All right, why don't we get this session kicked off? Good afternoon, everyone. Welcome to day two of the Jefferies New York Healthcare Conference. My name is Young Li, one of the med tech analysts on the U.S. team. Really pleased to be joined by management from Hyperfine. We have Maria Sainz, President and CEO, and Brett Hale, CFO and CAO. So this is a presentation session. So, Maria, Brett, welcome. Thanks for coming, and I'll hand it to you.
Good afternoon, and thank you again for the opportunity to share with all of you here the Hyperfine story. I wanna get right into it. Start from base one, who are we? We do have and commercialize the first cleared, ultra-low field, portable brain MRI equipment. We actually have highly proprietary AI-powered technology and a proven track record of innovation and fast iteration. We consider our technology platform as it will serve patients and clinicians across a very broad spectrum of clinical conditions. We are reshaping the brain imaging paradigm. We are complementary to high-field MRI, and we have the opportunity to play in very large markets of clear unmet need for some of the more devastating neurological conditions that keep growing and affecting the population globally. We're able to deploy our system across multiple sites of care.
You'll hear that from me multiple times, but that means anywhere from a critical care room inside a hospital to a neurology office on Main Street. We are a revenue-generating business. We have very broad labeling. We can scan patients of any age, from neonates to patients before death. We're also able to do any kind of brain scanning. We benefit from existing reimbursement. We have early clinical, commercial, and economic proof points, and we already have systems anywhere from high-profile flagship institutions in a country like the U.S., down to remote, low-resource setting, settings in Zimbabwe. So why did we design what we designed? Our intent was to democratize brain MR, to really make brain MRI accessible, affordable, and equitable globally. The intent is to serve clinicians more so than radiologists.
The idea is to make sure that we can enable timely and/or early clinical decisions for patients that suffer from neurological conditions. And we believe, given the clinical work that I will share with you in a few minutes, that we have the opportunity to lower the burden of some of the more devastating neurological conditions, and I'll name just two, which are acute ischemic stroke or Alzheimer's, and as I said before, across a number of sites of care. So conventional MRI has existed for many years, and it is the gold standard for many, many neurological applications. However, it is not readily available, it is not accessible to most. It requires heavy investment, not only in equipment costs, but also in facility setting.
It requires highly sophisticated personnel to operate, and very often, patients that desire or need to get an MRI have to wait a long time until it becomes available. Inside the hospital, moving patients that are critically ill, post-surgical patients in ICUs down to the MRI suite, is also fraught with risk of adverse events that is not insignificant. This is our equipment. This is our instrument. This is our Swoop system. It provides diagnostic quality imaging at ultra-low field. I don't know how many of you know conventional MRI. The field strength is measured in Tesla. Most machines that you might have actually gotten an MRI with are 1.5 or 3 Tesla. Our system is 0.6—0.064—64 millitesla, and yet at that field strength, we provide diagnostic quality imaging.
We offer the standard sequences that conventional MRI does for brain imaging, T1, T2, FLAIR, and diffusion-weighted imaging. We are safe at multiple sites of care. I could have one of our systems right here and take a volunteer and scan your brain, and all of us would be perfectly safe. It's the first in its class. We got cleared by FDA in 2020, and we have over 150 patents. Most of our technology is AI-enabled, and a lot of the sequence magic happens in the software, and all the software is AI-powered. As I said, it's platform technology, which means that we really can play across a variety of adult and pediatric neurological conditions. The broad FDA clearance, as I said, is not restricted to indications. It is really for all broad brain imaging of patients of any age. We're commercially available.
We operate through a small, direct network of sales and implementation specialists here in the U.S. and through a small network of international distributors outside of the U.S. And in our international deployment, we've benefited from a partnership with the Bill and Melinda Gates Foundation through their partnership with King's College London and have close to 50 systems across a variety of low-resource settings with remote implementation, bringing a lot of clinical value to patients. I like to say this is the new face of brain MR. I'll take it from the left. We're talking about a kid undergoing a brain scan, and mom is right there. Mom is right there comforting the kid that everything is gonna be okay. That is not what you get with conventional MRI.
In the middle picture, you see how it rolls down the hallway, through a standard door, rides on standard elevators, so it can be upstairs right behind a critical bed, a critical care bed right now, and then be going down to the emergency room, where it's needed for an incoming stroke patient. On the right-hand side, you see, or at least my right-hand side, sorry, you see actually how it operates from a simple tablet. You do not need to be highly trained to be able to actually pick the right exam for your patient. It connects to the electronic medical records. It takes the images right from our scanner into the PACS system, so it's seamlessly integrated into the workflow at any hospital.
I hope the images help you understand that this can be a win-win-win for patients, for clinicians, and also for healthcare systems. I also would like to mention that I think post-COVID, we all understand that there is a strong push to decentralize healthcare and make sure that the healthcare meets the patient where the patient resides and meets actually the care down from specialty into primary care. I believe those are great tailwinds for the kind of value proposition that we're offering. I already mentioned what a patient gets, but that was a kid. If you're an adult, we hear more often than not about the claustrophobia of going under the tunnel in an MRI chamber, where you are really locked up for a few minutes on your own. This removes all of that. There's a lot more compatibility.
I have to say, this morning alone, somebody asked me whether a woman needed to remove a bra that would have wiring to undergo an MRI, and the answer is no. If you have braces, we will see where your braces are, but you do not need, you actually can have a brain scan with our system, even if you have braces, and that is particularly meaningful for the adolescent population. Clinicians want the information now. We often talk, we talk a lot to neurologists, neurosurgeons, endovascular neurologists, neurologists that are taking care of patients with Alzheimer's, and they want the image right here, right now, to be coupled with clinical symptoms, with comorbidities, with a history of the patient, to make the decisions early before things escalate timely, when really time is brain and time is life.
Hospitals, we have a variety of people that have implemented our system and are reporting economic benefit a variety of ways. There is a very compelling argument to decrease the cost of care when you have access to brain scanning early and can then make a decision about moving a patient from critical care down to a step-down unit or discharge a patient rather than keep a patient waiting for an MRI. You also have a very compelling argument of how we can generate more revenue, because by using our system in critically ill patients, you're freeing up slots in the conventional MRI to drive more patients to those scanners.
Last but not least, in remote care settings, you are able to triage patients and only send a short, a small number of patients to the conventional MRI when warranted, while not incurring the cost of transportation of the full suite of patients that present with any kind of symptoms. This is our journey. We have started inside the hospital. We have started in inpatient care, critically ill patients, because you cannot safely move them down to the scanner. Hydrocephalus pediatric patients because they undergo multiple scanners, multiple years in a row, and no one wants to expose them to the radiation that comes with using CT for that purpose.
We're quickly moving to the right of this chart and actually working on big conditions where the value proposition is also very strong, Alzheimer's disease, and I'll spend quite a bit, a few minutes on it in a minute, and acute ischemic stroke triage. When we start moving to the right, we move outside of the hospital into the outpatient setting, into the emergency rooms, and starting the end of this year, we'll have the opportunity with accreditation, which is something we're working on right now, to also be deployed in neurology offices on Main Street, for the follow-up of patients, for the assessment of patients with cognitive decline, for the triage of patients that present with heavy headache symptoms and the like.
To the far end of this chart, you really see the big blue sky opportunity of really being all about brain health, being about early screening, early diagnosing, monitoring of brain health, just like we do with many other organs of our bodies, the heart being one for women, breast being another one, for men, prostate being another one, but not yet happening in the brain. This is the accessible, affordable, equitable platform that would allow for that to be possible. We're dipping our toes in those waters already with a number of programs that we have started on select populations, like retired athletes, to name one, where we have a strong partnership with an entity called Athletic Heart. So the TAM, the TAM is gigantic at any stage of our journey.
We start with about a $1.5 billion market opportunity inside the hospital for critical care and pediatric hydrocephalus. Cumulative, it moves to about $6 billion. This is U.S. alone, and that is when we start understanding our opportunity really to affect Alzheimer's care and acute stroke triage. And then when we talk about well brain and brain health, it moves quite quickly up to about $16 billion. This is another view of how our TAM works. These are not just big, fat numbers. These are really built up of layers of clinical use cases down the vertical axis and sites of care across the horizontal continuum here.
And you end up with an opportunity to really place units at multiple sites of care to tackle any one of these clinical use cases, some which are chronic, some which are acute, some which are more predominant in an ER setting, again, critical care, or all the way to the neurology office, where, as I said, starting early 2025, we'll have accreditation, be able to be covered by CMS in that setting as well. So I wanna double-click on Alzheimer's. I think Alzheimer's has become a bit of a hot topic in med tech and in pharma since really the amyloid targeted therapies started getting some traction with LEQEMBI's approval last year, that is Biogen Eisai's drug, and then subsequently, a quite quick turnaround for CMS to cover that as well.
The disease is large, the disease is devastating, the disease is growing, and the disease is global. There are some numbers here that you may have read in many, in many other, sort of, or seen in many other presentations. I'd just like to mention one more statistic. I was recently at the American Society of Neuroradiology annual meeting, and I was there last year as well. Last year, there was maybe one session dedicated to Alzheimer's care. This year, there were probably less than over a handful of sessions. And there was someone on the podium that said, "The amount of additional MRIs that are required, if only 20% of the U.S. population that today has Alzheimer's gets the drugs, is 13.5 million additional brain MRs." That indeed creates a bottleneck.
If you were paying attention at the beginning of our, my presentation, I already said there was not enough capacity today, let alone adding something like 13.5 million scanners. That is the area of opportunity for us. Our value proposition is that we have a cleared indication that allows us to scan brains of patients with Alzheimer's already. And, and really, the differentiating factor is the fact that we can streamline the care for those patients. So I'm talking to sites today that want to put our system in an infusion clinic so that right before an infusion, the patient gets an MRI. I have another set of sites that wanna put it at a neurology clinic because that is where they monitor the progression of the disease. And both answers are yes, yes, and yes.
There is no in terms of where you can deploy our system to take care of your Alzheimer's patients. So we're really ready to address this opportunity and have mobilized into a program that I'll describe in the following. First of all, I wanna make sure that everyone understands the opportunity for MRI in Alzheimer's is broader than just monitoring for the ARIA complications that are associated with the amyloid-targeted therapies. It starts from early screening. It starts from really early spotting of the patients that are candidates and likely will develop. It also will develop dementia and then Alzheimer's. It also allows clinicians to really find a more accessible, affordable, and easy-to-use imaging technology to diagnose the patients or follow them longitudinally, as things like volumetric assessment, white matter assessment, and atrophy assessment are really important surrogates for the progression of the disease.
So on the third vertical here is where we're active today. We're actively enrolling in a study called CARE PMR, which is actually comparing our ability to find ARIA complications compared to high-field MRI. We have three sites actively enrolling, and we have a number more in initiation on the study. But we do have R&D efforts across all of the other verticals of the Alzheimer's opportunity. MRI will democratize Alzheimer's care, and will do so globally. So this is the activities today. First of all, we are already gathering the data on our ARIA detection and ARIA monitoring ability. As I said, that study is actively enrolling.
Our technical team is already looking at ways in which we can optimize and address some of the particular custom programs that we may want to develop for Alzheimer's monitoring through AI and our sequence development efforts. And although it is a new disease state for us, we are relatively well embedded already in the ecosystem, establishing advisory boards, relationships with KOLs, attending the relevant meetings, and making sure that that world that didn't really understand that there was a portable brain MR imaging option now understands that exists. So the study is a study that will run in two phases. The first phase is really that comparison with high-field MRI.
It's called the detection phase, and all of these patients are now, are undergoing two scans, one on our Swoop system, the other one on a conventional MRI, to be able to understand our ability to detect ARIA. And then we'll move into a workflow phase, which will actually be broader in reach across more institutions to really understand the different workflow models in which we are able to streamline the care based on a neurology clinic, an infusion center, or potentially even more sites of care that might be desirable to streamline the care for the patients. This is really what it translates into. Today, we're asking the patients to go to an MRI suite.
They'll get a scanner from one of the lead high-field providers, Siemens, Philips, or GE. And we're shifting that in the ability to really bring us closer to the patients and meet them where they are. They could be at the neurology clinic, they could be in a hospital-based infusion center or in a standalone sort of infusion center, if that is the case, or just at an infusion chair at one of the infusion locations throughout the country. Before I close, I wanna make sure that you also understand the fundamentals that drive our execution and the execution of the strategy. Three really important efforts that we're funding and that we're supporting: innovation, clinical data, and commercialization. On innovation, I love this chart. I said before, FDA cleared for the first iteration of the device and the software in 2020.
We're onto our ninth iteration of AI-powered software. We've continuously improved the image resolution, the available sequences, the amount of AI that we add to each of our sequences, and we've been incredibly prolific, not only in innovation, but also in regulatory clearances, with a good track record of FDA clearances, 1-2 a year, and the related international certifications with CE marking and CE certification and UKCA certification. Have close to 50 different published papers across the different use cases that I have mentioned, and I'm also listing on this slide the studies that we have done on some of our use cases of today, hydrocephalus, HOPE, PMR, SAFE- MRI, that's a critical care study with a look at really stroke incidents in patients on ECMO.
I have to tell you already that a patient on ECMO would never have a conventional MRI 'cause they would never be moved down. If they are moved and disconnected, they won't be alive. So that's as simple as that. The active studies right now on acute ischemic stroke triage, that is ACTION PMR, and on Alzheimer's ARIA monitoring, and that is CARE PMR. This is our commercial footprint. We operate directly in the U.S., a relatively small footprint. We have a selling team, an implementation team, and we also have, of course, a technical service team, and we have strong partners internationally. We have a handful of distributors in key European markets, and we recently signed a strong partnership with a distributor in India to bring our technology to India.
I am particularly excited about that market because of how vast it is and how underpenetrated it is for MRI. This is our financial profile. You have our 2023, and then our guidance for 2024. Posted 60% growth, $11 million in revenue in 2023. For a company of our stage and our size, quite an impressive gross margin at 43% last year and a pretty significant reduction in spending last year alone, with a cash burn of $42 million. We've guided to $12 million-$15 million for the top line this year. A further improvement in gross margin, 45%-50% gross margin, and a cash burn that would sit right around the $40 million. We operate lean, and I have a very lean but high-performing team. Brett is here with me.
Tom is our Chief Operating Officer and run all things, manufacturing and technology. I'll just leave you with a high-level story. FDA first FDA cleared in its kind, so we're really building a new market. We're not competing. We're complementary to conventional brain MRI. We are a prolific engine of not only innovation, but regulatory approvals and clearances. We have a blueprint of really changing the paradigm in brain imaging to render it more accessible, more affordable, and more equitable. I believe our financial profile is very impressive for a company of our stage, and we have a very experienced team leading the charge forward with myself. Thank you very much.