Video Transcription
Caitlin Morse 00:02
Set. My name is Caitlin Morse. I'm the CEO and co-founder of BrainSpace, and we are launching today our 15 million Series A to transform brain health. So the brain is the one organ we can't transplant. It's what makes us who we are, and yet, one in three people on this planet will suffer from a brain-related illness. Now the good news is our industry has contributed towards helping keep people alive longer; they're surviving, which means that a larger percentage of them are facing neuro trauma that was previously fatal, that they're now having to recover from, or they're facing neuro degeneration that they previously wouldn't have made it to. So that's the good news, but the bad news is there is still so much we don't know about the brain, about how to treat it, and how to keep it healthy. Now, if you think about everything we know about blood, all 10 of the world's largest medical device companies are in some way involved in analyzing or treating something related to blood. So that could be everything from measuring blood pressure and flow and volume to make sure we're getting sufficient nutrients to the body. That could be looking at an analysis of blood for infection, disease, drug effectiveness. That could be managing metabolites such as glucose. You think about diabetes, and it can also be dialysis, transfusion; it can be stents and surgical, right? There's so much we look at about the body for blood. Unfortunately, because of the blood-brain barrier, we don't know as much about the brain from the blood, and so cerebral spinal fluid gives us a window into the brain the way that we have been using blood to see into the body. So we are developing an innovation platform for cerebral spinal fluid. We have an opportunity with automated, real-time, closed-loop systems to be able to see what is happening with the brain, as well as an opportunity to see how we can treat it better in the future. A CSF biomarker enablement platform allows us to combine our proprietary hardware, which is providing access to hard-to-reach places; cerebral spinal fluid is not easy to come by, and it also allows us to develop a unique data set for an area of the body that's not yet understood. However, we've all seen this, right? Where do we start? Platforms are exciting. Biomarkers are fantastic, but we've all seen where, if you don't have initial adoption, people don't know what the clinical trajectory looks like. They don't know how to use that information to treat people. Well, we've all seen the movie. We don't want that to be our story. So this is the part I'm the most excited about because we have a problem worth solving that has existing reimbursement, that has a clear existing need, that has clear existing clinical workflows, and that is around brain pressure. So the plan today, if you have a hemorrhagic stroke, severe TBI, acute hydrocephalus, post-surgical or post-infection, you're going to end up on a system like this. Yes, that is a bubble level. Yes, that is what top hospitals in the world today are going to hopefully use to manage your brain pressure and avoid long-term brain injury. Now, as you can imagine, this is life-saving, but incredibly labor-intensive. It's high risk for over-drainage. It means that they're not getting the data that they need, and it requires specialized nursing care. This was a problem we could solve as an excellent starting point, and so we put the team together to do so. We have a team of people who have developed these kinds of complex systems. They know the hardware, the software, translating user needs into usability, making devices intuitive. And then I also went out and recruited the right advisors, so we have representation from each of the key stakeholders within the hospital system who are making the decisions and driving technology adoption, and so together, we have built the Intellidrop. The Intellidrop solves this problem with an automated connected device. It's a wearable that sits at the ear that's in the fluid path of the catheter, and it's a bedside unit that drives gravity-based drainage. Neurosurgeons have told us they don't want to pump on the brain. It automates the nursing workflows, and it allows for patients to get up and move around. They're no longer stuck in bed, which allows for early mobilization post-stroke and a number of other benefits for the clinical workflows within the supply chain. All of this means that hospitals are able to get patients moving faster. They're able to get them out of the ICU, freeing up those ICU beds, not only for other trauma patients, but also for increased neurosurgical revenue. And while we're doing all this, we're building the data set we need. So this first product, as we achieve clinical adoption, we then start building our first biomarker, and that's leveraging the data that product one generates, and that is around personalized compliance curves. Now there's a saying in neuro: you injure the brain you have, meaning that, depending on the health, the atrophy, that's the state the brain is in at the time you experience a stroke or a traumatic brain injury, you're going to have a different course of action. And yet, today, the Brain Trauma Foundation gives a single number, and most doctors are targeting that single number. Yeah. So the problem is that for some patients, they're going to have significant decompensation, they're going to get bad much faster, and there's not going to be time to intervene. For other patients, they're going too conservative and they're going too slowly, and they're losing additional brain capacity while they're getting that treatment. And so what we have developed is a way to have a biomarker that gives a precision approach for each patient for exactly the care that that patient needs. Now that's the first one. From there, we're actually able to have a platform that allows the incorporation of third-party sensors. So if you think about all the innovation that goes on in the lab, generally, our colleagues in biotech are fantastic at figuring out what should be measured. They don't always have the experience in product to bring that to the market and to the bedside, and so our platform is actually going to allow for that innovation that's happening at the lab to have a much faster path to the bedside and making a difference for patients. And that, combined with our automated therapy, allows for a closed-loop system where we're not just evaluating the biomarker, but we're actually treating as a result of it. So while CSF draining is the starting point right now, it is time to move beyond that, to really see what is possible within the brain and receive the insights that are possible from the brain. So where are we? Well, on the Intellidrop, which is the first product, we started with proof of concept. We hand-soldered the boards, we 3D printed the shells, we wrote the Arduino code. We put it in the hands of 300 doctors and nurses. At this point, we got feedback, and through that iterative process, we have existing DRG codes, we have patents, we have a manufacturable product with high gross margins, and we are in the final testing of V&V and we'll be submitting to the FDA here shortly. On our second product, this digital biomarker, we've been able to do initial benchtop studies demonstrating the efficacy of this approach and demonstrating that the data that we're collecting is sufficient to be able to measure this across a variety of brain compliance cases. And on our third platform, we've done the initial feasibility and have patents pending. So the 15 million Series A that is really to take us on product one into clinical use. So the more that we have clinical adoption of that first product, the faster we generate these novel data sets to drive future growth. Also, having high-margin recurring revenue is never a bad thing, as we all know in the startup world. Commercial activities are funded as part of this and really positioning us with the training materials, the marketing materials, all of what we need to be able to take on that mass market afterwards. And then for this digital biomarker, really being able to go from what is benchtop now into in vivo, and getting that validation that this is a marker that is able to be used in the future, and really ultimately getting us to first in human with that use of funds, and then on the broader platform, there's still a lot of development work to be done. As you know, there are a number of sensors that people have been attempting and started that we're able to then integrate into our platform. So that's really that third step. So this is what our 15 million Series A is for. If this is something you would like to be a part of, we will be not only obviously fundraising, but also looking for the best talent. So if either one of those are things that apply to you, I'd love to hear from you. Thank you very much. Applause.
