Caitlin Morse Presents BrainSpace at LSI USA '23

Transcription

Caitlin Morse  0:05  

The brain is the one organ we can't transplant. It's what makes us human. And when it gets damaged, we lose a piece of who we are personalities change, independence is lost. Now, there are many causes of dangerous pressure on the brain, stroke, traumatic injury hydrocephalus, we heard last night, that time is brain, all of these in the acute case, need time to recover, to heal for the swelling to go down. And all of that is accomplished with a common method. Unfortunately, top hospitals today are still depending on a drain that was developed in 1927. The same year, we went from the pocket watch to the wrist watch. It's high risk, it's labor intensive. And it's missing critical data, it means that these patients have to be in the ICU, and they can't move for days on end. So we have developed a solution that is automated that combines continuous monitoring, and automated controls of drainage. With our small wearables sitting at the ear, were able to get patients up and moving around. There has been research showing that early mobilization, post stroke can improve long term outcomes. And we are creating data that is annotated, clean and labeled at the source. So when you think about what does that look like in terms of a market, there are three primary types of patients that benefit from our system. And today, they're all found in the neuro ICU, from neuro trauma, dementia, and surgical recovery. So we're taking an existing workflow with existing DRG codes. And we're following the existing trauma guidelines to automate care. So when you think about the market, most of us in med tech are familiar that those neuro ICUs, those specialty centers are really who starts things off. So that's where we're focused. Initially, there are about 25 facilities around the country that really drive standard of care. Beyond that level, one, two and three trauma centers, and then ultimately, any hospital with a neurosurgeon, and frankly, for lumbar drains, any anesthesiologist can place it's a very simple surgery to get the device in. And our recurring revenue is a huge part of that expansion. So when you think about our first type of customers, what are they excited about? Well, they're excited about that high fidelity data. They're spending an average of eight hours per MD PhD time right now per patient just to clean up that ICP waveform. So when we're able to tell them, yeah, that one doesn't matter. That was when the nurse was rolling over the patient, Oh, this one does matter. Nothing was happening right now, why did the brain have a change that is incredibly relevant for them for their machine learning training sets, as well as for future biomarkers. Then you think about those early adopters who are looking at the clinical workflow. So as I said, right now, this is a manual process. It requires our IRB back to study showed four to 20 times per shift, nurses are coming in and fixing the system, they're going through all of these steps of recalibration of re zeroing. And the patient that entire time cannot move. In our system, they don't have to worry about any of that we're tracking it all. We're managing it all, we have automated controls based on pressure or flow, allowing them to experience what they need to recover. And it's not even just the time that the nurses spending themselves. It's also the fact that anytime anyone else comes in one of our advisors recently had a patient drop into a coma, after a tech adjusted the height of the bed for a test they needed to run and caused over drainage with the existing systems, it is extremely dangerous. So getting that nurse available means that these patients can get out of the ICU in a lot of cases into a step down unit into lower cost of care. And when you think about mass adoption, so say 10 years from now, everybody's using a brainspace device, what changes then? Well, it's not just the care of those patients today. But if you have automated algorithm based controls, you can offer precision medicine in a way that's just not possible right now, that leads to more equitable access, you don't have to be within 30 minutes of a tertiary Academic Center to get this kind of care. Optimizing nursing also addresses the shortages that are going on right now there are more ICU nurses retiring than there are getting trained. And what that means on the data sets is we're able to understand the brain in a way that humanity doesn't currently. It also means that running clinical trials, which right now in the ICU is extremely challenging, randomized clinical trials have considerable ethical considerations when you're talking Life and Death patients. There is now the data that's needed to be able to run those retrospectively, to be able to follow protocols of other hospitals. And so there's been tremendous industry interest from the neuro intensivist group around how can we actually improve practice of care across the full range of hospitals and patients? So who's building all this? Well, we have an experienced team we all have spent a decade or more in med device development. We have walked alongside startups as well as strategics. On how do you take a product from a hack together prototype to scale production, we have experienced in the 510 K pathway have taken many products through that process and are very familiar with what it takes to get not only that initial clearance, but really a product that will scale with the margins that you need to be successful. We've also gone out and recruited a team of clinical advisors. So we are not a university spin out, we've had to go one by one and find those people and convince them that this was the thing they wanted to spend their time and energy on. And they can not only come from academic institutions like NYU and tufts and Columbia with that expertise, but they also have experienced in the private system such as Providence, they also have experienced in more rural areas where a neurosurgeon might get three calls in the first 24 hours with the existing technologies. And they also have sat on value boards and hospital decision making. And so they're really able to give us that input and are involved on a weekly basis. So we've made efficient progress. So far, we started in 2021, built out this proof of concept, which was in our wetlab, aka guests bathroom, thank you COVID. And have then been able to build a functional prototype that we put into the hands of more than 200 more than 100, doctors and nurses and talk to another 100 We have seen products that only talked to a few people and get into the market and discovered that's not what people really want. So it was really important to us that we really talked to people across the full range of process and full range of practice to make sure that we were developing a solution that would work consistently. We now have built, we're now under controls building and testing for what will be our FDA submission later this year. As we get on market, we will continue to innovate. So part of what our clinical partners are most excited about is running these studies to really be able to identify new biomarkers. This is all information that is available with our system to be able to show how we improve long term outcomes and reduce long term disability for these patients. And really beyond that, we're not going to be one hit wonder we've got not only our first patent which covers this system, but it also covers a number of other pressure. So blood pressure, intra abdominal pressure, and longer term, we have a number of patents that are pending around how to really make this a biomarker enablement platform. Access to cerebral spinal fluid is a real challenge. Right now it's a limitation for a lot of researchers that are looking at neuro dementia that are looking at TBI. And unfortunately, a lot of models from the animal have not really translated well into humans. And so there's a real opportunity beyond the initial case of treating patients today to really advance the scientific understanding and future treatment of patients with neurodegenerative disease. So, we're a strong founding team. We've done this before, we know what we're doing first time CEO, but not first rodeo. We have an existing workflow existing DRG codes were fitting in with the existing workflow, we are not replacing the internal catheter neurosurgeons have their favorites and they don't want it messed with we connect where you exit the skull to keep neurosurgeons happy. And that also makes it easier for us. We have not only the pricing parity in the DRG for now, but we also recruiting this novel data which is allowing that expansion into the future, which is allowing for machine learning and AI applications that right now are cost prohibitive because what it takes to put the training set together, and we really are building for a highly profitable and highly meaningful business. So we're raising our Series A we're also recruiting and we have clinical partners that we're putting in place for launch. If any of those things are of interest to you. I'd love to hear from you. Thank you very much