Okay, we'll get started here. Good morning. Welcome to the twenty twenty five Piper Sandler Healthcare Conference. My name is Kyle Winborne. I'm one of the MedTech Analysts here at Piper Sandler.
I'm pleased to introduce the management team from Cerebell. With us, we have Jane Chow, Co Founder and CEO. Thank you for being here this year and I'll let you take away with the presentation.
Thank you, Kyle. Good morning. So we have about fifteen, twenty minutes. I'm going to walk you through the overview of the company, the clinical unmet needs we're trying to solve, as well as our product solution commercial model. And we also had a fantastic year in 2025.
We'll give you overview of what we have accomplished. At the highest level, Cerebell has developed a novel neuro monitoring platform. It has the hardware which you see here that makes EEG acquisition really easy. I'll walk into more details instead of specialized technician, nurse or anyone can set up EEG, which is a very tedious and long process in just a few minutes. We also have a very strong AI algorithm called Clarity.
So for now, Clarity use AI and EEG focus on seizure detection. As we'll talk later, we are also using it for other indications as well. For now, we laser focus on seizure detection in acute care settings. That is ICU ED and the floor. And in US alone, that translate to more than $2,000,000,000 TAM.
We use AI and EEG for other indications, still focusing on acute care, potentially delirium or stroke, and that would be a significant market expansion. The last quarter, we did 22,600,000 and we're active in more than 600 accounts already and we're US only. And that translate to 31% year over year growth and the company wide gross margin is 88%. So I mentioned we currently focus on seizure detection. So I'm going to walk you through what is the unmet need there.
Often when we think about seizure, we think about epilepsy. And three things come to mind. You see these patients have convulsion, you see seizure. And then usually patient sees for a few minutes and seizure stop. And even though it's a devastating disease state, but it's not life threatening.
Patient can live with epilepsy for decades. Now, when you go to ICU, everything you usually associate with seizure are wrong. Most of the seizures in ICU are not visible. So you have to have a EEG to detect seizure. And they don't last just for couple of minutes, they can last for hours or even days.
And as a result, they lead to very high mortality and mobility. So as I mentioned earlier, it's very common. About a third of the patient in the neuro ICU have seizure. You can see following convulsive status epilepticus, you're going to hear me saying status or status epilepticus over and over again, is one of the major neuro emergency in the ICU is defined as seizure lasting for five minutes and longer. So if you see patient have a convulsion, have five minutes longer seizure, more than about fifty percent of the time they will follow-up with a non convulsive seizure or patient have brain tumor, TBI, post stroke, somewhere between twenty percent to forty percent of these patients would have seizure.
It also goes beyond neuro patient, as you can see sepsis patient, post cardiac arrest patient. The common theme here is when patient had a neuro attack, It's this type of seizure is a very aggressive autoimmune response. That's why the seizures are much, much more aggressive as you typically see in epilepsy seizures. Ninety two percent of these seizures in ICU are non convulsive. So you can see patients lying in bed quietly, family members sitting next to them, and they are having a condition that can lead to very high mortality and morbidity.
So you have to have EEG. This is, we often say time is brain for stroke. And our physicians use this over and over again, say time is brain for seizures as well. It's considered as again the second neuro emergency right after stroke. And here's why.
On the left side, you can see if patient sees for hours, ten, twenty hours, thirty three percent mortality rate. More than twenty hours, eighty five percent mortality rate. The gray bar on the top is the comorbidity. So even when patients survive seizure, they would go secondary brain injury. You might wonder which modern ICU will leave patients seized for ten, twenty hours.
That's unthinkable. I'll explain to you why. It's very common. We can walk to a neighborhood hospital, very likely without cerebellar patient will cease for ten, twenty hours. And another reason very similar to stroke, early detection is important.
If you treat this seizure within first thirty minutes, patient respond to the first line medication really well, eighty percent and case closed usually for these patients. It's a large dose of benzos, nurse and physicians can easily admit it if they knew patient have seizure. So therefore, the early detection, therefore early EEG is one of the most important factors for seizure management in acute care setting. And guidelines already shown this. More than ten years ago, Neuro Critical Care Society required EEG within fifteen to sixteen minutes.
And then later American Heart Association, American Stroke Associations have different guidelines for post cardiac arrest patient management or post stroke management. Before Cerebell, not a single hospital globally can be complying to this guideline, especially about fifteen to sixty minutes. And the reason is that the standard of care is the conventional EEG. It was invented more than one hundred years ago and very little has changed. It was designed for epilepsy monitoring, which is outpatient, where a patient can wait for weeks or months.
It's not designed for acute care where every minute counts. So here's why. The conventional EEG requires a EEG technician. Nobody else in the hospital can set it up. If you go to a typical hospital, there'll be one or two EEG tech.
They have banker hours, non investment banker hours, commercial banker hours, nine to five, Monday to Friday. And that's 25% of the total hours. So 75% of the time, there is no EEG coverage and patient don't choose to cease doing working hours. And even then tech arrive, it takes thirty minutes to set up, and it's a big cumbersome machine. And even when you set up EEG, it doesn't help patient care.
Very, very few, even neurologists can read EEG, and mostly they are epileptologist and neurophysiologists. Again, go to a typical hospital. If you are lucky, you have one or two physicians in the entire system can read EEG. So the reality of getting a EEG is always taking hours and often days, and nobody really continuously monitor these EEGs for seizure. So if you were a ICU or ED physician on the bedside, your choice are very limited.
You are kind of shooting the dark quoting our physicians. Have three options. You wait for EEG, but then if you wait, you know this mortality rate go up. What if your patient have seizure? So often physicians decide just to treat, just guessing, just to be safe in case patient have seizure.
But if you treat before any EEG, often this seizure medication repress the respiratory system, you have to intubate the patient, send the patient to the ICU. It's already against guideline, of course, it lead to very long length of stay when you intubate the patient. And the third option is barely option, you transfer patients out because you're really worried about it, you want to go to a tertiary center. So we changed that because the information the doctor need is, is my patient seizing or is my patient in status epilepticus lung seizures. So instead of waiting for hours and days, calling your neurologist, then 5 later or a day later get a read.
We have a system that nurse can set up in a few minutes and have AI algorithm and read every ten seconds. So how does it work? This is a system you see on the top side is the disposable single patient use headband. And they connect to a recorder that's a little bit bigger than your phone. This allows nurses, really residents, anybody on the bedside set up EEG in just a few minutes.
That's equivalent to majority of the functionality of conventional EEG. And then the data will stream through hospital WiFi to our portal, and this is where neurologists can log in and review EEGs in real time if you have a neurologist available. More commonly, you do not have a neurologist available. So this is where our clarity comes in. This is our AI algorithm.
So I walk you through. If you look at the the side of the screen, the top part is what you see if you were a neurologist. That's EEG raw tracing. I hope this help you to appreciate why this is so complex. It takes about two year fellowship training to really managing and master reading this.
But at the bottom is this curve. I don't think I need to educate you anything. Your instinct is, okay, the red thing and the peak doesn't look good. And that's exactly where seizure happen. So what what Clarity does is we look at the EEG every ten seconds, and then we decide whether or not that ten seconds EEG is seizure or not.
And then we report the curve called seizure burden is defined by American Neurophysiology Society is the percentage of time patients spend in seizure during the past five minutes. Hundred percent means five minute seizure, that status epilepticus. Zero percent means patient seizure free. And also on the bedside, the device would turn red if status is suspected because that's really ICU physicians are are are monitoring and and managing. They don't really care too much about quick short seizure.
And you can also see the seizure curve. So that's a lot of information. I walk you through a patient case. So this is a hospital, actually a community hospital, about 200 bed in the major hospital system in the heart of San Francisco. It's not a rural area.
Right? Very typical. They have two EEG tech. They go home after 5PM. This patient at 1AM, nurse worried about the patient had very some very subtle symptom.
She's not sure of seizure or not, and she called the ICU doc. The ICU doc was still at home, and ICU doc said just put the EEG on because he's covering remotely. Within the first five minutes, the device turned red and start beeping, Saying your patient is in sync status. So almost very, very few hospitals you can count with your two hands how many hospitals can get EEG at 1AM in the entire country. So we got that.
And then even when you get one AM EEG, most hospital would have nobody to read it. And immediately, the bedside no patients in status. And you see the first little pink icon there with the needle. That's actually the best site annotation. The nurses treat the patient right away.
But in this case, patient actually didn't respond to the first line medication, if you recall the earlier site, Eighty percent patient respond, twenty percent don't. So half an hour later, the device turned red again and alert, hey, your patient's still in status. And they escalate the treatment, the second pink needle. And you can see the curve, the patient stopped seizing. So they see patient responded, but seizure is dynamic.
You don't manage seizure once. At 4AM, this patient actually returned to seizing again, and then the device turned red. And then we treated and the patient become seizure free again. This patient is not outlier. It happens all the time.
So in many hospitals, we set which patient will be left in seizure for ten, twenty hours. If this patient is lucky, she would get a device the day after, and that will be at least twelve hours, and mortality rate is thirty three percent, and mobility rate is more than fifty percent. And in this case, patient actually woke up the next day and was discharged from ICU many a couple of days later. So this is anecdotal. How about the real clinical evidence?
We have published more than 45 peer reviewed journal, more than 100 abstract already. In the earlier days, we try to validate, hey, our device is equivalent to conventional EEG, how clarity performs really well. More recently, the past few years, we more focused on the clinical outcome. We have shown multiple publications, about twenty to fifty percent of the time when physician use our device, they change their treatment decision. That's a really high portion.
It's either I decide to intubate the patient to, okay, I decide patient actually have no seizure. I don't need to send the patient to the ICU. I can just monitor and look for other things or I didn't think patient have seizure. And then you find patient have status, you were able to intervene right away. The biggest study came out last year, SAFR trial.
It's a retrospective of 1,000 patient. We showed that we reduced length of stay in the ICU by four point one days. We also showed that we improved clinical outcome by eighteen percent if you count the percentage of patient have severe disability at discharge. That's one out of five patient were able to not having severe disability after after in the ICU stay. So and we also published a lot on the health economics front.
Our business model have two components. Our revenue 25% is from the subscription fee and that's a monthly fee hospital pay us. They have access to our entire system hardware as well as clarity. The disposable part is the single use headband that's about 75% of our total revenue. We are very proud what we have accomplished in terms of commercial.
And as I mentioned in the earlier past quarter's earnings call, in all our 30 commercial history, we don't have a single quarter that's not higher than the previous quarter. Right? And including COVID and everything, it really speak for the business model itself, as well as the big unmet need we're addressing that the behavior change is quite sticky once physicians see the value here. I mentioned our total TAM is about 2,000,000,000 and how do we get there? It's three million patients in The US and then we did both bottom up and top down counted what are the populations that potentially have high risk of seizure.
It also accounted into about total 6,000 more than 6,000 hospitals. All the short term acute care hospitals and recently as we achieved a FedRAMP high, we were able to expand to the 200 have access to the 200 VA hospitals, critical access hospitals, freestanding ED, and children's hospital as we expand to the pediatric population, which I'll talk more about. So our growth strategy is for the next couple of years, they are going to be laser focused on the commercial existing product in The US. And that because even though we're very proud of what we have accomplished, we're only about 3% penetrated in The US market. With that, we're going to drive account adoption and utilization, continue to drive the disease awareness as well as generate more clinical evidence.
We also have the second and third horizon of our growth opportunity, which I'll dive deeper, and that include goes beyond seizure, and that's potentially a multibillion dollar TAM expansion. So what do we mean by that? We look at our growth in three horizons. The first one is seizure management in the acute care setting. That's three percent penetrated in The US, 2,000,000,000 market TAM.
The second horizon is to make EEG a new vital sign. Brain remain a black box, even in the best ICUs in the country. We monitor the heart and many of our different organs. We have doctors say, okay, let's say you have a cardiac arrest, you have a patient who did a major cardiac surgery and patient come back and didn't wake up after surgery. And now patient have zero point five percent chance, one percent chance having a stroke.
A patient could be just over sedated. A patient can have non convulsive seizure. You actually don't really have a way to know in the best hospital. You can send patient to a CT, that's a quick not accurate check only for stroke. And so you don't have any monitoring.
So this is where we believe with AI and our big EEG database more than a million hours. We can open this white space that you can potentially have a continuous brain monitor that would tell you this patient's having nonconvulsive seizures, or this patient might have a stroke, or this patient might be over sedated. So just like we monitor all the EKG with all the patients that have any cardiac risk, we should be monitoring patients' brain in all the neuritis use. So that's the second horizon we are taking a lot of action on already. The third horizon is potentially goes beyond acute care setting.
EEG has been proven to be any neurological disease like depression or dementia. So I'm going focus on the first and second horizon. For the first horizon, we continue effort in the past year, in this coming, in this year to become standard of care. On the market expansion front, we are the first and only medical device company achieved FedRAMP high cybersecurity. And that give us access to the entire VA hospital system.
We successfully finished the pilot and we have the commitment from the VA to roll out to additional hospitals. And in terms of population, we have gained clarity and hardware on both pediatric one year and older, as well as neonate. Again, we are the first and only company that has a seizure detection algorithm covered this population. That's a 400,000,000 market TAM expansion as well as access to two eighty children's hospital. On the second horizon, it's not a science fiction we're talking about.
We are taking very tangible milestones. We are well on track with our delirium five ten k indication. And we also have received a very positive feedback at American Delirium Society. We are also making major progress on the stroke algorithm as well as our potential second second gen hardware that further improve both for seizure and as well as our future indications. So in summary, this is a platform that's truly saved lives every day and has a validated reoccurring commercial model and has strong first mover advantage And also not just in seizure market, only 3% penetrated, but multiple indications on the horizon in the next couple of years can further significantly expand the TAM.
Thank you.