Hyperfine Inc (HYPR) 2025 Q2 法說會逐字稿

Good afternoon and welcome to Hyperfine's second-quarter 2025 earnings conference call. (Operator Instructions). I would now like to turn the call over to Webb Campbell from Gil Martin Group for introductory disclosure.

Thank you for joining today's call. Earlier today, Hyperfine Inc. released financial results for the quarter ended June 30, 2025. A copy of the press release is available on the company's website, as well as sec.gov.

Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements.

All forward-looking statements, including, without limitation, those related to our operating trends and future financial performance; expense management; expectations for hiring, training and adoption; growth in our organization; market opportunity; commercial and international expansion; regulatory approvals; and product development are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results and events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of these risks and uncertainties associated with our business, please refer to the Risk Factors section of our latest periodic filing with the Securities and Exchange Commission.

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 13, 2025. Hyperfine Inc. disclaims any intention or obligation, except as required by law to update or revise any financial performance or forward-looking statements, whether because of new information, future events, or otherwise.

With that, I will turn the call over to Maria Sainz, President and Chief Executive Officer.

Good afternoon and thank you for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Brett Hale.

In the second quarter of 2025, we delivered revenue of $2.7 million, up 26% sequentially with the sale of eight systems, including the sale of our first next-generation Swoop System in a hospital before quarter end, with a second hospital deal closing one day after the end of the quarter on July 1. We also expanded gross margins by approximately 800 basis points sequentially, reaching 49%. Importantly, we drove a meaningful reduction in cash burn, down 19% sequentially excluding financing.

Q2 was rich in critical milestones for Hyperfine. First, we received FDA clearance for two major new technologies. We have discussed our plan to bring one new product to market every half year. And with these two clearances in May, we are executing well ahead of schedule. Second, we completed our office pilot program.

In the US, we now have launched our new next-generation Swoop System powered by Optive AI software with transformative image quality and additional user- and patient-friendly features. Optive AI software was also cleared as a standalone software, and we have now begun rolling it out to our install base of Swoop Systems, bringing significantly improved image quality to our users. Our AI technology is amongst the leading AI-enabled health products cleared by the FDA. The market response to the next-generation Swoop System and the Optive AI software has been immensely positive thus far.

Our new next-generation Swoop System will be the platform to drive adoption growth and scale for Hyperfine going forward. The advancements in image quality have been the culmination of years of innovation in sequence development and AI to bring high quality consistency and uniformity to the Swoop System images while reducing scan time. The level of image quality we offer now allows the Swoop System to be adopted across multiple sites of care for the triage and diagnosis of different neurological conditions, representing a total market opportunity in excess of $6 billion where our technology is a first mover and has a highly proprietary position.

We have also demonstrated strong execution, moving rapidly from FDA clearance to first commercial placements. I would like to congratulate our team and partners for successfully completing the many tasks necessary to achieve the first commercial sale of our full next-generation system within 30 days of clearance. We have now scaled manufacturing and built inventory to broaden commercial efforts with both new products.

We are executing on our growth catalyst that we have previously outlined, the launches of our next-generation Swoop System and our Optive AI software, and the transition from pilot phase to full launch in the office setting. Our revenue is now diversified across US hospitals, office settings and international markets, and we are poised to drive growth, scale, and leverage going forward.

Hyperfine's journey to-date has been driven by continuous innovation and iteration to deliver portable AI-powered MR technology ready for mainstream adoption and scale. Five years ago, we introduced the first FDA-cleared portable MRI system for the brain, creating a new category.

It was a first generation system which was portable, accessible, and safe for scanning patients when and where conventional MRI is not readily, timely, nor conveniently available. Since 2020, we have released 10 software updates, incorporated AI to image denoising and processing, and received clearance for a new Swoop scanner. Together, these have brought us to a critical inflection point today, the launch of our next-generation AI-powered Swoop System ready for broad market adoption.

AI plays a crucial role in our portable, accessible MR technology, capable of producing high-quality brain images across unconventional care settings for imaging, namely critical care, the emergency room, and neurology clinics and offices. I am very proud of the AI expertise and leadership we have demonstrated in our field. We have been recently recognized as a leader in AI-powered image quality by Health Imaging and featured prominently on the recent AI-enabled medical devices list published by the FDA.

The next-generation Swoop System and Optive AI software are the pillars of our future growth. The new system is designed to deliver the highest level of image quality, functionality, and usability to-date, unlocking a new brain imaging paradigm for clinicians and their patients.

Major upgrades include advancements in AI, as well as hardware changes to drive increased signal-to-noise ratio, which provides the basis for image quality and continued sequence and software improvements in the future. The next-generation Swoop System also delivers a user- and patient-centric design to accommodate a broad patient population, especially beneficial for paediatric, elderly, or anxious patients, making MRI more accessible for all.

It has been 10 weeks since the FDA clearance. In those weeks, we have taken the system on the road to customer product demos and our first congresses. We have sold the first systems and we have witnessed an amazingly positive response to the new image quality from the radiology and neurology communities.

We are experiencing an activation of our commercial deals, markedly different than anything I have observed in my tenure as CEO, with many inbound requests for quotes, product demonstrations, and image reviews.

Clinicians have noted that this image quality approaches that of conventional 1.5 Tesla MRI scanners. We can now deliver compelling clinical value to complement conventional MRI and alleviate the bottlenecks intrinsic to conventional MRI scanning with a system safely deployable at any site of care that can meet patients where they need it. We are now selling into three channels: the hospital, the office, and international markets, providing a diversified foundation for future growth.

And we will now elaborate further on our hospital and office businesses. In US hospitals, we are laser focused on the launch and first commercial sales of our next-generation Swoop System. As I mentioned earlier, we were able to execute commercial orders and shipments in just a few weeks post FDA clearance, with seamless executions from our manufacturing, technical, and commercial teams.

The devised MSRP of the new Swoop System is $550,000, roughly a 15% premium to the prior version. We continue to focus on the favorable economics of adopting the Swoop System in critical care and emergency rooms where data supports a fast and compelling return on investment.

Several of our recent Swoop System placements have been in institutions that are part of IDN networks. Going forward, we are allocating additional field resources to broaden our reach inside IDNs. We are already actively engaged with some healthcare systems on enterprise-wide programs for our technology.

Across the hospital setting, our commercial execution strategy is three-pronged: selling to radiologists, clinical stakeholders and administration. As I mentioned earlier, radiologists are already enthusiastic about the valuable role of our next-generation Swoop System.

Clinicians see the value of timely and easily accessible imaging to care for their patients. And for administrators, there is a strong economic value proposition associated with the adoption of the Swoop System by reducing cost, accelerating patient progress, and freeing up conventional scanners for additional elective procedures as documented by some of the largest hospital users of our Swoop System over the last few years.

In hospitals, we are expanding into emergency departments. We know that the Swoop System offers a strong value proposition here, given the importance of time to scan and the focus on patient progress. To support our expansion in this setting, we have initiated the PRIME Study at Yale School of Medicine to evaluate the potential of AI-powered portable MRI technology to triage a broad, diversified set of patients presenting in the emergency department. MRI availability for the triage of patients in the ER is very limited and often very delayed. The PRIME Study is actively involving patients using the next-generation Swoop System with Optive AI software.

Turning to the office. In the past few weeks, we completed the pilot program and commenced our launch in the office. The first commercial pilot sites are IAC-accredited for scanning patients and going through the reimbursement process with CMS and private payers successfully.

Neurology offices will present a very compelling opportunity for the Swoop System. Neurologists directly impact 100 million patient lives in the US. They order an average of 500 to 600 MRIs annually, and only 5% of private neurology practices have MR imaging equipment on site.

Last April, we announced the initiation of involvement in NEURO PMR, our office study. As a reminder, NEURO PMR is a multi-center prospective observational study comparing portable ultra-low-field MRI and conventional high-field MRI with respect to pathology findings, clinical utility and patient experience in the neurology office setting to assess diverse use cases for the Swoop System.

The study is being conducted using the next-generation Swoop System powered by Optive AI software at both participating sites. We recently announced reaching 100 patients enrolled in the study, which happened significantly ahead of our enrolment expectations. Our plan is to keep enrolment open for a few more weeks to collect additional data for key clinical uses and expect findings to be available in early 2026.

We are now in the launch phase of our office business with a trained sales team selling into both single and multiple clinician practices. We are also partnering with NeuroNet to promote the Swoop System to their network of neurology practices. I look forward to updating you on our progress here in the coming quarters.

Finally, turning to our international markets where we are focused on selling into the hospital setting. I am pleased to share that Optive AI software is now available in Canada, Australia, and New Zealand, and we expect to launch in Europe by the end of 2025.

Our next-generation Swoop System should be available in international markets by the end of 2026. In addition, we continue to anticipate regulatory approval in India by the end of 2025.

As I have said previously, 2025 will be the tale of two halves. Our first half performance was based on our legacy business with a heavy mix of hospital deals as our new sales team members were trained and begun building the pipelines. In the second half of 2025, we expect our two new product launches, our entry into the office setting, and our increased traction in new and existing international markets to serve as tailwinds.

Our strong execution on our growth catalysts in the first half of 2025 put us in a position to deliver strong revenue growth in the back half of the year and beyond. Going forward, we expect improved financial performance across our P&L quarter over quarter, driven by strong commercial executions across our channels and disciplined capital preservation.

I will now turn the call over to Brett to review our financial performance and 2025 guidance.

Thank you, Maria. I will recap our financial results for the second quarter of 2025 before providing an update on our financial guidance.

Revenue for the second quarter of 2025 was $2.7 million, up 26% sequentially. In the second quarter of 2025, we sold eight units with a strong average selling price. Upon receiving FDA clearance of our next-generation Swoop System, we converted our pipeline of US hospital deals to the new system and sold our first next-generation system before quarter end.

A second next-generation system deal was on track to close before the quarter end, but slipped to July 1. Revenue for the second quarter would have been in excess of $3 million had this next-generation system deal closed the day prior.

Early in 2025, a few of our deals were delayed in connection with NIH grant cancellation. In the second quarter, we did not have any NIH-funded deals, and our broad forward-looking pipeline does not rely upon NIH grant-related funding.

Our average selling price remains strong and the increased MSRP for the new Swoop System will provide additional pricing upside in the US going forward.

Gross profit for the second quarter of 2025 was $1.3 million, and gross margin for the second quarter of 2025 was 49.3%, representing an 800-basis-point increase sequentially driven by the increased number of units sold and increase in average selling price.

We continue to drive healthy margins for our stage, and we believe we are well-positioned for meaningful margin expansion at scale. R&D expenses for the second quarter of 2025 were $4.5 million a sequential quarterly decrease from $5 million in the first quarter of 2025.

We are realizing the benefits of the reorganization completed in the first quarter as we transition to a commercial growth stage organization. Sales, general, and administrative expenses for the second quarter of 2025 were $6.4 million a sequential quarterly decrease from $6.7 million in the first quarter of 2025.

Net loss for the second quarter of 2025 was $9.2 million, equating to a net loss of $0.12 per share, as compared to a net loss of $9.4 million or a net loss of $0.12 per share, the prior sequential quarter.

Our net cash burn, including financing in the second quarter of 2025, was $7.7 million. As of June 30, 2025, we have $25.4 million in cash and cash equivalent on our balance sheets. For the second quarter of 2025, our net cash burn excluding financing was $8.1 million, down 19% sequentially from the prior quarter. Reducing our cash burn remains a significant focus of ours, and we'll continue to prioritize spending discipline and optimize our operating leverage in 2025.

Now turning to our financial guidance. For the full-year 2025, we continue to expect revenue growth to be in the range of 10% to 20% over 2024. This guidance equates to a significant revenue step-up in the second half of 2025 and accounts for the multiple growth drivers recently put in place going into the second half of the 2025, including the launch of our next-generation Swoop System, launch into the office setting, site of care expansion in the hospital setting, updated health economic selling, and continued international commercial traction.

Given our multiple simultaneous launches, expansion efforts, and atypical deal closing processes, we expect revenue to be stronger in the latter part of the second half of 2025. We anticipate a sequential step-up in Q3 and a more significant sequential step-up in Q4 and beyond. Given the growing momentum in our business, we anticipate our sequential step-up in Q3 will be 50% greater than the revenue improvement we delivered from Q1 to Q2.

We continue to expect gross margin to be 47% to 50% for the year, representing a 280-basis-point increase in gross margin on a year-over-year basis at the midpoint. We expect the progression of gross margin percentage increase to closely follow our sales growth. We remain optimistic that we will surpass 50% gross margin comfortably and sustainably as we realize higher volume given our growth catalyst.

Lastly, we now expect total cash burn to be in the range of $27 million to $29 million for the full-year 2025, representing a 27% decline in cash burn on a year-over-year basis at the midpoint. Our second half investments will be focused on capitalizing on the multiple product launches, including our next-generation Swoop System and full commercial launch into the office setting. We continue to see a cash runway for the business to the end of 2026.

Before turning the line back to Maria, I want to highlight the inflection point we just passed and its impact on our ongoing financial results and profile.

With several growth catalyst milestones completed in the first half of 2025, we are now entering a new phase where we expect steady quarter-over-quarter financial improvements. We expect revenue growth to be driven by continued penetration and traction into our very large and diverse market opportunities, continued margin expansion driven by volume and healthy pricing, and realization of operating leverage. The second half of 2025 marks the beginning of an exciting phase for Hyperfine.

I would like now to turn the call back to Maria for closing comments.

Thank you, Brett. This quarter marks an important turning point for Hyperfine. We are entering the second half of 2025 with FDA-cleared next-generation technology, scaled manufacturing, a trained commercial team, and a validated path to revenue growth across three verticals.

I am incredibly proud of the team's execution and excited about the opportunities ahead to deliver on our mission to make brain imaging accessible anytime, anywhere.

With that, we now open the line for your questions.

(Operator Instructions).

Larry Biegelsen, Wells Fargo.

Good afternoon. Thanks for taking the questions. This is (inaudible), on for Larry. Maybe just the first one on your guidance. You kept full-year 2025 revenue guidance the same which, as you said in your prepared remarks, does imply a pretty significant step-up in the second half. Could you maybe just elaborate on what gets you to the low end versus the high end of the guidance range? And how should we think about the growth sequentially in Q3 and Q4? I think I heard in the prepared remarks that's a 50% greater step-up in Q3 versus Q2. Could you just clarify that comment?

Hi, (inaudible). This is Brett. I'll take the latter part, and we'll go to the front end of the question. Yes, in the prepared remarks, we commented about the sequential growth. We have multiple launches going on at the same time. So we see the second half of or the latter part of the second half of the year being obviously a higher revenue base than the beginning part of that.

So we comment in terms of how to think about Q3 and Q4 in terms of the progressive sequential growth. So for Q3, we commented a 50% increase over the revenue increase that we just posted between Q1 and Q2. So we posted about $560,000 increase in Q1 to Q2, and we would see it being at least 50% higher going into Q3 versus -- from Q2 to Q3.

Hi, (inaudible). If I can comment on our confidence, I think as we think about the inflection point that we have crossed, we really now have different layers that are all incremental revenue contributors. So the US hospital business with the new technology is to accelerate. You add to that moving from pilot phase to full launch phase. In the office business, in the US, that is another layer. The third layer is the continued expansion into international markets. We did message that we still expect India approval by the end of the year.

And all of that is now fuelled by what is really a remarkably improved product, whether we're talking about the first generation of the product with the latest software which is Optive AI or the brand new system that also has Optive AI. That is getting market activation which, really, we were confident we were going to see; but sort of 10 weeks into it, we are seeing.

Got it. That's very helpful. And maybe for my follow-up question around the next-gen Swoop launch. Can you just talk about your expectations of the launch cadence here in the second half? I mean, any incremental color about how we should be thinking about the upgrade cycle or trade-ins versus driving new system placements? And are you offering different price points for each of those different accounts? And just to round it out, how are you thinking about contribution from new system placements and a higher ASP tier guidance?

I think you've given us a list of things that are all incremental and beneficial to the revenue trajectory for the second half. And I would argue the mix of all of those components may play out in different ways. But all of it is positive and beneficial.

So we have a step-up in ASP which is clearly there. We also have the opportunity to do brand new placements. But we also have a more modest revenue opportunity to upgrade all systems. I would say we are primarily focused on the sale of new systems across hospitals for the different types of care and use cases that we have been focusing on.

So we have a number of pipeline deals in the work where we're talking about an adult and a pediatric or a critical care in an emergency room. I did mention as well that we see some IDNs or big hospital groupings want to engage in dialogue after a first placement that is more enterprise-wide. We also see that with Optive AI, the first generation system, if I can call it that way, is getting a terrific traction which is also available in some international markets.

There is a possibility, and I wouldn't be 100% definitive on it, of segmenting in the office market between the two technologies, only because there are really two very different types of offices. There are multi-practitioner offices that I would argue are almost mini hospitals. And there are other solo practitioner offices that are very, very different in capability as well as volume of scans. And in order to cater to both, we may figure out a way to play with both of our technologies knowing that with Optive AI, the level of image quality on both A version or B version is spectacular now.

Okay. Got it. That's very helpful. And if I could just squeeze one last one in here about the office, can you maybe just elaborate on the traction that you're seeing in that side of care? And any metrics that you're willing to share around, the number of placements or deals that you have in the pipeline or utilization in the office versus in your other sites of care?

I'll share genetically some commentary here that is helpful. We have been primarily focused on what we have labelled the pilot phase because we wanted to take really a handful of sites to tune up. So we wanted to make sure that they would buy; that they would also get AIP accredited; that they would get trained and be able to scan with the personnel they have available at their facility, some of them are very small and very much a solo practitioner with an assistant that could be more medically trained or more administratively trained; and then they went through CMS registration and then CMS claim submission, payment, and also private payers. We do see there is a third way of using the scanner in some of these neurology offices which is the self-pay route.

I think we've been clear all along that for the offices to be attracted to our image and modality, the economics need to work, and the economics are predicated on three things: The number one is volume of scans which tells you that we are uber focused on utilization. Volume is the number one driver. The second one is really the mix of uses that they would give between self-pay, Medicare, or private payers. And of course, the third one is what you multiply in terms of dollars based on the rates they are getting from either private payers at a premium or Medicare in the more flat rate.

So utilization is really, really important. The handful of offices have taught us a lot of things of what we need to do right. We've also been very engaged with the other side of the spectrum which is the neuro network, which is a network of pretty high profile, very large offices. We selected the head of the neuro net hub or the hub of neuron net more likely, that is the DENT Neurologic Institute, and that has been one of our sites participating in NEURO PMR.

And for a reason, although we were not very public with the fact that we were working on a full new system, we actually did NEURO PMR from day one with the next-generation Swoop System, so we wanted to make sure that we could see the potential of the newest technology in the use case in the office. And as I said in my prepared remarks and it was a press release not too long ago, that study has evolved way ahead of expectations.

I think we announced the beginning of enrollment on April 15. We messaged that we thought we would be enrolled in the 100-patient target by the end of the year. And a week and a half ago or a week or so ago, we announced that we had already reached the 100 patients. So the enthusiasm has been incredibly high. And the use cases clinically have been quite diversified. So that is very encouraging. We can go now to offices and investigate what the potential is, as I say, leading with volume to make sure that the economics are going to work.

So going forward, we're not going to be opening our offices without committing to a strong business partnership with them that will have us come in for quarterly business reviews to assess where they're using it. We've been also helping them figure out a way to get their scans read, so we partner with the -- we haven't, but we've had the offices partner with STAR Teleradiology, which is actually a third-party radiology services that can read for offices across the country.

So clearly use is really important as we not only look at new placements, but also as we look at making sure that the offices that we open are successful.

Got it. That's very clear. Thank you so much, Maria.

Sure. Thank you. Thanks for calling in.

Frank Takkinen, Lake Street Capital Markets LLC.

Great. Thanks for taking the questions. Congrats on all the exciting progress. I wanted to start with one more on funnel interest as it stands. I think in broad strokes, first half of the year, you placed about 14 systems. And the second half guide is essentially calling for about doubling that in broad strokes. I know there's nuances with ASPs and the service line. But it seems like you need to be in that mid-20s to 30 systems placed. So any quantification of the funnel that you can provide to help us support that guidance would be very helpful.

Sure. We are incredibly focused on making sure that territory by territory, we're managing the funnel. But really two funnels. There's a funnel of hospital opportunities and there's a different funnel of office opportunities.

Hospitals have what we've always described as a relatively involved process, so it's easy to follow step-by-step and understanding the timelines of the hospital deals. Offices are managed a little bit different sometimes because of the fast decision-making, they sort of come out of thin air and then all of a sudden happen. And others show a lot of enthusiasm, but then as they go through some of what would it take, am I ready or not, they sort of hunt for later. But every territory that we have now has two funnels, one for office deals and one for hospital deals.

Outside of the US, we're managing the funnel by country and by partner, really, by distributor. And making sure that, as I think I've said before, we're trying to start going deeper, not opening more markets, but just going deeper and deeper. And we're seeing very good success in select markets in Europe where we're seeing subsequent placements after the first flagship institutions. Those could be big markets like Germany or the UK and possibly Italy as well moving into that. So there is really multiple funnels.

Remember, we also had a number of individuals that joined our team at the beginning of the year. I just spent some time with them about a week ago or so. The level of maturity in competence, process, knowledge, the successes they've collected puts us going into the second half at a totally different level of human capabilities, sales power, than anything we had in the first half as well.

Got it. That's helpful. And then maybe just higher level, obviously, you have a lot of different opportunities in the office setting OUS, new next-gen Swoop System, which of these do you think is going to be most powerful related to growth? Which is going to be the primary driver of the second half inflection?

I don't know that there is a primary drive. I would say the primary driver isn't down to that. I think the primary driver is how we show what the technology can do now. The number of use cases keep multiplying. I mean, people are coming in saying, now, I want to use it in my pre-operative and post-operative; now, I would like to really seriously explore a mobile opportunity for this technology. At this level of image quality, we can do things that we didn't think we could do before in a way that is accessible in ways that never --

So I think that is what is driving any of these. People are actually challenging the pricing less. People are willing to embrace it in an office setting where imaging didn't exist before. People that have been using it in an academic hub are also now thinking about a second system that would also allow them to remotely do things that they couldn't do otherwise and had to transport patients.

So all of those are layers of good things. And I don't know that we can forecast how all of those play, but I know as all of those play, we're trying to capitalize on all of them to just drive what I would prefer to drive more placements and higher value. But I would prefer not to have to come down on price so that we can flood the market, and I also wouldn't propose that we try to become an elite technology that is only available for a few that can afford it.

So we need to strike that middle ground so that this truly delivers on the promise of accessibility. But I would go back and say, there is a slide in our investor date that I think is posted on our website that shows the image quality where we started in the 2020 sort of time frame with the first images that were approved by FDA. That wasn't ready for the masses. That was not ready for adoption across people that didn't want to invest in something disruptive.

I think we've totally changed the game with Optive AI, which applies to both systems, and then also what we can deliver with the new hardware and the new scanner.

Got it. That's helpful. Thank you for taking the questions.

Sure. Thanks, Frank.

Yuan Zhi, B. Riley Securities.

Hi. This is Brandon Carney, on for Yuan. Thanks for taking our questions. First, just on the ASP, is there anything in addition to the first sale of the next-gen hardware that contributed to the increases (inaudible)?

And so Brandon, are you talking about the from Q1 to Q2 or are you talking about the --

MSRP, right?

I'm talking about the ASP. There was one -- you mentioned the one sale of the next-gen hardware (inaudible). But I'm just wondering if there were any other factors going into the increase in ASP this quarter.

Okay. I'll take that. Yeah, this quarter, we did see an increase of our ASP from Q1. As we've always talked about, our ASP has been a mix -- a blend between the different channels in which we sell. So in Q2, we had a more favorable mix as well as we had MSRP increases that we had taken earlier in the year in the US and then obviously with the next-generation technology which we had sales in Q2 that was also at a higher MSRP.

So going forward, we see the benefits of the price increases that we've taken in the US and that should help contribute and drive towards margin expansion as well as part of the revenue lift that we anticipate in the second half of the year and beyond.

Got it. Would you expect an effect on your international business in anticipation of the new hardware becoming available? Do you think that that could push out timelines for some customers?

I think on the prepared remarks we mentioned that the new hardware of the new scanner will be available at the end of next year. We first are going to bring to our European business the new software and that should be by the end of this year, so that's relatively short order. And I have to say that the first generation with Optive AI is a significant step-up in image quality that is being very, very well received.

We have an opportunity to do investigational use only units in select cases if people want to use it for some kind of clinical evaluation and clinical work. And we anticipate that there may be a trickle of placement that are next-generation system in international markets in some of these flagship institutions that want to do more clinical work so that they can get their hands on that technology a little bit sooner than it will be broadly available.

Got it. And finally, I'm wondering if Swoop would have any special use case for patients with neural implants. Does the lower magnet field strength provide an advantage in that situation?

I would have to know exactly what you have in mind. We have seen that clearly, the low field and the low strength of the magnet is very favorable for any kind of magnetic interferences. So that's why although they are off-label on the other devices, ultimately, we do not have a labelling for devices. It is those devices that have a labelling for MRI. But we know a lot of people are actually scanning patients with pacemakers, that there is a lot of equipment in incubated patients that is in the magnetic field of our device that doesn't cause any interferences. So there's definitely an increased safety profile both at the site of care because nothing around it is problematic and for whatever the patient has that makes our system more valuable.

I'll give you another example, braces, so metal in your mouth. There is a little bit of interferences when you have braces, but a high field magnet creates just an impossible picture for a patient with braces. I mean, if you're looking for what is around it, you have this halo of white around the mouth area that masks a lot of the brain. So there's definitely, definitely a safety profile.

We also got some very favorable labelling from FDA in our next-generation around projectile risk. And I don't know if you can picture what our system looks like that it has this orange ring above it that you actually expand to show what is the reach of the magnetic field. We now no longer need to have it deployed if there is a human that is tending to the equipment. So if somebody's moving the scanner, if somebody's scanning a patient, that does not need to be opened. It only needs to be opened where there is no human supervision for the scanner, primarily during storage.

Got it. Thanks for taking our questions.

Sure.

That concludes the question-and-answer session. I would like to turn the call back over to Maria Sainz for closing remarks.

Thank you. Thank you all for listening in today and following our story. We look forward to updating you shortly again. Take good care.

Ladies and gentlemen, that concludes today's call. Thank you all for joining and you may now disconnect.