Earnings Call Transcript - HYPR Q2 2025

Operator, Operator

Good afternoon, and welcome to Hyperfine's Second Quarter 2025 Earnings Conference Call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Webb Campbell from Gilmartin Group for introductory disclosure.

Webb Campbell, Investor Relations

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'd 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.

Maria Sainz, President and CEO

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 8 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 financings. 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're executing well ahead of schedule. Second, we completed our office pilot program. In the U.S., 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 standalone software, and we have now begun rolling it out to our installed 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 combination 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'd 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're executing on our growth catalysts 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 U.S. 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 de-noising 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 Healthy 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 pediatric, elderly, or anxious patients, making MRI more accessible for all. It has been 10 weeks since the FDA cleared, and 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 immensely positive response to the new image quality from the radiology and neurology community. 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, proper 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're now selling into three channels: the hospital, the office, and international markets, providing a diversified foundation for future growth. I will now elaborate further on our hospital and office businesses. U.S. 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 execution from our manufacturing, technical, and commercial teams. The device 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 costs, 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 the emergency department. 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 emergency department is very limited and often very delayed. The PRIME study is actively enrolling 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 scanning patients and going through the reimbursement process with CMS and private payers successfully. Neurology offices represent a very compelling opportunity for the Swoop system. Neurologists directly impact 100 million patient lives in the U.S. 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 enrollment in Neuro PMR, our office study. As a reminder, Neuro PMR is a multicenter 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 enrollment expectations. Our plan is to keep enrollment open for a few more weeks to collect additional data for key clinical users 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're 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'm 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 subsystems 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 began building their 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 execution across our channels and disciplined capital preservation.

Brett Hale, Chief Financial Officer

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 8 units with a strong average selling price. Upon receiving FDA clearance of our next-generation Swoop system, we converted our pipeline of U.S. 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 remained strong, and the increased MSRP for the new Swoop system will provide additional pricing upside in the U.S. 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 had $25.4 million in cash and cash equivalents on our balance sheet. 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 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 a typical 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 margins comfortably and sustainably as we realize higher volume given our growth catalysts. 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 improvement. 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.

Maria Sainz, President and CEO

Thank you, Brett. This quarter marks an important turning point for Hyperfine. We're 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'm 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, Operator

And our first question comes from Larry Biegelsen with Wells Fargo.

Gursimran Kaur, Analyst

This is Simran 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, it's a 50% greater step-up in Q3 versus Q2. I think you maybe just clarify that comment.

Brett Hale, Chief Financial Officer

Simran, this is Brett. I will address the latter part of your question and then go back to the beginning. In our prepared remarks, we discussed the sequential growth. We are launching multiple initiatives simultaneously, which leads us to expect that the latter half of the year will have a significantly higher revenue base compared to the beginning of the year. We mentioned how to assess Q3 and Q4 regarding progressive sequential growth. For Q3, we anticipate a 50% increase in revenue compared to the growth we experienced between Q1 and Q2. Specifically, we saw an increase of about $560,000 from Q1 to Q2, and we expect at least a 50% increase going into Q3 compared to the revenue from Q2.

Maria Sainz, President and CEO

Simran, I’d like to share our confidence regarding the inflection point we’ve reached. We now have multiple layers contributing to revenue growth. The U.S. hospital sector with new technology is set to accelerate. Additionally, transitioning from pilot to full launch in our U.S. office business adds another revenue layer. We are also continuing our expansion into international markets, and we anticipate receiving approval in India by year-end. Our confidence is further bolstered by a significantly improved product, including the first-generation version with the latest software, Optive AI, and a brand new system that also features Optive AI. We are beginning to see market traction and activation, as we expected, and after about 10 weeks, we are observing positive results.

Gursimran Kaur, Analyst

Got it. That's very helpful. And maybe for my follow-up question around the Next-gen Swoop launch. Can you just talk about sort of 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 to your guidance?

Maria Sainz, President and CEO

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 sites of care and use cases that we have been focusing on. So we have a number of pipeline deals in the works, where we're talking about an adult in 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 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 many hospitals, and there are other solid 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.

Gursimran Kaur, Analyst

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?

Maria Sainz, President and CEO

So I'll share, generically, from some commentary here that is helpful we have been primarily focused on what we have labeled the pilot phase because we wanted to take really a handful of sites, soup to nuts. 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 facilities. Some of them are very small and very much a solid practitioner with an assistant that could be more medically trained or more administratively trained. And then they went through CMS registration and then CMS claims 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 imaging 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 ever focused on utilization because volume is the number one driver. The second one is really the mix of use 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 sort of in a 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 neuron network, which is a network of pretty high profile, very large offices. We selected the head of the NeuroNet hub, or the hub of NeuroNet more likely, that is DENT Institute, and that has been one of our sites participating in Europe. And for the 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 1 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 there was a press release not too long ago, that study has involved way ahead of expectations. I think we announced the beginning of involvement on April 15, and we messaged that we thought we would be enrolled in the 100-patient target by the end of the year and 1.5 weeks 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 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 also been helping them figure out a way to get their scans read. So we partner with a star teleradiology, which is actually a third-party radiology services that can lead 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.

Operator, Operator

Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets.

Frank James Takkinen, Analyst

Congratulations on all the exciting progress. I wanted to begin by discussing the current state of funnel interest. In summary, during the first half of the year, you placed around 14 systems, and the guidance for the second half suggests that this number will roughly double. I understand there are nuances with average selling prices and the service line, but it appears you will need to place between 20 and 30 systems. Any details you can share about the funnel to support this guidance would be greatly appreciated.

Maria Sainz, President and CEO

We are highly focused on managing opportunities in each territory, distinguishing between two types of funnels: one for hospital opportunities and another for office opportunities. The process for hospitals is generally well-defined, allowing us to track the timelines for these deals easily. In contrast, office opportunities can be a bit unpredictable, as decisions are often made quickly. Sometimes these opportunities appear suddenly, while others initially show interest but later hesitate as they assess their readiness. Each territory we operate in now has a dedicated funnel for both office and hospital deals. Outside of the U.S., 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 placement after the first sort of flagship institutions. Those could be big markets like Germany or the U.K. and partly 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, and the successes they collected puts us going into the second half at a totally different level of human capabilities, and sales power than anything we had in the first half as well.

Frank James Takkinen, Analyst

Got it. That's helpful. And then maybe just a 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?

Maria Sainz, President and CEO

I don't think there is a single primary driver. Instead, the main factor is how we demonstrate the current capabilities of our technology. The number of applications continues to grow. People are now approaching us expressing interest in using it for preoperative and postoperative purposes. They are also keen to explore mobile opportunities with this technology. With the current level of image quality, we can achieve things that previously seemed impossible in more accessible ways. I believe that is what is influencing all of this. 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 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, both.

Operator, Operator

And our last question comes from the line of Yuan Zhi with B. Riley Securities.

Brandon Carney, Analyst

This is Brandon Carney on for Yuan. First, just on the ASP. Is there anything in addition to the first sale of the next-gen hardware that contributed to the increase this Q?

Brett Hale, Chief Financial Officer

I'm sorry. So Brandon, you're talking about from Q1 to Q2? Or are you talking about the...

Maria Sainz, President and CEO

MSRP, right?

Brandon Carney, Analyst

I'm asking about the average selling price. You mentioned the sale of the next-gen hardware contributing to that. I'm curious if there were any other factors that contributed to the increase in average selling price this quarter.

Brett Hale, Chief Financial Officer

Okay. So I'll take that. So yes, 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 U.S. 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 U.S., 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.

Brandon Carney, Analyst

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?

Maria Sainz, President and CEO

So I think on the prepared remarks, we mentioned that the new hardware, so the new scanner will be available sort of 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 placements 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.

Brandon Carney, Analyst

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

Maria Sainz, President and CEO

I would need to know precisely what you're thinking. We've observed that the low field and strength of the magnet are very beneficial for minimizing magnetic interferences. Although the other devices are off-label, we do not have specific labeling for devices, except for those that are MRI-labeled. However, we know many people are scanning patients with pacemakers, and a lot of equipment used for incubated patients operates within the magnetic field of our device without causing any interference. There is an improved safety profile at the care site because nothing nearby poses a risk. Our system becomes more valuable based on the patient's specific condition. For instance, when it comes to braces, although the metal in the mouth can cause some interference, a high-field magnet generates a significantly obstructive image for patients with braces. If you're examining the area around the mouth, there's a notable white halo that obscures much of the brain. Hence, we definitely have a strong safety profile. Additionally, we received favorable labeling from the FDA regarding projectile risk with our next-generation system. You can visualize our system with an orange ring above it that can be expanded to indicate the extent of the magnetic field. We no longer need to deploy it if a person is operating the equipment.

Operator, Operator

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

Maria Sainz, President and CEO

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

Operator, Operator

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