Ryan Myers Presents CranioSense at LSI USA '23

CranioSense is developing a noninvasive solution to monitor intracranial pressure.
Speakers
Ryan Myers
Ryan Myers
President & CEO, CranioSense

Transcription

Ryan Myers  0:04  

My name is Ryan Meyers, I'm the CEO and co founder of CranioSense, a clinical stage medical device company in Boston, Massachusetts raising a seed round, I want to introduce you to a non invasive intracranial pressure assessment and monitoring tool for intracranial hypertension diagnosis. So intracranial hypertension, is a hidden danger to our brains is essentially the over pressurization following medical conditions like traumatic brain injury, stroke, things we've heard about kind of all week cardiac arrest, right. And it affects our healthcare system, from pre hospital to the ICU to at home care. For example, every five seconds in the US, somebody comes into the emergency department with significant risk of intracranial hypertension, risks that include blindness, secondary brain damage, even death, and then they proceed to sit there for six and a half hours as we triage them. In comparison, folks with cardiac problems, chest pains, they're triage in about two hours. So we're either saying to ourselves that the brain is less important than the heart, or we're just not doing a good enough job triaging. And I think we all know in this room that the brain is important. In fact, Intracranial Hypertension is essential to our neural neurological diagnostic workflows. It's just incredibly difficult to diagnose right now. The symptoms are common headache, blurred vision, and the current means of assessing intracranial pressure are highly invasive, and highly technical. And basically, the majority of the United States hospital system does not have those specialties on staff. So we're left the 99% of us with relying on unreliable tools, whether that's kind of analog kind of assessment, like the Glasgow Coma Scale, or secondary imaging, that tells you how damaged the brain is after Intracranial Hypertension has taken set. Now relying on those unreliable tools has both health economics consequences and patient outcome consequences. In an industry where you've seen it on multiple slides, time equals brain, we're basically left to wait for the brain to be damaged to such a state that we can assess it with the current tools today. Now, unfortunately, time also equals money. So that disparity between the six and a half hours and the two hours that we talked about before means that we're we're we have health economic wastage to the tune of about $300,000 per year in the emergency department. And then lost opportunity cost because we're not triaging effectively to the tune of about two and a half million dollars per year per emergency department. So why don't we just triage better? Well, we are not doing well enough getting our doctors the the appropriate diagnostic tools that they need in this space. Now taking examples from cardio, the device should be objective and accurate, of course, right. But it also needs to be rapid continuous, it needs to be not specialized. So we don't have to wait for the neurologist to come down and do this test. And let's face it has to be economically viable for the emergency department itself. This is why we're developing the system. This is why we're going down this road, we're developing a non invasive intracranial pressure assessment and monitoring tool using near infrared light to look into the brain and assess the hemodynamic changes as pressure builds up. Now just in concept alone, this basically ticks the majority of the boxes we just talked about, right? It's rapid, we can move it throughout the IDI we, it fits health economics wise, it's reimbursable. And it's a razor and blades model something that we're all familiar with. And it's non specialized nurses can order this and apply this and take this wherever they need to to get their assessment done. Now, our huge differentiator in this space is that is the fact that we're not just looking at the brain, we're also looking at another part of your body, whether whether that's the extra cranial space on the on the forehead, your ear or your finger, and we're using you as your own baseline. I'm sorry, we're using you. But we are right. Nobody else is doing this today. And it sets us apart in a big, big way. Essentially, what happens is now we don't have to worry about how you come in when we get on you, right? We don't have to worry about your race, your age, your cardiological symptoms, what medications are on board, we can take you and assess your brain and assess your hemodynamics in another place. And that's all we've needed to show. Now we've been able to demonstrate this as this is accurate at our young stage here. My co founder and I have been working on this for about 12 years, or I'm sorry for five years with $12 million in DOD contracts for traumatic brain injury. We've been able to publish healthy human subject data to say that the readings that we're getting off of our system correlate to intracranial pressure that's been published. We're in seven clinics right now, assessing individuals with traumatic brain injury and the EPDs that we've been all been talking about the gold standards today. And with a preliminary data set, we've been able to show remarkable separation between those individuals that are hypertensive so that red and those individuals that are normotensive. So that green, right? This alone is going to kind of rock the noninvasive world. And we're going to publish this data later this year when when our study is complete. So we have the Grail, right? This is great, great news. Why are we going to the emergency department? Well, there are current workflows, we totally intend to service all of these areas, the 10s, or hundreds of millions of people across the globe annually that could benefit from this. But within the emergency department, there are current workflows and current ecosystems that know precisely what to do when we say this patient is hypertensive. And the best part is that disparity with that time, if we can cut that down to just two and a half hours, three hours, the impact is huge, both economically and for patient outcomes, we need to go here first, it's the quickest way to help people right off the bat, within the emergency department, we can help a lot of people as well. But by targeting headache and non traumatic and head trauma, we can we can capture about six and a half million people in the US alone, leveraging a razor blades model that just captures about 10% of those cost savings that I talked about earlier, we can achieve an AR Arr, about 850 million when we do 65% penetration. This is a completely new market, nobody's doing this right now. Now we do have multiple exit opportunities just because of the way our technology works. And because of the size of the market, the logical place to start for us. Because there can be both collaboration and partnership as well as exit opportunities is multimonitor space, you saw our blades, they can plug right in, they look very familiar. It's going to be great for us in terms of a distributorship initially, but then also an exit opportunity. We do have a measured roadmap to get to this point. My co founder and I, having taken this out of the company that we worked with previously have invested now ourselves into cranial sensor, we're raising 1.5 million in a seed round, to essentially finish our clinical data. Hierarchy personnel and start product development and ensuing Series A round will get us all the way to FDA approval. In our first huge valuation bump where we're seeing a lot of our comparables exit. It's our go to market strategy is bolstered by four issued issued US patents that we've exclusively licensed from our the company that we're spinning out from. We do have additional applications and as well, and we'll continue to bolster this around our algorithm and our sensors. We also have an amazing team. This team has been specifically curated for the task at hand. Like I said, my co founder and I have been working on this together for five years. Combined, we have about 45 years experience in bringing innovation from concept all the way through to market. That experience is supplemented with just an amazing clinical teams, some of the leaders in neuro in neurocritical care in our country, and commercialization regulatory reimbursement folks that that we've been working with for quite a while now. Ultimately, the outcome looks incredible cranial sense is going to help early detection, early decision making that early intervention, right that's what we all want to get to is early intervention. Now we're raising $1.5 million. Like I said, we have the team, we have the technology, we can call it the holy grail if we want to, I guess. And we have the timing. We're just looking for the capital to essentially get there. So I want to thank you all for having me. And I'll give you guys 41 seconds back. Thank you

 

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