Great. Thanks, everyone, for being here. I'm Jason Bednar from MedTech here at Piper. Really happy to have with us for our next presentation, from Hyperfine, President and CEO, Maria Sainz, and Chief Accounting Officer and CFO, Brett Hale. Turn it over to Maria.
Great. Thank you, and thank you for the opportunity here to share a little bit more about our Hyperfine story. These are our standard disclosures. At Hyperfine, we have developed, and we commercialize today, a unique, ultra-low field, portable brain imaging system. The system has been designed to provide affordability and accessibility to brain imaging to patients and clinicians in multiple sites of care. The Swoop system, which is the brand name for the system, provides clinicians with timely and early diagnostics for critical brain conditions and multiple critical brain conditions. As I said, we are commercial today. Our beachhead market today is inside the hospital, primarily focused on critical care patients and pediatric units.
But we're starting to explore utilizing our system to triage acute ischemic stroke, so migrating from the ICU to the emergency department of hospitals and further out into office-based settings for the monitoring of brain risk for patients on the new amyloid-modifying drugs for Alzheimer's disease. If any of you know of brain imaging today, MRI is extraordinarily effective but has multiple limitations. It is high-cost equipment. It requires hospitals and facilities to provide infrastructure to shield the units for safe operation. With that, they also require highly specialized personnel, and all of that creates the limitations of availability, which ultimately creates wait lists, delays in getting the brain imaging, and with that, delays in getting the brain care that patients need.
Inside the hospital, this becomes even more problematic, as a lot of the patients that are in critical care that would benefit from brain imaging cannot be safely or efficiently transported down to the MRI suite to get their brain image in a timely manner. So I want to introduce you to the new face of brain MRI. It is one where you, as a loved one of someone undergoing brain imaging, can hold their hand and say, "It's going to be okay." So everybody hears of claustrophobia. There's none of that. This is very patient-friendly. In the middle picture, you see really how this is transported throughout the hospital. It is designed to go through standard doors, ride in standard elevators, and go from patient to patient to really bring the brain imaging to the patient's bedside, where it's needed the most.
The other picture here illustrates how patients that are very compromised and cannot easily or safely be transported to the MRI suite can get their brain imaged by just bringing our unit behind their bed and actually scooching the patient's head into the head coil and running whatever sequence are most appropriate for that patient. I've talked about a number of brain conditions, but two that strike me as incredibly compelling opportunities ahead of us are really the opportunity to play in acute ischemic stroke and Alzheimer's. Two conditions that have daunting numbers associated with them. The numbers are global, and the numbers are not going to get any smaller as the population ages on a global basis. So this is the system. It is 64 millitesla, so 0.064 tesla.
At that incredibly low field strength, we're able to provide diagnostic-quality brain images in multiple sites of care. We do have the safety profile that allows us to image anyone right here, right now. We are the first and the only one in its category, so we are building a brand-new market of a new medical imaging technology. We have a highly proprietary position with over 150 patents, and all of our software is AI-powered. We have a very broad FDA clearance. First clearance was obtained in 2020. Our clearance does not have any age limitations, so we can go from birth to death, and our clearance is for brain imaging, so it is not tied to any of the critical brain conditions that I have described, which means that all of the clinical studies that we run are not about regulatory approvals.
They are more around market development, market adoption, penetration, market expansion. In the U.S., we are covered under existing CPT codes, and although our focus commercially is in the U.S., we have started to see the potential globally through a partnership that we have had for the past three years with the Bill & Melinda Gates Foundation, where they have run a research study on infant brain development from age zero to five years of age in low and middle-income settings. So I know it is real when I say you plug and scan in Ghana, in Uganda, in Kenya, and in Bangladesh. It does not require the sophisticated personnel that we have at NewYork-Presbyterian Hospital.
It can be just plug and scan. The shift in paradigm is really going from bringing the patient to the MRI, which is the world in which GE, Siemens, Philips, the big magnet guys operate, to really bringing the MRI to the patient in the multiple sites of care that are described on the slide. Anywhere from the emergency department, all the way to community-based settings in rural and remote locations. I also believe that we are a technology that complements and expands the reach of MRI for brain imaging over and above where conventional MRI has taken it. So we are complementary, and we see that in our early adopters already. The change in paradigm translates very quickly into an extraordinary simplification of the steps required to image a patient in critical care today.
From 22 steps with a lot of risk and time sink for personnel, which is in short supply across healthcare systems throughout the world, to three steps. When we go from 22 to three, there's no question that we are saving time, and if we're saving time and we're saving personnel, we're saving cost. It is a win, win, win. It is a much better, friendlier, patient experience. Clinicians get what they need here and now. In some brain conditions, you need timely information. If it is an acute decision you need to make. Acute ischemic stroke is such a condition. In other, it's about early intervention, knowing that the patient has a tumor that is building up on their brain. Healthcare systems benefit as well.
There are a couple of different economic angles to look at how this complements conventional MRI and is attractive to healthcare systems. I'll cite a couple that are actually real in some of our early adopters. There are people that are seeing this as an opportunity to free up slots in the conventional MRI and run full body scans, and realize additional revenue from those cases by not having to utilize those slots for critical care patients. Others are seeing the benefit in reducing the cost of care, but knowing quicker where their critical care patients stand from a brain function perspective, and if appropriate, treat them, and if appropriate, discharge them, moving them a little faster from a $5,000 a day bed to a $500 a day bed. So this is our journey. Again, I'll repeat, we are complementary to conventional MRI.
In orange on this chart, really our beachhead markets today, critical care, where there is risk and time sink and inefficiency in transporting those patients to the conventional magnet and pediatrics, where we really have an advantage without exposing the children, especially Hydrocephalus condition, to subsequent radiations through a CT scan in lieu of ours. From here, we are already in development and clinical studies moving the system to emergency departments for triaging and diagnosing acute ischemic stroke, and also further out into office-based setting or the infusion center workflow to explore our ability to help with the detection and the monitoring of ARIA risk associated with Leqembi today and other drugs that are coming down the pipeline to treat the very big problem of Alzheimer's disease. From there on to remote care, and I would argue, preventative care.
This could well be the colonoscopy of the brain, the mammogram of the brain. And additionally, expansion opportunities by moving the business from where we've chosen to focus today in the U.S. onto international expansion and further on globally, where this really realizes a lot of value by providing an alternative that does not exist in many locations throughout the world. So our strategy. We're still in the early innings of building the business, and as all medical technology, we need to be balanced in our investment and our spending across these three verticals. There is a lot of innovation still ahead of us. We continue to invest in making sure that the innovation's coupled with the data that shows the clinical value, the clinical relevance of what we do, and then on to commercialization. Starting with innovation. Our first clearance, I said it before, 2020.
Eight subsequent clearances, primarily of AI-powered software, which has continuously improved the breadth of our sequences, the resolution of our sequences, and also through software, some of the user-friendliness of our system, aiding users in two primary things, which are really the positioning of the patient and the control of the motion. I'm also incredibly proud that we translate innovation very quickly into regulatory approvals, so an extremely effective track record of not only FDA clearances, but then CE mark under MDR, Canadian approval and, and, and others. From a clinical evidence perspective, again, these are not regulatory trials. These are clinical studies to drive use, clinical application, penetration, and adoption. We have 34 peer-reviewed journal publications across the three phases in which we're developing our business. So some data exists to support the business of today in critical care and pediatrics.
The business we're developing in acute, ischemic stroke, as well as, Alzheimer's, and also in the benefit we provide when this is deployed in remote locations.... Most excited about the trials, the prospective, studies that we are running right now. I'll start from the one that was published, actually presented, sorry, at the ECMO meeting in Seoul, South Korea, in early November, which is the Safe MRI. Johns Hopkins and Memorial Hermann in Houston, used our system for 50 ECMO patients, and were able to demonstrate our ability to capture stroke in those patients, so they are a, stroke-rich patient population, but really the merit of being able to safely image those patients that otherwise would never be moved to the MRI suite.
Hydrocephalus, our HOPE study, enroll 150 patients, and we should start seeing those that data published and presented in the early part of 2024. Actively enrolling ACTION PMR is really our acute ischemic stroke. We have four institutions with the systems in emergency departments, three in the U.S., one outside of the U.S., actively enrolling acute ischemic stroke patients, and we should start seeing data from that trial preliminarily also in 2024. Last but not least, commercialization. We have a direct sales force in the U.S. The U.S. is our primary commercial focus today. We're looking to expand into Europe in the next year or two, and from there on, more broader global expansion thereafter.
And we've also built what I believe is really a very, scalable and low-cost ecosystem to be able to manage a very large footprint of installed base, utilizing the cloud effectively to provide all of the software upgrades and continue to make sure that our customers and our units have the benefit of the latest magic sauce in our AI-powered software. We're also able to support them technically, remotely through the cloud, and we have created a cyber ecosystem that first of all, is solid and has received the HITRUST and SOC 2 Type 1 certification, but allows for seamless integration across a variety of setups, PACS systems, electronic medical records, as well as some of the new, AI platforms that drive, from imaging to decision-making for clinicians. And wrapping up our financial profile, start with revenue.
We will deliver $11 million-$13 million here in 2023. That is nice growth from our $6.8 million last year, all primarily driven by additional penetration, the seasoning and the maturing of our sales force, as well as a new pricing structure that we put in place in early 2023. In the 13 months that I have been in the role, we've also been on what we have labeled our financial transformation, improving gross margin substantially at a very small scale.
We posted 48% last quarter, and we'll deliver 44%-46% in this year over our 13% last year, and a very significant reduction in cash burn from $71 million last year to where we've guided for the year, $41 million-$44 million, which allows us with the roughly $85 million in hand, to have about cash runway for about two years through the end of 2025. Very proud of a small, lean, but incredibly high-performing management team that is doing this with me and leave you with a few sort of summary thoughts here, where we are really doing something no one has done before. First, FDA-cleared device of our kind, highly proprietary position. We are a commercial stage company. Today, we are continuously iterating and translating the benefits of new innovation into clinical data.
I'd see us as really platform technology, able to be deployed across a multiplicity of important brain conditions that create a lot of burden for patients and for healthcare systems, and very proud of our early financial trajectory with the progress on the top line, the gross margin line, and being able to have the runway for the next two years to continue to post great things along the different projects that I've shared with you today. Thanks for your interest, and I'll take any questions if we have a couple of minutes. Sure.
There are many positives.
It is new.
But is it quality?
The qu-
What is the price?
No, the price is. The design is for affordability. So what are the negatives, what is the quality, and what is the price? So the price is $400,000 upfront, which compares incredibly favorably with portable CT, which is anywhere between $750,000-$1 million. So the design is for affordability. There is a service contract, 10% a year from years two to five. So price is definitely not the issue. As a new category of imaging that does not sit in the confines of the radiology department, that sits in the clinical units, it does require an adjustment around where the staff goes. MR techs do not go to the ICU.
You do not need an MR tech to run our device, but if the hospital imposes an MR tech, they're solving for the workflow, integration, newness, not, not challenges, newness of what we offer.
What about.
That's totally possible, and that's an area we're gonna be evolving into as well. I love it when we have something that otherwise they can't get. In the hospital, it's more a matter of time and the criticality of the patient that makes it a delayed option. Anything else? Thanks very much for your interest.