Join us for a conversation with Frank Jaskluke and Dave Rosa, President and CEO of NeuroOne Medical Technologies Corporation. Dave shares more about the innovation happening at NeuroOne, which develops thin high-definition film electrodes that can be used for numerous neurological conditions including epilepsy.
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Frank Jaskulke, Medical Alley Association (00:39):
Good morning, good evening, good afternoon to everyone out there in Medical Alley. Thank you for joining us for another episode of the Medical Alley podcast. We've got a great conversation ahead with Dave Rosa from NeuroOne, and I'm really excited to have this conversation because it's a really kind of an amazing technology. It's a great business, but it's also a person in Dave who's been involved in the industry with a number of companies for a long time and has just a great perspective on medical technology on healthcare. So, Dave, I wanna say welcome to the podcast and maybe you could start with introducing yourself and introducing NeuroOne.
Dave Rosa, NeuroOne (01:19):
Sure. Well, first of all, Frank, thanks for having having me as a guest today. Always exciting to catch up with you and have a conversation with you. As you said, my name's Dave Rosa, I'm the CEO of NeuroOne Medical Technologies Corp. Been with the company since late 2016 and NeuroOne, really what our objective is, is to develop and commercialize thin film, high definition electrodes that really could be used for a variety of different neurological conditions. Most people have heard of epilepsy, Parkinson's disease, you know, chronic back pain due to failed back surgeries, which I actually fit into that category. But these electrodes are really intended to perform multiple functions, both diagnostic and therapeutic, which is one of the things that separates us from some of the other technologies out there.
Frank Jaskulke, Medical Alley Association (02:13):
That is really unique that you can do the diagnostic side and deliver therapy. Is that one of the things that attracted you to this opportunity?
Dave Rosa, NeuroOne (02:23):
Sure. It was kind of an interesting way. I got involved with company. I had had a medical issue that came up and I wasn't able to work for just about six months. I was on blood thinners and, long story short, I was approached by the co-founders of the company, really just for some help — introductions to investors, cause they were looking to raise money and I really wasn't doing anything. So I decided I would, you know, help. So for about nine months, I looked at the technology, worked with one of the co-founders, actually spoke to some of the physicians, the Mayo Clinic, obviously one of our local partners here. I spent time there with the inventor at the University of Wisconsin and really what I came away with from all of this was that this technology not only was it a later more advanced version of what was already being provided, but the ability to offer both the diagnostic and therapeutic function within one device. When I looked at that, I thought that was really unique. And in the end, this is all about improving patient care, making it safer, less invasive. And here we had the, what I felt the opportunity or the potential to eliminate a second hospitalization, a second surgical procedure, in addition to really providing a more or a higher tech, more up to date version of products that were already being used.
Frank Jaskulke, Medical Alley Association (03:59):
Oh, I love that when it's, you can improve on something that exists, but in doing so you make a real meaningful impact for the patients. Avoiding a second surgery, I have to imagine any patient that's confronted with that, that that'd be the direction they'd wanna go.
Dave Rosa, NeuroOne (04:17):
Yeah. We actually had a patient that had gone through this procedure at the University of Minnesota. And I had posted about putting together an advisory board for this one particular technology that combined both diagnostic and therapeutic functions, and I was surprised when I saw the post. His comment was, he said, I just went through this. I wish you the best because this will have a very impactful, really when I say impactful, it'll have a great impact to patient acceptance because it's two procedures that are done over months, over a period of typically two to three months. You know, we're, we're talking about drilling holes into people's brains you know, which is pretty intimidating for a lot of people. So the ability to get everything done at one time offers really a great advantage to how things are done today.
Frank Jaskulke, Medical Alley Association (05:21):
Indeed. And, and maybe you can talk a bit about that. So epilepsy's one of the areas the product addresses. And I'm just wondering, could you maybe use that as an example to tell our listeners who maybe don't know as much about the space, what's kind of the big issue or big issues that are out there today and then how does NeuroOne's technology address them?
Dave Rosa, NeuroOne (05:42):
Yeah, it's it's a good question. So while the technology is really intended for a number of different indications in the neuro space, epilepsy is really where we started. And what's really come to my attention in terms of the challenges, one was pretty obvious, the other wasn't. But the first one reminds me of my days in the cardiovascular space where cardiologists or interventionalists would say, gosh, you know, I'm really relying on the, a cardiologist, just general cardiologist to refer patients to me and, you know, that's not happening. And that's the reason why I can't do more procedures. We've heard the same thing actually from neurosurgeons that, you know, in, in many cases they're just not getting referrals from the neurologists. So that's one of the reasons why more of these procedures aren't done when. You look at just the raw numbers there's over 3 million patients that have epilepsy in the United States and a third of them are refractory to medications.
Dave Rosa, NeuroOne (06:52):
So typically they will put a patient through three different types of medications, each medication they're on for a month. And you know, they would progress the second and third, if the first was not effective. So you're talking about over a million patients that, you know, that are candidates for the surgical procedure. And when you look at the wrong numbers, there's probably, you know, it's under 10,000 patients who opt for the surgery. So if you speak to any neurologist or neurosurgeon, you would hear them say it's probably one of the most underutilized therapies that has proven to be very effective. So one is referrals, but second is you can imagine the gold standard until about five years ago was for these procedures to remove the top part of a patient's skull.
Dave Rosa, NeuroOne (07:46):
And, you know, there, you can imagine there's very little enthusiasm for a patient to come in and find out the top part of their skull is gonna be off, their brain's gonna be exposed. And most of these patients they're awake for the procedure because the doctor does have to perform some tests while they're awake to make sure that if they do go in and remove certain brain tissue, that it's not going to impact a patient's motor function or speech or vision, because obviously different parts of the brain different functions. So the invasiveness has definitely been a barrier for patients to move forward. And that really spawned about five years ago, the emergence of a procedure where instead of removing the top part of the skull, they would drill tiny holes into the brain tissue.
Dave Rosa, NeuroOne (08:41):
Now, you know, I would say, okay, if, if you're not removing the top part of the skull, but you're gonna drill about 15 holes deep within my brain, I'm not sure that I'm really excited about that either. But it has helped in terms of patients being more willing to go through the procedure. And again, you know, the data shows that it's still resection. Removing brain tissue is still the most effective way if you're refractory to medication. But all of these, as I mentioned a few minutes ago, require a diagnostic and then a therapeutic procedure. And, you know, when you asked, well, how are we trying to address some of this from a technology standpoint, we're trying to make electrodes that are thinner, more flexible so that instead of having to make large cuts, whether it's in the skull or in the spine, that you can place these devices through smaller holes, or even through needles to make it less invasive.
Dave Rosa, NeuroOne (09:43):
So that's one piece. The second piece is to combine the diagnostic and therapeutic procedure into one device so that, again, the patient doesn't have to go back for a second procedure. And really, the last thing I'll mention is you also have to consider that half the population is patients that are adolescents to, you know, and as young as neonates, and you can imagine how many parents are really really struck with the doctor telling you that your newborn needs to have an invasive procedure to correct, you know, and irregularity in the brain. It's just, it's very daunting. And unfortunately you'll hear many neurologists and neurosurgeon and say that the longer you delay surgery for epilepsy the less likely you are to cure the condition.
Dave Rosa, NeuroOne (10:46):
And it's been proven time and time again, that some of these parents wait too long, the child either passes away or is left with with some sort of physical defect over time due to the fact that, you know, the, the epilepsy wasn't addressed early enough. So, you know, my feeling is the less invasive we can make this, and the more we can get this all done in one procedure, the more likely parents and older patients will be willing to adopt it.
Frank Jaskulke, Medical Alley Association (11:21):
That's awesome. The psychological barriers to care, I think, are things we don't often talk about as an industry and that right there, if I were a parent, especially with a newborn, confronted with that condition, confronted with that kind of procedure, it would give me pause. So having a less invasive alternative, fewer surgeries, I could see how that would in a very positive way, speed up the decision making, and then hopefully deliver better outcomes as a result. That's pretty cool.
Dave Rosa, NeuroOne (12:01):
Well, it's funny you mentioned that because, I rarely bring this up, but it was probably about five years ago. I was attending as many of these conferences on epilepsy and Parkinson's as I could. And one of 'em, I remember one of the titles kind of struck me as being odd, but it said the psychological impact of epilepsy surgery. And I thought, well, you know, it never occurred to me that I would be sitting in a conference watching a presentation on this. But during the presentation, what the neurosurgeon showed were photos of, you know, children, different ages that had had to have the top part of their skull removed. And sometimes you have to do it, especially if there's a tumor that needs to be removed and it's causing the epilepsy. But the whole presentation really centered around what happens over time when these patients have these very invasive procedures.
Dave Rosa, NeuroOne (13:04):
And it was actually pretty sad to see that it had a — the very invasive ones — a tremendous psychological impact, because when the bone heals after it's been placed back over the brain, you would see, you know, like 16 year old girls with ridges and space between the bone. And you can imagine an adolescent growing up, you're in school, you know other classmates make comments, friends. There really is a psychological impact to it. And I hadn't even thought of it until I sat down and watched that presentation. It was it was really gut wrenching.
Frank Jaskulke, Medical Alley Association (13:45):
Yeah. I mean, it's probably a good lesson for all of us around this world to be thinking about its much broader of an impact on the patient's life than the things we may see in the doctor's office or in the operating room. And that's an opportunity to make better innovations and improve care alongside making better technologies. That's fantastic.
Dave Rosa, NeuroOne (14:12):
Yeah. No question about it.
Frank Jaskulke, Medical Alley Association (14:15):
Well, and I'm curious, so there's a bit more to NeuroOne, as I understand it, though, right? So it's not just a device company. I saw on your website, you have an AI advisory board, and I'd just be curious, the data part of what you guys are doing, what's the AI aspects of your work?
Dave Rosa, NeuroOne (14:37):
Yeah. So good question. Really what we're doing, and this is, by the way, a very complicated space in terms of trying to use artificial intelligence to treat patients that have these types of conditions. And really, where NeuroOne comes into play is the electrode side of things. So what, what we're really doing our part in this whole equation is really to develop the tools or the electrodes that have the capability to generate the amount of data that would be needed to really enable artificial intelligence. But there, you know, we are not the part of the equation that and then there's, you know, the hardware, the software and the disposable. We're really the disposable. Without our device, without the ability to generate thousand and thousands of contact points in the brain makes it very challenging to really see artificial intelligence become a viable piece of treating these conditions.
Dave Rosa, NeuroOne (15:43):
But you know, the whole concept behind the advisory board was to actually partner with other companies that are working on the hardware and software aspect. And it seems quite honestly that those technologies are further off or further out, I should say in development. None of this, you know, is obviously simple to do, but you know, I think the, the NeuroOne technology, while, you know, we have to make some changes to the device, the ability to make these electrodes that can generate all this data certainly exists today. So we're kind of at the mercy of some of these other companies that are working on being able to transmit thousands and thousands of data points back and forth to the brain to a computer to really fully recognize the benefits of using artificial intelligence. And it's not a trivial piece to develop that. So we're just one leg of the stool and waiting for some of the other pieces to develop further before we're really able to deliver what we hope to.
Frank Jaskulke, Medical Alley Association (17:03):
Yeah. Oh, that's fascinating. And I always feel like that position, the tools to generate, to be able to generate data, it's an under appreciated aspect of artificial intelligence and machine learning. Yet, computer scientists always say, garbage in, garbage out. You need to be able to get in that high quality and high volume of data. In the biotech world, it makes me think of companies like Bio-Techne that enable all the other companies to do their drug research. AI and ML companies need that enabling technologies to be able to do their work. So that's great to hear you guys are contributing to that broader ecosystem and helping to make some of that work possible.
Dave Rosa, NeuroOne (17:49):
That's the idea.
Frank Jaskulke, Medical Alley Association (17:51):
Yeah. Well, I want to turn to a slightly different part and kind of the business side of what you guys have been up to. You'd announced a partnership with Zimmer, I believe about a year or ago, or maybe a year and a half ago now. And while we don't want to talk about the details of the Zimmer deal itself, I'm just wondering if you could maybe share with the listeners some perspective or some understanding of, for other companies that are working with large established organizations, developing partnerships, how do you go about thinking how you're gonna make those partnerships and how you're gonna manage 'em so that there's successful, right? Small company working with a large company. How do you know about making that work well?
Dave Rosa, NeuroOne (18:36):
Yeah I'm kind of smiling because there's no question, it's not hard to identify the companies that make sense to look to partner with. I mean, in our case, a lot of people said to me, gosh, I can't see how Zimmer Biomed is a fit. Everybody knows them as an orthopedics company. But what few people knew was that they had a robotic system that had a variety of applications. And one of them was a neurosurgery procedures as the one that our electrodes would be used in. And the reason why I really targeted them was they're a smaller division of Zimmer Biomed that obviously has pretty big aspirations for growth. And I think many of these companies today are looking for ways to to grow revenue that are outside the organization.
Dave Rosa, NeuroOne (19:37):
And obviously partnering with a company like ourselves is one of the ways, but how do you manage them? I'll say you try to manage the process. And what we did upfront was since both of us were contributing technology, they were contributing accessories that are required to be used with their robot and our device. And we were obviously focused on the electrode. We actually formed a team, and so we had individuals on our side along with team members from their side and every week, we went through the progress, the project, the deliverables, what some of the barriers were or risks were. So I think like anything, having more communication as to what's going on and having a partner that really that your device really matters in their business in terms of growth is really important.
Dave Rosa, NeuroOne (20:42):
You've gotta be important to them because if you're not, you're probably not gonna get the attention. When I worked in big companies, it's kind of funny, the mindset is that small companies don't have the resources, but the biggest argument that we used to make in big companies is, gosh, we can't do all this. We don't have the resources. But compared to a smaller company like NeuroOne, we would love to have in the bank just the interest that they generate off the money that they have to spend. We would be thrilled for that. So I really have enjoyed working with them. You're always concerned going into these things about how they're gonna play out, but having a team, we've made many visits to their site, they've come out here.
Dave Rosa, NeuroOne (21:29):
I think we've just developed really solid relationships you know, with the group and right. It helps, you know, when when people trust each other and we're really working towards a common goal. This wasn't just, oh, we'll sign a deal with NeuroOne. They'll give a us a device and we'll sell it. They had a development piece of this. We had a development piece and we've really worked together well, even though you're always concerned about how serious they are and how really interested they are in promoting your technology. But for us, it was a no-brainer because their robot with their robotic procedures and the neuro space, someone's electrode is always used with their device. And if they're in the procedure, they're not realizing any revenue. Once the robot is sold, it's sold. But in this case now, you know, they had the razor, the old razor razor blade analogy, they had the razor, we have the razor blade. So it's not like they have to go out and build a new sales force. They just need the the razor blade. And that's what we have to offer.
Frank Jaskulke, Medical Alley Association (22:50):
So well said of finding the business where, what you do can be important to them, that it is treated to their growth and building that relationship. I think that's a great place to wrap up the conversation on that really informative side of things. And so, Dave, I just wanna say thank you for the great work you're doing. It truly matters that companies in Medical Alley are making people's lives better around the world. And thank you for taking some time out of your busy day to join us for this discussion.
Dave Rosa, NeuroOne (23:23):
Well Frank, thank you. And all of Medical Alley. I mean, you guys have been a great asset. I've been in Minnesaota I think 20 plus years now. And from the day I started in the medical device industry, you may have had a different name, but you guys have always been there to lend a helping hand to companies like ourselves that don't have all the resources and relationships sometimes that we need to be successful. So thank you as well.
Frank Jaskulke, Medical Alley Association (23:50):
Wonderful. We appreciate it. And folks, with that, that's another episode of the Medical Alley podcast. If you're not a subscriber already, make sure to check out medicalalleypodcast.org, or you can find us on Apple Podcast, Spotify, Stitcher, or wherever you get your podcast fix. Have a great day, and we'll see you on the next episode.