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Cognivive is Transforming Recovery from Stroke with their At Home Personalized Virtually Reality Treatment Games
Dr. Tony J. Simon
Tony J. Simon Ph.D.
Interview conducted by:
Lynn Fosse, Senior Editor
Published – September 7, 2020
CEOCFO: Dr. Simon, what is the concept behind Cognivive, Inc?
Dr. Simon: Cognivive is a company that develops what are called digital therapeutics, which fit into the regulatory category of software as a medical device. Our focus is on treatments that improve the functioning of the brain and how it controls motor and behavioral functions. Unlike pharmaceuticals, the mechanism of action targets information processing, which is a common feature of computing machinery and the brain. So, because most central nervous system functions are defined and measured in terms of behavior and, as I like to say – “you can’t swallow behaviors” – most brain-
CEOCFO: What is your approach?
Dr. Simon: The approach for this first indication is to start with standard clinical protocols that would be used by neuro-
The problem has been trying to find a way to deliver very effective treatments that patients will use at home and to make them highly motivating so they will want to use them. Our therapeutic will augment the existing treatment system, so that people will essentially self-
CEOCFO: Where does virtual reality come in?
Dr. Simon: It is very powerful for us. I think about virtual reality (VR) as essentially the perfect delivery vehicle, or “digital gel capsule” for our kinds of digital drug. So, using the digital drug analogy, Cognivive’s proprietary algorithms, developed from strong scientific and clinical evidence, make up the active compound or the digital chemistry of the drug, as it were. However, you have actually first got to get people to swallow the drug. If you have a great medicine and no one takes it, it cannot possibly be effective. That is why the highly-
The reason why virtual reality is the optimal delivery vehicle is that the brain responds in almost exactly in the same way as it does in the real world when people have a fully immersive virtual reality headset on. That is not the case when doing things in front of a screen or on a mobile device. Also, in virtual reality one responds physically in the same way as the real world, so we set up situations where people are virtually picking objects up or dropping them or pulling objects or using a tool like a bat to hit an object like a ball; all of the things that you are trying to recover, particularly in upper extremity motor control, which is one of the key problems after stroke. Therefore, you get naturalistic activation in the brain and the same relationship between the brain and motor system as in the real world, so that is huge! However, the other crucial part of this is that, because these activities are not actually taking place in the real world, we can control the physics in virtual reality, so that we can allow patient to do things they could not do in the real world. For example, if a patient reaches somewhat close to an object that they would be trying to pick up in the real world, we can allow that object to simply snap into the virtual hand without them having to have the ability to actually pick it up and then do something goal-
Because the VR systems allows us to measure what the patient is doing hundreds of times each minute, we can the constantly adapt the difficult of every activity, so the patient gets a fully personalized treatment for themselves in that moment. That is one of the really powerful parts of virtual reality; that it allows us to essentially change the capabilities of that person in this virtual world and then continually adjust the challenge to bring their abilities closer to what they need to do, to function effectively, in the real world.
CEOCFO: How comfortable are older people who are more likely to be stroke victims, with the concept of virtual reality?
Dr. Simon: That is a great question. People are always a little bit skeptical, but actually, older people do play a lot of games using technology. Most tend to like puzzle games that they play on mobiles devices, so they are not necessarily averse to the whole idea. However, when you put most people into virtual reality, including older people, they are excited or even thrilled! In fact, particularly with people who have reduced capabilities, it can give them back capabilities that they did not have.
We have patients literally saying, “This is awesome, this beats Candy Crush, this is addictive,” which they do not do trying to stack soup cans in the rehab gym, for sure! However, we have to be very careful. For example, we are focused on the upper extremity neuro-
CEOCFO: Would you tell us a little more about the new classification, “Interactive Rehabilitation Exercise Device” and why and how the FDA decided this is the time?
Dr. Simon: The FDA has, in recent years, taken a very different approach to the whole notion of medical devices when it comes to digital. In fact, they developed a very specific program modeled on the Pre-
One aim of the 21st Century Cures Act was to try to get these products safely into the hands of patients that need them ever more quickly and to determine the minimum level of the requirement to make sure that the device is going to be safe do what its manufacturers claim. Many of these devices can be classified as 510(k)-
CEOCFO: Where does the doctor or the physical therapist come into play?
Dr. Simon: Cognivive’s treatments are designed to be prescription digital therapeutics, which is a concept that is increasingly becoming widely accepted. There is a very strong move towards digital treatments that can be prescribed and paid for – even though the whole system has still not been completely worked out. The need is especially true now we are facing the COVID crisis where in-
So our therapeutics are designed to add the treatment that the physical and occupational therapist would be doing in the outpatient clinic, and they can be used there too, as well as in inpatient settings and at home. Now, if people are not coming into the clinic there is not even a way to deliver that therapy, so that we are essentially adding the ability for the patient to undergo treatment at home. The treating clinician, who is generally the PT or OT, has access to the patient’s data through a clinician dashboard and they can monitor and change the treatment if they need to.
CEOCFO: Does the clinician indicate the programs, the length of time? Is the patient setting up themselves? What are the actual mechanics?
Dr. Simon: It is a bit early for a definitive answer because we are just launching real world clinic and home feasibility trials. We have taken a great deal of care to develop a system that requires almost no setup by the patient at home and that guides them through the basic experience of VR and our treatment games through interactive characters and tutorials.
The idea is that a set of treatment modules will be available in the system for upper extremity and neuro-
CEOCFO: What has been the response from the medical community that is aware of what you are doing?
Dr. Simon: It has been very positive. That first became clear when we met our now Chief Medical Advisor, who is a very well-
Physical therapy providers are very interested too, because they are all trying to solve the same problems. For that reason, we have been able to set up feasibility trials with some private rehab facilities as well as hospitals in two major healthcare networks who are looking to find ways to do that extension of treatment back into the home. They understand that Cognivive’s treatments are not taking something away from them. It is really adding to what they have been able to effectively do in person, but not remotely, for a long time.
CEOCFO: Has COVID helped you get a foot in the door?
Dr. Simon: Theoretically yes, because home treatment is a very big need. I think the limitation for us is was just being a little but too early; we could not just sort of jump in and provide treatments to patients, because we were not quite finished building and testing yet. Because of risk to their patients, COVID did stop the progress of the trial we were just about to start with the large rehab hospital. But, by the same token it caused us to ask, “What about all of these clinics who cannot get to their patients at the moment?” We reached out to other clinics for that reason and they were very interested because there is a wide recognition that Cognivive is ofeering the right kind of solution.
The way I often put it is that we have been building for a home solution from the beginning and now the whole world needs a home solution, and so it is definitely bringing more attention. I cannot quantify it exactly, but it is definitely going to help us move forward and we are accelerating because of that.
CEOCFO: Are you seeking funding, partnerships or investment as you move forward?
Dr. Simon: Absolutely! It is always a critical thing for a small company like ours. We are actively raising funds at the moment to expand our team and accelerate our Go To Market date. We are also working on looking for medical systems that might be interested in partnering with us to try Cognivive’s treatments with their patients. Because our system is such a low risk device and we now have FDA registration, there is nothing to stop a physiatrist or a neurologist from deciding “I would like to try that with my patient and just see how it goes”. The more we can do that, the more potential customers and of course the more data that we have. Therefore, we are always looking for partnerships as well as investors.
CEOCFO: We reach people in health, as well as the investment community. Why should both of those groups; with so many ideas to look at, pay attention to Cognivive?
Dr. Simon: Because as I said, we are trying to solve this very intractable problem that has existed for a very long time but is even more desperate now that COVID has transformed healthcare. Patients recovering from stroke need a way to have very effective, evidence-
As the neurology experts tell us, the optimal treatment is one that is constantly adjusted, that is specialized for that specific patient and that can be used at home. Not only does Cognivive do just that but it does so in a very cheap and effective manner, by sending out treatments installed in a small, light headset with hand controllers, and that do not require one on one supervision by the clinician. So our solution provides patients with a lot more treatment and also ensures a lot more access to care for many more patients, all at very low cost. Therefore, specialist clinicians can treat many people, hopefully much more quickly, that get better outcomes and also save the health system a tremendous amount of money.
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“our solution provides patients with a lot more treatment and also ensures a lot more access to care for many more patients, all at very low cost. Therefore, specialist clinicians can treat many people, hopefully much more quickly, that get better outcomes and also save the health system a tremendous amount of money.” Dr. Tony J. Simon