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Hyperfine, Inc.
3/18/2026
Hello and welcome to the Hyperfine Q425 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, just press star followed by the number one on your telephone keypad. And if you would like to withdraw your question, press star one again. Thank you. Now I would like to turn the call over to Webb Campbell. Webb, you may begin.
Thank you for joining today's call. Earlier today, Hyperfine Inc. released financial results for the quarter ending December 31st, 2025. A copy of the press release is available on the company's website as well as sec.gov. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor 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 relating to our operating trends and future financial performance, expense management, expectations for hiring, training and adoption, growth in our organization, market opportunity, commercial and international expansion, regulatory approvals, and product development are based upon current expectations 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 these risks and uncertainties associated with our business, please refer to the risk factors section of our latest periodic filing with the Securities and Exchange Commission. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, March 18, 2026. 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.
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. Fourth quarter revenue of over $5 million demonstrated our very strong performance with the next generation subsystem for the second straight quarter. the mid-2025 introduction of our second-generation soup scanner, the updated AI software, and the addition of a new market with our launch into the neurology office setting mark a turning point in the adoption of portable brain MRI, the potential of ultra-low-field MRI, and the future of our company. We have now demonstrated that we hold a highly proprietary and differentiated technological position in our ability to produce diagnostic quality images with an ultra-low field magnet, making HyperFind's technology safe, accessible, and deployable across a continuum of preventative, acute, and chronic brain health settings. In 2025, we validated that the SUSE system offers unequivocal clinical and economic value to clinicians and providers ready for mainstream adoption and scale across a growing number of sites of care inside and outside the hospital. I want to start by summarizing some of the key highlights from the last several months. to illustrate why I feel very optimistic about the future of the SOOP system for brain health and Hyperfine's unique position with ultra-low-field MRI long-term. From a market perspective, the feedback on SOOP's image quality with Optive AI software continues to be outstanding from the neurology, neurosurgery, and radiology communities, leading to deal activation, reactivation, larger deals, and interest from IDNs and health systems. The FDA clearance in December 2025 of our first update after the release of Optive AI software represents the 11th generation of software releases and confirms our commitment to continuous image quality advances with ultra-low-field MRI. This latest soup software incorporates features in our diffusion-weighted imaging to further refine the value of the soup system in stroke workflows. The recently published SLEEM Stroke Publication and the newer PMR Presentation validate the clinical diagnostic utility of the SUP system for stroke triage and for patient care in neurology offices, respectively. The publication of the health economic impact data adds an incredibly important element to our selling approach. We now have published evidence to support the cost savings in medical supplies, staff usage, and a significant improvement in patient progress when using the SUP system. Finally, the approval of the first generation subsystem in India opens a new large geographic expansion opportunity for hyperfarm. Throughout 2025, we executed on our operational milestones across innovation, clinical and economic evidence generation, and site of care and geographic expansion. We delivered strong revenue growth in the second half of the year, and importantly, we see market activation momentum continuing as we progress through 2026. This transformation was achieved in the context of a continued reduction in cash burn and gross margin expansion, demonstrating the scalability and leverage of our business model. We ended the year with a healthy balance sheet, And with the growth capital added from our recent financing, we are well positioned for sustained growth and investment in our technology, current markets, and potential future expansion opportunities into 2028. Over the past six years, we have maintained an unwavering commitment to continuous innovation and market development, transforming our original concept for an ultra-low-field portable brain MRI system into a highly differentiated and clinically relevant platform ready for broad adoption to help address the real limitations related to brain imaging. The next-generation subsystem with OptipAI software represents the culmination of phenomenal innovations in electronics, physics, and AI technology. to make image quality at 64 milliTesla approach that of high-field MRI. Looking ahead, these advancements represent a new beginning and a stronger platform to further increase clinical capabilities and expand into additional use cases across sites of care. We received FDA clearance for the next upgrade to the OptifAI software last December. This latest software focuses on advanced multidirectional diffusion-weighted imaging to enhance stroke detection. Going forward, you can continue to expect a cadence of one to two software releases per year as we expand upon our leadership in the AI-enabled ultra-low-field MR imaging space. We have now sold over a dozen next-generation systems since June, and have launched incredibly busy and successful SUP programs across critical care, emergency departments, and neurology offices. Exiting 2025, our primary call points are adult and pediatric critical care, emergency departments, and neurology clinics and offices. More recently, we have actively begun pilot efforts in the neurosurgical and neurointerventional setting, as well as in mobile units for dementia screening research. We will continue to lean on our strengths, not only in continuous innovation, but also in clinical data generation to support a growing number of use cases and widespread adoption. A good example of this is our contrast PMR study. a prospective multicenter clinical study to evaluate the feasibility and visualization benefits of contrast-enhanced ultra-low-field portable MRI. I'm pleased to share that we are approximately 20% towards our enrollment goal. The study is designed to support a future FDA submission late 2026 to expand the subsistence intended use to include gadolinium-based contrast agents potentially unlocking new applications as we focus broadly on neurodegenerative diseases and surgical use. Brain scans with contrast will potentially broaden the use of the subsystem across office and hospital settings. In outpatient care, scans with contrast are reimbursed using a dedicated CPT code Turning to our clinical work in the ED, we are seeing significant traction with accounts interested in deploying the subsystem in the ED for faster stroke triage using MRI. The excessive wait time for MRI in the ED is a costly and widespread patient care issue across hospitals of all sizes. Beyond the recently published VIN paper, the PRIME study, being led by the Yale School of Medicine, is an additional project to validate the subsistence utility in England's faster triage of old-comer patients in the ED. As a reminder, this study evaluates the potential of AI-powered portable MRI for broad patient triage in the ED. I'm happy to share years of completed enrollment ahead of schedule and expect to share an update on the findings later this year. The compelling image quality of the next-generation subsystem with Optive AI software is activating our hospital pipeline to levels we have not experienced before. Driven by interest from both clinical and administrative stakeholders, and evolving deal discussions to multiple placements, as well as first and subsequent deals at IDNs across the U.S. These larger, more strategic deals are very encouraging for the future growth of our business. Although larger deals have increased administrative processes and are more dependent on budget cycles, creating some potential for quarterly lumpiness and variability. With a recently published health economic impact data analysis as reference, hospitals evaluating the subsystem are now modeling one to one and a half year return on investment timelines, substantially better than the three to four year typical for capital equipment. The recent publication summarizes the data compiled at Jefferson Abington across 143 scans, related to their savings in cost of care driven by reduction in supplies, faster clinical decision-making, accelerated patient discharge, and freed up capacity on conventional scanners for elective procedures. These real-world, peer-reviewed health economic data have become powerful catalysts for deals and elevating conversations to C-suite decision-makers. With our device MSRP of $590,000 for our next generation system, we can capture significant value while delivering strong ROI for our customers. The neurology office represents an additional growth vector for our business. Neurologists prescribe a high volume of MRIs, yet only approximately 10% of private neurology practices have MRI imaging onsite, which creates an enormous addressable market opportunity with minimal incumbent competition. Our full commercial launch into this market in Q3 has progressed rapidly through Q4. Our pilot program in the first half of 2025 confirmed the process through accreditation, training, and reimbursement to scale portable brain MRI as an ancillary business in the office setting. We have proven that physicians can obtain diagnostic quality MR brain images within their offices, providing patients with timely and convenient access at the point of care. In January 2026, data from our office's study, NeuroPMR, was presented at the American Society of Neuroimaging. In this study, patients received brain imaging on both the portable subsystem and conventional high-field MRI. In the study, portable MRI demonstrated 92% concordance with a standard MRI in identifying the presence or absence of intratranial pathology during a blinded review by independent neuroradiologists. In unblinded paired image reviews incorporating clinical history, concordance increased to 98% as assessed by a neurologist and neuroimager. Furthermore, patients expressed a strong preference for portable MRI, reporting that they were four times more likely to choose portable MRI over standard MRI. Across all experience measures, including comfort, anxiety, claustrophobia, noise, and overall satisfaction, portable MRI was rated superior to standard MRI. Trained clinical staff successfully operated the system within neurology offices without the need for MR technologies, highlighting its safe and straightforward operation. In Q4, we accelerated our selling efforts across both single and multi-clinician practices, building robust pipelines of both our first and next-generation subsistence. We deployed a segmentation pricing strategy, offering different configurations to serve practices of varying sizes and profiles. We're also leveraging our Neuronet partnership to promote adoption across their network of neurology practices. The office market is still in its early days, yet reception has been robust and has been further fueled by the presentation of data from Neuro PMR. Turning to our international business, where we have made significant progress in the quarter, we have launched Optic AI software in 10 different European languages, with the software now available in the international markets we serve. We're going through the European regulatory process to bring the next generation subscanner to the UK and CE markets before the end of this year. Additionally, in late 2025, we also received regulatory approval in India, unlocking a key new market. With our local partner, we are planning the launch, engaging top KOLs in the country to help drive awareness and adoption. In accordance, we expect placements in India to scale at a measured pace throughout the year. Market feedback on the subsystem with Optic AI software remains consistently very positive. I firmly believe the subsystem today is ready for broad adoption and our image quality positions as well to continue to broaden and deepen use cases. We have three diverse and differentiated business opportunities to drive growth in the near future through placements across the hospital, neurology offices, and international markets. I will now turn the call over to Brett to review our financial performance and 2026 guidance.
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