My name is Matthew Caulfield. I'm a senior biotechnology analyst here at H.C. Wainwright. H.C. Wainwright is a full service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors. We have a total of 24 publishing senior analysts and over 600 companies covered across all sectors. So our next presenting company today will be Hyperfine Incorporated, and we're grateful to be joined by Maria Sainz, President and CEO, as well as Brett Hale, CFO. So please take it away.
Thank you, and thank you for the opportunity to share the Hyperfine story with all of you here today. These are our standard disclosures. At Hyperfine, we have developed the first FDA-cleared, portable, ultra-low field brain MRI system, and it is highly proprietary technology. It is also platform technology, as it can be deployed across multiple sites of care, from critical care departments to clinics, as well as across a multiple brain conditions. We are a revenue-generating business, and we have early revenue traction with existing reimbursement, a broad FDA indications for use, and initial accounts across flagship institutions, as well as remote global care settings. The reason for Hyperfine is to really render brain MRI affordable, accessible across the globe for patients with different conditions and in different sites of care.
What we enable is for clinicians to be able to make decisions early and decisions timely related to their patients' neurological conditions, and as we stand here today, it's incredibly exciting to be able to participate, transform, and improve the care of patients with a stroke and Alzheimer's with our technology, two of the biggest unmet areas of clinical need, as well as huge burdens for patients and systems across the globe. This is our device. It is the Swoop brain MRI system. There's a few of these things that I have touched upon, but this is definitely very different than an MRI suite, the conventional MRI, which is something I will refer to several times during the rest of my presentation. We have ultra-low field technology. This is 64 millitesla, yet it does provide diagnostic quality brain imaging.
We have over a hundred and fifty patents, making it highly proprietary, and again, platform technology, so that it can be deployed across multiple sites of care and many neurological conditions. Our goal is to expand MRI, not to compete against the conventional MRI, but change the paradigm in terms of access, equity, and affordability for patients across the globe to MRI. Our indications for use is very broad. We have no age restrictions. We scan brains from newborn babies to very elderly patients, and we can scan brains for all kinds of conditions. We are commercially available. We use a direct channel in the U.S. and distributors outside of the U.S.
We benefit from existing reimbursement, and we have actually the same CPT codes as conventional MRI, and we also have developed a global footprint of systems across very remote, low, and middle-income settings, thanks to a partnership with the Bill and Melinda Gates Foundation and King's College London. This is the new face of brain MRI that Hyperfine proposes. On the left, you see the patient experience. It is safe for loved ones, for clinicians to stay very close to the patient, which is, of course, extra special in the case of a pediatric patient while they're undergoing their brain scan. It is a system that easily moves through standard doors, rides on standard elevators, so that it can go where the patient needs it, where the clinician needs that early, that timely decision in the healthcare facility.
It is a system that is incredibly easy to learn and intuitive to use. It operates out of a standard tablet interface, and we do not require a specialized MR technician to operate our equipment. We have successfully trained nurses, X-ray techs, physicians themselves to actually operate the equipment and get the brain scans of their patients. Now, let me introduce you to our footprint for growth. Our growth is gonna come across the expansion of MRI into sites of care, where conventional MRI is not traditionally available and is not easily available. The second vector of expansion is the opportunity to change the paradigm of care in very large unmet need areas, such as stroke and Alzheimer's, with an ultimate destination of being a tool that will help improve brain health globally, providing a solution for early detection and routine screening.
But let me go back to where we started. We started looking for the patients that were most compromised by having to access MRI, and that turned us into critical care and pediatric patients. Often enough, critical care patients have a difficulty from a safety perspective, from a resource consumption perspective, from an equipment that they are connected to perspective, to go to the conventional MRI, and it does require a lot of planning. It is potentially a situation that could cause some side effects, and it does require additional personnel to move those patients to the conventional MRI. So that felt like a perfect way to show the clinical value of our technology by literally wheeling our system right behind their bed and performing an MRI very quickly after an event that got them into critical care.
In the case of pediatrics, it was about having an opportunity to provide a diagnostic modality for conditions that require frequent scans to pediatric patients that was not radiation-based. Now, we are already moving to the right of this chart and getting out of just the hospital setting, the DRG environment, into the emergency room for the triage of acute ischemic stroke, and into clinics and potentially also offices for participating in the care of Alzheimer's patients, which I will touch on in a few slides. We are particularly excited about the opportunity to start really being another tool in neurology office settings, and in order to do that, we have initiated a process of accreditation that I would also outline in a couple of slides. As I said, the ultimate destination is brain health.
It's being able to make sure that all of us will routinely monitor our brain through an affordable, accessible scan that would allow for our clinicians to make timely and early decisions on any conditions that might occur. The last vector of growth is turning our business, which was very focused on the U.S. market, into a global business, and that is a trajectory that we have initiated earlier this year. Now, this footprint for growth translates into really very considerable and very large market opportunities. The market in which we play today, the market of the hospital environment with critical care and pediatric focus, is about a $1.5 billion market opportunity, and this is all measured in sites of care where we could place a system at our ASPs.
As we move into Alzheimer's and stroke, that growth is very steep, and we get to a market opportunity north of $6 billion, and brain health is ultimately even larger at $16 billion and more when we get to really, a more community, more primary care-based setting to screen all patients. Now, I want to translate this footprint for growth and the opportunity ahead of us into the near term. I think it's really important to understand what it is that we feel confident we can deliver literally in the next, one to two years. There are three really important vectors that are going to transform our growth profile in just the next three quarters.
One is technology development, the second one is the expansion into new clinical sites of care with more presence in Alzheimer's and stroke, and the third one is, of course, the geographic expansion into international markets. We were first cleared by FDA in 2020, and we have been on a cadence of about two software upgrades and software revisions per year. All of our software is AI-powered, and we remain committed to that cadence going forward. Earlier this year, we launched our eighth-generation software version, and just a month ago, we announced the FDA clearance of our ninth generation. So again, that's the pace at which you should expect that our technologies continue, it's gonna continue to improve going forward, and all of this is AI-powered software.
We will continue to expand in our initial market, in our beachhead market of critical care and pediatrics, adding more flagship institutions and institutions across the world, and then, as we think about the expansion into new sites of care, as well as clinical new conditions, this is what to expect. We have initiated a number of market adoption studies, as we do not need a specific indication cleared by FDA, in the areas of acute ischemic stroke and Alzheimer's. So let's start with stroke. Stroke gives an entry point into emergency rooms. The ACTION PMR study started last year, and I'll touch into it in a little bit more. It started with a detection phase that has been completed.
We will move into a workflow phase in the first half of next year, and with that, we feel we will be poised to start adding emergency rooms to the call points for our technology second half of next year. Similar trajectory on our Alzheimer's clinical work. CARE PMR is a study that we launched earlier this year. Yet again, it is a market adoption study. We have started to see the initial data at the most recent Alzheimer's conference in Philadelphia three weeks ago. We will expand that study into more of a workflow study, also giving us access to clinics and offices for the care of Alzheimer's patients in the second half of next year. The office in itself goes beyond Alzheimer's, and it's a care setting that is particularly attractive to us.
As I mentioned before, we have initiated an accreditation process through IAC that should be completed by the end of this year. Given that the business model in that care setting is somewhat differentiated from our current hospital business, we intend to run a pilot study in the first half of next year, giving us again access to yet a third incremental call point in the office setting by the second half of next year.
We have signed a number of international distributors in European and Asia Pacific markets earlier this year, and we will see the full year effect of that into 2025, as well as the entrance into the India market that has a slightly longer regulatory process through their organization called CDSCO, which we expect to have completed by the second half of next year, and also be in launch mode in India, which is a large market opportunity for us in the second half of 2025. Now, a couple of slides on Alzheimer's.
I truly believe that MRI is coming to be really a go-to modality to really change the care of Alzheimer's patients through the continuum of monitoring of the disease, all the way to the current need that has presented with the recent approval of the amyloid-targeting therapies from Biogen and most recently, Eli Lilly. We're running our CARE PMR study to assess the ability for us to monitor the ARIA complications associated with the amyloid therapies, and it is actually a requirement in the labeling of that device that is causing an increase of MRI that is very substantial, as the Biogen drug requires three MRIs in the first year of administration. The Lilly drug requires four MRIs in the first year of administration.
But we see the potential way beyond, as really the topic of access and equity in Alzheimer's is incredibly prominent, and MRI, an accessible and affordable MRI modality is highly desirable. So this is our program. We're already collecting data on ARIA monitoring. We are understanding our own data and feeding it into our R&D teams to optimize the sequences and the protocols for ARIA detection and other avenues to offer clinical value in Alzheimer's care. And we're also getting deeper in understanding the market.
We participated for the first time in the history of our company in the Alzheimer's Conference, and it was incredibly encouraging to see the warm reception we got from clinicians and researchers across the globe for what the value proposition of our technology is for their patients, and the bottlenecks that are created by the lack of easy access to MRI for the condition that they need to treat their patients for. Similar program outline for stroke. Again, our ACTION PMR is the study in the stroke field, have completed the detection phase with over a hundred patients enrolled. We're also optimizing sequences to go back into a workflow phase and really understanding how to realize the workflow benefits of these in a variety of different stroke care settings, which are a little less standardized, but some challenges in the workflow and the flow of patients in the emergency rooms.
Some additional challenges from the networks where, hubs and spokes operate with different equipment to triage their patients. So we're committed to really going from detection, which allows us to compare with conventional MRI, to workflow, where really we feel we will show and illustrate the value we deliver, both clinically as well as economically, in terms of time to discharge or time to treat, given the importance of timely decisions in this acute care setting. Now, a couple of words just on what kind of a company we are. We're driven by execution, and we need to execute on these three pillars. It's about innovation, it is about clinical evidence, and it's about excellence in commercialization.
I mean, extraordinarily proud of the trajectory of our company with nine software upgrades and updates to our systems since the first cleared package from FDA in 2020. As I said, it has also been coupled with a stellar international performance of certifications and approvals across really important markets like CE, the UKCA, as well as Canada, Australia, and New Zealand. On the clinical realm, a number of impressive publications across really the three growth drivers of our business and expansion of brain imaging into different sites of care for different kinds of patients. 15 publications in the business we are in today, 19 already in the area of Alzheimer's and stroke, and 10 publications on brain health. I've also listed here the studies that we are ongoing.
HOPE PMR was a study that was completed last year, and publication should be forthcoming in the area of pediatrics, a very powerful dataset on scanning patients on ECMO, which are highly compromised critical care patients, and the two studies I just spent a minute on, on Alzheimer's and stroke. And last but not least, commercialization excellence. So our business model is attractive in that there is upfront revenue as well as recurring revenue. At one call point, we have multiple placement opportunities when you think about a critical care unit and then an emergency room unit, and maybe even a unit in a neurology clinic. We have started with flagship institutions and creating the right reference centers.
We also have our pioneer users assembled in user groups to continue to help us lead the way in how to really expand the reach of brain MRI across healthcare settings and healthcare problems. We have about a hundred and fifty, and growing number of, installed base, and that is across the globe. And I said before, we have our direct channel for distribution in the U.S., but we operate through third-party distributors outside of the U.S. And with that, I would like to turn over to Brett to cover our financial trajectory and what lies ahead on key financial metrics.
Thank you, Maria. We have a strong foundation, are poised to deliver a financial leverage from multiple growth drivers that Maria talked about. From a revenue perspective, we've been commercial since 2020 and have demonstrated strong revenue growth since launch. Our revenue growth has been driven by increased capital placements, the robust pricing, recurring revenue, as well as the initiation of the international expansion plans that we've initiated here in 2024. As we look ahead, we have several growth catalysts that will accelerate the business forward. We have a strong set of placement opportunities in the emergency department, clinics, and offices, with Alzheimer's and stroke being the use cases of focus, and we have the international expansion opportunity that Maria talked about, as well as the very large market opportunity in India.
Turning to gross margins, over the last several years, we have seen a significant improvement in the gross margin profile of the business. This has been accomplished by significant leverage through our commercial growth, cost efficiencies from a connected ecosystem, as well as the robust system pricing of our systems. We are driving healthy margins even at small scale, and we have a very attractive margin profile for medical imaging companies. As we look ahead, we look to continue to expect scale and volume to expand our margin profile. The transformation of the financial profile has resulted in a significant reduction in our cash burn. We continue to be laser-focused on our spending discipline, and while at the same time investing in our key catalysts for growth.
As we look ahead, our business will reflect that of a commercial growth profile, whereby sales and marketing and scale will drive the business. Lastly, we see a cash runway for the business into early 2026, while at the same time funding the commercial realization of the growth catalyst that will accelerate the business in 2025 and beyond. At this point, I'll turn the presentation back to Maria.
Thank you, Brett. I would be remiss without sharing at least a quick slide on the phenomenal team that is helping me drive this business. I believe I have an outstanding collage of incredible tech and medical experience by my side to continue to do what we have done so well over the last two years since I took over this role. And in closing, I'd love to leave you with the key takeaways of our story. This is a first FDA-cleared, unique portable brain MRI that has very proprietary technology. We're already a commercial stage company, and we're poised to solve very large unmet needs for both providers as well as clinicians and their patients across a number of conditions, but most excited about the opportunity in Alzheimer's and stroke, which is relatively near-term for us.
We've demonstrated to be a prolific engine of fast innovation, as well as clinical data and evidence. We have a growth blueprint driven by our ability to really expand the reach of brain MRI into new sites of care, into incremental sites of care, where conventional MRI has not been easy to deploy, and that is emergency departments, that is neurology clinics in the hospital setting and neurology offices all over. Our financial profile is very solid, with healthy top-line growth, very solid gross margin for a company of our scale, and good cash management, and I have an incredible executive team to take this forward. Thank you very much for your attention.
Okay, great. With that, I'd like to thank Hyperfine. Maria and Brett, thank you very much for sharing the Hyperfine story. Thank you to our viewers, and thank you again to the H.C. Wainwright team. Thank you, everyone.