All right, good morning everyone. Welcome to day three. I'm Jason Bednar, I cover med tech here at Piper. Our next presentation this afternoon is with Hyperfine. It's a pleasure to have with us today CEO Maria Sainz and CFO Brett Hale. Glad to have you both here with us today. I'll turn it over to Maria for your presentation, and if we have time at the end, we can take some questions.
Thanks, Jason.
Good morning, and thanks for the opportunity to share Hyperfine here this morning. These are our disclosures. Hyperfine has the first FDA-cleared portable brain MRI. We enable MRI for the brain in sites of care where traditionally you don't have access to MRI: a critical care unit, an emergency room, an operating theater. We actually have an incredibly compelling both clinical as well as economic proposition for the adoption of our technology. The market opportunity is incredibly large. The total addressable market today we estimate is about a $6 billion market opportunity, and our fundamentals are very strong: attractive growth rates, attractive gross margins, tremendous spending discipline, and the opportunity to drive operating leverage.
Our growth strategy was recently de-risked with the introduction after FDA clearance of our next generation Swoop scanner with the latest software, which we have branded Optive AI, which provides the best ever image quality at 64 millitesla, which is ultra-low field magnetic field. Today we're focused on the brain, but with time and proprietary position, we have the right to drive additional indications in other anatomies or complementary services. Our vision is not to compete, not to replace conventional MRI, rather to change the paradigm for MRI by bringing it into a form factor that allows it to be accessible and affordable in very different ways. Our system does not need shielded facilities, reinforced floors, dedicated operators. We bring it to the patient.
We do not have the patient incur any kind of risk or cost or burden to go to the MRI when appropriate, such as critical care patients. So as I said, our market opportunity today is about $6 billion when you take into consideration all the cold points that we are targeting today, which are both inside the hospital, multiple sites of care inside the hospital, the neurology office setting, as well as our international markets. Our vision with time is to turn our technology into a tool that would allow for prevention of brain conditions by being closer to community settings and primary care settings. That would, of course, drive the market opportunity and the total addressable market north of $15 billion. This is the new phase of MRI when people use our Swoop scanner, our Swoop system. As I said before, it is ultra-low field magnetic field.
We operate at 64 millitesla. For anyone familiar with the larger scanners, the lowest field strength of a conventional MRI is 1.5. That allows us to make it a small footprint and portable, drive around the hospital through standard doors, elevators, and hallways. It allows the operation is very intuitive out of an iPad interface, and a clinician can very quickly get access to the images, although of course the images also go into the PACS system, and at the point of care be able to have a first assessment, the first triage of the images to take care of their patients, so in our journey, we are building a new market segment. ultra-low field and portable MRI has not existed before Hyperfine and before the Swoop system.
I'm very pleased to report that I believe we have built a terrifically strong foundation for our business over this first phase that any medical device business undergoes, which is that development, clinical, and early commercial stage. We definitely have a first mover advantage, over 200 patents issued, very proprietary position. We were the first FDA-cleared. The first clearance happened in 2020. We have over 190 installed units on a global basis, and we have amassed over 250,000 images, which you will understand created very important competitive advantage as it relates to our ability to embed AI into our system and into our image quality going forward. Our clearance with the FDA is very broad. It's any brain imaging for patients of any age.
The scans performed with our scanner are reimbursed under the same reimbursement codes as conventional MRI, and we have a lot of data, not only clinical but also economic, as to how this impacts positively workflow and healthcare costs. We've been a very prolific engine of innovation and iteration over the first five years in the market. We're on our second generation of hardware, but we're on our 11th generation of software, and there is a lot of clinical evidence that has been brought to bear across different sites of care, different neurological conditions, over 80 peer-reviewed publications, and over 215 presentations. I mentioned our growth strategy has been recently de-risked with the introduction of what you see in the middle of the slide, which is our next generation Swoop system, which operates on Optive AI software.
We have been working on our strategy of actually expanding across sites of care, and that coupled with the technology allows us now to execute on this commercial expansion strategy, going inside the hospital deeper, going outside the hospital into office environment, and also expanding further international, so this generation was cleared by FDA at the very end of May. We announced it June 2nd. We launched it in Q3. I have sort of the 100-day proof points of what we've been able to accomplish with it, and I'm pleased to report we've already placed next generation Swoop systems on all the sites of care which we call the neurology office and inside the hospital, pediatric, and adult critical care units, as well as emergency rooms.
As we mentioned, our commercial expansion drives across three verticals, which is how we actually structure our business: the hospital vertical, the office vertical, as well as our international vertical. In the hospital, it's all about expanding across multiple sites of care. We started in critical care, but we're clearly moving into the emergency room and have a lot of interest as of late as well in placements for ORs as well as hospital-based clinics. We are building a brand new business, which is the neurology office, and it's incremental to our hospital business, over the last 18 months or so, we've been on a trajectory through third-party distributors to expand internationally. We have a very, very strong contract manufacturer that allows us to scale very substantially as we grow, and as I said, our financials are solid.
Gross margins are very attractive for a company at our stage and compared to other imaging players. Growth rates are attractive. Our spending discipline is very strong, and we have the ability to drive operating leverage. So this is the pride flight. This is the ability to take 64 millitesla field strength and produce amazing images. This is a case from a study that we have conducted in the office setting, which is called Neuro- PMR. And this is a direct comparison in a patient of a 3 tesla conventional MRI with our little 64 millitesla MRI system. This is what radiologists are in awe about, and this is what really gets them to be very, very excited that this is something now that is mainstream for them. This is something they're familiar with. This is something they can read. This is something that seamlessly integrates into their workflow.
So how do we drive a 64 millitesla magnet to produce that level of image quality? There is a lot of effort and time that has gone into sequence development, but as of late, we've definitely taken advantage of AI. We use AI for two primary purposes. The first one is to denoise imaging. Because we operate in sites of care where there's a lot of artifacts from other equipment, we really need to make sure that our scanner produces images that are only taking the signals from the brain and not from everything around in a critical care unit in an emergency room. The second one is really the reconstruction of the images. We do not produce images. This is not synthetic MRI. This is really an AI-based reconstruction of the image that mimics, although cleanly and sharply, what linearly we would have done in the good old-fashioned.
It is also great to see that we rank really high in the list that FDA issues of companies with the most clearances on AI-enabled technologies, side by side, big, big names, not only in imaging but across the medical device ecosystem. So as I mentioned before, our business is structured in three verticals: hospital, office, and international. The value proposition is strong. If you look at what we can accomplish in the hospital, we can definitely help providers increase revenue and lower cost of taking patients down to the scanner, improve significantly patient progress metrics, improve the utilization of staff and infrastructure. As I said before, we do not need a dedicated facility or building it out in any shielded fashion. We clearly reduce the wait times to MRI, and we avoid the cost, the burden, and the risk of transporting the patient.
We have ROI investments across the office as well as the hospital, and we have a number of studies that have proven really the clinical utility of our system. So if you look at the hospital ACTION PMR, it's a study in stroke. PRIME is another study in actually the hospital setting in the ER for all comers presenting with neuro conditions. That one is running at Yale. And PRISM PMR is an OR study where we're looking really at the opportunity to use a dedicated MRI in the OR to quickly triage the completion of an OR case without having to wait for the patient to go out for imaging and then keep the room open for whatever could have happened. In the office, we're talking about building a new revenue stream for ourselves, but also for the clinicians that usually prescribe the exams but do not perform them.
They have the ability to be more of a one-stop shop where the patient gets in the consult, the consultation in the consult room, the consultation as well as the scan. They are clearly, it is a scan modality that patients prefer, and we have data to document that. We have been running a study called Neuro- PMR at two very, very large neurology practices in the U.S., the Dent Institute in Buffalo, New York, and Texas Neurology in Dallas, Texas. The case I showed you a few slides earlier came from that data set. A nd in international markets, although our business follows more along the lines of our hospital business in the U.S., there is clearly an issue of access to MRI that is more acute outside. There's also a need for remote or rural care.
We have had a partnership with Bill and Melinda Gates and King's College in London that have allowed us to have scanners in incredibly remote and low-resource locations, some of which I have personally visited, like Bangladesh and some sites in Africa, where you see really the resilience of a scanner like us and the clinical utility it can bring in those low-resource settings. But we have also a lot of interest in doing things in rural America, given the complexity of transportation, the cost of transportation of patients into the hub. Because our labeling is very broad and we can do brain scanning of patients of any age, we really see a very rapid and agile evolution of the clinical use cases from one side of care to the next. And we have definitely seen that accelerate with the image quality that we produce today.
So clearly, critical care, both adult and pediatric, have been our sort of niche market for quite some time. The ER is an active market right now. I would call the operating room an emerging new market. The neurology office space is a new market for us. In our international expansion, Europe has been the first place where we've gone, but we are actually awaiting India clearance, and that will be a reality in terms of commercial revenue in 2026. So quick double-click here. Hospital, nothing that I haven't said before other than, again, the reimbursement is the same as conventional MRI. The code for a brain MRI is 70551.
One of the things that's very attractive now is that given the image quality and the interest in our technology, we're seeing not only individual hospitals go for multiple placements, but we are now being asked to be at the table of IDNs and health systems to discuss system-wide deployments. On the office setting, this is a perfect picture of looking at what nothing too dissimilar to when you visit your dentist. A chair where you can be talking to a physician that turns into a bed and immediately sort of scooches you into the scanner, and you get your brain MRI right there because you presented with chronic headaches. This is an opportunity for these neurologists to bring imaging into their practice rather than just prescribe the imaging.
For us, it is an incremental layer of opportunity and business that doesn't cannibalize in any way, shape, or fashion our hospital business. Then for international, again, following more on the hospital business model, we're always a little bit behind in regulatory clearances. The software with the high-quality image quality, sorry, pun intended, is coming to international markets here this month. We're actually just launching it in Europe next month. We're also doing that in 10 local languages. We're going to be able to have greater applicability of our technology with a local language beyond the first five markets that we introduced with local languages a few months ago. We expect the next generation Swoop system there in the second half of the year. India is a very attractive new market for us.
We've been working on regulatory approval with our partner there for a number of quarters now, and we're really at the final stages so that, as I said, would be commercial reality for us in 2026. CDSCO is the FDA equivalent for India. And again, the ability to also have a lot of KOL support internationally through our association with King's College and the work they've done with funding from Bill and Melinda Gates to take really scanning and actually brain imaging for pediatric use primarily into low and middle-income settings. From a distribution perspective, we are direct commercially in the U.S. I have a team of about 15 customer-facing professionals deployed across the country.
They can drive a lot of productivity and depth by going into the same sites of care, so into the same hospital environment, and actually driving multiple placements and going from there to IDN discussions that allows the same channel to drive significant growth. Outside of the U.S., we use distributors. We have about 10 partners and access to north of 10 markets by now. Our business model is CapEx, so we sell the equipment upfront. Our MSRP in the U.S. for the next-gen Swoop system is $550,000. We actually provide a one-year warranty that covers software upgrades. We do a software upgrade to the tune of one to two per year and also technical service. And then there is a software and service fee that intervening years two through five for about 10% of the purchase price per year. As I said, very strong contract manufacturer.
We use Benchmark International. They're U.S.-based, Nashua, New Hampshire. We could actually expand right there, but they also have a global footprint that would allow us to expand in other jurisdictions. A lot of great proof points where we've been already in the first sort of now maybe 130 days since launch, so sold in all of the sites of care that we're targeting, seeing terrific market activation. All of that is sort of incredibly nicely staged setting for a very strong commercial outlook 2026 and beyond. We have not only the IDN in the hospital environment opportunity. We're partnering with NeuroNet, which is an equivalent to a health system outside of the hospital in the office setting. Strong performance in Q3. Our revenue was up 27%. We posted a $3.4 million quarter. We also did incredibly strong on cash burn, down 27% sequentially.
And that is the beginning of this transformation that we've talked about where 2025 is the tale of two halves with a transformative second half as it relates to our financials on the revenue side, on the cash burn side, with very, very strong gross margins. A terrific team. Brett is here. Others are back at home working hard. And then leave you with just a few thoughts as a recap. Clearly, a first mover building a terrific new market opportunity that brings clinical and economic value to patients and providers. AI-enabled technology with incredibly fast iteration and innovation opportunity, broad clearance, existing reimbursement, direct commercial in the U.S., an established distributor partnership network outside of the U.S., de-risk growth strategy as I speak to you today with a cleared and already well-appreciated second-generation technology in the marketplace coming to international markets in a couple of quarters.
Today, brain only, but a lot more in the future. Thank you very much.