Hyperfine at H.C. Wainwright: Portable MRI Technology Unveiled

On Monday, 08 September 2025, Hyperfine (NASDAQ:HYPR) presented at the H.C. Wainwright 27th Annual Global Investment Conference, showcasing its pioneering portable brain MRI technology. The company highlighted its strategic advantage in expanding MRI accessibility beyond hospitals, while acknowledging the challenges of market penetration and competition.

Key Takeaways

• Hyperfine’s Swoop® system, powered by Optive AI™, aims to revolutionize MRI accessibility with portability and ease of use.
• The company has over 200 patents and is expanding into international markets, including partnerships with King’s College London and the Bill and Melinda Gates Foundation.
• Hyperfine anticipates significant revenue growth with a large total addressable market (TAM) and healthy gross margins.
• Recent FDA clearance for the next-generation scanner is a critical milestone for de-risking growth strategies.
• Expansion efforts focus on multiple care sites, including neurology offices and international markets like India.

Financial Results

• TAM: Hyperfine estimates a market opportunity exceeding $6 billion, with potential growth to $16 billion.
• Revenue Growth: Transformative growth is expected in the latter half of the year, with 1.5% device penetration in the U.S. potentially generating $100 million in revenue.
• Gross Margin: The company reports healthy margins with expectations for further expansion.
• ROI: Hospitals can expect a return on investment in approximately one to one and a half years, favorably compared to the industry standard of three to four years.
• MSRP: The Swoop® system is priced at $550,000 in the U.S. hospital market, with contracts typically lasting two to five years.

Operational Updates

• Commercialization: Hyperfine employs a direct sales channel in the U.S. and third-party distributors internationally.
• Partnerships: Collaborations with King’s College London and the Bill and Melinda Gates Foundation aim to enhance pediatric MRI access in low and middle-income settings.
• FDA Clearance: The latest generation scanner with Optive AI™ has received FDA clearance, facilitating accelerated growth.
• Market Expansion: Hyperfine is poised to enter the India market, where remote and rural healthcare needs are significant.

Future Outlook

• Growth Strategy: The company plans to expand into multiple care sites, bringing MRI technology closer to patients.
• Technology Development: Hyperfine is focused on advancing its platform for targeted clinical applications, potentially extending beyond brain imaging.
• Additional Revenue Streams: The development of decision-making platforms for specific clinical use cases, such as cognitive impairment screening, offers new revenue opportunities.

For more detailed insights, readers are encouraged to refer to the full transcript.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Eduardo Martinez, Equity Research Associate, H.C. Wainwright: Good afternoon, everyone, and thank you for joining us for another company presentation at H.C. Wainwright’s 27th Annual Global Investment Conference. My name is Eduardo Martinez, and I am an Equity Research Associate here at H.C. Wainwright. It is my pleasure to introduce Mr. Brett Hale and Ms. Maria Sainz from Hyperfine.

Maria Sainz, Hyperfine: Thank you. Thanks for the opportunity to present Hyperfine here today. We’re excited about what we’ve done and most excited about our future. Here are our disclosures. At Hyperfine, we have developed and we commercialized the first FDA-cleared portable brain MRI. We have developed a very strong proprietary position as a first mover in the field. We take MRI to multiple sites of care and will show how different it is from conventional MRI, although it does not replace conventional MRI. The technology has incredibly compelling clinical reasoning for it, as well as economics. The market opportunity in front of us is north of $6 billion. We are in early commercialization on a global basis. We enjoy existing reimbursement, just like conventional MRI, and we are at the forefront of a strong revenue growth opportunity.

We have demonstrated and will continue to drive solid gross margins, spending discipline, and operating leverage. Our growth strategy has recently been de-risked with the introduction of our next-generation scanner with the latest software, which we have called Optive AI™. We do have platform technology with a proprietary position on our IP that covers multiple use fields. Although we’re focused on the brain today, we could do a lot more than the brain with time. I don’t think it is clicking. MRI is not new. It is the gold standard for soft tissue detection. It’s widely and successfully used for the brain across institutions throughout the world. As I said, we do not intend to replace conventional MRI.

What we are doing is adding capacity of MRI and bringing MRI to sites of care closer to the patient in ways that it transforms the clinician experience, the patient experience, and actually the fundamentals of MRI for institutions as well. Probably many of you may have had an MRI yourselves, so you probably went downstairs into the basement of a hospital into a very protected chamber. We do not need any of that. We do not need a dedicated chamber. We do not need siting or shielding. We can actually perform MRI right here. We have a very low field magnet. We also do not require and have designed the technology so that any healthcare professional with a little bit of training can actually operate it.

Conventional MRI needs to be operated by a dedicated MR technologist, which is a fairly sophisticated healthcare professional that is also in relatively high demand and short supply these days. Often enough, you have to wait to get an MRI. We basically bring the advantage of timeliness. You can actually bring the MRI right here and perform it without the wait for the scheduling. In the case of inpatients, especially patients in critical care, the advantage is limiting the risk of transporting, the cost, and the burden of transporting a patient in critical care tied to a number of life-supporting technologies as well as important meds. Actually removing all of that burden, cost, and risk and bringing the MRI right behind the critical care bed to perform it right there in the critical care unit.

I mentioned at the very beginning our technology has a market opportunity of north of $6 billion. If I look at where we started, we started primarily in critical care because the value proposition was most compelling for those patients where the risk of transport was very high. That was primarily critical care beds in both pediatric and adult hospitals. With the performance of our image quality, which I will spend a minute on later in the presentation, we’ve been able to get access and see the reason to bring our MRI into emergency departments beyond critical care, as well as ORs and clinics. We’ve added a new line of business actually targeting neurology offices. Now we are outside of the hospital as well as inside the hospital.

When you add up the market opportunity of placing systems in all those sites of care, that’s where you get to north of $6 billion. In our early starts, it was primarily that $1.5 billion opportunity. Down the road, we start seeing and planting some seeds of what I would call the community deployment. Think about where external defibrillators have gone with the semi-automatic defibrillators. You no longer just find them inside the hospital. You find them at the mall. You find them on the airplane we all travel on. Thinking about putting MRI very close to primary care, to community screening, we’re seeing some hub-and-spoke models already where they’re really trying to limit the cost and the burden of transporting the patients from remote and rural locations for screening and placing it a little closer to where the population is.

The market opportunity will grow significantly north of $16 billion. These market estimates are only U.S. This is our system. We call it the Swoop® system. It is the Swoop® system powered by Optive AI™, which is the brand for our software. As I said, we are the first in the space. We have over 200 patents that cover different fields of use. It is AI-enabled image quality ultimately. We have earned a pretty good spot as a leader in AI-enabled clearances from the FDA. You’ll see how well we stack against some of the big companies because after all, we’re only about 100 people strong at Hyperfine. Our FDA clearance is very strong and very broad. It covers patients from newborns all the way to end of life, so no limitation on age.

It is for all brain scanning, so there are no condition-specific clearances that we are tied to. As I said, our scans are reimbursed the same way as conventional MRI. It is a brain MRI with the same CPT code. As we said earlier, commercial stage both in the U.S. and OUS. In the U.S., through a direct channel that covers both the hospital opportunity and the office opportunity. Outside of the U.S., we operate through third-party distributors. We’ve also enjoyed a partnership with King’s College London globally, and they receive funding from Bill and Melinda Gates Foundation to do pediatric MRI in low and middle-income settings. We have some global footprint through that.

As I said, right now we’re focused on the brain, but we do have ultra-low field MRI that is portable and that now delivers a level of image quality that is really, really impressive that could have a lot of other non-brain applications down the road. This is the scanner. I’m going to talk a little bit hardware first, but this is the experience that we are creating with an MRI. It is a device that easily moves through the hallways and up and down elevators at hospitals, designed dimensionally for just that. It is one where the images come real-time to the iPad and a physician could be sharing them with a patient or could be interpreting them right there. It can go, as I said, to multiple sites of care.

You can find it in an emergency room, you can find it in a critical care area, or potentially in the OR. It is incredibly intuitive in its usability. You see to the right actually an individual just operating out of the iPad. The protocols are standard and you pretty much pick and choose the scan that you need to run for your patients almost as you would be picking your playlist from a Spotify menu. The system does its self-positioning check and goes on into scanning at the sequences that have been programmed. Very different experience than what I related before of you going down, stripping up everything, making sure you have no metal anywhere, and getting into a very protected chamber. Now, making a portable low-field MRI is not rocket science.

What is rocket science is to deliver diagnostic imaging with a portable device that operates at 64 milli-Tesla. Just for comparison purposes, a high field starts at 1.5 Tesla, but goes up from there. There are three Tesla systems in most hospitals. From a research perspective, there are five and seven Teslas. We operate at 64 milli-Tesla, which is an ultra-low field magnet, which makes it safe at any site of care, which also makes it portable. The trick is to produce the image quality that ultimately delivers the same clinical relevance as your conventional MRI. That is what our journey has been. It is probably not foreign to any of you that you start with a technology in the early days with something a little bit rougher somewhere, right? I mean, you probably have clear safety. You may have efficacy. You may not have perfect ease of use.

What we did not get perfect from the get-go was the image quality. We have embedded a lot of AI. The chart at the bottom is the amount of AI clearances that we have received from FDA over the last few years, which has earned us that leadership spot in the rankings of AI-cleared technologies. There are two purposes to AI in the way we use it. The first is because we operate anywhere, you need to make sure that you are removing all of the artifacts that come from the interaction with everything else. Imagine being in a critical care unit. There is everything beeping, buzzing, sending signals, receiving data, sending data. All of that needs to be cleared. AI helps us with denoising of the images and creating more clarity. The second thing is reconstruction.

We do both linear and AI reconstruction that allows us to have the highest confidence, and that has been vetted by FDA, that we are not inventing pathology and we are not removing pathology. If somebody has a problem, that problem is just clearer with a reconstruction by AI, but it is still there. Our Optive AI™ is our 10th generation of AI-powered software in the five years we have been FDA-cleared. As I said, the FDA has actually acknowledged the value of how we have processed our algorithms. This is the result. As I said, to the left is the early days. That is when we didn’t have a lot of AI. We had a really cool portable 64 milli-Tesla system. That’s all the juice we could extract. That is all of the signal-to-noise ratio.

With that little currency in signal-to-noise ratio, the best we could do is create a pretty blurry, grainy, sandy image. Fast forward just five years, 10 generations of software upgrades, and we are right there in the middle. That is a T2 image. That is a T2 sequence, just like the left, just like the right, with our current system, with our current technology, all of that cleared this summer by the FDA. For comparison, I’ve chosen to put to the furthest right what a 1.5 Tesla conventional image of a T2 sequence looks like today. I would say it is fair to say we are getting really close to what a 1.5 conventional system image looks like today. That was the unsolicited feedback we received as we were doing the development of this latest Optive AI™ with the latest AI embedded for reconstruction.

A lot of clinical evidence over the years. What’s most exciting is the fact that it does cover a lot of our clinical use cases from patients under ECMO, which were enrolled in that SAFE PMR study, to children followed for hydrocephalus in the HOPE PMR study, two stroke studies, one completed ACTION PMR, one ongoing with PRIME at Yale Medical Center, a neuro PMR study that has allowed us to document and show the benefit of our system in a neurology office for the first time outside of the hospital, and CARE PMR, which is a single-site, but very exciting study looking to screen patients on Leqembi or Kisunla, the two amyloid-modifying therapies for Alzheimer’s for area edema incidents. As I briefly mentioned, this summer we crossed an incredibly important inflection point.

We got clearance for this latest generation scanner, which is only the second version of the scanner we have produced, and the 10th generation of software with Optive AI™. This has positioned us really, really well now to accelerate our growth strategy. Our growth strategy all along was predicated on expansion into multiple sites of care to bring the scanner closer to the patient everywhere where it’s warranted. We were waiting for the right scanner with the right image quality to be able to propel us into the future. As I said, we’re dealing with hospitals now across multiple sites of care with sites wanting to buy for different departments. We have officially launched into the office at the middle of the year. We were in a pilot phase before that.

We continue to expand internationally, and we are awaiting a very exciting milestone before the end of the year, which is clearance to go into the India market where remote care is really important. Rural care is really important. We are excited about the opportunity there as well. As I said, we have a hospital business and we have an office business. If this is advancing, can you go one forward? Sorry. Before I go there, this is some of the quotes that we have received on the image quality, which speak for themselves, but they also immediately hint to the fact that now we have earned with this image quality the right to do a lot more.

I’m also incredibly proud that although we announced the clearance at the very beginning of June, it only took us 31 days to get the first sale done, which means the team really hustled from manufacturing to launch readiness to be able to place the first system, which was in the Jefferson system at Jefferson Township, which is in New Jersey. They are incredibly excited to launch here very, very soon. Our hospital business, as I said, multiple sites of care, existing reimbursement, the CPT code that you can use for one of our exams is 70551. They have really compelling economics. They can actually unload some of the volume from the conventional MRI, realize more revenue from the conventional MRI for full-body scans.

They can also lower the cost of care by shortening the time to scan, the time to discharge, or the overall use of resources in the move of the hospital of the inpatients down to the scanner. The ROI is roughly a year to a year and a half, which is very favorable compared to other capital equipment, which is usually three to four years. Multiple sites of care also provide an exponential revenue opportunity with one hospital process, which as we all know is burdensome through cyber vetting and contracting and whatnot. Most excited now is the fact that a lot of the hospitals belong to IDN. As we place one system, the next order of business is to sit down and sometimes think about hospital-wide, but often enough now about system-wide.

In the office, a typical neurologist in this country orders 500 to 600 MRIs a year, but only 5% of their offices have an MRI machine. There is a lot of interest in building this sort of line of business in. They can now get accredited through an organization called IAC, which is CMS approved, to perform MRIs for as long as they fulfill very simple requirements around training. We have, through our pilot, chaperoned a few, a few like a handful of sites all the way through accreditation, CMS registration, and CMS reimbursement and private payer reimbursement. We have recently launched in the office with the new system as well. The same CPT code applies to them.

The interesting thing about having both a hospital and an office business is that the offices usually have a single decision maker that makes the call for both the dollars and the clinical merit. The sales cycle is significantly shorter. Okay. One more.

Brett Hale, Hyperfine: Yeah. In terms of our scalable commercial, we have a direct sales force, as mentioned previously. We have a selling team and an implementation team. We are global. We have a distribution network that covers parts of Europe and Asia Pacific. As Maria mentioned, we’re very excited about the India market opportunity. In terms of our revenue stream, we have both a direct component. We have a unit device sale, and then we have a recurring revenue. The MSRP for our new Swoop® system in the hospital in the U.S. is $550,000. That covers the first year of contract. We typically have contracts that go from two to five years thereafter. We’ve had an international footprint that’s been supported also by our relationship with the Bill and Melinda Gates Foundation. Next slide. In terms, real quickly, in terms of market opportunity, the TAM is very large.

It takes a very light penetration to get to very significant revenues. 1.5% gets you to $100 million worth of revenue. That’s just U.S. and device penetration. In terms of our financial profile, as Maria mentioned, we see a transformative growth in terms of our top line growth in the second half of the year. We have a very healthy gross margin, and we’ve seen significant operating leverage as we drive top line growth, gross margin expansion, and operating efficiency.

Maria Sainz, Hyperfine: I mentioned briefly, we consider a technology platform because we have a highly proprietary position across many fields of use. We have also mastered this image quality out of a 64 milli-Tesla, which could have a lot of other applications outside of the brain. For today, we’re focused on the brain. Besides the capital purchase or capital sale and the service and software fees that we charge on an annual basis, we see also opportunities for additional revenue stream as we develop platforms that are more targeted towards decision making based on a clinical use case. For instance, screening of cognitive impairment or potentially patient triage for something else and potentially other anatomies. In some cases, we could use the existing hardware as it is. Imagine instead of going head in, you would go foot in and you could be triaging diabetic foot.

In other cases, we may need to modify the hardware, but a lot of opportunities. Strong team, have a Chief Medical Officer that is a retired neuroradiologist, have actually heads of strategy for each of our business units who actually drive a lot of the execution and a very strong technical team. The technical team is in Guilford, Connecticut, and our administrative team is on the other coast in Palo Alto, California. I’ll just leave you with the way I started. Very exciting new technology, huge market opportunity, commercial stage, just crossed an incredibly important chasm for us that de-risks our growth strategy and the ability really to take this technology to many more places than we have to date. Thank you.

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