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Helius Medical Technologies, Inc. (CSE:HSM) |
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January 12, 2015 Issue |
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The Most Powerful Name In Corporate News and Information |
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PoNS Medical Device Targeting Neurological Symptoms Relief |
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CEO
Helius Medical Technologies, Inc. (CSE:HSM)
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – January 12, 2015
CEOCFO: Mr. Deschamps, what is the concept at Helius Medical Technologies? Mr. Deschamps: Helius is a medical device holding company, and our first asset is the acquisition with Neurohabilitation Corporation, which had as its only asset the PoNS™ device. That is the item of the day. It was a technology developed by three scientists at the University of Wisconsin that potentially could help relieve the neurological symptoms associated with disease and trauma. It is very exciting.
CEOCFO: Were you specifically looking in that field, or was it more opportunistic? Mr. Deschamps: No, the reverse happened. The Neurohabilitation Corporation was a 50/50 joint venture between the scientists who developed the PoNS technology and a company that Montel Williams, Johathan Sackier and I formed. We reverse merged into a purpose built shell called Helius Medical Technologies. We just gave Helius a larger mandate to seek out other technologies that would also help patients afflicted with neurological disease to relieve their symptoms.
CEOCFO: Your site indicates Helius is creating a paradigm shift in neurological rehabilitation. How so? Mr. Deschamps: The paradigm shift is that the whole regulatory system is built around disease states and the PoNS device is really targeted at neurological symptom relief regardless of etiology. For example, it does not matter if a patient’s balance disorder caused by a traumatic brain injury or multiple sclerosis. The treatment with the PoNS is the same. You do balanced exercises combined with neurostimulation and anecdotally the symptoms are relieved. We have yet to prove this in a well controlled clinical trial but we are engaged in doing that right now.
CEOCFO: How does it work? Mr. Deschamps: That is the $64 million question. When you move your arm, there are neural impulses that flow from your arm, through your spine and up to your brain. That produces a movement, and essentially what your brain is doing is it is interpreting the signal. Through the network of neurons that are firing at a very specific time, you have a smooth movement of your arm. When disease or trauma interferes with that, what is really happening is the electrical conductivity of your brain is disrupted at some points. You end up having spastic movements or when you want to move your leg, your brain does not fire fast enough for your leg to go along with exactly what you want and then you trip over or your gait is affected. What happens here is through a process that is known as brain plasticity, the PoNS device supplies 27 million impulses through your tongue directly to your brain stem by traveling down to major cranial nerves. It is believed that these neural impulses combined by the impulses coming from the physical therapy combine to amplify signaling to the brain thus tricking it into thinking that the movement that you are combining with that stimulation is a lot more important to the brain than it would be without the stimulation. Essentially, the brain says there is something really important going on. Even if I do not have the normal neural pathways to do it, let me find another way to accomplish the movements that the brain is telling me are really important to accomplish. That is what in very lay language seems to be happening. We are essentially augmenting or amplifying the body’s own ability to heal itself by raising the importance of the signals that are generated by physical or mental exercises that are done in combination with the PoNS.
CEOCFO: How does the brain figure out another way? What happens after the impulses? Mr. Deschamps: We believe what is at play here is the concept of neuroplasticity. It is the same process when you do brain exercises like Lumosity.com that have become very popular now. Your brain can be exercised like every other part of the body, and it can be instructed through exercise to change itself. When disease or trauma has disrupted the neural net, the combination of neural stimulation and physical and cognitive exercises seems to trigger the brain remodeling process. It is a little bit of the same notion when people who are congenitally deaf and use sign language their whole lives. Interestingly, sign language is a movement, yet it is the auditory part of the brain that is mediating the sign language. Your brain has adapted to the fact that your communication and your hearing is actually being done through your hands. It is the same concept here. Your brain adapts to the stimulation and to the challenge of the exercise by finding ways to accomplish something that has been destroyed or disrupted by disease or trauma.
CEOCFO: Why 27 million impulses? Mr. Deschamps: The pulse pattern developed by the scientists is designed to mimic neural impulses that are generated through movement and cognitive thought. In the development of their research, they discovered that the optimal time to derive maximal benefit from the therapy is combining 20 minutes of stimulation with 20 minutes of exercise simultaneously.
The 20 minutes, which ultimately yield the 27 million impulses, came when they tested several patients through studies under the umbrella of an IRB. When patients stimulated, combined with exercise for 30 seconds, they seemed to get 30 seconds of benefits. When they tried five minutes or 10 minutes, they seemed to get a mirror amount of benefit, which was pretty fascinating in it of itself because you seem to have a lingering effect after you stop stimulation. When the stimulation hit 20 minutes, something happens in the brain that allows the benefit to last three to four hours. That is what they discovered through clinical trial and error. The minimum time required to engender this brain plasticity was 20 minutes. They then of course tried 25, 30 and 25 minutes, and they found no increase after the 20 minutes. That is why the therapy is essentially 20 minutes twice a day so that you can hopefully control your symptoms throughout the day. This of course needs to be tested in controlled larger clinical trials.
CEOCFO: Are there potential side effects? Mr. Deschamps: That is a really tough question. The first thing you notice with this device so far is that you drool like a Saint Bernard when you first try it because it seems to stimulate your salivary glands. You thus have to get used to swallowing with the device in your mouth. As far as all of the patients that have been followed so far, we have not observed any reported adverse effects yet. That is something we are going to be monitoring in the clinical trials as we develop in the first indications, but so far we have not found any.
CEOCFO: What would happen if someone who did not need it used the device? Mr. Deschamps: That is what is particularly exciting and something that is going to happen way past the times where we validate the science of what is going on. Many patients who participated in the pilot clinical trials report that their symptoms are getting better but their cognitive ability seems to get sharper. We will eventually be looking at the device for potentially increasing cognitive and physical performance. Before we go there we feel that it will be most important for us to establish the medical equity of this product through beyond reproach clinical trials. We will tackle the “well brain” later. Those are all things that in the future could become exciting ways in which this technology could help.
CEOCFO: Where are you today in the process of development and/or commercialization? Mr. Deschamps: We are engaged in full registrational clinical trial program. We are collaborating with the US Armed Forces to develop the indication for balance disorder and traumatic brain injury in a co-development program with the army. We are about to embark on the clinical trials, and we are just going through all of the IRB approvals today. The trials have started today, all the preliminaries are ongoing and we are getting the IRB approvals and protocols all completed, and we expect that the first patients in the study will be sometime in March or April. The studies will take 6-8 months to complete. Then if we are lucky and the science pans out, submissions to the FDA will be roughly in the end of the first quarter 2016 for clearance sometime in the third quarter of 2016. That is what I call the army pathway. We are also investing in a clinical trial at the Neurological Institute in Montreal, and we are doing pilot work there. The pilot work will start in mid-December this year, and the pilot will last three to four months. Based on the information that we yield from the pilot study, we are going to go to the registrational study, and that will start sometime in May or June and will roughly take about six months and then we will submit to the regulatory board for clearance sometime in the second quarter of 2016.
CEOCFO: Is the medical community paying attention overall? Mr. Deschamps: So far, I would characterize that probably as a no. We have just formed our Scientific Advisory Board, and we had our first meeting on November 24. Quite frankly, the scientists who developed this technology really did it almost covertly in the sense that treated patients at the University of Wisconsin under IRB approvals for different types of conditions. It really was not something that was particularly well-publicized. I fully expect and celebrate the scrutiny of the medical community to ensure and hold us accountable for the highest level of quality science and developing this product so that ultimately our science will do the talking and start to bring the medical community on board as they seek new treatments for these areas. Relieving neurological symptoms is a very high unmet need area. There is really nothing you can do once you are afflicted with a neurological disorder or a traumatic brain injury. Basically, you are taught to cope with your newfound deficits. There is really nothing proven that can treat or relive those symptoms, so I think that the high unmet need is going to make it possible for us to be able to convince the medical community once we demonstrate through the clinical trials that this is a viable way in which we can help these patients.
CEOCFO: Are you funded for the next steps? Mr. Deschamps: Yes. We are collaborating with the armed forces, and the armed forces are supporting us with both personnel and money. We are in a good place for us to be able to complete our clinical work.
CEOCFO: What surprised you along the way? Mr. Deschamps: The biggest surprise for me was that I have been doing health care commercialization in the neurology area for 28 years, and every time I got up and addressed the medical community or our sales representatives I would start the speech the same way. I would say that with neurological disorders, you have to discount two-thirds of what I say because these products only work 15 to 30 percent of the time at best. In this one, although I characterized them as compelling anecdotes rather than science, I have seen people recover from neurological disorders and relieve the symptoms of disorders that they have had for five to 15 years within five to six days, they become perfectly normal. That is not science, those are anecdotes, but they are pretty compelling when you see them with your own eyes. Somebody who cannot walk is able to run five days later. Mr. Montel Williams, who is one of the people that participated in early trials of this device was heading toward ambulatory assistance with a cane or a wheel chair, and now he jogs on a treadmill every morning. Those are the things that surprised me a great deal and that had given me great hope that we will be able to help lots of people with neurological symptoms.
CEOCFO: Put it all together. There are many companies to look at in the medical; why Helius Medical Technologies? Mr. Deschamps: I think the biggest reason is because the area that we are focusing on has such a high unmet need and there is virtually nothing that can be done for these people. If it turns out that our science proves that only a very small subset of people might be able to get benefits, it will still be a worthwhile endeavor. If the compelling anecdotes that we have seen in the early pilot work turn out to be something that we can prove through the clinical trial program, then we potentially will be helping tens of millions of people across the world to relieve neurological symptoms. That is certainly something that not only got my attention but that I think is a wonderful opportunity from a humanitarian standpoint and through that, a great business opportunity. |
“If the compelling anecdotes that we have seen in the early pilot work turn out to be something that we can prove through the clinical trial program, then we potentially will be helping tens of millions of people across the world to relieve neurological symptoms.” - Philippe Deschamps
Helius Medical Technologies, Inc. (CSE:HSM)
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Philippe
Deschamps