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HyperfineF
Nasdaq / Health Care Equipment & Services
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Investor releaseQuarter not tagged2026-08-14

Hyperfine (HYPR) Q2 2026 Earnings Call Transcript

Motley Fool
Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET President and Chief Executive Officer - Maria Sainz Chief Administrative Officer and Chief Financial Officer - Brett Hale Operator: Good afternoon, and welcome to Hyperfine's Second Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the call over to Webb Campbell from Gilmartin Group for introductory disclosures. Webb Campbell: Thank you for joining today's call. Earlier today, Hyperfine, Inc. released financial results for the quarter ended June 30, 2026. 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 the federal securities laws and made pursuant to the safe harbor provision 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 include, without limitation, those related to our operating trends and future financial performance, expense management, 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 or 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 the 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 today's live broadcast. Hyperfine, Inc. disclaims any intention or obligation, except as required by law, to update or revise any financial projections 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: Good afternoon, and thank you for j…Read full document

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET President and Chief Executive Officer - Maria Sainz Chief Administrative Officer and Chief Financial Officer - Brett Hale Operator: Good afternoon, and welcome to Hyperfine's Second Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the call over to Webb Campbell from Gilmartin Group for introductory disclosures. Webb Campbell: Thank you for joining today's call. Earlier today, Hyperfine, Inc. released financial results for the quarter ended June 30, 2026. 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 the federal securities laws and made pursuant to the safe harbor provision 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 include, without limitation, those related to our operating trends and future financial performance, expense management, 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 or 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 the 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 today's live broadcast. Hyperfine, Inc. disclaims any intention or obligation, except as required by law, to update or revise any financial projections 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: 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. The second quarter was another strong quarter for Hyperfine as we continue to execute across our commercial, operational, and financial priorities. Second quarter revenue was $3.9 million, our second highest quarter ever, up approximately 45% year over year, bringing our first half revenue to $7.8 million. We sold 12 systems in the quarter, up 50% year over year, with a majority of placements coming from our next-generation system and a high percentage of international sales. We also delivered our 4th consecutive quarter of gross margin above 50% and improved our cash burn both year over year and sequentially. Mid last year, we launched our next-generation Swoop system powered by Optive AI and entered the neurology office market. We refer to this next-generation version of the Swoop system as Model 2. At the time of launch, we believed improvements in image quality, expanding clinical utility, a growing body of real-world evidence, and a broader, more diversified commercial strategy could unlock meaningful growth opportunities across hospitals, offices, and international markets. One year later, we have accumulated important proof points supporting that thesis. We have broadened adoption across sites of care, increased IDN engagement, entered new geographies, expanded our clinical evidence, strengthened our balance sheet, and improved the financial profile of the business. As a result, we are now more focused on translating this stronger foundation into broader commercial scale. With our strong execution in the first half of the year, we are reiterating our full year 2026 revenue and cash burn guidance and remain confident in our growth, margins, and long-term opportunities. Market demand remains healthy, and we are driving growth across our 3 verticals: hospitals, including our growing presence in health systems, neurology offices, and international markets. I will now walk through updates from each of these businesses in more detail. The hospital market remains our largest commercial vertical and an important source of clinical and commercial validation. Over the past year, the Swoop system has moved beyond niche use in critical care toward broader platform utility across critical care, emergency departments, and hospital-based clinics, with emerging use in neurological workflows and mobile deployment models. Hospital programs launched over the last few quarters with the Model 2 Swoop system have reported high utilization, increased scan volume, and meaningful clinical, workflow, and economic benefits. This broader utility and strong utilization matter because they support repeat deployments, deeper health system engagement, and enterprise-level adoption over time. We have made progress with large health systems and IDNs. In recent months, we have sold Model 2 systems to several new health systems, including an initial placement within one of the largest national IDNs in early July, while also expanding beyond the first site within other health systems during the second quarter. As hospitals enter their first full capital planning cycle since the Model 2 launch, our hospital pipeline is increasingly supported by clinical evidence, economic validation, and more strategic IDN-level conversations. Expansion into emergency departments has been a priority in 2026. PRIME data presented at the SAEM 2026 meeting provided compelling evidence to support the use of the Swoop system to triage patients in the ED. PRIME showed that portable MRI reduced the median order-to-scan start time in the ED from 7.76 hours for conventional MRI to 1.28 hours with portable MRI. Faster access to imaging can help hospitals reduce workflow bottlenecks, support more timely clinical decision-making, and integrate MRI more easily into ED workflows where conventional scanner availability can be constrained. These proof points and near-term catalysts give us increasing confidence in hospitals and IDNs as a durable growth engine supported by the success of initial programs, clinical evidence, and economic validation. We are seeing a different but complementary opportunity develop in neurology offices, where the Swoop system can bring imaging closer to patients and reduce friction in the care pathway. Our office market continues to develop into a distinct growth vertical supported by utilization, reference site development, patient preference, and ease of access to imaging. We have now placed the Swoop system in over a dozen offices since launch, supporting the office ecosystem value proposition. Office staff have been able to operate the system without an MR technologist, underscoring its ease of use. Several offices also report very high scan volume. Also, we continue to see increasing interest from adjacent use cases, including dementia screening applications, as well as from concierge and wellness practice models seeking convenient, closer-to-patient imaging. Our NEURO PMR data supports this opportunity with 92% blinded concordance with conventional MRI identifying pathology, rising to 98% with clinical history, and patients 4x more likely to choose portable MRI. Our planned expansion to add contrast to our labeling is expected to be an important catalyst for the office vertical by broadening clinical utility and supporting additional use cases with established reimbursement under dedicated contrast-related CPT codes. These proof points give us increasing confidence that the office market can, over time, become a meaningful second U.S. growth vertical supported by utilization, patient preference, ease of use, and planned contrast labeling expansion. Beyond our U.S. hospital and office opportunities, we're also beginning to build a stronger international foundation. Following CE and UKCA Mark approvals earlier in 2026, our Model 2 Swoop system is now commercially available in Europe and the U.K., and we sold the first 2 Model 2 systems in the quarter. We expect to advance the European rollout of the Model 2 system with our distribution partners in the second half of 2026. In France, inclusion of Model 2 in the UniHA procurement listing creates a more efficient purchasing pathway across French public hospitals. And in India, following CDSCO approval of Model 1 late last year, AIIMS New Delhi became our first India deployment, serving as a high-profile clinical reference site in the region. These milestones give us increasing confidence in international markets as an emerging growth vertical with regulatory approvals, initial sales, procurement access, and reference sites, creating a stronger foundation for broader execution. We are pleased with our diversified commercial profile and the progress made in each of the verticals. We continue to invest in product and software capabilities that can expand the Swoop system's clinical utility across existing and new sites of care. Looking ahead, software remains a key driver of the Swoop system as a continuously improving AI-enabled platform. We expect our next software release later this year, building on our cadence of frequent software-driven enhancements that improve image quality, clinical utility and speed, workflow and user experience. We're making good progress on a plan to extend labeling to include brain MRI with contrast. Enrollment in Contrast PMR is approximately 75% complete, and the study is progressing well. We continue to target an FDA submission by year-end 2026 to support an expansion of our labeling to include gadolinium-based contrast agents. In addition, we see early interest in neurosurgical workflows and mobile deployment models, both of which reinforce the broader platform potential of the Swoop system beyond traditional fixed-site imaging. In surgery, a newly formed advisory board and the operating room pilots are evaluating the potential for portable MRI to support immediate post-procedure assessment, while mobile models could extend access to brain imaging across distributed care settings where conventional MRI availability is limited. These initiatives reinforce our view of the Swoop system as a scalable, AI-enabled platform with increasing clinical utility and multiple future growth catalysts. With that, I will turn the call over to Brett to review our financial performance and guidance. Brett Hale: Thank you, Maria. I'll recap our financial results for the second quarter of 2026 before providing an update on our guidance. Revenue for the second quarter of 2026 was $3.9 million, compared to $2.7 million in the second quarter of 2025, representing an increase of $1.2 million, or approximately 45% year over year, and modestly above the first quarter of 2026. First half revenue was $7.8 million compared to $4.8 million in the prior year period, an increase of $3 million, or approximately 62%. In the second quarter, we sold 12 units compared to 8 units in the prior year period, an increase of 50%. In the first half, we sold 22 units compared to 14 units in the prior year period, an increase of approximately 57%. Gross profit for the second quarter of 2026 was $2 million, compared to $1.3 million in the second quarter of 2025. Gross margin was 50.7% compared to 49.3% in the prior year period, representing approximately 150 basis points of gross margin expansion. This is our 4th consecutive quarter with gross margin exceeding 50%, and we believe we are well positioned for meaningful margin expansion over time as we scale. R&D expenses for the second quarter of 2026 were $3.9 million compared to $4.5 million in the second quarter of 2025, a decrease of approximately 15%. We continue to realize the benefits of the reorganization completed in the first quarter of 2025, while focusing our R&D investment on the highest priority product and software initiatives that support commercial growth. Sales, general, and administrative expenses for the second quarter of 2026 were $6.6 million compared to $6.4 million in the second quarter of 2025, an increase of approximately 3%. We operate with one U.S. sales team covering both the hospital and office market opportunities and are focused on driving sales productivity and operating leverage. Net loss for the second quarter of 2026 was $9.3 million, equating to a net loss of $0.09 per share, compared to a net loss of $9.2 million, or $0.12 per share, in the second quarter of 2025. The second quarter of 2026 net loss included a $0.6 million non-cash loss from the change in fair value of warrant liabilities, with no meaningful comparable impact in the second quarter of 2025. Net cash burn excluding financing in the second quarter of 2026 was $7.9 million compared to $8.1 million in the second quarter of 2025, an improvement of $0.3 million or approximately 3%. First half net cash burn excluding financing was $16.6 million compared to $18.2 million in the prior year period, an improvement of $1.6 million or approximately 9%. We remain focused on reducing cash burn through disciplined spending and improved operating leverage in 2026. As of June 30, 2026, we had $43.5 million in cash and cash equivalents on our balance sheet, an increase of $2.7 million during the quarter. This increase reflected $10.6 million of net proceeds raised through our ATM program at an average price of $1.52 per share, strengthening our balance sheet and supporting our cash runway. With a stronger financial position, we remain focused on converting our commercial progress into sustained revenue growth, gross margin expansion, reduced cash burn, and improved operating leverage. As we continue to scale, quarterly revenue may be influenced by placement timing, customer purchasing cycles, and geographic and product mix. Over time, we will continue to measure our progress through install-based expansion, sustained revenue growth, gross margin expansion, and a more scalable commercial model. Now turning to guidance. We continue to expect full-year 2026 revenue of $20 million to $22 million, representing year-over-year growth at the midpoint of approximately 55%. Our confidence in the second half outlook is tied to identifiable drivers, including continued adoption of our Model 2 Swoop system, hospital and IDN conversion, health system capital planning cycles, office adoption and utilization, international launch execution, clinical and health economic evidence, and product catalysts. We continue to expect gross margin to be in the range of 50% to 55% for the year, supported by 4 consecutive quarters above 50%. The key drivers supporting this range are already visible in our results, including increasing scale, a strong value proposition, service revenue growth, and disciplined commercial execution. We continue to expect total cash burn to be in the range of $26 million to $28 million for the full year 2026, representing approximately a 10% year-over-year decline at the midpoint, inclusive of our debt service payments. Lastly, we continue to expect our cash runway to extend into 2028, supported by a strengthened balance sheet, improved cash burn, and a commercial plan built on identifiable growth drivers. The debt facility we entered into earlier this year also provides additional financial flexibility. This positions us to execute against our commercial growth plan while maintaining our disciplined approach to operating expenses and capital deployment. I will now turn the call back to Maria for closing comments. Maria Sainz: Before we open the call for questions, I would like to leave you with a few key takeaways. First, Hyperfine's financials are stronger than it was a year ago, supported by revenue growth, sustained gross margins above 50%, lower cash burn, and a strengthened balance sheet. Second, the launch of the Model 2 system is gaining traction. Over the past year, we have expanded utility and grown adoption across hospitals, offices, and international markets, and strengthened clinical evidence. Third, we are seeing early validation of our enterprise health system strategy through increased IDN engagement and initial large system adoption. Fourth, the office market continues to develop into an attractive growth opportunity supported by utilization, evidence generation, and planned contrast labeling expansion. And finally, we have multiple catalysts ahead, including Model 2 international rollout execution, the next AI-enabled software release, Contrast PMR enrollment completion and FDA submission, and overall broader commercial expansion. I'm proud of what the team has accomplished over the past year, and we remain focused on disciplined execution as we enter the second half of 2026. Operator? Operator: [Operator Instructions] Your first question comes from the line of Frank Takkinen with Lake Street Capital Markets. Your line is open. Nelson Cox: This is Nelson Cox on for Frank. I wanted to start with guidance a little bit. In the past, you've talked about budgetary cycles for the IDN initiatives and the back half kind of lining up with that. So you have $7.8 million on the board in the first half, and then the guidance assumes around $12 million to $14 million in the second half. I guess when you built that, how much assumes second and third sites at completion, kind of those existing IDNs versus first placements at new ones? I guess, just trying to understand how much of the ramp is repeat, kind of add-on orders at existing IDNs versus completely new ones. Thanks. Maria Sainz: Sure, Nelson. Thanks for the question. So there are several elements built into how we're looking at the second half over the first half, and definitely on the hospital side, there is subsequent placement in some of the IDNs in which we have opened. And across all hospitals, there is an effect of the budgetary sort of new year starting, the July sort of to June cycle, which wasn't available to us when we introduced Model 2 sort of at the midpoint of last year. But there's also the continued rollout of the office business, as well as other things that we're doing with the new software coming to the market in the second half, some of the pilots we're doing around neurosurgery and mobile. So I would say there are all of those layers that just keep adding to what we have built in the first half. The first half was a significant step-up, but we're expecting more of that in the second half. And I think overall we do have these identifiable catalysts. They're not just about the hospital business or just around the IDN. Nelson Cox: Got it. Very helpful. And then maybe on the office business, as you've gotten a few more quarters of experience with practices of different sizes, maybe talk about how you're thinking about offering. Is there still going to be an offering for the Model 1 versus the Model 2, with maybe the Model 1 being more of a fit for smaller practitioner practices at maybe a lower price point, or how are you thinking about that? Maria Sainz: So we've mentioned segmentation, and clearly the call point has segments, and they are very much based on the number of practitioners and with that the volume that they drive. We have seen that our initial adoption, I think we mentioned in the prepared remarks that we are in over a dozen offices since we launched, it has translated more into the larger offices that have greater volume, that have been able to support the Model 2 and are very excited about the capabilities of the Model 2 today and into the future. In the last year, we've done a few Model 1 placements, but I would expect that there will be more Model 2 in the offices that have the larger volume, and also the opportunity to have contrast in our indications for use in relatively short order will support additional cases in larger offices and the ability for those offices to use the dedicated CPT codes for contrast brain MRIs, which also pay higher. So all of that would create an economic picture for the office that probably will support more the Model 2 than the Model 1 going forward. Nelson Cox: Very helpful. Congrats on the progress, guys. Thank you. Maria Sainz: Thank you. Operator: Your next question comes from the line of Yuan Zhi with B. Riley Securities. Your line is open. Liwen Wang: This is Liwen Wang from B. Riley for Yuan Zhi. So for the 12 commercial systems during 2Q, do we have more color on the breakdown between hospitals, neurology office, and international placement? And do we see the neurology office channel become a meaningful contributor given it's been roughly a year since the next-generation Swoop launch? Brett Hale: Thanks for the question. This is Brett. I'll address the first part of that question in regards to the 12. What I'll comment on is just much like last quarter, we had a broad distribution from all of our verticals. So we had placements that came from international, the office, as well as the hospital. So we had placements that cut across all 3. One thing that we highlighted in the prepared remarks is the higher percentage of international mix for this quarter, but we did have a contribution that cut across all of them. The way we're thinking about each one of them is there's growth opportunities in each one of the segments. So we do see the office being a contributor to the growth in the second half of the year and beyond, given all the catalysts that Maria had mentioned. Operator: I would now like to turn the call back over to Maria Sainz for closing remarks. Maria Sainz: Well, thanks all for joining us today. We look forward to continuing to update you in future cycles. Thanks very much and have a great evening. Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect. Before you buy stock in Hyperfine, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Hyperfine wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* Now, it’s worth noting Stock Advisor’s total average return is 964% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Hyperfine (HYPR) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-08-07

Hyperfine, Inc. Q2 2026 Earnings Call Summary

Moby
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Performance was driven by the first full year of the next-generation Model 2 Swoop system, which now accounts for the majority of placements due to improved image quality and clinical utility. The hospital vertical is transitioning from niche critical care use to broader platform utility in emergency departments and mobile deployment models, supported by data showing a significant reduction in order-to-scan times. Management is successfully penetrating Integrated Delivery Networks (IDNs), securing initial placements in large national systems that serve as foundations for future enterprise-level adoption. The neurology office market is emerging as a distinct growth driver, with adoption by larger practices where the system's ease of use allows operation without a specialized MR technologist. International expansion accelerated following CE and UKCA Mark approvals, with the first Model 2 sales in Europe and a high-profile clinical reference site established in India. Operational efficiency improved through a 15% reduction in R&D expenses following a prior reorganization, while maintaining a 50%+ gross margin for four consecutive quarters. Full-year 2026 revenue guidance of $20 million to $22 million assumes a second-half ramp driven by hospital capital planning cycles and international rollout execution. A critical regulatory catalyst is the planned FDA submission by year-end 2026 to include gadolinium-based contrast agents in the system's labeling. Management expects the addition of contrast labeling to unlock higher-reimbursement CPT codes, particularly benefiting the neurology office vertical's economic profile. The software roadmap includes a late-2026 release focused on AI-enabled enhancements to image quality, speed, and user experience to maintain competitive differentiation. Cash runway is projected to extend into 2028, supported by disciplined spending, a strengthened balance sheet via the ATM program, and a new debt facility. Quarterly revenue remains subject to fluctuations based on placement timing, customer purchasing cycles, and geographic product mix. The company utilized its ATM program to raise $10.6 million in net proceeds during the quarter to strengthen its liquidity position. Net loss for…Read full document

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Performance was driven by the first full year of the next-generation Model 2 Swoop system, which now accounts for the majority of placements due to improved image quality and clinical utility. The hospital vertical is transitioning from niche critical care use to broader platform utility in emergency departments and mobile deployment models, supported by data showing a significant reduction in order-to-scan times. Management is successfully penetrating Integrated Delivery Networks (IDNs), securing initial placements in large national systems that serve as foundations for future enterprise-level adoption. The neurology office market is emerging as a distinct growth driver, with adoption by larger practices where the system's ease of use allows operation without a specialized MR technologist. International expansion accelerated following CE and UKCA Mark approvals, with the first Model 2 sales in Europe and a high-profile clinical reference site established in India. Operational efficiency improved through a 15% reduction in R&D expenses following a prior reorganization, while maintaining a 50%+ gross margin for four consecutive quarters. Full-year 2026 revenue guidance of $20 million to $22 million assumes a second-half ramp driven by hospital capital planning cycles and international rollout execution. A critical regulatory catalyst is the planned FDA submission by year-end 2026 to include gadolinium-based contrast agents in the system's labeling. Management expects the addition of contrast labeling to unlock higher-reimbursement CPT codes, particularly benefiting the neurology office vertical's economic profile. The software roadmap includes a late-2026 release focused on AI-enabled enhancements to image quality, speed, and user experience to maintain competitive differentiation. Cash runway is projected to extend into 2028, supported by disciplined spending, a strengthened balance sheet via the ATM program, and a new debt facility. Quarterly revenue remains subject to fluctuations based on placement timing, customer purchasing cycles, and geographic product mix. The company utilized its ATM program to raise $10.6 million in net proceeds during the quarter to strengthen its liquidity position. Net loss for the quarter included a $0.6 million non-cash loss related to the change in fair value of warrant liabilities. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management attributed the expected growth to the July-to-June hospital budgetary cycle, which was not fully captured during the Model 2 launch period last year. Growth is also expected from repeat placements within established IDNs and the introduction of new software capabilities. While Model 1 remains an option for smaller practices, management expects Model 2 to dominate the office vertical due to higher volume requirements and the upcoming contrast capability. The economic value proposition for offices shifts toward Model 2 as it supports more complex cases and higher-paying contrast-related reimbursement codes. Management declined to provide specific unit counts per vertical but noted a 'higher percentage' of international mix compared to previous periods. Placements were distributed across all three core segments: hospitals, neurology offices, and international markets.

Investor releaseQuarter not tagged2026-08-07

Hyperfine Q2 Earnings Call Highlights

MarketBeat
Interested in Hyperfine, Inc.? Here are five stocks we like better. Revenue and system sales accelerated: Second-quarter revenue rose 45% year over year to $3.9 million, with 12 systems sold versus eight a year earlier. First-half revenue increased 62% to $7.8 million, while gross margin reached 50.7%. Model 2 adoption broadened: Most quarterly placements were next-generation Model 2 systems, spanning hospitals, neurology offices and international markets. Hyperfine also reported strong utilization and faster emergency-department scan times, with portable MRI reducing median order-to-scan-start time to 1.28 hours versus 7.76 hours for conventional MRI. Outlook and expansion plans were maintained: Hyperfine reiterated 2026 revenue guidance of $20 million to $22 million, gross margin of 50% to 55% and cash burn of $26 million to $28 million. The company is targeting an FDA submission for contrast-enhanced brain MRI labeling by the end of 2026 and expects its cash runway to extend into 2028. Hyperfine (NASDAQ:HYPR) reported second-quarter revenue of $3.9 million, up approximately 45% from a year earlier, as the portable MRI company cited growth across hospital, neurology office and international markets. The company sold 12 systems during the quarter, compared with eight in the prior-year period. First-half revenue totaled $7.8 million, a 62% increase from $4.8 million a year earlier, while unit sales rose 57% to 22 systems. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth President and Chief Executive Officer Maria Sainz said the quarter was Hyperfine’s second-highest revenue quarter and marked its fourth consecutive quarter with gross margin above 50%. “The second quarter was another strong quarter for Hyperfine as we continue to execute across our commercial, operational, and financial priorities,” Sainz said. → Visa’s BioCatch Deal Could Make Fraud Prevention a Bigger Business Hyperfine said its next-generation Swoop portable MRI system, now called Model 2 and powered by Optive AI, continued to gain commercial traction. The company launched the system in mid-2025 and entered the neurology office market at that time. According to Sainz, most of the 12 systems placed in the second quarter were Model 2 systems, and international sales represented a high percentage of quarterly placements. The company said it is pursuing three principal commer…Read full document

Interested in Hyperfine, Inc.? Here are five stocks we like better. Revenue and system sales accelerated: Second-quarter revenue rose 45% year over year to $3.9 million, with 12 systems sold versus eight a year earlier. First-half revenue increased 62% to $7.8 million, while gross margin reached 50.7%. Model 2 adoption broadened: Most quarterly placements were next-generation Model 2 systems, spanning hospitals, neurology offices and international markets. Hyperfine also reported strong utilization and faster emergency-department scan times, with portable MRI reducing median order-to-scan-start time to 1.28 hours versus 7.76 hours for conventional MRI. Outlook and expansion plans were maintained: Hyperfine reiterated 2026 revenue guidance of $20 million to $22 million, gross margin of 50% to 55% and cash burn of $26 million to $28 million. The company is targeting an FDA submission for contrast-enhanced brain MRI labeling by the end of 2026 and expects its cash runway to extend into 2028. Hyperfine (NASDAQ:HYPR) reported second-quarter revenue of $3.9 million, up approximately 45% from a year earlier, as the portable MRI company cited growth across hospital, neurology office and international markets. The company sold 12 systems during the quarter, compared with eight in the prior-year period. First-half revenue totaled $7.8 million, a 62% increase from $4.8 million a year earlier, while unit sales rose 57% to 22 systems. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth President and Chief Executive Officer Maria Sainz said the quarter was Hyperfine’s second-highest revenue quarter and marked its fourth consecutive quarter with gross margin above 50%. “The second quarter was another strong quarter for Hyperfine as we continue to execute across our commercial, operational, and financial priorities,” Sainz said. → Visa’s BioCatch Deal Could Make Fraud Prevention a Bigger Business Hyperfine said its next-generation Swoop portable MRI system, now called Model 2 and powered by Optive AI, continued to gain commercial traction. The company launched the system in mid-2025 and entered the neurology office market at that time. According to Sainz, most of the 12 systems placed in the second quarter were Model 2 systems, and international sales represented a high percentage of quarterly placements. The company said it is pursuing three principal commercial verticals: hospitals and health systems, neurology offices and international markets. → Dodging Deutsche Telekom: T-Mobile's Strategic Win In hospitals, Hyperfine said Model 2 deployments have moved beyond critical-care use into emergency departments, hospital-based clinics, neurological workflows and mobile deployment models. The company also reported sales to several new health systems, including an initial placement within one of the country’s largest national integrated delivery networks in early July. Sainz said hospitals that launched Model 2 programs in recent quarters have reported high utilization, increased scan volumes, and clinical workflow and economic benefits. Hyperfine expects these results to support additional deployments and more enterprise-level health system engagement over time. The company highlighted data from its PRIME study, presented at the Society for Academic Emergency Medicine’s 2026 meeting. Hyperfine said the data showed that portable MRI reduced the median time from order to scan start in emergency departments to 1.28 hours, compared with 7.76 hours for conventional MRI. Hyperfine said it has placed Swoop systems in more than a dozen neurology offices since entering that market. Sainz said office staff have been able to operate the system without an MRI technologist, while several practices have reported high scan volumes. The company is seeing interest in dementia screening, concierge medicine and wellness practice models, according to management. Hyperfine also cited results from its NEURO PMR data, which showed 92% blinded concordance with conventional MRI in identifying pathology, increasing to 98% when clinical history was included. The company said patients were four times more likely to choose portable MRI. Hyperfine is pursuing an expansion of its labeling to include brain MRI with gadolinium-based contrast agents. The company said enrollment in its Contrast PMR study is about 75% complete and continues to target an FDA submission by the end of 2026. Sainz said a contrast indication could expand the system’s clinical uses in offices and allow practices to use dedicated contrast-related CPT codes, which she said provide higher reimbursement for contrast brain MRI procedures. During the question-and-answer session, Sainz said the office market’s early adoption has been concentrated among larger practices with greater patient volume. She said these offices are more likely to support Model 2 placements and could benefit from a future contrast labeling expansion. Hyperfine said Model 2 is now commercially available in Europe and the United Kingdom following CE Mark and UKCA Mark approvals earlier this year. The company sold its first two Model 2 systems in those markets during the second quarter and expects to advance the European rollout with distribution partners in the second half. In France, Hyperfine said Model 2’s inclusion in the UniHA procurement listing provides a purchasing pathway for public hospitals. In India, the company said AIIMS New Delhi became its first deployment after Model 1 received CDSCO approval late last year. Chief Administrative Officer and Chief Financial Officer Brett Hale said the company’s 12 commercial placements during the quarter were distributed across hospitals, offices and international markets. He noted that international placements accounted for a higher percentage of the quarterly mix. Second-quarter gross profit was $2 million, compared with $1.3 million a year earlier. Gross margin was 50.7%, up from 49.3% in the prior-year period. Research and development expense fell 15% year over year to $3.9 million. Sales, general and administrative expense rose 3% to $6.6 million. Net loss was $9.3 million, or $0.09 per share, compared with a loss of $9.2 million, or $0.12 per share, a year earlier. Second-quarter net cash burn excluding financing was $7.9 million, compared with $8.1 million in the prior-year period. Hale said the second-quarter net loss included a $0.6 million non-cash loss related to the change in fair value of warrant liabilities. Hyperfine ended June with $43.5 million in cash and cash equivalents, up $2.7 million during the quarter. The increase reflected $10.6 million in net proceeds raised through the company’s at-the-market program at an average price of $1.52 per share. Hyperfine reiterated its full-year 2026 outlook, including revenue of $20 million to $22 million, gross margin of 50% to 55%, and total cash burn of $26 million to $28 million, inclusive of debt service payments. The company also maintained its expectation that its cash runway will extend into 2028. Management said second-half growth is expected to be supported by continued Model 2 adoption, hospital and integrated delivery network conversions, office utilization, international launch activity, software releases, clinical evidence and product-related catalysts. Hyperfine, Inc (NASDAQ: HYPR) is a medical technology company focused on expanding access to advanced neuroimaging through its portable magnetic resonance imaging (MRI) system. The company's flagship product, Swoop®, is designed to enable bedside MRI scanning in a wide range of clinical environments, including emergency departments, intensive care units and outpatient clinics. By leveraging a compact, high-performance permanent magnet and a custom-designed gradient system, Hyperfine aims to reduce the logistical and financial barriers associated with traditional, large-scale MRI installations. The Swoop system features a lightweight, wheeled design that can be maneuvered directly to a patient's bedside, allowing clinicians to conduct diagnostic imaging without the need to transport critically ill or immobile patients. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Hyperfine Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-07

Hyperfine Inc (HYPR) (Q2 2026) Earnings Call Highlights: Revenue Surges 45% on Strong System ...

GuruFocus.com
This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Second quarter revenue of $3.9 million, up 45% year-over-year, marking the second highest quarter ever. Gross margin exceeded 50% for the fourth consecutive quarter, reaching 50.7%. System sales increased 50% year-over-year to 12 units, with strong international contribution. Cash burn improved by 9% in the first half of 2026 compared to the prior year period. Progress in international expansion with CE and UKCA approvals, first Model 2 sales in Europe, and entry into India. Clinical evidence supports growth, including ED triage data showing reduced scan start times and high concordance in office settings. Contrast labeling expansion on track with FDA submission targeted by year-end 2026, expected to open new reimbursement opportunities. Strengthened balance sheet with $43.5 million in cash, extending runway into 2028. Net loss of $9.3 million in Q2 2026, with a non-cash loss from warrant liabilities. Revenue guidance for 2026 implies a significant second-half ramp, which may be challenging to achieve. Dependence on capital planning cycles and IDN conversions for second-half growth, which can be unpredictable. International sales still nascent, with only two Model 2 systems sold in Europe in Q2. Office market adoption is still early, with only a dozen placements since launch, and may not scale as quickly as expected. R&D expenses decreased, but SG&A increased, indicating limited operating leverage in the near term. Cash burn remains high at $7.9 million in Q2, despite improvements, and the company relies on ATM offerings for liquidity. Warning! GuruFocus has detected 4 Warning Signs with HYPR. Is HYPR fairly valued? Test your thesis with our free DCF calculator. Q: How much of the second-half revenue ramp is driven by repeat add-on orders from existing IDNs versus first placements at new ones?A: Brett Hale (CFO): The second-half outlook is built on several layers beyond just hospital placements. This includes subsequent placements within existing IDNs, the effect of the July-to-June budgetary cycle for hospitals (which wasn't available when Model 2 launched mid-last year), continued rollout of the office business, new software releases, and pilots in neurosurgery and mobile. The first hal…Read full document

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Second quarter revenue of $3.9 million, up 45% year-over-year, marking the second highest quarter ever. Gross margin exceeded 50% for the fourth consecutive quarter, reaching 50.7%. System sales increased 50% year-over-year to 12 units, with strong international contribution. Cash burn improved by 9% in the first half of 2026 compared to the prior year period. Progress in international expansion with CE and UKCA approvals, first Model 2 sales in Europe, and entry into India. Clinical evidence supports growth, including ED triage data showing reduced scan start times and high concordance in office settings. Contrast labeling expansion on track with FDA submission targeted by year-end 2026, expected to open new reimbursement opportunities. Strengthened balance sheet with $43.5 million in cash, extending runway into 2028. Net loss of $9.3 million in Q2 2026, with a non-cash loss from warrant liabilities. Revenue guidance for 2026 implies a significant second-half ramp, which may be challenging to achieve. Dependence on capital planning cycles and IDN conversions for second-half growth, which can be unpredictable. International sales still nascent, with only two Model 2 systems sold in Europe in Q2. Office market adoption is still early, with only a dozen placements since launch, and may not scale as quickly as expected. R&D expenses decreased, but SG&A increased, indicating limited operating leverage in the near term. Cash burn remains high at $7.9 million in Q2, despite improvements, and the company relies on ATM offerings for liquidity. Warning! GuruFocus has detected 4 Warning Signs with HYPR. Is HYPR fairly valued? Test your thesis with our free DCF calculator. Q: How much of the second-half revenue ramp is driven by repeat add-on orders from existing IDNs versus first placements at new ones?A: Brett Hale (CFO): The second-half outlook is built on several layers beyond just hospital placements. This includes subsequent placements within existing IDNs, the effect of the July-to-June budgetary cycle for hospitals (which wasn't available when Model 2 launched mid-last year), continued rollout of the office business, new software releases, and pilots in neurosurgery and mobile. The first half was a significant step up, but we expect more of that in the second half, driven by identifiable catalysts across all verticals, not just hospitals or IDNs. Q: As you gain more experience with neurology office practices of different sizes, how are you thinking about offering Model 1 versus Model 2, with Model 1 potentially being a lower price point for smaller practices?A: Maria Sainz (CEO): The office market is segmented based on the number of practitioners and the volume they drive. Initial adoption has translated more into larger offices that can support Model 2 and are excited about its capabilities. While we've done a few Model 1 placements in the last year, we expect more Model 2 placements going forward in larger offices. The planned contrast labeling expansion will support additional use cases and allow offices to use dedicated, higher-paying CPT codes for contrast brain MRIs, creating a better economic picture that supports Model 2 over Model 1. Q: For the 12 commercial systems sold in Q2, can you provide more color on the breakdown between hospitals, neurology offices, and international placements? Is the neurology office channel becoming a meaningful contributor a year after the Model 2 launch?A: Brett Hale (CFO): Similar to last quarter, the 12 placements had a broad distribution across all verticals, including international, office, and hospital. We highlighted a higher percentage of international mix this quarter, but contributions cut across all segments. We see growth opportunities in each segment, and the office market will be a contributor to growth in the second half of the year and beyond, given the catalysts mentioned by Maria. Q: What are the key drivers behind the company's confidence in reiterating full-year 2026 revenue guidance of $20-22 million, given the strong first-half performance?A: Maria Sainz (CEO) & Brett Hale (CFO): The confidence is tied to identifiable drivers, including continued adoption of the Model 2 Swoop system, hospital and IDN conversion, health system capital planning cycles, office adoption and utilization, international launch execution, clinical and health economic evidence, and product catalysts. The company sold 12 systems in Q2 (up 50% YoY) and 22 in the first half (up 57% YoY), with revenue of $3.9 million in Q2 (up 45% YoY) and $7.8 million in the first half (up 62% YoY). Q: Can you elaborate on the progress and impact of the contrast labeling expansion for the Swoop system?A: Maria Sainz (CEO): Enrollment in the contrast PMR (post-market study) is approximately 75% complete and progressing well. We continue to target an FDA submission by year-end 2026 to support expanding labeling to include gadolinium-based contrast agents. This is expected to be an important catalyst, particularly for the office vertical, by broadening clinical utility and supporting additional use cases with established reimbursement under dedicated contrast-related CPT codes. Q: What evidence supports the expansion into emergency departments, and how does this impact the hospital growth strategy?A: Maria Sainz (CEO): Prime data presented at the SAEM 2026 meeting showed that portable MRI reduced the median order-to-scan start time in the ED from 7.76 hours for conventional MRI to 1.28 hours with portable MRI. Faster access to imaging helps hospitals reduce workflow bottlenecks, support more timely clinical decision-making, and integrate MRI more easily into ED workflows. These proof points give us increasing confidence in hospitals and IDNs as a durable growth engine. Q: What is the current status of the international expansion, particularly in Europe and India?A: Maria Sainz (CEO): Following CE and UKCA mark approvals earlier in 2026, the Model 2 system is now commercially available in Europe and the UK, and we sold the first two Model 2 systems in Q2. We expect to advance the European rollout with distribution partners in the second half of 2026. In France, inclusion of Model 2 in the UNIHA procurement listing creates a more efficient purchasing pathway across French public hospitals. In India, following CDSCO approval of Model 1 late last year, AIIMS New Delhi became our first Indian deployment, serving as a high-profile clinical reference site. Q: How is the company managing its cash position and what is the expected cash runway?A: Brett Hale (CFO): As of June 30, 2026, we had $43.5 million in cash and cash equivalents, an increase of $2.7 million during the quarter, reflecting $10.6 million of net proceeds raised through our ATM program at an average price of $1.52 per share. Net cash burn excluding financing was $7.9 million in Q2 2026, an improvement of 3% YoY, and $16.6 million in the first half, an improvement of 9% YoY. We continue to expect total cash burn of $26-28 million for full-year 2026 and expect our cash runway to extend into 2028. Q: What are the key financial highlights for the second quarter of 2026?A: Brett Hale (CFO): Q2 2026 revenue was $3.9 million, up approximately 45% YoY. Gross margin was 50.7%, marking the fourth consecutive quarter above 50%. R&D expenses decreased 15% YoY to $3.9 million, while SG&A expenses increased 3% to $6.6 million. Net loss was $9.3 million, or $0.09 per share, compared to a net loss of $9.2 million, or $0.12 per share, in Q2 2025. The net loss included a $0.6 million non-cash loss from the change in fair value of warrant liabilities. Q: What is the company's view on the office market opportunity and what evidence supports it?< For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-06

Hyperfine, Inc. Reports Second Quarter 2026 Financial Results

Business Wire
GUILFORD, Conn., August 06, 2026--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced second quarter 2026 financial results and provided a business update. "Q2 was another strong quarter for Hyperfine, marked by solid growth in placements and revenue, continued gross margin expansion, disciplined operating expense management, and a strengthened balance sheet. One year into the launch of the next-generation Swoop® system and our entry into the neurology office market, we are seeing broader use across care settings and international markets. We are executing on our strategy to expand MRI access across sites of care, increase the clinical utility of our technology, and broaden our international reach. With record U.S. scan volume, continued momentum across hospital and office settings, and international commercial progress, portable brain MRI is moving from early adoption toward broader mainstream clinical use," said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. Recent Achievements and Business Highlights Obtained CE Marking and UK Conformity Assessment (UKCA) approval for both the next-generation Swoop® system and the latest Optive AI™ software in Europe. Announced the European launch of the next-generation Swoop® system, with initial systems sold. Achieved record U.S. Swoop® system scan volume milestones across multiple sites of care, reflecting expanding clinical utility and increasingly diverse use cases across hospital and office settings. Formed a Global Neurosurgery Advisory Council of leading neurosurgeons from around the world to help guide the role of the Swoop® system in neurosurgical care. Presented results from the PRIME study showing portable MRI substantially reduces time to imaging in emergency departments. Expanded Swoop® system evidence base with new peer-reviewed Stroke and Journal of Neurosurgery publications, adding to more than 180 publications and 280 scientific presentations to date. Second Quarter 2026 Financial Results Revenues for the second quarter of 2026 were $3.9 million, increasing 44.8% compared to $2.7 million in the second quarter of 2025. Sold 12 commercial Swoop® systems in the second quarter of 2026, in…Read full document

GUILFORD, Conn., August 06, 2026--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced second quarter 2026 financial results and provided a business update. "Q2 was another strong quarter for Hyperfine, marked by solid growth in placements and revenue, continued gross margin expansion, disciplined operating expense management, and a strengthened balance sheet. One year into the launch of the next-generation Swoop® system and our entry into the neurology office market, we are seeing broader use across care settings and international markets. We are executing on our strategy to expand MRI access across sites of care, increase the clinical utility of our technology, and broaden our international reach. With record U.S. scan volume, continued momentum across hospital and office settings, and international commercial progress, portable brain MRI is moving from early adoption toward broader mainstream clinical use," said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. Recent Achievements and Business Highlights Obtained CE Marking and UK Conformity Assessment (UKCA) approval for both the next-generation Swoop® system and the latest Optive AI™ software in Europe. Announced the European launch of the next-generation Swoop® system, with initial systems sold. Achieved record U.S. Swoop® system scan volume milestones across multiple sites of care, reflecting expanding clinical utility and increasingly diverse use cases across hospital and office settings. Formed a Global Neurosurgery Advisory Council of leading neurosurgeons from around the world to help guide the role of the Swoop® system in neurosurgical care. Presented results from the PRIME study showing portable MRI substantially reduces time to imaging in emergency departments. Expanded Swoop® system evidence base with new peer-reviewed Stroke and Journal of Neurosurgery publications, adding to more than 180 publications and 280 scientific presentations to date. Second Quarter 2026 Financial Results Revenues for the second quarter of 2026 were $3.9 million, increasing 44.8% compared to $2.7 million in the second quarter of 2025. Sold 12 commercial Swoop® systems in the second quarter of 2026, increasing 50.0% compared to 8 in the second quarter of 2025. Gross profit for the second quarter of 2026 was $2.0 million, compared to $1.3 million in the second quarter of 2025, representing 50.7% gross margin in the second quarter of 2026, compared to 49.3% gross margin in the second quarter of 2025. Research and development expenses for the second quarter of 2026 were $3.9 million, decreasing 14.9% compared to $4.5 million in the second quarter of 2025. Sales, marketing, general, and administrative expenses for the second quarter of 2026 were $6.6 million, increasing 3.2% compared to $6.4 million in the second quarter of 2025. Net loss for the second quarter of 2026 was $9.3 million, equating to a net loss of $0.09 per share, as compared to a net loss of $9.2 million, or a net loss of $0.12 per share, for the second quarter of 2025. The second quarter of 2026 net loss includes a $0.6 million loss from a change in the fair value of warrant liabilities, compared to a less than $0.1 million gain in the second quarter of 2025. Cash and cash equivalents were $43.5 million as of June 30, 2026, compared with $35.1 million as of December 31, 2025, primarily reflecting financing activities completed during the first half of 2026. 2026 Financial Guidance Management continues to expect revenue for the full year 2026 to be approximately $20 to $22 million, representing 55% growth at the midpoint as compared to full year 2025. Management continues to expect cash burn1 for the full year 2026 to be approximately $26 to $28 million, representing a 10% decline at the midpoint as compared to full year 2025. 1Cash burn is calculated as change in cash and cash equivalents less net financing proceeds. Conference Call Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Thursday, August 6, 2026 to discuss its second quarter 2026 financial results and provide a business update. Those interested in listening should register online by visiting https://investors.hyperfine.io/ and clicking on News & Events. Participants are encouraged to register more than 15 minutes before the start of the call. A live and archived audio webcast will be available through the Investors page of Hyperfine, Inc.’s corporate website at https://investors.hyperfine.io/. About Hyperfine, Inc. and the Swoop® Portable MR Imaging® Systems Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first U.S. Food and Drug Administration (FDA)-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit hyperfine.io. The Swoop® Portable MR Imaging® systems are FDA cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop® system also has CE Mark in the European Union and UKCA Mark in the United Kingdom. The Swoop® system is commercially available in a select number of international markets. Hyperfine, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the "Company") may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations about the Company’s financial and operating results, including, the Company’s expected revenue and cash burn for the full year 2026, the Company's cash runway, the Company’s goals and commercial plans, including the Company’s commercial rollout of the Company’s Optive AI™ software and next generation Swoop® system, the acceleration of the adoption of the Swoop® system across multiple sites of care in the hospital, neurology office and international markets, the benefits of the Company’s products and services, progress on improvements and advancements in the Company’s products and services, and the Company’s future performance, including its financial performance, and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the Company’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the ability of the Company to raise financing in the future; the ability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the ability of the Company to identify, in-license or acquire additional technology; the ability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; existing and potential future National Institutes of Health funding pressures; existing and potential future effects from U.S. export controls and tariffs; the ability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; the Company’s ability to successfully complete and generate positive data from the PRIME study, ACTION PMR study, Contrast PMR study, CARE PMR study and NEURO PMR study; the Company’s ability to generate clinical evidence of the benefits of the Company’s products and services and to progress on product advancements and improvements; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under "Risk Factors" therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806773078/en/ Contacts Investor ContactWebb CampbellGilmartin Group [email protected]

TranscriptFY2026 Q22026-08-06

FY2026 Q2 earnings call transcript

Earnings source - 39 paragraphs
Operator

Good afternoon, welcome to Hyperfine's Second Quarter 2026 Earnings Conference Call. Currently, all participants are in a listen-only mode. Following management's prepared remarks, we will open the call for questions. As a reminder, this call is being recorded. I would now like to turn the call over to Webb Campbell from Gilmartin Group for introductory disclosures.

Webb Campbell

Thank you for joining today's call. Earlier today, Hyperfine, Inc. released financial results for the quarter ended June 30th, 2026. 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 the Federal Securities Laws and made pursuant to the safe harbor provision 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, market opportunity, commercial and international expansion, regulatory approvals, and product development are based upon our current estimates and various assumptions.

Webb Campbell

These statements involve material risks and uncertainties that could cause actual results or 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 the 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 today's live broadcast. Hyperfine, Inc. disclaims any intention or obligation, except as required by law, to update or revise any financial projections 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

Good afternoon, thank you for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Brett Hale. The second quarter was another strong quarter for Hyperfine as we continue to execute across our commercial, operational, and financial priorities. Second quarter revenue was $3.9 million, our second highest quarter ever, up approximately 45% year-over-year, bringing our first half revenue to $7.8 million. We sold 12 systems in the quarter, up 50% year-over-year, with a majority of placements coming from our next-generation system and a high percentage of international sales. We also delivered our fourth consecutive quarter of gross margin above 50% and improved our cash burn both year-over-year and sequentially. Mid last year, we launched our next-generation Swoop system powered by Optive AI and entered the neurology office market.

Maria Sainz

We now refer to this next-generation version of the Swoop system as Model 2. At the time of launch, we believed improvements in image quality, expanding clinical utility, a growing body of real-world evidence, and a broader, more diversified commercial strategy could unlock meaningful growth opportunities across hospitals, offices, and international markets. One year later, we have accumulated important proof points supporting that thesis. We have broadened adoption across sites of care, increased IDN engagement, entered new geographies, expanded our clinical evidence, strengthened our balance sheet, and improved the financial profile of the business. As a result, we are now more focused on translating this stronger foundation into broader commercial scale. With our strong execution in the first half of the year, we are reiterating our full year in 2026 revenue and cash burn guidance and remain confident in our growth, margins, and long-term opportunities.

Maria Sainz

Market demand remains healthy. We are driving growth across our three verticals: hospitals, including our growing presence in health systems, neurology offices, and international markets. I will now walk through updates from each of these businesses in more detail. The hospital market remains our largest commercial vertical and an important source of clinical and commercial validation. Over the past year, the Swoop system has moved beyond niche use in critical care toward broader platform utility across critical care emergency departments and hospital-based clinics, with emerging use in neurological workflows and mobile deployment models. Hospital programs launched over the last few quarters with a Model 2 Swoop system have reported high utilization, increased the scan volumes, and meaningful clinical workflow and economic benefits. This broader utility and strong utilization matter because they support repeat deployments, deeper health system engagement, and enterprise-level adoption over time.

Maria Sainz

We have made progress with large health systems and IDNs. In recent months, we have sold Model 2 systems to several new health systems Including an initial placement within one of the largest national IDNs in early July, while also expanding beyond the first site within other health systems during the second quarter. As hospitals enter their first full capital planning cycle since the Model 2 launch, our hospital pipeline is increasingly supported by clinical evidence, economic validation, and more strategic IDN-level conversations. Expansion into emergency departments has been a priority in 2026. PRIME data presented at SAEM 2026 meeting provided compelling evidence to support the use of the Swoop system to triage patients in the ED.

Maria Sainz

PRIME showed that portable MRI reduced the median order to scan start time in the ED from 7.76 hours for conventional MRI to 1.28 hours with portable MRI. Faster access to imaging can help hospitals reduce workflow bottlenecks, support more timely clinical decision-making, and integrate the MRI more easily into ED workflows, where conventional scanner availability can be constrained. These proof points and near-term catalysts give us increasing confidence in hospitals and IDNs as a durable growth engine supported by the success of initial programs, clinical evidence and economic validation. We are seeing a different but complementary opportunity develop in neurology offices, where the Swoop system can bring imaging closer to patients and reduce friction in the care pathway. Our office market continues to develop into a distinct growth vertical supported by utilization, reference site development, patient preference, and ease of access to imaging.

Maria Sainz

We have now placed a Swoop system in over a dozen offices since launch, supporting the office value proposition. Office staff have been able to operate the system without an MR technologist, underscoring its ease of use. Several offices report very high scan volume. We continue to see increasing interest from adjacent use cases, including dementia screening applications as well as from concierge and wellness practice models seeking convenient closer-to-patient imaging. Our NEURO PMR data supports this opportunity, with 92% blinded concordance with conventional MRI identifying pathology, rising to 98% with clinical history, and patients four times more likely to choose portable MRI. Our planned expansion to add contrast to our labeling is expected to be an important catalyst for the office vertical by broadening clinical utility and supporting additional use cases with established reimbursement under dedicated contrast-related CPT codes.

Maria Sainz

These proof points give us increasing confidence that the office market can, over time, become a meaningful second U.S. growth vertical supported by utilization, patient preference, ease of use, and planned contrast labeling expansion. Beyond our U.S. hospital and office opportunities, we're also beginning to build a stronger international foundation. Following CE Mark and UKCA Mark approvals earlier in 2026, our Model 2 Swoop system is now commercially available in Europe and the U.K., and we sold the first two Model 2 systems in the quarter. We expect to advance the European rollout of the Model 2 system with our distribution partners in the second half of 2026. In France, inclusion of Model 2 in the UniHA procurement listing creates a more efficient purchasing pathway across French public hospitals.

Maria Sainz

In India, following CDSCO approval of Model 1 late last year, AIIMS, New Delhi became our first India deployment, serving as a high-profile clinical reference site in the region. These milestones give us increasing confidence in international markets as an emerging growth vertical, with regulatory approvals, initial sales, procurement access, and reference sites creating a stronger foundation for broader execution. We are pleased with our diversified commercial profile and the progress made in each of the verticals. We continue to invest in product and software capabilities that can expand the Swoop system's clinical utility across existing and new sites of care. Looking ahead, software remains a key driver of the Swoop system as a continuously improving AI-enabled platform. We expect our next software release later this year, building on our cadence of frequent software-driven enhancements that improve image quality, clinical utility, scan speed, workflow, and user experience.

Maria Sainz

We're making good progress on our plan to expand labeling to include brain MRI with contrast. Enrollment in Contrast PMR is approximately 75% complete, and the study is progressing well. We continue to target an FDA submission by year end 2026 to support an expansion of our labeling to include gadolinium-based contrast agents. In addition, we see early interest in neurosurgical workflows and mobile deployment models, both of which reinforce the broader platform potential of the Swoop system beyond traditional fixed-site imaging. In surgery, a newly formed advisory board and the operating room pilots are evaluating the potential for portable MRI to support immediate post-procedure assessment, while mobile models could expand access to brain imaging across distributed care settings where conventional MRI availability is limited. These initiatives reinforce our view of the Swoop system as a scalable, AI-enabled platform with increasing clinical utility and multiple future growth catalysts.

Maria Sainz

With that, I will turn the call over to Brett to review our financial performance and guidance.

Brett Hale

Thank you, Maria. I'll recap our financial results for the second quarter of 2026 before providing an update on our guidance. Revenue for the second quarter of 2026 was $3.9 million, compared to $2.7 million in the second quarter of 2025, representing an increase of $1.2 million, or approximately 45% year-over-year, and modestly above the first quarter of 2026. First half revenue was $7.8 million compared to $4.8 million in the prior year period, an increase of $3 million, or approximately 62%. In the second quarter, we sold 12 units compared to eight units in the prior year period, an increase of 50%. First half we sold 22 units compared to 14 units in the prior year period, an increase of approximately 57%.

Brett Hale

Gross profit for the second quarter of 2026 was $2 million, compared to $1.3 million in the second quarter of 2025. Gross margin was 50.7% compared to 49.3% in the prior year period, representing approximately 150 basis points of gross margin expansion. This is our fourth consecutive quarter with gross margin exceeding 50%, and we believe we are well positioned for meaningful margin expansion over time as we scale. R&D expenses for the second quarter of 2026 were $3.9 million, compared to $4.5 million in the second quarter of 2025, a decrease of approximately 15%. We continue to realize the benefits of the reorganization completed in the first quarter of 2025, while focusing our R&D investment on the highest priority product and software initiatives that support commercial growth.

Brett Hale

Sales, general and administrative expenses for the second quarter of 2026 were $6.6 million compared to $6.4 million in the second quarter of 2025, an increase of approximately 3%. We operate with one U.S. sales team covering both the hospital and office market opportunities and are focused on driving sales, productivity and operating leverage. Net loss for the second quarter of 2026 was $9.3 million, equating to a net loss of $0.09 per share, compared to a net loss of $9.2 million, or $0.12 per share in the second quarter of 2025. The second quarter of 2026 net loss included a $0.6 million non-cash loss from the change in fair value of warrant liabilities with no meaningful comparable impact in the second quarter of 2025.

Brett Hale

Net cash burn excluding financing in the second quarter of 2026 was $7.9 million compared to $8.1 million in the second quarter of 2025, an improvement of $0.3 million, or approximately 3%. First half net cash burn excluding financing was $16.6 million compared to $18.2 million in the prior year period, an improvement of $1.6 million, or approximately 9%. We remain focused on reducing cash burn through disciplined spending and improved operating leverage in 2026. As of June 30th, 2026, we had $43.5 million in cash and cash equivalents on our balance sheet, an increase of $2.7 million during the quarter.

Brett Hale

This increase reflected $10.6 million of net proceeds raised through our ATM program at an average price of $1.52 per share, strengthening our balance sheet and supporting our cash runway. With a stronger financial position, we remain focused on converting our commercial progress into sustained revenue growth, gross margin expansion, reduced cash burn, and improved operating leverage. As we continue to scale, quarterly revenue may be influenced by placement timing, customer purchasing cycles, and geographic and product mix. Over time, we will continue to measure our progress through installed base expansion, sustained revenue growth, gross margin expansion, and a more scalable commercial model. Now turning to guidance. We continue to expect full year 2026 revenue of $20 million-$22 million, representing year-over-year growth at the midpoint of approximately 55%.

Brett Hale

Our confidence in the second half outlook is tied to identifiable drivers including continued adoption of our Model 2 Swoop system, hospital and IDN conversion, health system capital planning cycles Office adoption and utilization, international launch execution, clinical and health economic evidence, and product catalyst. We continue to expect gross margin to be in the range of 50%-55% for the year, supported by four consecutive quarters above 50%. The key drivers supporting this range are already visible in our results, including increasing scale, a strong value proposition, service revenue growth, and disciplined commercial execution. We continue to expect total cash burn to be in the range of $26 million-$28 million for the full year 2026, representing approximately a 10% year-over-year decline at the midpoint, inclusive of our debt service payments.

Brett Hale

Lastly, we continue to expect our cash runway to extend into 2028, supported by a strengthened balance sheet, improved cash burn, and a commercial plan built on identifiable growth drivers. The debt facility we entered into earlier this year also provides additional financial flexibility. This positions us to execute against our commercial growth plan while maintaining our disciplined approach to operating expenses and capital deployment. I will now turn the call back to Maria for closing comments.

Maria Sainz

Before we open the call for questions, I would like to leave you with a few key takeaways. First, Hyperfine is financially stronger than it was a year ago, supported by revenue growth, sustained gross margins above 50%, lower cash burn, and a strengthened balance sheet. Second, the launch of the Model 2 system is gaining traction. Over the past year, we have expanded utility and grown adoption across hospitals, offices, and international markets, and strengthened clinical evidence. Third, we are seeing early validation of our enterprise health system strategy through increased IDN engagement and initial large system adoption. Fourth, the office market continues to develop into an attractive growth opportunity supported by utilization, evidence generation, and planned contrast labeling expansion.

Maria Sainz

Finally, we have multiple catalysts ahead, including Model 2 international rollout execution, the next AI-enabled software release, Contrast PMR enrollment completion and FDA submission, and overall broader commercial expansion. I'm proud of what the team has accomplished over the past year, and we remain focused on disciplined execution as we enter the second half of 2026. Operator?

Operator

At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. We request to limit yourselves to one question and one follow-up. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Frank Takkinen with Lake Street Capital Markets. Your line is open.

Nelson Cox

Hey. This is Nelson Cox on for Frank. Thanks for taking the questions. I wanted to start with guidance a little bit. In the past, you've talked about budgetary cycles for the IDN initiatives and the back half kind of lining up with that. So you have $7.8 million on the board in the first half, and then the guidance assumes around $12 million-$14 million in the second half. I guess when you built that, how much assumes second and third sites at kind of those existing IDNs versus first placements at new ones? I guess just trying to understand how much of the ramp is repeat, kind of add-on orders at existing IDNs versus completely new ones. Thanks.

Maria Sainz

Sure, Nelson. Thanks for the question. There are several elements built into how we're looking at the second half over the first half. Definitely on the hospital side, there is a subsequent placement in some of the IDNs in which we have opened. Across all hospitals, there is an effect of the budgetary sort of new year starting the July sort of to June cycle, which wasn't available to us when we introduced Model 2 sort of at the midpoint of last year. There's also the continued rollout of the office business, as well as other things that we're doing with the new software coming to the market in the second half, some of the pilots we're doing around neurosurgery and mobile. I would say there are all of those layers that just keep adding to what we have built in the first half.

Maria Sainz

The first half was a significant step up. We're expecting more of that in the second half. I think overall, we do have these identifiable catalysts. They're not just about the hospital business or just around the IDN.

Nelson Cox

Got it. Very helpful. Then maybe on the office business, as you've gotten a few more quarters of experience with practices and of different sizes, maybe talk about how you're thinking about offering. Is there still going to be an offering for the Model 1 versus the Model 2, with maybe the Model 1 being more of a fit for smaller practitioner practices at maybe a lower price point, or how are you thinking about that?

Maria Sainz

We've mentioned segmentation. Clearly the cold point has segments, and they are very much based on the number of practitioners and with that, the volume that they drive. We have seen that our initial adoption, I think we mentioned in the prepared remarks that we are in over a dozen offices since we launched. It has translated more into the larger offices that have greater volume that have been able to support the Model 2 and are very excited about the capabilities of the Model 2 today and into the future.

Maria Sainz

In the last year, we've done a few Model 1 placements, but I would expect that there will be more Model 2 in the offices that have the larger volume and also the opportunity to have contrast in our indications for use in relatively short order will support additional cases in larger offices and the ability for those offices to use the dedicated CPT codes for contrast brain MRIs, which also pay higher. All of that would create an economic picture for the office that probably will support more the Model 2 than the Model 1 going forward.

Nelson Cox

Very helpful. Congrats on the progress, guys. Thank you.

Maria Sainz

Oh, thank you.

Operator

Your next question comes from the line of Yuan Zhi with B. Riley Securities. Your line is open.

Liwen Zhang

Hi, good afternoon. Congrats on the quarter. This is Liwen Zhang from B. Riley for Yuan Zhi. For the 12 commercial systems sold in 2Q, do we have more color on the breakdown between hospitals, neurology office, and international placement? Do we see the neurology office channel become a meaningful contributor given it's been roughly a year since the next generation suite launch?

Brett Hale

Thanks for the question. This is Brett. I'll address the first part of that question in regards to the 12. What we'll comment on is just much like last quarter, we had a broad distribution from all of our verticals. We had placements that came from international, the office, as well as the hospital. We had placements that cut across all three. One thing that we highlighted in the prepared remarks is the higher percentage of international mix for this quarter, but we did have a contribution that cut across all of them. The way we're thinking about each one of them is there's growth opportunities in each one of the segments. We do see the office being a contributor to the growth in the second half of the year and beyond, given all the catalysts that Maria had mentioned.

Liwen Zhang

Thank you.

Maria Sainz

Thank you.

Operator

I would now like to turn the call back over to Maria Sainz for closing remarks.

Maria Sainz

Well, thanks all for joining us today. We look forward to continue to update you in future cycles. Thanks very much and have a great evening.

Operator

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

Investor releaseQuarter not tagged2026-08-05

Earnings To Watch: Hyperfine Inc (HYPR) Q2 2026 -- GF Value Sees 72% Upside

GuruFocus.com

This article first appeared on GuruFocus. Hyperfine Inc (NASDAQ:HYPR) is set to release its Q2 2026 earnings on Aug 6, 2026. The consensus estimate for Q2 2026 revenue is 4.14 million, and the earnings are expected to come in at -0.09 per share. The full year 2026's revenue is expected to be $20.16 million and the earnings are expected to be $-0.35 per share. More detailed estimate data can be found on the Forecast page Warning! GuruFocus has detected 4 Warning Signs with HYPR. Is HYPR fairly valued? Test your thesis with our free DCF calculator. Over the past 90 days, revenue estimates for Hyperfine Inc (NASDAQ:HYPR) have increased from $20.03 million to $20.16 million for the full year 2026 and from $26.25 million to $26.30 million for 2027. During the same period, earnings estimates have remained flat at $-0.35 per share for the full year 2026, while estimates for 2027 have declined from $-0.33 per share to $-0.34 per share. In the previous quarter of 2026-03-31, Hyperfine Inc's (NASDAQ:HYPR) actual revenue was $3.90 million, which beat analysts' revenue expectations of $3.54 million by 10.25%. Hyperfine Inc's (NASDAQ:HYPR) actual earnings were $-0.09 per share, which met analysts' earnings expectations. After releasing the results, Hyperfine Inc (NASDAQ:HYPR) was down by -8.09% in one day. Based on the one-year price targets offered by 3 analysts, the average target price for Hyperfine Inc (NASDAQ:HYPR) is $2.17 with a high estimate of $2.50 and a low estimate of $2.00. The average target implies an upside of 110.36% from the current price of $1.03. Based on GuruFocus estimates, the estimated GF Value for Hyperfine Inc (NASDAQ:HYPR) in one year is $1.77, suggesting an upside of 71.84% from the current price of $1.03. Based on the consensus recommendation from 3 brokerage firms, Hyperfine Inc's (NASDAQ:HYPR) average brokerage recommendation is currently 1.70, indicating an "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-07-23

Hyperfine, Inc. to Announce Second Quarter 2026 Financial Results on August 6, 2026

Business Wire

GUILFORD, Conn., July 23, 2026--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced that it will report financial results for the second quarter 2026 on Thursday, August 6, 2026. Management will host a corresponding conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. A live audio webcast and an archive of the recording will be available through the Investors page of Hyperfine, Inc.’s corporate website at https://investors.hyperfine.io/. Participants are encouraged to register more than 15 minutes before the start of the call. For more information about the Swoop® system, please visit HyperfineMRI.com. About the Swoop® Portable MRI Systems The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. About Hyperfine, Inc. Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit HyperfineMRI.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260723270257/en/ Contacts Media Contact Devin [email protected] Investor Contact Webb CampbellGilmartin Group [email protected]

Investor releaseQuarter not tagged2026-05-22

Hyperfine Announces Presentation of Results from the PRIME Study Showing Portable MRI Substantially Reduces Time to Imaging in Emergency Departments

Business Wire
Prospective randomized ED study shows rapid bedside imaging, detection of critical neurological findings, and potential workflow efficiency benefits with portable MRI GUILFORD, Conn., May 22, 2026--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced the presentation of results of the PRIME (Portable Rapid Imaging for Medical Emergencies) study at the Society for Academic Emergency Medicine (SAEM) 2026 Annual Meeting. PRIME is a single-center, prospective, randomized controlled trial designed to evaluate the role of portable MRI in neurological emergencies in the emergency department (ED), including the technology’s potential effectiveness and efficiency in supporting triage decisions for a wide range of brain-related emergency medical conditions. Conducted at a tertiary emergency department, the study enrolled 100 participants and compared standard clinical workflow using conventional MRI, along with a care pathway that incorporated a portable MRI system at the patient’s bedside. Results presented at SAEM demonstrate a significant reduction in time to imaging for patients randomized to the portable MRI arm. Median time from imaging order to scan start was 1.28 hours in the portable MRI group, compared with 7.76 hours in the conventional MRI only control arm—a median difference of 6.35 hours. 18.6% of the scans completed revealed critical pathology, including acute ischemic stroke, mass lesions, mass effect, and hydrocephalus, all of which were successfully detected by portable MRI and confirmed on conventional MRI. "These findings suggest that portable MRI can be integrated into emergency department workflow far more quickly than conventional MRI and can provide clinically meaningful information when time matters most," said Dr. Charles Wira, Associate Professor of Emergency Medicine at Yale University. "By bringing advanced imaging to the bedside, portable MRI has the potential to improve diagnostic efficiency, reduce delays, and support faster treatment decisions for patients with neurological emergencies." "Portable MRI also has the potential to meaningfully reduce emergency department boarding by helping to alleviate delays associated with waiting for access to conventional MR…Read full document

Prospective randomized ED study shows rapid bedside imaging, detection of critical neurological findings, and potential workflow efficiency benefits with portable MRI GUILFORD, Conn., May 22, 2026--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced the presentation of results of the PRIME (Portable Rapid Imaging for Medical Emergencies) study at the Society for Academic Emergency Medicine (SAEM) 2026 Annual Meeting. PRIME is a single-center, prospective, randomized controlled trial designed to evaluate the role of portable MRI in neurological emergencies in the emergency department (ED), including the technology’s potential effectiveness and efficiency in supporting triage decisions for a wide range of brain-related emergency medical conditions. Conducted at a tertiary emergency department, the study enrolled 100 participants and compared standard clinical workflow using conventional MRI, along with a care pathway that incorporated a portable MRI system at the patient’s bedside. Results presented at SAEM demonstrate a significant reduction in time to imaging for patients randomized to the portable MRI arm. Median time from imaging order to scan start was 1.28 hours in the portable MRI group, compared with 7.76 hours in the conventional MRI only control arm—a median difference of 6.35 hours. 18.6% of the scans completed revealed critical pathology, including acute ischemic stroke, mass lesions, mass effect, and hydrocephalus, all of which were successfully detected by portable MRI and confirmed on conventional MRI. "These findings suggest that portable MRI can be integrated into emergency department workflow far more quickly than conventional MRI and can provide clinically meaningful information when time matters most," said Dr. Charles Wira, Associate Professor of Emergency Medicine at Yale University. "By bringing advanced imaging to the bedside, portable MRI has the potential to improve diagnostic efficiency, reduce delays, and support faster treatment decisions for patients with neurological emergencies." "Portable MRI also has the potential to meaningfully reduce emergency department boarding by helping to alleviate delays associated with waiting for access to conventional MRI," said Dr. Kevin Sheth, Professor of Neurology and Neurosurgery at the Yale School of Medicine and principal investigator for the PRIME study. "Reducing imaging-related bottlenecks may help ED teams move patients through care pathways more efficiently while maintaining access to advanced neuroimaging." The PRIME study builds on prior research evaluating portable MRI in emergency settings and expands the evidence base by studying a broader emergency department population. PRIME was conducted using the Hyperfine Model 2 Swoop® portable MRI system powered by Optive AI™ software, which is designed to deliver sharper anatomical detail and support broader use of portable brain imaging across emergency care environments. "Enrollment in PRIME was very fast, signaling how frequently MRI is needed as a triage tool in the ED. The presentation of these data at SAEM represents an important milestone for Hyperfine and for the future of emergency neuroimaging," said Maria Sainz, President and CEO of Hyperfine. "We believe these results reinforce the potential for portable MRI to help clinicians access actionable imaging information sooner, improve emergency department workflows for ruling in and ruling out pathology, and expand access to advanced brain imaging where conventional MRI remains difficult to obtain." Hyperfine is committed to advancing the role of portable MRI in emergency care, where timely access to conventional MRI remains a challenge for many hospitals. The PRIME study adds to a growing body of evidence supporting portable MRI as an efficient adjunct to emergency neuroimaging and underscores its potential to reduce diagnostic delays and improve patient care at the point of care. For more information about the Swoop® system, please visit HyperfineMRI.com. About the Swoop® AI-Powered Portable MRI Systems The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. About Hyperfine, Inc. Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit HyperfineMRI.com. Hyperfine, the Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the "Company") may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future performance and its ability to implement its strategy, including its entrance into new markets. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop ® system is accepted and used by healthcare professionals; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future ; the inability of the Company to progress on product advancements and improvements ; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; existing and potential future National Institutes of Health funding pressures; existing and potential future effects from U.S. export controls and tariffs; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under "Risk Factors" therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. View source version on businesswire.com: https://www.businesswire.com/news/home/20260522721021/en/ Contacts Media Contact Devin [email protected] Investor Contact Webb CampbellGilmartin Group [email protected]

Investor releaseQuarter not tagged2026-05-13

Hyperfine Inc (HYPR) Q1 2026 Earnings Call Highlights: Revenue Surge and Strategic Advances ...

GuruFocus.com
This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Hyperfine Inc (NASDAQ:HYPR) reported a significant revenue increase of 83% year-over-year, reaching $3.9 million for Q1 2026. The company achieved a gross margin of 51%, marking the third consecutive quarter with margins exceeding 50%. Hyperfine Inc (NASDAQ:HYPR) obtained CE and UKCA marks for its next-generation subsystem and advanced DWI Optiv AI software, facilitating international expansion. The company has a strong cash position with $40.8 million in cash and cash equivalents, providing a healthy runway into 2028. Enrollment in the contrast PMR study has surpassed 50% of the target, supporting potential FDA submission by the end of 2026. Despite revenue growth, Hyperfine Inc (NASDAQ:HYPR) reported a net loss of $8.6 million for Q1 2026. The company's R&D expenses decreased by 24%, which may impact future innovation and development. Sales, general, and administrative expenses remained flat, indicating potential challenges in cost management. The company faces longer sales cycles with IDN opportunities, which could delay revenue realization. Hyperfine Inc (NASDAQ:HYPR) continues to experience high cash burn, with $8.8 million burned in Q1 2026, despite efforts to reduce it. Warning! GuruFocus has detected 4 Warning Sign with HYPR. Is HYPR fairly valued? Test your thesis with our free DCF calculator. Q: Can you discuss the decision criteria and timelines for Integrated Delivery Networks (IDNs) and how many are at the standardization stage versus single-site pilots? A: Maria Sainz, CEO: We've had the next-generation subsystem for three quarters, and our IDN strategy is about three-quarters deep. One IDN has moved from a single site to multiple sites. The process involves regional or national approvals, and once the first system is implemented, it takes about two to three months of data collection before other sites move forward. We have visibility to multiple sites within an IDN, but procurement processes start after initial data collection. Brett Hale, CFO, added that the 2026 guidance reflects growth across hospital, office, and international business, with IDN initiatives aligning with budgetary cycles in the second half of the year. Q: What is the profile of adopters in the office segme…Read full document

This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Hyperfine Inc (NASDAQ:HYPR) reported a significant revenue increase of 83% year-over-year, reaching $3.9 million for Q1 2026. The company achieved a gross margin of 51%, marking the third consecutive quarter with margins exceeding 50%. Hyperfine Inc (NASDAQ:HYPR) obtained CE and UKCA marks for its next-generation subsystem and advanced DWI Optiv AI software, facilitating international expansion. The company has a strong cash position with $40.8 million in cash and cash equivalents, providing a healthy runway into 2028. Enrollment in the contrast PMR study has surpassed 50% of the target, supporting potential FDA submission by the end of 2026. Despite revenue growth, Hyperfine Inc (NASDAQ:HYPR) reported a net loss of $8.6 million for Q1 2026. The company's R&D expenses decreased by 24%, which may impact future innovation and development. Sales, general, and administrative expenses remained flat, indicating potential challenges in cost management. The company faces longer sales cycles with IDN opportunities, which could delay revenue realization. Hyperfine Inc (NASDAQ:HYPR) continues to experience high cash burn, with $8.8 million burned in Q1 2026, despite efforts to reduce it. Warning! GuruFocus has detected 4 Warning Sign with HYPR. Is HYPR fairly valued? Test your thesis with our free DCF calculator. Q: Can you discuss the decision criteria and timelines for Integrated Delivery Networks (IDNs) and how many are at the standardization stage versus single-site pilots? A: Maria Sainz, CEO: We've had the next-generation subsystem for three quarters, and our IDN strategy is about three-quarters deep. One IDN has moved from a single site to multiple sites. The process involves regional or national approvals, and once the first system is implemented, it takes about two to three months of data collection before other sites move forward. We have visibility to multiple sites within an IDN, but procurement processes start after initial data collection. Brett Hale, CFO, added that the 2026 guidance reflects growth across hospital, office, and international business, with IDN initiatives aligning with budgetary cycles in the second half of the year. Q: What is the profile of adopters in the office segment, and what signals have you seen from larger offices? A: Maria Sainz, CEO: We are predominantly placing the second-generation system in larger offices, often grouped under organizations like NeuroNet. These larger offices see the utility of the SEWP system across their patients, making it easier to justify the investment. Single practitioner practices have lower volumes and resources, so larger offices are more likely to find the investment attractive. Brett Hale, CFO, agreed with this assessment. Q: How has the helium shortage in the U.S. impacted your interactions with potential customers? A: Maria Sainz, CEO: Our system does not require helium, which is a key selling point. We emphasize that our system is maintenance-light and helium-free. While helium shortages have been in the news, we haven't heard much directly from customers about it. Brett Hale, CFO, added that being helium-free and portable are elements they've highlighted, and recent news amplifies this advantage. Q: What are the key economic factors you highlight when selling the SWOOP system to new customers, particularly in stroke care? A: Maria Sainz, CEO: The key data point is the wait time for MRI in stroke-suspected patients, which can be very high with high-field MRIs. Reducing this wait time builds a strong economic case for faster triage in the ED. In the ICU, the focus is on cost savings from reduced need for MRI-compatible supplies. These factors contribute to a one to one-and-a-half-year ROI, even with the current MSRP of $590,000. Q: How will the gadolinium contrast impact adoption in hospital and office channels, and are purchases being delayed for this indication? A: Maria Sainz, CEO: There hasn't been a case where hospital purchases are delayed for contrast. There's excitement for contrast use in both hospital and office settings, as it represents a substantial number of scans. The increased utility will make multiple systems more necessary, and in offices, higher reimbursement rates for contrast cases will improve the economic calculation for adoption. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-05-13

Hyperfine Q1 Earnings Call Highlights

MarketBeat
Interested in Hyperfine, Inc.? Here are five stocks we like better. Hyperfine posted first-quarter revenue of $3.9 million, up 83% year over year, driven by adoption of its next-generation Swoop portable MRI system and neurology office placements. The company also sold 10 units in the quarter, with most being next-generation systems. Gross margin expanded to 50.7% from 41.3%, while net loss narrowed to $8.6 million and cash burn improved versus last year. Hyperfine ended the quarter with $40.8 million in cash, aided by an initial $15 million debt tranche. The company reiterated full-year 2026 guidance for revenue of $20 million to $22 million and gross margin of 50% to 55%, expecting growth to accelerate through the year. Management highlighted pipeline strength in hospitals, neurology offices, and international markets, plus progress toward a potential FDA submission for contrast-enhanced MRI use by end-2026. Hyperfine (NASDAQ:HYPR) reported a sharp year-over-year increase in first-quarter revenue and reiterated its full-year 2026 outlook, as management pointed to continued adoption of its next-generation Swoop portable MRI system across hospitals, neurology offices and international markets. President and Chief Executive Officer Maria Sainz said the company delivered revenue of $3.9 million in the quarter ended March 31, 2026, up 83% from $2.1 million a year earlier. She described the result as Hyperfine’s “second-highest quarter ever” and said it reflected the company’s third full quarter selling the next-generation Swoop system in the U.S. market, as well as sales into its newer neurology office business. → MercadoLibre Boldly Invests in Growth: Discount Deepens “The first quarter was a strong start to 2026 as we executed across our commercial and financial priorities,” Sainz said. Hyperfine sold 10 units in the first quarter, compared with six units in the prior-year period. Management said the majority of unit sales were next-generation systems, supporting a strong average selling price. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Gross profit rose to $2.0 million from $0.9 million a year earlier. Gross margin expanded to 50.7% from 41.3%, an improvement of about 940 basis points. Management said this marked the third consecutive quarter in which gross margin exceeded 50%. Research and development expenses declined 24% to $…Read full document

Interested in Hyperfine, Inc.? Here are five stocks we like better. Hyperfine posted first-quarter revenue of $3.9 million, up 83% year over year, driven by adoption of its next-generation Swoop portable MRI system and neurology office placements. The company also sold 10 units in the quarter, with most being next-generation systems. Gross margin expanded to 50.7% from 41.3%, while net loss narrowed to $8.6 million and cash burn improved versus last year. Hyperfine ended the quarter with $40.8 million in cash, aided by an initial $15 million debt tranche. The company reiterated full-year 2026 guidance for revenue of $20 million to $22 million and gross margin of 50% to 55%, expecting growth to accelerate through the year. Management highlighted pipeline strength in hospitals, neurology offices, and international markets, plus progress toward a potential FDA submission for contrast-enhanced MRI use by end-2026. Hyperfine (NASDAQ:HYPR) reported a sharp year-over-year increase in first-quarter revenue and reiterated its full-year 2026 outlook, as management pointed to continued adoption of its next-generation Swoop portable MRI system across hospitals, neurology offices and international markets. President and Chief Executive Officer Maria Sainz said the company delivered revenue of $3.9 million in the quarter ended March 31, 2026, up 83% from $2.1 million a year earlier. She described the result as Hyperfine’s “second-highest quarter ever” and said it reflected the company’s third full quarter selling the next-generation Swoop system in the U.S. market, as well as sales into its newer neurology office business. → MercadoLibre Boldly Invests in Growth: Discount Deepens “The first quarter was a strong start to 2026 as we executed across our commercial and financial priorities,” Sainz said. Hyperfine sold 10 units in the first quarter, compared with six units in the prior-year period. Management said the majority of unit sales were next-generation systems, supporting a strong average selling price. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Gross profit rose to $2.0 million from $0.9 million a year earlier. Gross margin expanded to 50.7% from 41.3%, an improvement of about 940 basis points. Management said this marked the third consecutive quarter in which gross margin exceeded 50%. Research and development expenses declined 24% to $3.8 million from $5.0 million in the first quarter of 2025, which management attributed to benefits from a reorganization completed in early 2025 as the company transitioned toward a commercial growth-stage organization. Sales, general and administrative expenses were $6.7 million, flat from the prior-year quarter. → MP Materials Is Quietly Building a Rare Earth Powerhouse Net loss narrowed to $8.6 million, or $0.09 per share, compared with a net loss of $9.4 million, or $0.12 per share, a year earlier. The latest quarter included a $0.2 million non-cash loss from a change in the fair value of warrant liabilities, compared with a $1.6 million gain in the year-earlier period. Net cash burn excluding financing was $8.8 million, compared with $10.1 million in the first quarter of 2025. Management noted that the first quarter is typically the company’s highest cash burn quarter because of annual payments such as bonuses and insurance. Hyperfine ended the quarter with $40.8 million in cash and cash equivalents. That total included the initial $15 million tranche from an up to $40 million long-term debt facility put in place during the quarter. The company said it has the option through the end of 2027 to access up to $25 million in additional tranches if prescribed commercial targets are met. Hyperfine maintained its full-year 2026 outlook. The company continues to expect revenue of $20 million to $22 million, which represents year-over-year growth of 55% at the midpoint. Management also reiterated its expectation for full-year gross margin of 50% to 55%. The company said it expects revenue to strengthen progressively throughout 2026, supported by its pipeline across hospitals, neurology offices and international markets. Management also said it expects gross margin to improve over the course of the year as sales volumes increase, with second-half gross margin percentages expected to exceed first-half levels. Hyperfine also reaffirmed its expected 2026 cash burn range of $26 million to $28 million, including quarterly debt interest payments of about $400,000. Management said its cash runway extends into 2028, including the initial $15 million debt tranche but excluding the additional $25 million available under the facility. Sainz said demand for the next-generation Swoop system remains strong and that Hyperfine is continuing to diversify revenue across three commercial verticals: hospitals and health systems, neurology offices and international markets. In hospitals, she said the company is seeing interest from adult and pediatric critical care and emergency departments. Hyperfine is also pursuing health system and integrated delivery network opportunities, including repeat sales within IDNs across multiple sites over the past couple of quarters. Sainz said the pipeline is shifting toward multi-unit and IDN opportunities, though those accounts can involve longer sales cycles because of additional stakeholders and procurement steps. In response to an analyst question, she said one IDN has moved from initial placement to multiple systems at one site and then to additional sites, while other conversations remain earlier in the process. “We do have visibility to multiple sites within an IDN,” Sainz said, adding that broader procurement typically begins after initial implementation and about eight weeks of data collection and sharing. In neurology offices, Sainz said placements contributed to first-quarter revenue, with most placements in larger offices. She said data from the company’s NEURO-PMR study, presented at the American Society of Neuroimaging, showed use of the Swoop system across conditions including headaches, dementia, multiple sclerosis follow-up and tumor follow-up. The study also showed favorable patient experience compared with conventional MRI, according to management. Internationally, Sainz said Hyperfine launched its Optive AI software in Europe during the quarter and received CE and UKCA marks for the next-generation Swoop system and latest Optive AI software. The company is working through translation and documentation processes and expects to be in position to launch the next-generation system in Europe in the third quarter. In India, Sainz said the first Swoop system is now in clinical use at a leading key opinion leader center in Delhi through a distribution partner. Hyperfine also highlighted progress on several clinical and regulatory fronts. Sainz said the company launched its advanced DWI Optive AI software at the 2026 International Stroke Conference, supported by a paper in Stroke: Vascular and Interventional Neurology demonstrating enhanced stroke detection capabilities. She said the software is now implemented in most scanners across Hyperfine’s installed base. The company also reported progress in its Contrast PMR study, a prospective multicenter study evaluating contrast-enhanced ultra-low field portable MRI. Sainz said three study sites are active and enrollment is now more than 50% of the target. Hyperfine expects the study to support a potential FDA submission by the end of 2026 to expand the Swoop system’s intended use to include gadolinium-based contrast agents. Sainz said she does not know of any hospital purchase that has been put on hold while awaiting a contrast indication, but said contrast could increase clinical utility in both hospital and office settings. In offices, she said contrast cases may also affect the economic calculation because brain MRI exams with contrast use dedicated CPT code 70553 and are reimbursed at a higher rate. Management also discussed potential new sites of care, including operating rooms, angiography suites and mobile units for community-based brain screening programs. Sainz said the company is seeing growing interest from surgeons and interventionalists and expects single-case and small-case-series publications or presentations this year. She said Hyperfine is forming an advisory group and aims to exit 2026 with a clearer plan for any software, coil or hardware modifications that may be needed. Reflecting on the first year since FDA clearance of the next-generation Swoop system and Optive AI software, Sainz said Hyperfine has “meaningfully improved” its revenue and margin profile, entered new markets and continued to innovate. Hyperfine, Inc (NASDAQ: HYPR) is a medical technology company focused on expanding access to advanced neuroimaging through its portable magnetic resonance imaging (MRI) system. The company's flagship product, Swoop®, is designed to enable bedside MRI scanning in a wide range of clinical environments, including emergency departments, intensive care units and outpatient clinics. By leveraging a compact, high-performance permanent magnet and a custom-designed gradient system, Hyperfine aims to reduce the logistical and financial barriers associated with traditional, large-scale MRI installations. The Swoop system features a lightweight, wheeled design that can be maneuvered directly to a patient's bedside, allowing clinicians to conduct diagnostic imaging without the need to transport critically ill or immobile patients. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Hyperfine Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Investor releaseQuarter not tagged2026-05-13

Hyperfine, Inc. Reports First Quarter 2026 Financial Results

Business Wire
GUILFORD, Conn., May 12, 2026--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced first quarter 2026 financial results and provided a business update. "Our execution in Q1 was strong. We delivered our second-highest revenue quarter to date with over 80% year-over-year revenue growth, driven by our accelerating commercial engine. We believe the international regulatory clearances we secured, the clinical data we released to the neurology and stroke communities, and the continued momentum in our office and hospital businesses all indicate portable brain MRI is becoming mainstream, and we are leading the charge," said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. Recent Achievements and Business Highlights Obtained CE Marking and UK Conformity Assessment (UKCA) approval for both the next-generation Swoop® system and the latest Optive AI™ software in Europe. Enrolled first patient in Contrast PMR, a study designed to support a future FDA 510(k) submission to expand the Swoop® system’s intended use to include gadolinium-based contrast agents; enrollment currently is over 50% of target. Presented NEURO-PMR results at the 2026 American Society of Neuroimaging showing high diagnostic value and superior patient experience in neurology clinics. Published paper in Stroke: Vascular and Interventional Neurology (SVIN) demonstrating the Swoop® system’s enhanced stroke detection capabilities. Published paper in Clinical Neuroimaging demonstrating the significant health economic benefit of using the Swoop® system. Began launch activities in India market with first Swoop® system live in clinical use at All India Institute of Medical Sciences (AIIMS), New Delhi. Bolstered balance sheet through $15.0 million debt financing, extending the expected cash runway into 2028, and providing capital for commercial growth. First Quarter 2026 Financial Results Revenues for the first quarter of 2026 were $3.90 million, increasing 83% compared to $2.14 million in the first quarter of 2025. Sold 10 commercial Swoop® systems in the first quarter of 2026, compared to six in the first quarter of 2025. Gross profit for the first quarter of 2026 was $1.98 million, compared…Read full document

GUILFORD, Conn., May 12, 2026--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced first quarter 2026 financial results and provided a business update. "Our execution in Q1 was strong. We delivered our second-highest revenue quarter to date with over 80% year-over-year revenue growth, driven by our accelerating commercial engine. We believe the international regulatory clearances we secured, the clinical data we released to the neurology and stroke communities, and the continued momentum in our office and hospital businesses all indicate portable brain MRI is becoming mainstream, and we are leading the charge," said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. Recent Achievements and Business Highlights Obtained CE Marking and UK Conformity Assessment (UKCA) approval for both the next-generation Swoop® system and the latest Optive AI™ software in Europe. Enrolled first patient in Contrast PMR, a study designed to support a future FDA 510(k) submission to expand the Swoop® system’s intended use to include gadolinium-based contrast agents; enrollment currently is over 50% of target. Presented NEURO-PMR results at the 2026 American Society of Neuroimaging showing high diagnostic value and superior patient experience in neurology clinics. Published paper in Stroke: Vascular and Interventional Neurology (SVIN) demonstrating the Swoop® system’s enhanced stroke detection capabilities. Published paper in Clinical Neuroimaging demonstrating the significant health economic benefit of using the Swoop® system. Began launch activities in India market with first Swoop® system live in clinical use at All India Institute of Medical Sciences (AIIMS), New Delhi. Bolstered balance sheet through $15.0 million debt financing, extending the expected cash runway into 2028, and providing capital for commercial growth. First Quarter 2026 Financial Results Revenues for the first quarter of 2026 were $3.90 million, increasing 83% compared to $2.14 million in the first quarter of 2025. Sold 10 commercial Swoop® systems in the first quarter of 2026, compared to six in the first quarter of 2025. Gross profit for the first quarter of 2026 was $1.98 million, compared to $0.88 million in the first quarter of 2025, representing 51% gross margin in the first quarter of 2026, compared to 41% gross margin in the first quarter of 2025. Research and development expenses for the first quarter of 2026 were $3.85 million, decreasing 24% compared to $5.04 million in the first quarter of 2025. Sales, marketing, general, and administrative expenses for the first quarter of 2026 were $6.69 million, compared to $6.75 million in the first quarter of 2025. Net loss for the first quarter of 2026 was $8.62 million, equating to a net loss of $0.09 per share, as compared to a net loss of $9.42 million, or a net loss of $0.12 per share, for the first quarter of 2025. The first quarter of 2026 net loss includes a $0.24 million loss from a change in the fair value of warrant liabilities, compared to a $1.62 million gain in the first quarter of 2025. 2026 Financial Guidance Management continues to expect revenue for the full year 2026 to be approximately $20 to $22 million, representing 55% growth at the midpoint as compared to full year 2025. Management continues to expect cash burn1 for the full year 2026 to be approximately $26 to $28 million, representing a 10% decline at the midpoint as compared to full year 2025. 1Cash burn is calculated as change in cash and cash equivalents less net financing proceeds. Conference Call Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Tuesday, May 12, 2026 to discuss its first quarter 2026 financial results and provide a business update. Those interested in listening should register online by visiting https://investors.hyperfine.io/ and clicking on News & Events. Participants are encouraged to register more than 15 minutes before the start of the call. A live and archived audio webcast will be available through the Investors page of Hyperfine, Inc.’s corporate website at https://investors.hyperfine.io/. About Hyperfine, Inc. and the Swoop® Portable MR Imaging® Systems Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first U.S. Food and Drug Administration (FDA)-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit hyperfine.io. The Swoop® Portable MR Imaging® systems are FDA cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop® system also has CE Mark in the European Union and UKCA Mark in the United Kingdom. The Swoop® system is commercially available in a select number of international markets. Hyperfine, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the "Company") may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations about the Company’s financial and operating results, including, the Company’s expected revenue and cash burn for the full year 2026, the Company's cash runway, the Company’s goals and commercial plans, including the Company’s commercial rollout of the Company’s Optive AITM software and next generation Swoop® system, the acceleration of the adoption of the Swoop® system across multiple sites of care in the hospital, neurology office and international markets, the benefits of the Company’s products and services, progress on improvements and advancements in the Company’s products and services, and the Company’s future performance, including its financial performance, and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the Company’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the ability of the Company to raise financing in the future; the ability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the ability of the Company to identify, in-license or acquire additional technology; the ability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; existing and potential future National Institutes of Health funding pressures; existing and potential future effects from U.S. export controls and tariffs; the ability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; the Company’s ability to successfully complete and generate positive data from the PRIME study, ACTION PMR study, Contrast PMR study, CARE PMR study and NEURO PMR study; the Company’s ability to generate clinical evidence of the benefits of the Company’s products and services and to progress on product advancements and improvements; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under "Risk Factors" therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. View source version on businesswire.com: https://www.businesswire.com/news/home/20260512320170/en/ Contacts Investor Contact Webb Campbell Gilmartin Group LLC [email protected]

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook