Cognivive Inc., Dr. Tony J. Simon, Stroke Recovery At Home

CEOCFO Magazine, PO Box 340
Palm Harbor, FL 34682-0340
Phone: 727-480-7070

Email: info@ceocfocontact.com

IN-DEPTH INTERVIEWS WITH Top CORPORATE EXECUTIVES (727) 480-7070 info@ceocfocontact.com

Lynn Fosse, Senior Editor

Steve Alexander, Associate Editor

Bud Wayne, Marketing
& Production Manager

Christy Rivers - Editorial Associate

Cognivive is Transforming Recovery from Stroke with their At Home Personalized Virtually Reality Treatment Games

Dr. Tony J. Simon

Co-Founder, CEO & CSO

Cognivive Inc.

www.cognivive.com

Contact:

Tony J. Simon Ph.D.

530-361-6006

tony@cognivive.com

Interview conducted by:

Lynn Fosse, Senior Editor

CEOCFO Magazine

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-based treatment require a very different kind of medical intervention. Our first target is to address the issue of neuro-motor control and cognitive recovery after stroke but our treatment system is really a platform on which we plan to deliver treatments for a range of brain-based disorders.

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-rehabilitation therapists, such as physical and occupational therapists, but to take apart those activities and to deliver components of them, using virtual reality, to the patient in very engaging and motivating game environments. The great problem with recovery from stroke is that patients are sent home from the hospital after a very short period of time and given very boring and un-motivating and unpleasant activities to do, which they often do not do, and then essentially treatment and recovery stops.

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-administer treatment at home frequently and change the terrible outcome that two thirds of the people who have experienced a stroke still not being able to be physically independent after about five years of attempted recovery.

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-motivating game structure is important.

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-directed with it.

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-motor control; arms, shoulders, hands, and so forth. This is why we have all treatment take place in a seated position so there is no chance of someone falling over. We have very much reduced the perception of induced movement, so that you do not really get that problem of your brain thinking you are moving, but your body knowing that you are not moving, which can induce nausea. Therefore, we are very careful to design around those issues.

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-Check Traveler program we know from airports. In this approach they are evaluating the capabilities of the company rather than the specifics of each of their products. One key reason is that digital treatments can be updated through software after being released, which cannot happen with regular pills. This is the software as a medical device concept I mentioned before. Most of these things are very low risk, so it is not likely that they are going to have dangerous side effects. The FDA classifies most digital health products as low risk devices; what would generally be considered a Class II device, much like many other kinds of devices, like a wheelchair or a walker.

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)-exempt. In other words, it has been ruled that they just do not need the level of evidence and clinical data, determined through a process known as 510(k) review, to show that they are safe. Therefore, we have to show that what we are providing for people is precisely a system that allows the user to execute the prescribed rehabilitation activities interactively within the system and provide a clinician access to that information. The new code is a recognition that devices like ours are needed, are low risk and should be made available to appropriate patients with a prescription from an appropriate medical professional.

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-person treatment is extremely difficult, and, as you mentioned before, many stroke patients are older and have other fragilities, so it makes in-person treatment even less appropriate for them. The way this will work is that a prescription for treatment with CogniviveVR will be written by a neurologist or a physical medicine rehab doctor, known as a physiatrist. Once the patient is discharged from the hospital our VR headset and software will be delivered to their home and will be covered by insurance as Durable Medical Equipment (DME), in the same way as an oxygen tank or a walker is. Once it is determined that no more treatment is necessary the DME comes back to us and can be used for another patient. The idea here is that we are augmenting and extending the treatment, out of the clinic, into the homes, so the patient can get much more treatment more intensively. This is how best to leverage the neuroplasticity the brain retains in order to maximize recovery.

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-motor control and cognitive recovery. Our plan is for patients to voluntarily choose between the activities they want to do at any moment and how long they do them for. However, since the clinician will have access to the patient’s activity and performance in the clinician dashboard, they will be able to direct the patient by messaging or by phone to say, “You know, I think you need to do a bit more of this,” or “I am going to change the parameters so this is a little bit harder.” Therefore, treatment will be very voluntarily and intrinsically motivated by the patient, but the clinician will have control if they want to monitor or they actually want to adjust the treatment program remotely.

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-known rehabilitation neurologist and was excited the see the promise of what we were building. In general neurologists and the physical medicine rehab doctors have been desperately searching for a way to improve outcomes for their struggling patients. Neurologists and others who are doing research trials are excited by the idea of adding new devices to the complex and expensive robot devices out there to assist in recover. What we are proposing to do is to put a one- and one-half pound, very light, easy to use virtual reality headset into the hands and the homes of people who can use it almost anywhere, which adds to access to treatment.

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-based treatments that they will use at home, in a highly motivated way, so that they actually do lots of activity. However also, the thing that we can provide that other people cannot provide or have not to date, is a highly personalized approach to that, so no two patients get the same treatment from the system. It is always adjusting specifically to that patient. There is also potential for inpatient use, which may help patients leave the hospital in a more functional state.

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.

Cognivive Inc., Dr. Tony J. Simon, Stroke Recovery At Home, Stroke Recovery Video Games, CogniviveVR, Cognivive is Transforming Recovery from Stroke with their At Home Personalized Virtually Reality Treatment Games, CEO Interviews 2020, Medical Device Companies, Stroke Recovery, Stroke Rehabilitation, Stroke rehab at home, personalized medicine, personalized therapeutics, virtual reality therapy for stroke, virtual reality treatment for stroke, virtual reality treatment game for stroke, neuroplasticity, video games for stroke recovery, VR game for stroke, Cognivive Inc., Press Releases, News

“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

HOME

CURRENT ISSUE

INTERVIEW INDEX

CEOCFO SERVICES

CEOCFO MOBILE