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 » Fri Aug 30, 2019 3:36 pm

Hi,

As promised, here is my feedback after 8 weeks with the PoNS:

Actually, it's gonna be fast.
As I fell in the stairs last week, my ankle got a bit twisted, so I was able to perform only 50% of the assessment.
So, in summary, my balance was worst and my walking hasn't really changed.
Anyway, assessments for PWMS don't mean anything. What you can do at 9:00AM may not be possible at 11:00AM...
The most important is how you feel.

I do feel a bit stronger, but it may be due to the physical therapy. Quality of PT is really good in Canada.

I have to admit I met 2 patients with minor TBI (Traumatic Brain Injuries) who told me they felt the PoNS was helpfull.
But I also have to admit I've met more than 2 patients who haven't seen any benefit from the device.

Just a few things:

-I have been told (patients who discussed with the clinic top management) the price of the PoNS was cut in half, but I just went to the clinic's website and I noticed it was still 30K
https://neuromtl.com/pricing/

-The cost of "maintainance" (it's possible to prolong to 14 weeks) moved from 5K to 3.75K
This was confirmed to me by a physiotherapist.

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NHE
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by NHE » Thu Sep 05, 2019 9:44 am

Approximately one month after Helius' stock (HSDT) crashed on April 10th due to FDA's denial of their device application, the following preliminary trial data was posted to clinicaltrials.gov.

Helius study results posted to clinicaltrials.gov May 2019
https://clinicaltrials.gov/ct2/show/res ... 494&rank=1

Trial using normal PoNS stimulation vs. barely perceptible low frequency stimulation for mmTBI in combination with physical therapy (0-14 weeks, follow-up at 26 weeks).
Trial conducted at: University of Wisconsin, Madison May 2014 to October 2017.
43 patients: 22 treated, 21 controls

P-Value for Sensory Organization Test results at 2 weeks: 0.41
P-Value for Sensory Organization Test results at 14 weeks: 0.47
P-Value for Sensory Organization Test results at 26 weeks: 0.99

Recall that the P value must be P<0.05 in order for results to be considered statistically significant.

The P = 0.99 is amazing. That's not just comparing apples to apples. That's like comparing 20 Granny Smiths to 20 Granny Smiths that were picked at the same time, were at the same stage of ripeness, were all about the same shade of green and were all about the same size!

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zen2010
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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Fri Oct 11, 2019 1:26 pm

Hi,
I just received the below message on Whatsapp from one MSer I met in Montreal clinic.
I posted this today on Secondary progressive MS Facebook page:

For those of you who have followed and wondered about the PONS device over the last 5+ years, I would like to tell you about my experience. I have SPMS and walk with a cane. I should probably use a walker, but I am stubborn! Like many of you, I have watched the very impressive YouTube videos about the PONS. I have read the impressive published studies. I have closely followed the FDA decisions. I subscribed to Helius Technologies email newsletters. I was so happy to see it become available in Canada. After careful thought and discussions with my family, I decided that the investment was worth the possible results. It's a 14 week program. I traveled to Canada from the US in July. I spent 2.5 weeks in Montreal. I met other people from the US, Canada, Australia and several European countries. They were also there for the PONs device. Most had MS. Several had Parkinson's or had had a stroke. During the 2.5 weeks, I went to daily training using the PONS device. I returned home in the US on August 2nd with the promise to return on the 5th, 8th, 11th and 14 weeks for evaluation and follow up. I have flown to Montreal and stayed overnight for those subsequent trips. I continue to do the exercises with the PONs device and I am in my 12th week. So far, I have had no results. I have not had any improvements in my walking. My balance and hips may be a little stronger, but I would attribute that to the hours of PT. Though I will only speak for my experiences, I didn't witness anything significant in others that I met.

This device was one of the few hopes we had, but it yielded nothing for me. As my husband said, "You wouldn't know if you didn't try it." So this is my experience. It was costly in time and money. Now I have my answer about the PONs device. My advice to others is to seriously consider going to intensive PT to build your strength and gain some stability. The PONs device did not work at all for me.
I am not trying to bring down Helius or the PoNS , but I think it's important to be honest by sharing everything (positive AND negative feedbacks)

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Thu Oct 24, 2019 10:39 pm

Hi,

I was informed Montel Williams was in Montreal clinic yesterday.

Too bad I was not there. I have a lot of questions...

They apparently asked him how he felt the PONS helped him. From what laura (my former physiotherapist) said, Montel was vague, telling them that it just takes a lot of work and determination (which we all know!) Laura wasn't very clear as to her comment about Montel. She said something about him having some difficulties with walking.

Again, I don't want to bring down Helius. Also I still believe in neuroplasticity.
But, when I hear this kind of information, I am having serious doubts...

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by NHE » Fri Nov 08, 2019 2:42 pm

On Oct 24, 2019 Helius released the outcome of their discussions with the FDA regarding their PoNS medical device application.

https://www.cnn.com/business/newsfeeds/ ... 46221.html

The FDA has announced that it will need a new trial before it will reconsider Helius' device application for the PoNS.

On Oct 24th Helius stock traded at $1.59/share. It has since fallen 39% to $0.97/share. Apparently, Helius' investors are not seeing much of a future for Helius at this time.

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by NHE » Tue Nov 12, 2019 8:51 pm

On Nov 12, 2019 Helius released their 3rd quarter 10Q financial report to the SEC.

https://www.sec.gov/Archives/edgar/data ... 190930.htm

Shares of their HSDT stock fell in value by 15.8% to $0.88/share.

https://money.cnn.com/quote/quote.html?symb=hsdt

This doesn't bode well for Helius.

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by NHE » Sun Nov 24, 2019 3:50 am

Helius Medical Technologies, Inc. Announces Pricing of Public Offering
https://heliusmedical.com/index.php/new ... /2019/309-

NEWTOWN, Pa., Nov. 22, 2019 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, announced today the pricing of its previously announced underwritten public offering of 4,815,010 shares of its Class A common stock at a price to the public of $0.35 per share. The gross proceeds to Helius from this offering are expected to be approximately $1.7 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the securities in the offering will be sold by Helius. The offering is expected to close on or about November 26, 2019, subject to customary closing conditions including the approval of the Toronto Stock Exchange.

·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·-·

In response to Helius' public offering, their share price fell 33% from $0.60/share to $0.40/share. One year ago, Helius' HSDT traded at about $8.25/share. This marked decline does not bode well for Helius as they try to raise money to resubmit their PoNS medical device application to the FDA which requires additional trial data. Estimates are that their current funding may not support them past the first quarter of 2020. Their current status may have been exacerbated by poor management such as excessive executive compensation. The following document from the SEC shows that for the years 2015-2017 the top executives received a salary of $300,000 to $400,000/year. This is well before the company even had a marketable product which only became available in Canada in 2019 following Health Canada's approval of the PoNS in Oct 2018.

So what does the future hold in store for Helius? I believe that is unknown. Though we do know that there's a pending investor class action lawsuit filed against Helius. In addition, many mutual fund investment managers are currently selling off their holdings of Helius' HSDT stock. Lastly, stocks listed on the NASDAQ are required to have a minimum trading price of at least $1/share. If Helius does not acheive success such that the share price rises above this threshold, then I expect that they'll undergo a reverse split as they did in Jan 2018. These trends combined with the current dramatically low share price may be the proverbial double edged sword wielded against Helius.

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by NHE » Thu Dec 19, 2019 7:33 am

Helius Medical Technologies has recently published a journal article claiming positive results for their experimental PoNS therapy. https://www.sciencedirect.com/science/a ... 0028X#bib5

However, the data in this article are from their Wisconsin study previously discussed.
viewtopic.php?p=258404#p258404

Helius is claiming significant improvement in the PoNS treatment group. However, don't be fooled. Compared to the control group, there were no significant differences. Indeed, at 26 weeks, the P value was 0.99. This is an extraordinary P value. What it means is that the PoNS treatment group was statistically identical and indistinguishable from the control group.

Unfortunately, this study is insufficient for use in evaluating the efficacy of the PoNS treatment. What is needed is a study comparing PoNS therapy to physical therapy alone where both groups undergo the same physical therapy program.

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Fri Jan 03, 2020 11:44 pm

From one guy on Facebook:
I own shares and also subscribe to this feed which takes a 'short' view of the Helius stock. Pretty interesting reading. Hard for me to tell what's actually going on. On one hand, the continued US military investment in TBI studies is promising, on the other hand, if what this article says is true, than there's no difference between Physical Therapy + PoNS and just Physical Therapy. I don't know. I'm here to learn
https://seekingalpha.com/article/431466 ... neffective

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by NHE » Sat Jan 04, 2020 12:16 am

The Seeking Alpha article states...
The PoNS device and treatment program costs patients a whopping $30K CAD in Canada. This therapy isn’t covered by publicly funded health care systems or most private insurance. Six days a week for 14 weeks of intense physical therapy likely on its own would cost significantly less than $30K. That’s meeting a physical therapist 84 times. Let’s assume that the cost to the therapist is $100 per session, and insurance normally pays for half. That comes to an out of pocket cost to the patient of 84 x $100/2 = $4,200.
This calculation has a couple of problems. First, the cost of PT per session is underestimated. I had a family member go through PT after a hip replacement. Medicare was billed about $380 for a half hour session.

Another issue is that the author is unaware of the PoNS treatment protocol. After the first two weeks, the patient does their PT at home and only goes in once a week to be evaluated.

In addition, the cost of the PoNS therapy has been reduced. There are now three options and three different costs. They are...

· Light: $18,200
· Core (suitable to most clients): $20,900
· Premium: $24,900

They differ by how much time is spent working one-on-one with a physical therapist.

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Re: Experimental Tongue Therapy Helps Restore Brain Function

Post by zen2010 » Sat Jan 04, 2020 8:54 am

Hi NHE,

you are 100% right.

I wrote this post only to show that on December 31th, 2019, an article (one more) is claiming the PoNS is ineffective.
I believe the pricing is an other topic.

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