BrainScope | Susan Hertzberg, CEO

(Transcription)

Susan Hertzberg  0:02  

Good morning, everybody. Susan Hertzberg, I'm happy to be back at LSI this year, update you on our progress in commercialization of brain scope. First give you a little bit of background on who we are and our device. We are the first and only FDA cleared decision support tool for the comprehensive assessment of mild traumatic brain injuries, including brain bleeds and concussion. In terms of kind of a quick summary, we're revenue stage, disruptive neuro technology platform today we're focused on brainwaves and caution. But we see other indications in degenerative disorders, stroke, etc. We're exceptionally well validated at this point 32 Peer Reviewed clinical studies 23 clinical, over 90 clinical sites, highly experienced team and a rapidly growing customer base, which I'm excited to tell you about. 89 granting patents, and eight FDA clearances. So just to frame the problem. And so looking at some pre COVID numbers because as as activities reserves resume, we know that these numbers are coming back. 5 million head injured patients sought care at America's emergency departments pre COVID, 4 million of them received head CAT scans, noncontrast had CT'S, and of those 3.6 million or negative 91%. Patients are coming in seeking answers. If we think about the tragic death of Bob Saget, which was all over the news recently. Certainly you want the CT, you want the structural injury classifier to rule out the likelihood of a brain bleed. But the problem is, the vast majority of those patients don't have bleeds, it's very small percentage, the vast majority are often concussed. And all the CT in the world tells you absolutely nothing about that. As we started commercialization, what we see in in the data recorded back from our customers is that in fact, the vast majority of these patients are concussed. So if we think about what's happening in the emergency rooms where these patients are seeking care today, what we know is that head CT is most often the tool of choice, that's going to rule out the brain bleed really important tells you absolutely nothing about concussion. And on the concussion side, most DD'S do not do an assessment. The tools are old, they're highly subjective, we see it in the sports world all the time. They don't take the time to do it. They basically say to the patient, if your symptoms worsen, come back or call your primary care physician, these patients aren't getting steered to appropriate care. So what does brain scope do? Well, in a two minute EDG collection, using two separate FDA cleared algorithms, we can provide results for both structural injury, brain bleed, and functional injury concussion. It's a handheld, portable, Android based unit that can connect to a Disposable single patient single use headset, and the entire assessment takes under 15 minutes to run. If we think about what the tools are in the EDS today, what you can see in this slide is just how well we compare two standard of care tools for various assessments. Our performance characteristics are well above those of others. And the one we get compared to most frequently is actually d dimer, which is to rule out the likelihood of a blood clot. And here we're ruling out the likelihood of a brain bleed. If you're going to introduce yourself and triage into an emergency room, you better be fast, simple and intuitive. We can basically put a brain scope device in somebody's hand who's never seen it before, and have them run an assessment and get it done. Without any training at all, just based on the intuitiveness of the device. It can be used under the auspices of any physician so it does not require a physician or nurse. It can be done by a med tech or other personnel. And again, simple easy to use the screen actually right lights up red or green so you know you have good conductivity and placement. So we make it pretty difficult to make a mistake with the device. We're an all comer test also really important right? If you're going to come in you don't want people going through a lot of mental exercises of this patients on blood thinners therefore we can't use them. They've got to be this or that. So So 18 to 85 years of age within 72 hours of injury, Glasgow Coma Scale of 13 to 15, you are good to go with brain scope, you can be drug or alcohol impaired, which is 30 to 50% of head incidents, involve them on blood thinners or other medications, your brainwaves don't get altered by those chemicals. And so we're really come on if you meet those three basic criteria, you are a candidate for Brain Scope. Our results are really simple to interpret. On the structural side, big green and red boxes for negative and you know, that patient does not likely have a brain bleed and send them home. And then on the functional side, concussion, our FDA clearances that we scale with level of severity. And so we're showing that on a graph, so that it's easy to interpret the severity of a concussion. We also impact length of stay. And I'm going to share that in our clinical outcomes in just a moment. Taking a lot of time out of these low mid acuity patients who end up spending up to six and a half hours in an emergency department often waiting for a CT, we have a third FDA cleared algorithm specifically for concussions and concussion management, think about the sports world and anyone that you want to serially look at over time. So the concussion index is really groundbreaking. It's the first of its kind, and it is a stable measure that can be reliably interpreted in concussion management. So how are we doing? You know, we made the brilliant decision to commercialize this technology to America's emergency departments at the start of a pandemic, it was a challenge, to say the least. But we have made tremendous progress. And in fact, you know, and as many of you know, in early adoption, you think you're looking for the needles in the haystack, who'll give you a shot, we've actually found just an overwhelming, warm embrace of what we're doing and an understanding of the need. And we're getting through a lot faster than we thought. We conducted and completed two important pilots last year. And the first was with I know the Fairfax Hospital, a level one trauma center. And what they showed was a 60% reduction in their use of head CT, when they use brain scope and triage, just an enormous benefit. And by the way, twice as good as what we had in our validation study, which was 30.8%. And in that same population that 50% of the patients were actually concussed. They did a survey at the end and it was off the charts and customer satisfaction. They love the use of the technology. They loved getting the answers they actually need around concussion. At Coleman regional hospital level three Trauma Center, similar kinds of results there a 40% reduction in head CT 54% of the patients turned out to be concussed and there they actually were measuring length of stay. And they saw 138 minute reduction that is before optimizing workflows. So we know that there's more those lead to significant benefits. Overall value proposition there's established reimbursement there's opportunity cost benefit and getting these patients in and out high patient satisfaction, increased throughput and patient safety in the in in the reduction of radiation to the brain. We have gotten into over 25 customer accounts in this past year, GPO contracts. We're rapidly expanding we actually have a bit of a backlog as as we wait for COVID to recede and onboarding some specialty distributors. We have other indications as I said, this is a summary of key messages and where we are today is seeking new investment to more rapidly expand our commercial operations all the signal of the interest is there. We are out in the market and we are getting new adoption. Thank you.