The Ohio State University Wexner Medical Center, a leading U.S. neurorehabilitation center located in Columbus, OH to establish the Company’s first Clinical Experience Program for the Company’s Portable Neuromodulation Stimulator (PoNS™), an investigational medical device.

Helius’ Clinical Experience Programs (“CEPs”) are being sponsored by the Company to be implemented in partnership with leading, early-adopter, neurorehabilitation centers in the United States, including academic and research institutions, hospital systems and high-volume independent neurorehabilitation centers. CEPs will allow the Company to offer an open label clinical study of PoNS therapy in patients suffering from chronic balance deficit due to mild- to moderate-traumatic brain injury (“TBI”).

“We expect our Clinical Experience Programs will be an important component of the Company’s pre-regulatory clearance activities because they will enable us to build relationships with leading, early-adopter, neurorehabilitation centers and key opinion leaders in the area of TBI, generate clinical evidence and gain real-world experience in the use of our PoNS device,” said Philippe Deschamps, Helius’ Chief Executive Officer. “Our Clinical Experience Programs are open label clinical studies that enable us to treat patients in a real-world clinical setting in advance of a 510(k) clearance for our PoNS device from the U.S. Food and Drug Administration.”

Mr. Deschamps continued: “After we contract with a neurorehabilitation center to implement a new CEP, we will obtain institutional review board approval, train the CEP site’s physical therapists and then begin patient recruitment. We believe these CEPs will allow us to validate our proposed commercial model for use of the PoNS in the clinical setting after we receive 510(k) clearance. Importantly, Helius’ CEPs will generate health outcomes data which we intend to use to support the value proposition of use of the PoNS device in coverage discussions with payers. Looking ahead, we expect to begin patient recruitment and enrollment at The Ohio State University Wexner Medical Center during the fourth quarter of 2018 and we look forward to announcing additional CEP partnerships later this year.”
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby zen2010 » Mon Oct 22, 2018 10:13 am

Hello,

Good news for people in Canada suffering from Traumatic Brain Injuries : Helius Medical Technologies Received Medical Device License Clearance from Health Canada for PoNS™ Device:
https://heliusmedical.com/index.php/new ... /2018/246-

According to NHE:"Helius estimates the retail price for the PoNS at $2500".
The question now is "how pwms can get this device?"

Cheers
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby NHE » Wed Oct 31, 2018 4:55 am

Helius Medical Technologies, Inc. Announces Second Partnership to Implement Clinical Experience Programs with PoNS™ Treatment in the United States

https://money.cnn.com/news/newsfeeds/ar ... 407549.htm

NEWTOWN, Pa., Oct. 24, 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 partnered with Northwell Health’s Feinstein Institute for Medical Research in Manhasset, NY. This partnership will enable Helius to implement its second Clinical Experience Program (CEP) for its Portable Neuromodulation Stimulator (PoNS™) -- an investigational medical device in the US currently under review for market clearance by the US Food & Drug Administration. PoNS is a licensed class II medical device in Canada.

The CEP will be performed at three of Northwell Health’s clinical sites including North Shore University Hospital (NSUH) and Transitions of Long Island in Manhasset, NY and Southside Hospital in Bay Shore, NY.

CEPs are sponsored by Helius and implemented in partnership with leading neurorehabilitation centers, including academic and research institutions, hospital systems and high-volume independent neurorehabilitation centers. CEPs enable Helius to thoroughly investigate in the clinical setting, the PoNS treatment in patients suffering from chronic balance deficit due to mild- to moderate-traumatic brain injury (TBI).

“We are delighted to partner with NeuroHabilitation Corporation, as we look to further treatment options for our patients who suffer from TBI,” said Jamie Ullman, MD, Director of Neurotrauma at North Shore University Hospital and principal investigator of the Feinstein Institute study. “PoNS treatment is a promising new technology which may enhance recovery after TBI by integrating tongue stimulation with specialized physical therapy.”

“Helius is pleased to announce this important partnership with the Feinstein Institute for Medical Research,” said Philippe Deschamps, Helius’ Chief Executive Officer. “Following our recently announced CEP partnerships with Ohio State University Wexner Medical Center, our partnership with the Feinstein Institute will enable us to implement our second CEP, which we are pursuing as part of our pre-regulatory clearance activities for the investigational PoNS device.”

Mr. Deschamps continued: “By implementing CEPs, we aim to generate real-world clinical evidence and valuable health outcomes data, while building relationships with leading neurorehabilitation centers and key opinion leaders in the area of TBI. We look forward to working with Dr. Ullman and the staff at all of the participating Northwell Health clinical sites included in this CEP partnership to begin recruiting and enrolling patients for the PoNS Treatment in the fourth quarter of 2018.”
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Postby NHE » Thu Nov 15, 2018 10:50 pm

Helius Medical Technologies is set to offer shares of its class A common stock to raise funds to begin a clinical trial in MS.

https://www.sec.gov/Archives/edgar/data ... d424b5.htm

Use of Proceeds:

We estimate that the net proceeds to us from this offering, after deducting underwriting commissions and estimated offering expenses payable by us, will be approximately US$ ____ million, or approximately US$ ____ million if the underwriters exercise their option to purchase additional shares from us in full. We plan to use the net proceeds from this offering primarily to fund our commercial launch preparations for the PoNS Treatment, to build launch inventory, to fund research and development activities and other preparations for our submissions for marketing authorization of the PoNS device to regulatory authorities as well as to launch our Multiple Sclerosis clinical trial and the remainder for working capital and general corporate purposes. See “Use of Proceeds” on page S-11 of this prospectus supplement.


and...

https://heliusmedical.com/index.php/new ... /2018/254-

Helius Medical Technologies, Inc. Announces Pricing of Public Offering of Class A Common Stock

NEWTOWN, Pa., Nov. 15, 2018 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”) today announced the pricing of an underwritten public offering of 2,121,212 shares of its Class A common stock at a public offering price of $8.25 per share, before underwriting discounts and commissions. The net proceeds to Helius from this offering, after deducting the underwriting discounts, commissions and estimated offering expenses payable by Helius, are expected to be approximately $15.7 million. The offering is expected to close on or about Monday, November 19, 2018, subject to customary closing conditions including the approval of the Toronto Stock Exchange.
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