Mind Blowing Progress: The State of Neurotech | LSI USA ‘23

Transcription

Henry Peck  0:06  

Thank you everyone for being here and joining us for this panel titled Mind Blowing Progress the State of Neurotech. Hope you all liked the pun in the name but in all seriousness, this panel is going to be extremely exciting again, keeping with our focus on Alzheimer's, neurology neurodegenerative diseases. And we have some extremely innovative companies here on this panel, excited to talk to you. The panel is moderated by Chris Benko, the CEO of connects to health, which is an innovative digital biomarker company pioneering digital measurement tools for novel therapeutics. So Chris, I'll let you go take it away.

Chris Benko  0:37  

Thank you so much. Great to be here. I'm gonna take a moment to introduce our panelists. I'm really excited to be here because I work primarily in the biopharmaceutical industry. And so my mind has been blown and getting to meet you guys and learn a little bit about what your companies are doing which are incredibly exciting. So I'm gonna try to introduce you quickly so we can jump into the topics. Carolina Aguilar seated to my left from in brain is a neuroscientist and business leader with about 10 years of experience running parts of the Deep Brain Stimulation business at Medtronic correct. And you had the opportunity to do work in digital health and value based healthcare in the diabetes field before INBRAIN which really combines deep tech, med tech and digital health, using your platform to decode brain signals into breakthrough medicines. Meron, great to meet you, I had an opportunity to see the inner Cosmos booth over on the other floor earlier, which was really, really exciting, seeing how you were using a digital pool to rebalance brain networks to treat depression. And so you're starting to enter into human clinical studies and you have prior experience as CEO of an augmented reality company. Nishant Doctor as the business development leader for Syncron, which is an endovascular brain computer interface company that he's going to explain a little bit more about to us. It's approved by the FDA to run a clinical trial in the US. And you Sean has prior experience leading r&d and commercial in neuromodulation. And other devices, including it, Abbott. Ken Mariash the first person to actually tell me about this conference so I met a couple of weeks ago, is leading Synaptica Therapeutics. He also has a deep experience working in big medical device companies. Having first started in industry at CSL then at Baxter, and it's been a long time leading up strategy for Boston Scientific's neuromodulation division. He's done a lot of work in Alzheimer's. And right now he's come on board as CEO of Synaptica, their team is looking at personalized closed loop neuromodulation therapy for Alzheimer's. And they've generated some pretty exciting, Sham controlled data, I have the opportunity to see the paper on that it is very exciting. Cameron, Cameron, you have a long experience founding and leading medical device companies I know. You're the co founder and CEO of Synaptive Medical. And that's an incredibly exciting company that we're going to hear about today. You previously were also co founder of a medical device company called Santaniello medical that developed and manufactured MRI based breast imaging technologies. And I believe you exited that company after a hit about 20 million in revenue. So you're one of the serial entrepreneurs up here. Clearly a glutton for punishment. So I'm really excited to learn from all of you. One of the topics that we wanted to cover today are really the bioethical questions around emerging neuro tech. So I'd ask it to you in sort of feels like plain English for me. If I'm thinking about speaking, and I'm sure you've all thought about this with a relative or a loved one that's considering one of these therapies. And, you know, setting aside the real, like, sci fi nonsense, you know, you're not going to turn somebody into the terminator or the Manchurian Candidate. I think we get that. But what are the serious legitimate questions that you would be encouraging a loved one to ask if they were thinking about it, let's say an investigational product that involve neuro implantation or had any real ability to shape or reshape how your brain works? What are the things that we should care about as part of this increasingly exciting technology stack that's emerging as part of our healthcare field?

Carolina Aguilar  4:06  

Yeah, all right, sir. I think there is a difference between the implantable and non implantable, or let's say, the regulated and non regulated ones, right. And in a non implantable area, you have a lot of neurotech that you could buy on eBay or Amazon and try, you know, in your brains to concentrate on whatever claims they put forward. And I think that, for me is the dangerous path that at some point needs regulation. Because at the end, you're interfering with the brain when it comes to the regulated ones, and especially class three. So the implantable ones, there are very clear rules about what you can do or not with your brain implant. So if someone here would like to, I don't know, connect to the metaverse, you cannot, right. So there are certain rules and I think that's the safety that is required for patients and we will be all patients. So think is important. And patients know the difference between regulated and non regulated medical devices to start from.

Chris Benko  5:09  

That makes a ton of sense. And so that's also implying to me that you all feel that the regulatory frameworks that you're operating under have a lot of protections that are designed to make sure that we're doing things in a way that's safe and ethical. What about some other ideas from this group?

Ken Mariash  5:23  

I mean, in our case, we're non invasively, stimulating the brain with quite a lot of electricity, and directly impacting the default mode network, which is involved in episodic memory and Alzheimer's. So I can see why certain patients may kind of react with skepticism or worry and concern to that. You know, it is reassuring that the technology, the base technology has been around for 30 years, but we are modifying how the brain is wired and how it fires, Colloquially speaking, of course, and so it does raise some questions. What are you doing to the brain? Are you changing the connections in the brain? Yes? Are you changing the oscillatory patterns? In fact, we are, are you preserving gray matter? In fact, we are. So it does raise some interesting questions about changing the brain. But I think of it more as restoring the normal functioning of the brain. I think that satisfies A lot of people. You think about risk benefit analysis, though, the latest drugs like like Canna Mab, they barely have clinical significance. There's a large debate right now about whether or not they're even clinically meaningful. And that's at 18 months, with some pretty interesting or concerning side effects, brain bleeding, brain swelling, requiring MRI monitoring for safety. So you think about ethical considerations. I mean, the safety profile of these new drugs has to be considered weighed against the clinical efficacy, which at best is marginal. So I think there's a lot of really interesting questions there about risk benefit analysis. And I'm glad that the non invasives kind of tend to tilt towards the more benefit, less risk.

Chris Benko  6:56  

Very interesting way to think about it. And of course, many patients are going to have an increasing range of technologies and therapeutics in front of them.

Meron Gribetz  7:03  

Yeah, thank you. So in addition to the regulatory and the effect, efficacy calculations, I spent a lot of time looking at the market and kind of seeing what ethical questions are popping up around the web now that, you know, Elon is out and everyone is coming out. And there's a lot of excitement in this industry. It provides a really interesting breeding ground to looking and organizing the groups of ethical questions. And that's what we've been doing. So a lot of people are asking about the concept of what it means to be human. And when does the line blur? When do I lose my humanity? I'm not gonna attempt to answer them here or explain how we answer them as a company. But I'm more trying to synthesize for the whole community, what I'm what I'm seeing, and it'd be interesting for all of us to provide some draft answers. The second kinds of questions are about identity. So you're modulating the default mode network to support episodic memory for Alzheimer's, we're increasing the cognitive control network, which is anti correlated with the default mode network in order to help depressed patients be more out of their head. And in the world, this is the way that we balanced depression, the largest chronic disorder in the world. So that means that there's going to be questions of identity shifts, who was I before? And who am I after, there's really interesting phenomena. When we get people out of severe treatment resistant or suicidal depression with brain stimulation, oftentimes, they'll leave their partner and their job. This is a well known phenomenon. It's like the person that was depressed is a different person to I feel right now. And what does that mean? And there are a host of other questions about agency, freedom to operate in the world when this thing is guiding in some way. controllability, am I able to turn it on and off? And a number of other super riveting questions? So I'm curious how folks here answer them or what other questions come up?

Nishant Doctor  9:07  

Yeah, I'd like to touch on something. So what we see here is very similar to what happened in CRISPR. About, I would say, 10 years ago, there was a lot of ethics questions that were raised in, like, how is this going to be used, and a lot of people are not ready for it to be used in medical application, even though there was a real need for it. But then just last year, there was a study now that's gone, FDA approved it for sickle cell, where CRISPR is now used for that. So that's kind of what I see here is that there is definitely at the concerns about like, are we hacking into people's brains, what of that data gets read and then people can know someone's emotions and thoughts. But then what we're doing at Syncron is kind of giving this independence and autonomy to patients with paralysis who have no alternative options right now. And that's kind of what we approved for. And that's what we're kind of going forward is like the patient ones with paralysis who can't move, the arms or legs are locked in syndrome. They just don't have any options. They just can communicate with their loved ones. So this is, again, going back to that risk versus benefit analysis. And we're operating in a very heavily regulated area. So,

Chris Benko  10:16  

so that's super helpful. Cameron, I wondering if you can maybe build on this for my next question. Someone referenced Elon, already a Neural Link, which is, of course, a company that gets a lot of media and popular attention around this notion of brain computer interfaces. So I'm really curious as somebody from an adjacent place, is somebody that's such a notorious disrupter, but somebody that also makes really bold and aggressive claims at times about technology. Is that force really helpful overall to this space and the evolution of the industry? Or is it it actually introduced more fear? Or, you know, maybe scare regulators and patients because they associate that character or that behavior with something that maybe is less than ideal?

Cameron Piron  11:02  

Yeah, you know, I think the energy and the focus and the the attention Elon brings is, you know, pretty, pretty spectacular. I think, you know, the reason why he's doing it is a complex one, you know, I think we're all up here on stage and thinking about ways you can modulate the brain to fix the brain. Right. And I think the motivation, publicly that is to get declared for Neuro link is to bypass the brain, right to get an interface to an AI that's a little more efficient. And that's, I think, a long way off from probably what we're trying to treat up here. So I think it gives, certainly a really a lot more focus on it. But then when you start seeing, you know, articles about not being able to move to the next step of FDA, because of worry of scarring for multiple implants of the brain, that really, you know, causes people to step back and at least think critically about it. And I think there's, there's probably nothing more than a brain implant that you should think critically about, right? You can modulate drugs, external energy sources, but when you put something in the brain, it's a little bit irreversible. Right. So that's now at least elevated to think about that, because that's a challenge with DBS. That's a challenge with any brain probe in the brain. So I think it's helpful to at least elevate that discussion, but but cautious about how progression progresses.

Chris Benko  12:20  

I'd love to hear others thoughts on this, it is really interesting that we have a group that's so grounded in the history, really, each of you have been in around your fields for a while. So you know, the precedents that others of us aren't familiar with. But I'm really curious to get some other perspectives on how neural link and Elon have inflicted this field.

Meron Gribetz  12:40  

One framework for looking at fields health in general is, you know, the Gartner hype cycle. So the, you know, peak hype and then the valley of death, when then it actually the technology actually picks up in some sustainable level. So oftentimes, the leader of the pack or a number of leaders of the pack inside of that hype cycle, their valuations relative to the real value, often create that cycle. And the good thing, the nice thing about Elon leading the pack in this in this awareness space, is that he has unlimited capital nearly to deploy towards this and continually raise the valuation. Sometimes artificially, sometimes not who knows. But that actually provides a measure of cover for us. In some level, I've spoken to a lot of CEOs in the space and net net, it's been quite positive for us. It allows us some flexibility to decide where if if NeuraLink Raising at you know, two, 3 billion and 8 billion post market or secondary market, then it allows us to pick somewhere between here and there to raise, we take a more do we try to take a more rational approach of trying to be really provide a good deal for our investors leave it at that. But that flexibility has been sustainable, and we've been able to, you know, to enjoy that. On the other hand, we are seeing the FDA rejection a couple of weeks ago, and we're monitoring that closely. Yeah, we'll see. It's an interesting one, currently, and anything to add on this one.

Carolina Aguilar  14:31  

As you said, many neuroscientists, then I went to business and I've been for a long while here, and I have to say that he has definitely revitalized this the scope of what we are looking when it comes to neuro tech. At some point, I lost hope about neurotech and I and I saw new materials and I saw new electronics and the coupling with microfabrication and and it's really a new perspective that some of us are also taking and following. And I think it's very inspiring. It brings a lot of energy and brings new. Yeah, a fresh, a fresh look to the field, and also from the VC perspective as well, as you said, because he has raised more than 370 something million. So it's a whole new game, and we needed it. So of course, we have to be cautious. I think they're, they were thinking more consumer goods, that metallic or deep tech, and that it's a learning curve that they are going through. And I think it's natural. Now this is about health. So we have to be very responsible and very ethical, and maybe a little bit more humble. But they the net for me is positive. I think it was it was needed.

Chris Benko  15:48  

It's really interesting to hear how just the flow of valuation probably also talent, capital, that's all a positive and you're all think very clearly delineating working on trying to change brain health is a different objective that shared by this group across here. So I guess that brings me to another topic that I'd like to probe with you all, which is where this is an emerging field still, that you're all working in? Where are they're better up, where where are their opportunities, to better collaborate across are there places where you know that rising tide does lift all boats, but in order to make that happen, we need to be working together maybe across some some boundaries between different areas of the healthcare field, or different areas of the technology field than what might be traditionally at play. And I'd love if you're seeing good examples of that starting to happen.

Nishant Doctor  16:40  

I can go here. So from a collaboration standpoint, as you guys know, Syncron right now isn't clinical trials, it's enrolling patients. And that's kind of been our focus, trying to get patients through early feasibility study. And we're actively enrolling, so we're constantly kind of working with sites, we're getting ready for our pivotal study as well. And so that's one area we're actively trying to collaborate with. Again, there's a big piece of education here, like what is real BCI? And what does it mean? So that's another thing that we're actively out there trying to kind of educate people around. What does BCI mean, and again, with Elon Musk out there, and all these ethics issues that are coming out with what they're doing, it brings a lot of skepticism in the market, and people are not sure. Is it safe? Is it not safe? So that is where I think some of the issues we're facing and trying to get people comfortable with how this technology is going to be beneficial going forward. But yeah, from a collaboration is yeah, I'd say that's where we are.

Ken Mariash  17:42  

Well, certainly in the Alzheimer's space, we know that disease is likely to be solved by a multifactorial solution because it is a multifactorial problem. And the idea that there's some silver bullet that's going to arrest the disease. While everyone hopes for that the reality is that's probably not likely. So combinatorial approaches, I've been on the drug side, I've been on the device side. And there's often not enough interplay between the two, neither at well, not as much at the business level for sure. Definitely not at the capital infusion level, sometimes at the research level. And then the companies themselves tend to specialize obviously. But for this to work, we need combinatorial approaches. So whether that's neuromodulation plus some other modality, that's medtech, or some other modality that's drug based, you know, I take some comfort from the fact that we're still connected to some great centers in academia, where there is that spirit of collaboration and sharing and knowledge transfer. That's fast, you know, that's accelerating because we know that patients can't wait another minute. And so I see things like our co founders at Harvard MGH. And he also teaches at MIT at the precision neuroscience and neuro modulation lab, they have a high throughput, almost like a skunk works to be able to fast prototype and get some clinical data really fast, which is a benefit of non invasive neuromodulation by the ways that you can prototype quickly and get answers quickly. And then share those across to our collaborators at the Santa Lucia foundation in Rome, for example, and other collaborators at Oxford University and so forth. So there needs to be a multifactorial approach, and that requires a lot of collaboration. And I wish that the business side worked as well as the academic side in that respect.

Cameron Piron  19:23  

I think one area that fully agree everything you said is the need a convergence of not just treatment modalities, you know dBs, TMS, pharmaceuticals, focused ultrasound, right, there's a whole summer one way street, there's no going back from it. So it's the ability to kind of get the pacing of trying things out in increasing doses and what's next, but we've been really focused on the imaging side we just saw such a big gap between the gold standard of imaging traditional MRI, high field MRI, tends to not be very compatible with Implant in this huge divide between these two worlds of the GE Siemens, Philips and the, you know, the Boston scientifics and Medtronics. And, and you use MRI as the gold standard to detect, you know, Alzheimer's, Parkinson's stroke, you know, tumor, but then once the implants in, that's no longer available to you. So that's been our focus is trying to get that imaging and implant, you know, really synergized

Carolina Aguilar  20:28  

I can give you a very practical example. When I was in Medtronic, we weren't alone. And then there was St. Jude, bought by Abbot, and then then Boston. And now you see how many we are. And every patient requires a different programmer, right? So you see all these doctors overburdened by the number of programming systems they have to learn. And then when the patient goes on holidays, if you show up in a center, and they don't have your programmer, what do you do? So I always say that collaboration is the new innovation, at least for patients. And we should think about interoperability, data exchanges, let alone ASICs and battery developments. But I think there is a field that needs to happen on the collaboration on this area that is urgent, actually, at some point, we have to do a good brainstorming together.

Meron Gribetz  21:20  

Yeah, I agree. I think there's three or four groups of risks that all of us face as companies on the path to market. The first is financing. So one of the things that's interesting is that a lot of us were not really competitive, or maybe in the same space and BCI, we would maybe be comparables. But I've been talking to a lot of the CEOs in our space and sharing investors and kind of pointing each other sometimes an investor wasn't the right fit for that particular moment in their fund or in growth. But then they'll refer them to us or we would refer someone to someone else. So that's a good area of collaboration as the first step. Second group of risks is, of course, the clinical so and the regulatory side. So group groups like ours can come together for lobbying to the FDA and having communication aligned communication with the FDA around risks and around benefits. And then the next one is reimbursement. And so I think we can all kind of think about CMS and unified ways that can make off all boats float together. And then there's ethics. So yeah.

Chris Benko  22:28  

So it leads me to a question that's maybe a little bit near and dear to my own heart and the world I work and so I'll share a quote with you guys. I first heard it from getting in Barry Peterson, who was medical director at Philips, who spent a long time at Pfizer. And he said, medicine is defined by what we know how to measure. And it really stuck with me as somebody who leads a company that builds measurement tools for health, that's our mission as an organization is improving lives by building health measurements that matter. I'm very often struck when I work in in drug programs, but also with new modalities, that oftentimes the measurement tools don't exist for the treatment effects that we haven't yet seen. Right. And so can you mentioned, you know, monetarist, excuse me modest benefit that we're seeing in some of these ad studies that use these endpoints that are scales that everyone will tell you are probably not very good. We know that the depression scales that exist, that have been used for drug studies for a long time have a lot of flaws. So how do you all think about approaching proving efficacy? Is it best to converge toward well understood models, which in a lot of cases, will be established by perhaps prior DBS solutions? Are you looking at disease models that would be making you competitive with pharmacotherapy? Because that's what's important for reimbursement? Or should we be reinventing how we measure some of these technologies benefit entirely? Because what you're doing is outside of the realm of what people may have even conceived of before. I don't know whose best to kick it off with that one, go for it again.

Ken Mariash  24:00  

I'm really excited by the question because it's kind of like what is the Heisenberg uncertainty, what you focus on what measures and then when you focus on it and measure it, it changes? Well, sometimes we're thrown off by measures, right. And there's been this obsession with amyloid for like 20 years, which is something that is measurable, you can see it you can see it on imaging, it's like staring you in the face is an obvious suspect. And that has attracted a lot of attention and 10s of billions of dollars and 20 years of development on what's not a dead end. It's not a dead end. But it's only one piece of the puzzle is amyloid and probably tau too. So measuring amyloid in different ways, is going to open the floodgates to some degree, because it is a marker, it is correlated, but it's not the be all end all. If we don't develop non invasive markers. I think we're doing ourselves a huge disservice because the technology exists digital biomarkers that can that can passively take in data on vocal quality or how Fast you type or even analyze the the intentionality behind your text messages. For example, I don't know I'm making this up, you're better at this stuff than I am, we need to partner on these kinds of markers. Because, you know, patients don't want to have to come in to a clinical study to get the ADAs cog and the MMSE, and the CDR some of the boxes in the ADLs, those are all really important. And I will say we hit all those endpoints, there's gotta be other endpoints that are passively taking into account. And then that would create the ability to learn on the fly too, because you have access to that digital data, for example, those digital biomarkers, so you can constantly improve, instead of waiting for the next $20 million study, to offer some improvement to your therapy, you can constantly improve based on digital biomarkers, and take population data at any time, and react and mine that data.

Cameron Piron  25:51  

Very helpful can others that maybe the, you know, there's interested, I always take, take solace looking at areas like cardiac care. So for years, there was really no quantitative normal, no means to kind of get really definitive numbers out to say what's healthy and what's not, because there's a certain degree of variability of heart, you know, circulatory system, but you can look at blood pressure and heartbeat and, and you know, ventricular size and blood gases and get a sense of where you are, and when you're abnormal. And what you need to do to treat. The brain, of course, is that much more complicated. But we're that much further behind in terms of I think, getting really good biomarkers out of the brain, we do things like brain tractography, to look at connectivity patterns. And, boy, they're very plastic, you know, that's something you see in surgery, remove a tumor in the brain is just fantastic at rewiring itself. So that stable normal is so many different connectivities, 90 billion neurons can connect any different way in the brain. So getting those quantitative normals, you know, I think we're starting to get they're starting to look at cortical volumes, deep brain structure, volumes and structures, what's normal, what's abnormal, I think they're starting to be the strides which is great, but quantitative tools that are non invasive, like you say, to define what the normal and abnormal is and how we modulate them.

Carolina Aguilar  27:20  

And I think we've been looking at the brain in very low resolution. However, there's fantastic clinical evidence from many years, you know, class one, many class one studies that we can use as reference. But as I said, we were looking at the brain in such a tunnel vision way because the tools were not there. And, and it's a constant evolution. So we as a result, we know so little about the brain that I think now with the new tools that are being emerging, we are discovering new signals that we need to correlate to symptoms and an AI, it's going to help us also great time to actually make those correlations and decode much more about the brain and see in much more of the brain. So I think what it's about to come is the exciting part. And I think is what is going to help us to establish new references. It will take, you know, let's say, two to five years to get to the next level, I think we felt that technology that it's been developed, but I think is happening now. And it's going to surpass all that we know.

Chris Benko  28:30  

So I want to ask a question that builds on that. And we've got about 10 minutes left, but this one could probably feel 10 minutes. So thinking about okay, measurement models may need to change to appreciate the advantage of these technologies. One of the things that may also need to change is business models. I lived through 25, I guess, gosh, now 35 years, something like that 30 years of being in the pharma industry, and watching how slow the industry was to respond to new, innovative business models that actually work very differently than selling somebody a pillar of vaccine. Certainly you look at things like cell therapy, right, that changes. Many of you are most of you have worked for classic large medical device players. They have straightforward business models of selling their devices. And they've evolved somewhat and they sell things like CGM, which are interesting solutions. But the business models that I'm hearing represented around this table, have learned a little bit about how your therapies work. It sounds like they may not be so straightforward. There might be a technology and a service or a support solution that gets bundled. Are you seeing business model innovation happen fast enough at the companies that are likely to be acquiring and commercializing your technologies? Do they appreciate how these things may change? Or you're going to have to build innovative commercial business models on top of your technology for it to realize its potential in the marketplace?

Carolina Aguilar  29:56  

I was many years working in valleywise Healthcare, which is a concept that I loved, which is paid member outcomes. So you don't pay for the system that you sell, but by the outcome study that is delivering to the patient. And you usually have bonus and mitosis. So if you get better results that the other therapies, you get a bonus because you are avoiding complications in the future. And if not, probably you have to pay a penalty because your product is fantastic. But he didn't really deliver the results. Now I got to a hospital and I said, Okay, this, it was, it was diabetes, this, this product, or this system is going to decrease 60% Your hospitalizations. And they said, Oh, but I lose 5 million. Right? So there's a lot of interest. That that needs to be changed. I mean, there's a lot of political interest. And then there's a lot of responsibility from all the stakeholders that need to be aligned for these models to be successful. Because the idea is are there but that the system needs to evolve towards a new model of care. So there's a lot of work to do, but valleywise healthcare, it's also getting a lot of ground. And I think it will be a model. I totally believe that it will be a model that is going to create definitely sustainability of the different healthcare systems. That's a lot of work, though.

Chris Benko  31:24  

Yeah, certainly. And we see different maturity around that model in different markets in the world.

Meron Gribetz  31:30  

Yeah. So adding to that there seems to be an orthodox business model of selling to hospitals with the margin to the hospital, in the margin to the surgeon etc. and hardware business essentially, is what what we're, if when we're marketing to the big companies, that's what we're sort of pitching and directly. But there's also the emergence of SaaS and subscription as a service, which software as a service, which really is aligned with what we do, because we're tracking depression, we can not only stimulate to rebalance you out of depression, but we're sensing and building accurate mood graphs on your iPhone, for example. So how can that become a SAS tool for a psychiatrist or social worker to monitor a patient's suicidality? That's another kind of concept. So the way the way, because we have these two, seemingly bifurcated model, we think of it as two layers, you're building your hardware business to make it attractive, and all the acquisition ways are and you're also building a software service on top of that, as a bonus, so to speak, and you don't have to do both in your core.

Nishant Doctor  32:40  

Yeah. So in our case, I mean, at the end of the day, I agree with a lot of the stuff said here, but there is this tool that not a lot of medical device or even pharmaceutical companies use which is cost effective analysis at the end of the day is are you really benefiting the healthcare? And are you really cost effective. So there are a lot of companies with medical device products or even pharmaceutical drugs out there that you see that their negative impact on the healthcare. And if you look through their analysis of the papers, they never ended up doing any of these cost effective analysis, which is kind of becoming I think it should become a norm. Exactly what Carolina said is, we should be doing some of that to really understand your long term impact, are you really saving the dollars or you're not because what happens is when the product is in the market, very rarely, someone does that analysis that, hey, you're being a negative impact on the healthcare. Once it's out there, it's out there, and then you just continue instantly start paying them for the rest of the until someone comes and says, comes up with a better product says hey, we're more really effective than what's been out there. So I think that needs to happen. A lot more in healthcare, I feel.

Ken Mariash  33:48  

I come from the world of Boston Scientific, where it's the usual model of we pay you $40,000 For a little battery that we stick in your back or in your brain. And that's fine. And I know that model and it keeps those big, top three med techs in business, their shareholders happy, but I've also seen the other side I've seen the non invasive stimulators that are not covered, especially the the homea stimulators, there's not a good enough framework, it's gotten to the opposite with with respect to non invasive at home stimulators, having lived that life in a couple of different forms. You know, with respect to art therapy, we're personalizing our stimulation. So what we do is we fire at the brain, and then we listen to the signals reverberating around the network of the brain. As far as I know, every brain is unique, maybe with the exception of twins. And so every patient is going to respond a little bit differently to our therapy. And this is not not unusual. Lots of therapies are like this. So personalizing it takes algorithms and those algorithms have to be refined, which argues for a payment model that that recognizes that value. I don't see that in a lot of areas, whether it's personalized dBs, or if it's The personalized TMS in our case, there needs to be a model for reflecting that. And it has to be beyond just do more work and get more pay. So outcomes have to be tied into it, there has to be a framework for this, it gets to your point about software as a service, that's you're seeing a lot more of that into these devices, especially as they start to close the loop and learn and get smarter over time, there has to be a framework for recognizing and paying for that value.

Chris Benko  35:27  

Cameron, anything to add on that?

Cameron Piron  35:28  

Yeah, you know, we're living this now, you know, CFOs in the audience, we've probably spent a few hours talking about the shift in business model in our area, just specifically under MRI, you know, typically invest millions of dollars in MR system, infrastructure to support it is, is at least that cost if not more, and then you get quite quite lucrative reimbursement each time you scan a patient, and typically it's late in the process. So if somebody is shown something symptomatic, you scan them, but what's now happening is the imaging is moving earlier, the technology is becoming better, less infrastructure, less cost, which means you can do it in a much more preventative manner. So it's going away from the traditional billing codes for late stage diagnostic. But the earlier preventative, and in that billing code is now changing a bit more, you know, like you're saying to not just doing a scan, but getting a full report back. So you don't care about the images as much you care about the data and the information that comes back. And that's happening very quickly, very dramatically now. So right, right in the midst of it, I think it's a really good evolution, and will impact all the different therapeutic approaches.

Chris Benko  36:42  

So it's really exciting to me, having watched the different areas of the digital space, I think recently, it's been covered in stat mine strong kind of coming to an end as a digital therapeutic concept pair is up for sale. And I my personal observation that those companies did not have the level of seriousness that I'm hearing from around the table, in really seeing the line of sight to how you prove outcomes and results and value in health care. Some of that's been chronicled in the media in terms of companies that just worked really hard to get their claims out there before they could necessarily substantiate that it feels, it feels so different with this group. In the two and a half minutes we have left let's just kind of go around in this direction. I'd love to know what is the next really exciting milestone that you hope to be able to hit or share what's what's the equivalent of the next breakthrough that that you want your company to be able to get to that should have us all excited about where the field can go.

Carolina Aguilar  37:37  

For us is first in-human first time graphing will be in the brain of a human being.

Chris Benko  37:45  

That's pretty, pretty amazing in and of itself.

Meron Gribetz  37:48  

We just got FDA IDE approval to conduct the first to first new technology, technology and depression for stimulation. And about 17 years, there's been no new innovations in the largest chronic disorder on the planet. And so we implanted our first patient six months ago, and we're going into a 50 person patient and study in the coming years. And that's what we're planning to raise for. So that'll be the largest invasive study, I think in history and the central nervous system for depression.

Chris Benko  38:22  

That's amazing Nishant

Nishant Doctor  38:24  

for us. So we are in our first inhuman right now we're looking to wrap that up soon. And then our next big milestone is kicking off our pivotal study. So that's going to be our major milestone for the company.

Ken Mariash  38:39  

So for us, we just published unprecedented phase two clinical trial results, Sham controlled, double blind, six months results that are better than any drug I'm aware of. And I've been in the Alzheimer's space for 20 years. The next milestone would be to be able to do that, with more patients in a pivotal study. We don't want to change anything on the recipe. What our scientific co founders have produced is is remarkable data. And if all we do is replicate that in a bigger study, then I'll be very happy and that's our next milestone.

Cameron Piron  39:17  

Track it, hopefully it's this year, but a launch on our head on the Mr. system that does full brain tractography and full resting state functional MRI with a single button push and not needing to, you know, pray, pray to the idols and kill kill a goat to get good data out of it. You need to just hit a button and get all out. 

Chris Benko  39:40  

that's so exciting. Well look, thank you all I have learned a ton I've been inspired and I'm going to look forward to here following all your companies and seeing your next milestone. So thank you for making the time to share your experiences with the group today.

Meron Gribetz  39:54  

Thank you, Chris.