Executive readout · one minute
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Conference · 2026-06-03
Executive readout · one minute
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Brandon Vasquez, I am one of William Blair's medical device analysts covering medical devices, but also some animal health names as well. I am required to inform you that if you would like a complete list of research disclosures or potential conflicts of interest, please visit our website at williamblair.com. With that, I'm happy that we have Sarah Bell's CFO here with us, Scott Bloomberg. He's going to run us through corporate presentation. We will then go to breakout room Jenny B. after. I'll remind you at the end, and we'll do a little bit of Q&A there.
So, again, I'm Scott Blumberg, CFO of Cerebell. What Cerebell has developed is a novel point-of-care electroencephalobically, or EEG, platform that targets a variety of serious neurological conditions in the acute care setting, so the ICU and the ED. We've accomplished this by developing a new form factor to make the EEG setup very quick and easy to acquire, and overlaying that with Clarity, which is our seizure detection algorithm, which allows for bed-sized diagnosis and triage of neurological conditions. Since we started commercializing our product in 2018, we've largely played within the U.S. market for seizure in adults in the acute care setting. That's roughly a $2 billion market. Over the course of the past year, we've expanded in additional indications, including pediatrics, neonates, and delirium, which has expanded our TAM, almost doubling the $3.5 billion where it stands today. In 2025, we delivered $89 million in revenue and are currently guiding to $112 to $116 million in revenue as of our last quarter. In Q1, we delivered $26.5 million in revenue, which is a 29% year-over-year growth rate, and we're operating at very high gross margins, 87% in Q1. just to set the stage for our discussion today we view our growth in three horizons we're initially focused in becoming the standard of care for seizure detection in the acute care setting we've made inroads to our longer term vision which is to create a new vital sign around eeg to detect a wider variety of conditions in the acute care setting and beyond that we expect to grow beyond the acute care setting to develop new clinical settings as well as brain biomarkers for a variety of conditions i'm only going to cover the first two horizons today starting first with seizure so typically when investors hear seizure they think about epilepsy and that's not the market we serve generally we serve seizures in the icu and the ed epileptic seizures are visible they're often characterized by convulsions they typically last a few seconds to minutes and although it's a very serious condition a single seizure is rarely life-threatening. Seizures in the acute care setting are almost the polar opposite. They're generally non-convulsive, meaning they're hard to see. They don't typically, the patients don't typically convulse. They can last hours or even days if not treated, and because of the aggressive nature of these seizures, they can be life-threatening. There's a wide variety of conditions in the acute care setting they can lead to seizure. This includes things that you typically think about as neurological in nature brain tumors traumatic brain injury stroke but also conditions that aren't necessarily thought of as neurological conditions things like cardiac arrest and sepsis essentially when there is an acute assault on the brain seizures and autoimmune response and as i mentioned these seizures up to 92 percent of the time are non-convulsive and thus eeg is the only means to diagnose these seizures reliably physicians often say time is brain for stroke and the same is true for seizure that's true for two reasons first is that if you let a patient linger in seizure for a prolonged amount of time the outcomes can get really bad as you see on the left chart there patients lingering seizure for hours can result in a very high more mortality rate or secondary brain injury rate that can that can be establishing seizures for the rest of your life permanent memory loss disability but beyond that the frontline medication which is a larger large dose of benzodiazepine typically if not administered promptly becomes much less effective you can see on the right chart that roughly 80 there's roughly 80 effectiveness of the front line therapy if administered within half an hour and that cuts in half if you wait just two hours and so the societies have started to appreciate and adopt guidelines around the reality that that seizures need to be diagnosed and treated promptly. The first society to adopt such guidelines was the Neuro Critical Care Society in 2012, which suggested that if a physician if a physician suspects status epilepticus, which is terminology for a seizure lasting for five minutes or more, that EEG should be administered very promptly within 15 to 60 minutes. And over the past six years, some of the specialty societies, including the American Heart Association and american stroke association have adopted similar guidelines appreciating the need for rapid eeg and that's just simply not possible with the standard of care this is a conventional eeg machine this this technology has been around in some form for literally 100 years 2024 was the the centennial of convention of the first conventional eeg and it was developed for the diagnosis of epilepsy in the outpatient clinic and it's very good for that purpose In the outpatient setting, speed is much less of an important factor. You can wait weeks for diagnosis, but it's very important to understand functionally where within the brain the issue is occurring for surgical preparation and other reasons. In the ICU and the acute care setting, speed is the most important factor and the precision matters less. And so this technology was applied to the acute care setting and we think misapplied side, and is really not set up to operate well within the setting. And that's because of inherent limitations of conventional EEG. First, it requires a specialized EEG technician to set up a conventional EEG system. They have to manually part hair, clean the scalp, tape or glue on dozens of electrodes. It takes 30 to 60 minutes to set up. But beyond that, you need the tech to get there. You need them to bring the machine in and get to the bedside. and techs are nationally in short supply most hospitals have tech staff nine to five monday to friday so it's hours of delay before you get a tech to the bedside and that's just for signal acquisition once you get the signal you need to interpret it and it takes a specially trained neurologist to interpret an eeg signal and they're not always available immediately and when they do interpret they don't continuously monitor so this results in something that is completely misaligned with what patients need what the guidelines suggest it results in hours or days of delay to get an eeg signal when the seizure is suspected and once the signal is acquired it's very rare that people are monitoring on an ongoing basis and that's what we're changing we've developed a system that allows for rapid signal acquisition and continuous monitoring our system is very simple to set up takes about five minutes to set up it can be set up by a nurse and typically is set up by a nurse in the majority of our hospitals and then overlaying the system is ai which allows for early detection of of status epilepticus and it continuously monitors the patient for the duration of the monitoring timeline the system is shown on the screen and the physical components of the system are composed of a reusable recorder which is shown in the bottom left and plugging into that is a disposable single patient headband which goes around the crown of the patient's head again it takes about five minutes to set up that headband and there's an interface on the recorder that allows the nurse to have a feedback loop to ensure that the signal quality is good and that the electrodes are set up properly and once the system is set up it transmits the eeg data to the web through the cloud to an eeg portal where the neurologist can promptly receive and review the eeg but overlaying the full system is clarity the seizure detection algorithm which allows for interpretation at the bedside as well as continuous monitoring and i'll highlight that here the the top left chart is raw eeg data that's what neurologists interpret it is what you would you see on the screen is 15 seconds of eeg data and these tests are typically administered for hours at a time so in order for a neurologist to interpret raw EEG data they need to flip through and review hundreds or up to thousands of pages of data clarity converts this very esoteric waveform into something that anybody can interpret it does that two ways first on the bottom you see this is on the bottom is the the clarity output for the entire recording of the patient's life cycle and what you see is seizure burden it's the percentage of time that the patient was in seizure over a trailing five minute window so So I would infer that unless there's an epileptologist in the room, there's nobody in the room who can read the top waveform, but I think we all can appreciate that when the bottom chart's high at 100%, the patient's been persistently in seizure, and when it's low in green, the patient's not in seizure. The other way the device translates data into actionable information is via alerts. on the top right you see the recorder in red when a seat when a persistent seizure lasting five minutes or more is detected which is the what what physicians worry about most in the acute care setting the device alarms and turns red i'll bring it to life with a real patient study here this was done a number of years ago at a small community hospital in the bay area and this is the clarity output from a about a five hour recording first thing i'll turn your attention to is the start time of 1am. In the conventional EEG infrastructure where most hospitals have tech staff 9 to 5, it would have been impossible to acquire an EEG waveform at 1am. So that already provides the value of having the nursing be able to set up at the bedside very simply. And when the device was put on, the seizure burden curve immediately shot up to 100%, suggesting the patient was and had been for some indeterminate amount of time been in continuous seizure and so the device alerted and uh the the staff was able to administer uh an anti-seizure medicine promptly um but it didn't resolve the seizure you can see a slight dip in the seizure burden but uh but remaining very high and then uh going back to about 100 seizure burden within 30 minutes or so so the care team was able to escalate treatment at that point and then resolve the seizure over the next hour or so but then at about 4 a.m seizure came back change of medication permanent resolution so this is a patient who spent some time in seizure but without cerebell very very likely they would have seized throughout the entire night the eg would arrive sometime during the the course of the next business day and the patient would have very likely had a very poor outcome we're a very well studied technology We've got 150 peer-reviewed publications and abstracts that demonstrate all aspects of the system, including the ability to change diagnostic care for the better, increase physician confidence, reduce length of stay, reduce transfer, things that matter both clinically and economically. From 2018 until just this year, we've focused only on the adult market. Our algorithm has only been cleared in patients 18 and up. last year we received clearance to for the seizure detection algorithm on younger patients uh both neonates and and children as well as a new form factor um for uh for uh for infants we just announced that we launched that technology in q1 of this year expands our total aggressive market by about 400 million dollars and we've gotten very positive reception on that technology and the reason is that the clinical need the core aspects of the clinical need are no different than adults it's still seizure occurs we don't have a means to diagnose the the implications of not missing a seizure are very high but because there's no baseline with with neonates you don't know what normal behavior is it's even harder to see a seizure without eeg and so the guidelines are actually much stronger in the neonate population they say if the patient has an online condition that has a risk of seizure put eeg on it doesn't matter if there's clinical suspicion or not you can't tell you need eeg and the the the repercussions of somebody right at the beginning of life when they've got years and years of life ahead are profound one hour in seizure alone can result in a 15 drop in cognitive and language ability permanently so that the call to action here is significant if you can promptly identify seizure in these these young patients you can change the entire life of their their the entire trajectory of their life i'm going to move now into the product and business model itself our business model is focused on two revenue streams First is subscription. We charge a monthly subscription for access to our physical hardware, the recorder, as well as the software, both the EEG portal where the information resides, as well as the AI overlaying both the portal and the recorder. That's roughly 25% of our revenue. Most of our revenue is a conventional razor razor blade model, where the razor blade is the single patient disposable headband, and that's roughly 75% of our business. business our business is really projectable we've been commercial for about 32 quarters we've had 32 quarters of sequential growth you can see on the chart the projectable nature of our business and that's inherent to the business model itself the SAS portion of the business model is quite literally a subscription so it compounds as we add more and more accounts and the recorder the headband portion of our business model the disposable is highly projectable we've got a very high customer retention rate. And all this represents itself in high projectability of the business. We're in 680 hospitals now. So we have proof of, we're in kind of that sweet spot where we've got proof of the market need, but we're still only in 11% or so of the hospitals in the U.S. There's roughly 6,000 hospitals in the U.S. that have acute care services, either or both of an ed or icu and then within our existing install base our 680 customers were roughly 30 penetrated in terms of the patients who should be monitored for seizure we have looked at that both looking at patient populations using claims data but also i think more compellingly looking at the difference between our top customers and our average customers when controlling for opportunity which bed size or patient inflows as a proxy for that and we see routinely across all hospital types our top adopters do roughly 3x the volume of the average so our strategy is two-dimensional and our core seizure market in alignment with uh with the two dimensions of growth the account acquisition side of our business really focus on acquiring new customers we added 33 new hospitals in q2 32 in q1 we've got 5400 left to go and so we continue to expand within within new hospitals as well as ancillary hospitals including va where we got a fed ramp high approval where the first medical technology to our knowledge to ever receive that level of cyber security clearance and now access to children's hospitals as well by virtue of our clearance in both neonates and pediatrics on the other side of the house we drive growth within our install base essentially three ways one is by training new doctors reinforcing habits making sure that that everybody within the the er and the icu is aware of our technology and using it actively secondly is training expanding to new departments within the hospital we serve the icu the ed larger hospitals might have specialized icus medical icu trauma icu neuro icu step down units so our our strategy once we're in the hospital is land and expand and try to expand to other departments within the hospital and then finally is uh is patient populations we are often used for a subset of the patients who are at risk of seizure some of that has to do with awareness there's varying levels of awareness of the many conditions that can lead to seizure the conditions that were on that early slide with the iceberg on it and our team is continually educating providers around various conditions that create risk for seizure so that's horizon one and horizon two will be will be much quicker but horizon one is really taking what we've already developed rinsing and repeating replicating our success and becoming the standard of care in the acute care setting as we move forward and we made tangible steps towards this over the course of the past year we intend to make eeg a new vital sign with the acute care setting that has primarily to do with expanding into new indications that are impacting the same patients within the same call point it can be leveraged very efficiently it targets the same doctors uses the same sales force and the the first such indication we got was was delirium we received clearance of that in q4 of last year when a patient comes into the icu or the ed they often present what's with what's called alter mental status which is simply they're acting in a way that's different than a normal baseline That can express itself in confusion or not being responsive or slurring their words. And a wide variety of conditions can lead to that, but the presentation is very similar across the conditions. And the three things that physicians worry about most in the acute care setting are stroke, seizure, and delirium. We're expanding our platform on the same technology deployed through the same sales force to address these top three conditions. we're active in seizure delirium we've got clearance and our just announced about a month ago that we've initiated a pilot with intentions to launch that product formally in q4 this year in q1 and in stroke we received breakthrough designation which allows us to have an accelerated review process as well as a path to favorable reimbursement delirium itself is about a 1 billion addition to our two billion dollar u.s tam and again this is all domestic domestic alone and we also announced uh in uh on our last earnings call that we received a supportive uh proposal from cms for favorable reimbursement for delirium through a new technology add-on payment which adds up to twenty one hundred dollars uh per patient for use of our delirium technology and that that is still preliminary the final decision is expected on q3 this year and if positive will uh will result in uh adoption of the the new new payment in uh in in october so i'm just going to drill into delirium uh quickly here it's it's actually a much more prevalent condition than seizure is in the u.s it's roughly impacts roughly 3 million patients in the u.s uh about 30 percent of patients in the icu suffer from delirium even more on the floor suffer from delirium as well. It really impacts older patients disproportionately. And if you're mechanically ventilated, there's a very high chance that you have delirium about 80%. And delirium is associated with significantly reduced outcomes. Every day that a patient lingers in delirium is associated with about a 10% increase in mortality. And even if you survive with delirium, it has long lasting implications on the patient's quality of life. It can lead to dementia or dementia-like symptoms, things like PTSD as well. It's a very, very unpleasant experience that the patient cares with them long after their ICU stay. And currently the standard of care for diagnosing delirium is a nursing protocol called CAM ICU. It's basically a survey that the nurses conduct on the patient. Physicians have told us this is one of the only serious conditions that they deal with in the ICU where they just don't have a diagnostic and rely on on a subjective measurement and when nurses conduct this survey it's done typically once or maybe twice a day and the output is binary it's just yes or no and so um what we uh are developing is a uh or have developed in our in process of piloting and moving towards launch is a delirium monitor that allows for continuous monitoring of delirium allows for quantification of amount of percentage of time that the patient had a positive delirium reading over a trailing window and allows for a better calibration of care by understanding how the patient's progressing as the doctor tries to rule and rule out the causes of delirium. It's essentially described as brain failure. It's organ failure of the brain. So much like organ failure of the kidneys or lungs or heart, you try to find the stressors that are causing the condition and then fix the environmental considerations in order to solve the condition. And it's very synergistic with our current product. As I mentioned, it affects many of the same patient populations. The symptoms present very similarly. Roughly not quite half of patients who have seizure in the the ICU also experienced delirium. And roughly 40% of patients who have delirium also have some sort of abnormal epileptiform activity seizure or seizure like events. But they're treated very differently. The if you anti seizure medication can actually be a delirium genegation. So if you're aware a patient is delirium, you might choose a different course of therapy. So we think this is a condition where not just as their standalone value of the technology, but there's overlapping values such that we're able to add where the whole of the sum of the parts is greater than the individual parts themselves so as we move into 20 as we move through 2026 our focus on delirium is to have a successful commercial pilot again we're live on that as of this quarter intend to launch towards the end of this year or early next year I haven't mentioned stroke but we we upon securing the breakthrough of stroke we need to conduct the remaining clinical and regulatory paths in order to seek approval for that technology we're also working on our hardware our current hardware is is perfectly capable of being deployed in these other indications but there's uh there's reason to believe that hardware modifications can accelerate growth as we make this a multi-functional brain monitor so where are we going from here we've taken this market from roughly two billion dollars in last year in in u.s tam this year we've with the launch of neonate we are in roughly two and a half billion dollar market and when we launched delirium towards the end of this year or q1 of next year it brings our tam up to three and a half billion and we've got opportunity to expand that even further with things like stroke other new indications or ou s expansion so i'll leave it there we got five five minutes remaining for q a we're happy to field any questions but um we are we are the first and only uh seizure detection algorithm for neonates we are the first and only for for pediatrics first and only delirium uh algorithm uh the first to get breakthrough on stroke uh and uh i didn't i didn't mention this but uh we've received uh fed ramp high clearance from the government uh for use of our cloud in the va system which has has a very high cybersecurity bar, which has been helpful both in expanding our TAM as well as being an indicator of the high standards of our cybersecurity program. So with that, I'll turn it to Brandon if you have any questions or the audience.
We'll get upstairs and we'll do some breakout and we are going to now, right then. We are going to JD for our broadcast. Thank you.