Financial Data and Key Metrics Changes - For the full year 2024, the company reported revenue of $12.9 million, representing a 17% year-over-year growth compared to $11 million in 2023 [5][9] - Gross profit for the full year 2024 was $5.9 million, up 24% from the previous year, with a gross margin of 46%, reflecting a 300 basis point expansion over 2023 [10][12] - The net loss for the full year 2024 was $40.7 million, or $0.56 per share, compared to a net loss of $44.2 million, or $0.62 per share in 2023 [12] - The company reduced its cash burn for the full year 2024 to $38.4 million, down 9% from $42.3 million in 2023 [12] Business Line Data and Key Metrics Changes - In Q4 2024, revenue was $2.3 million, down from $2.7 million in Q4 2023, attributed to longer deal cycles and a lower average selling price due to a higher mix of international deals [7][8] - The company sold nine units in Q4 2024, with a noted variability in sales productivity across U.S. regions [7][9] - Organic year-over-year revenue growth was 70% when excluding a one-time purchase order from King's College London in 2023 [10] Market Data and Key Metrics Changes - The total addressable market for the company's products in the U.S. is estimated to exceed $6 billion, covering placements in hospital and office settings [17] - The company exited 2024 with 13 distributors in place across European, Middle Eastern, and Asian markets, indicating initial placements and significant interest from clinicians [24][25] Company Strategy and Development Direction - The company aims to transform into a commercial stage company in 2025, focusing on diversification and expansion strategies across multiple sites of care and international markets [14][26] - Plans for 2025 include launching two new software releases that will significantly improve image quality, expected to drive quicker adoption of portable brain MRI technology [15][16] - The company is expanding its sales efforts into neurology offices and emergency departments, with a focus on demonstrating the economic and clinical benefits of its technology [18][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the strong foundation built in 2024 and the multiple growth catalysts expected to drive business acceleration in 2025 [33] - There are concerns regarding protracted capital allocation processes in U.S. hospitals, but the office expansion is seen as less tied to capital allocation and more focused on clinical and financial benefits [39][40] - The company anticipates a revenue growth range of 20% to 30% for the full year 2025 compared to 2024, with gross margins expected to improve to between 47% and 52% [29][30] Other Important Information - The company completed a $6 million financing to extend its cash runway to the end of 2026 and has implemented a restructuring to reduce operating costs [6][30] - Management is closely monitoring potential impacts from tariffs but does not expect material effects on the business [31] Q&A Session Summary Question: Can you provide details on the partnership with Navidea? - Management stated that it is an initiative related to future technology, with no further comments at this stage [37] Question: How are you thinking about capital trends in 2025? - Management noted that hospital processes are more complex, but the office setting has fewer decision-makers, making it easier to build a business case [39][40] Question: How should we think about contributions from the U.S. versus international markets? - Management indicated that ASPs have been increasing in the U.S., while international sales are through third-party distributors, affecting pricing variability [42][43] Question: Can you provide insights on the new sales representatives? - Management highlighted that new hires come from diverse backgrounds and have undergone rigorous training, preparing them for the upcoming technology releases [67][68]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39949 Hyperfine, Inc. (Exact name of registrant as specified in its charter) Delaware 98-1569027 (State or other jurisdiction of inc ...

GUILFORD, Conn., March 17, 2025 (GLOBE NEWSWIRE) -- 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 fourth quarter and full year 2024 financial results and provided a business update. “I am pleased with the many milestones we achieved in the fourth quarter of 2024. These set the stage well for us to execute on our expansio ...

Hyperfine, Inc. HYPR shares are surging on Monday.This medical device company company forged a major partnership with NVIDIA Corp NVDA to advance its portable brain imaging technology.By integrating NVIDIA’s AI knowledge and computing power with Hyperfine's Swoop system, the first FDA-approved AI-driven portable MRI, the collaboration seeks to make brain MRIs quicker, more intelligent, and more affordable worldwide, speeding up brain disease diagnosis.The Swoop system tackles a critical challenge in health ...

[Company Overview](index=3&type=section&id=Company%20Overview) Hyperfine is a medical technology company focused on the Swoop® Portable MR Imaging® system, led by an experienced executive team [Introduction to Hyperfine and the Swoop® System](index=4&type=section&id=Introduction%20to%20Hyperfine%20and%20the%20Swoop%C2%AE%20System) Hyperfine has developed the Swoop® Portable MR Imaging® system, the first FDA-cleared, AI-powered portable MRI for brain imaging, designed to improve access and economics with proprietary technology and existing reimbursement codes - **The Swoop® system** is the first FDA-cleared portable MR brain imaging system, utilizing ultra-low-field MRI and AI-powered software[10](index=10&type=chunk)[35](index=35&type=chunk) - The company holds a strong intellectual property position with **over 150 patents** for its proprietary technology[10](index=10&type=chunk)[42](index=42&type=chunk) - The system is commercially available in the US through a direct sales channel and internationally via distributors, supported by recent CE approval for its latest software[10](index=10&type=chunk)[42](index=42&type=chunk) - Reimbursement is established in the US under existing CPT codes for both hospital and office settings, facilitating adoption[10](index=10&type=chunk)[42](index=42&type=chunk) [Leadership Team](index=3&type=section&id=Leadership%20Team) Hyperfine is led by an experienced executive team with a proven track record of success, including key members from prominent medical technology and healthcare companies - The leadership team includes **Maria Sainz** (President and CEO), **Brett Hale** (CAO & CFO), **Tom Teisseyre** (COO), and **Edmond Knopp** (CMO)[8](index=8&type=chunk)[83](index=83&type=chunk) - The commercial and strategy teams are strengthened by executives with experience from leading medical technology and healthcare companies such as Intuitive, Philips, and Ceribell[8](index=8&type=chunk)[83](index=83&type=chunk) [Market Opportunity & Growth Strategy](index=5&type=section&id=Market%20Opportunity%20%26%20Growth%20Strategy) Hyperfine targets a multi-billion dollar market opportunity with a clear growth strategy focused on expanding sites of care, geographic reach, and continuous technology development [Total Addressable Market (TAM)](index=5&type=section&id=Total%20Addressable%20Market%20(TAM)) Hyperfine identifies a sizeable and growing U.S. Total Addressable Market (TAM) exceeding $6 billion, with sequential expansion plans from critical care to broader neurology and brain health markets U.S. Total Addressable Market Expansion | Stage | Timeline | Target Facilities | Market Size | | :--- | :--- | :--- | :--- | | Beachhead | 2024+ | 4,000 critical care units, 5,600 emergency departments | $1.5B+ | | Large Neuro Market | 2025+ | 2,400 neurology practices | - | | Brain Health | 2026+ | 10,700 urgent care facilities, 15,600 nursing homes, 3,600 infusion centers | $6B+ | [Growth Catalysts and Strategic Roadmap](index=6&type=section&id=Growth%20Catalysts%20and%20Strategic%20Roadmap) Hyperfine's growth is driven by a clear roadmap focusing on three main pillars: expanding sites of care into outpatient settings, geographic expansion into new international markets like India, and continuous technology development through a rapid cadence of AI-powered software releases - **Site of Care Expansion:** The company plans to move beyond US Critical Care into new outpatient markets, targeting Emergency Department entry in **2025** and office-based entry thereafter[14](index=14&type=chunk)[17](index=17&type=chunk)[54](index=54&type=chunk) - **Geographic Expansion:** Following the establishment of distributors in Europe and Asia Pacific, Hyperfine is targeting India market entry, with CDSCO submission and approval as key milestones[14](index=14&type=chunk)[17](index=17&type=chunk)[54](index=54&type=chunk) - **Technology Development:** A consistent pipeline of innovation is planned, with the **8th and 9th generation AI-powered software** released, and the **10th and 11th generations** anticipated for the future[14](index=14&type=chunk)[17](index=17&type=chunk)[54](index=54&type=chunk) [New Market Expansion Strategy](index=22&type=section&id=New%20Market%20Expansion%20Strategy) The company is actively pursuing new market segments by generating clinical evidence and establishing business models for Emergency Departments and Neurology Offices, enabled by new IAC Accreditation standards for ultra-low-field MRI - **Emergency Departments:** The strategy focuses on the acute ischemic stroke triage use case, supported by data from the ACTION-PMR study to drive adoption in emergency departments and stroke networks[56](index=56&type=chunk) - **Neurology Offices:** Adoption will be driven by the CARE PMR clinical study and collaborations with partners like Lilly and NeuroNet. The company is refining a scalable office-based business model[57](index=57&type=chunk) - The Intersocietal Accreditation Commission (IAC) published new standards in **November 2024** that include portable MRI, allowing accredited medical offices to qualify for CMS reimbursement, which significantly opens the office market opportunity[58](index=58&type=chunk)[61](index=61&type=chunk) [Technology, Innovation, and Clinical Evidence](index=8&type=section&id=Technology%2C%20Innovation%2C%20and%20Clinical%20Evidence) Hyperfine drives continuous innovation through AI-powered software releases, significantly improving image quality and building robust clinical evidence for diverse applications [AI-Powered Software and Innovation Cadence](index=8&type=section&id=AI-Powered%20Software%20and%20Innovation%20Cadence) Hyperfine maintains a rapid and consistent cadence of innovation through AI-powered software releases, continuously improving image quality and performance with features like AI denoising and deep learning-based image reconstruction - The company has demonstrated a fast cadence of software releases from **2020 to 2024**, progressively enhancing image quality and functionality[19](index=19&type=chunk)[63](index=63&type=chunk) - Key software improvements include **AI denoising in DWI sequences (Software 8.7)**, **faster imaging (Software 8.8)**, and advanced image reconstruction using **deep learning (Software 8.3)**[19](index=19&type=chunk)[63](index=63&type=chunk) [Image Quality Improvements](index=9&type=section&id=Image%20Quality%20Improvements) Through proprietary software and AI deep learning, Hyperfine has rapidly accelerated the clinical utility of its portable MRI by significantly improving image quality, with further enhancements anticipated - There has been a significant improvement in image quality, particularly in FLAIR contrast, from the initial FDA clearance in **Q1 2020** to the **8th Generation software** launched in **Q1 2024**[21](index=21&type=chunk)[65](index=65&type=chunk) - The company anticipates further image quality enhancements with its **next-generation (10th) software**, which is expected in the **first half of 2025**[21](index=21&type=chunk)[65](index=65&type=chunk) [Clinical Evidence](index=28&type=section&id=Clinical%20Evidence) Hyperfine is building a large and growing body of clinical evidence to support adoption across various use cases, with numerous peer-reviewed publications and ongoing prospective studies for future applications - The company has a substantial body of evidence with **over 50 peer-reviewed publications** and **more than 175 conference presentations**[66](index=66&type=chunk) - Prospective studies are in progress to support new use cases, including **ACTION PMR for stroke** and **CARE PMR for Alzheimer's disease**[66](index=66&type=chunk) [Commercialization and Business Model](index=29&type=section&id=Commercialization%20and%20Business%20Model) Hyperfine employs a scalable commercial model with direct sales and distributors, building a global installed base and generating significant recurring revenue from system sales and subscriptions [Commercial Strategy and Global Footprint](index=29&type=section&id=Commercial%20Strategy%20and%20Global%20Footprint) Hyperfine employs a scalable commercial model with a direct sales force in the U.S. and a network of global distributors, achieving an installed base of over 175 Swoop systems globally by December 2024 - The company utilizes a direct sales model in the US and a distributor network for international markets, including Canada and other regions[68](index=68&type=chunk) - As of **December 2024**, the global installed base exceeds **175 Swoop systems**, which includes both commercial and research units[68](index=68&type=chunk)[70](index=70&type=chunk) [System Economics and Revenue Model](index=30&type=section&id=System%20Economics%20and%20Revenue%20Model) The company's business model is built on an initial system sale followed by significant recurring revenue from software and technical service, driving attractive margin expansion as the installed base grows - The revenue model consists of an upfront system sale and a multi-year recurring revenue stream from software and service subscriptions[71](index=71&type=chunk)[72](index=72&type=chunk) System Pricing | Item | U.S. MSRP | | :--- | :--- | | Initial System Sale | $475,000 | | Annual Recurring Revenue (Software & Service) | $47,500 / Year | [Financial Performance](index=10&type=section&id=Financial%20Performance) Hyperfine demonstrates strong financial performance with revenue growth, positive gross margins, reduced cash burn, and a strategic shift towards organic commercial growth [Key Financial Metrics](index=10&type=section&id=Key%20Financial%20Metrics) Hyperfine demonstrates solid financial fundamentals with strong revenue growth, significant gross margin improvement, and disciplined cash management, extending its cash runway into the second half of 2026 Revenue and Gross Margin (2020-2024) | Year | Total Revenue | Device Revenue | Service Revenue | Gross Margin (%) | Systems Sold | | :--- | :--- | :--- | :--- | :--- | :--- | | 2020 | $1.5M | $1.5M | $0.0M | -162% | 23 | | 2021 | $5.2M | $4.9M | $0.3M | -78% | 35 | | 2022 | $6.8M | $5.3M | $1.5M | 13% | 37 | | 2023 | $11.0M | $8.7M | $2.3M | 43% | 48 | | 2024 | $12.9M | $10.5M | $2.4M | 46% | N/A | Annual Cash Burn (2022-2024) | Year | Cash Burn | | :--- | :--- | | 2022 | $71.0M | | 2023 | $42.3M | | 2024 | $38.4M | - As of **December 31, 2024**, the company had **$37.6M** in cash and cash equivalents, with an expected cash runway into the **second half of 2026**[27](index=27&type=chunk)[78](index=78&type=chunk) [Business Transformation and Revenue Mix](index=11&type=section&id=Business%20Transformation%20and%20Revenue%20Mix) The company is undergoing a transformation from a research-focused revenue base to organic commercial growth, with underlying commercial device revenue showing consistent growth despite a one-time purchase in 2022 - The company is shifting from research-driven sales to organic commercial placements, with initial commercialization focused on US Critical Care[28](index=28&type=chunk)[30](index=30&type=chunk) - A one-time purchase of **20 Swoop systems** by King's College of London (KCL) in **2022**, supported by the Bill and Melinda Gates Foundation, impacted historical revenue figures[30](index=30&type=chunk)[31](index=31&type=chunk) Revenue Mix Transformation (2022-2024) | Year | KCL Device Revenue | Device Revenue ex-KCL | Service Revenue | Total Revenue | | :--- | :--- | :--- | :--- | :--- | | 2022 | $4.6M | $0.6M | $1.6M | $6.8M | | 2023 | $0.0M | $8.7M | $2.3M | $11.0M | | 2024 | $0.0M | $10.5M | $2.4M | $12.9M | [Investment Summary](index=34&type=section&id=Investment%20Summary) Hyperfine offers a compelling investment opportunity as a commercial-stage company with a unique, FDA-cleared portable brain imaging system addressing significant global clinical needs [The Hyperfine Investment Opportunity](index=34&type=section&id=The%20Hyperfine%20Investment%20Opportunity) Hyperfine presents a compelling investment opportunity as a commercial-stage company with a first-of-its-kind, FDA-cleared portable brain imaging system, poised to address large unmet clinical needs globally - First FDA-cleared portable, AI-powered MR brain imaging system with strong proprietary technology[84](index=84&type=chunk) - Positioned to solve large unmet clinical needs like Alzheimer's and Stroke globally[84](index=84&type=chunk) - Growth blueprint is driven by expansion into new sites of care (emergency departments, clinics, offices), new geographies, and sustained innovation[84](index=84&type=chunk) - Features a solid financial profile with rapid topline growth and attractive gross margins[84](index=84&type=chunk)

Financial Data and Key Metrics Changes - Revenue for Q3 2024 was $3.6 million, representing a 56% year-over-year growth [5][14] - Gross profit for Q3 2024 was $1.9 million, resulting in a record gross margin of 52% [14] - Year-to-date revenue reached $10.6 million, up 27% from the first nine months of 2023 [14] - Net loss for Q3 2024 was $10.3 million, improving from a net loss of $10.8 million in the same period last year [15] - Cash burn for Q3 2024 was $8.9 million, with $45.8 million in cash and cash equivalents as of September 30, 2024 [15] Business Line Data and Key Metrics Changes - Sales of Swoop portable imaging systems drove revenue performance, with healthy contributions from international markets [5] - The company placed 13 systems in the quarter, with a balanced distribution between US and international placements [18] Market Data and Key Metrics Changes - The total addressable market opportunity in the US is over $6 billion for placements in hospitals and office settings [5] - The company is expanding its distribution network in European markets and has obtained CE approval for its latest generation software [12] Company Strategy and Development Direction - The company plans to enhance its commercial capabilities and expand into new sites of care, including neurology offices [12] - Upcoming software releases aim to improve image quality and accelerate adoption of the Swoop system [7][12] - The company is focusing on clinical studies related to Alzheimer's and stroke, highlighting the workflow benefits of its technology [9][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the business, citing strong revenue growth and upcoming catalysts for 2025 [13][17] - The company anticipates a narrowing revenue outlook for 2024 to a range of $14 million to $14.5 million, representing approximately 30% year-over-year growth [16] Other Important Information - The company received FDA clearance for its ninth-generation AI-powered software, enhancing imaging capabilities [5][7] - The integration of AI techniques is central to improving image quality and diagnostic value [7] Q&A Session Summary Question: How many capital placements were made in the quarter? - The company placed 13 systems, with a strong balance between US and international placements [18] Question: Why is guidance at the midpoint implying flattish sequential sales in Q4? - The company does not rely on traditional capital budgets for system placements, which affects seasonality [20] Question: When do you expect all US systems to add the latest software upgrade? - The rollout is progressing well, with the majority of accounts expected to be completed by the end of the year [22] Question: Is there a perception difference between US and EU doctors regarding Alzheimer's treatment? - There are similarities in recognizing MRI monitoring as a bottleneck, but European regulators have been more conservative [25] Question: What are the differences in MRI demand and reimbursement between the EU and US? - MRI density and reimbursement vary by country, with the UK facing unique challenges in wait times [26]

Hyperfine, Inc. (HYPR) came out with a quarterly loss of $0.14 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.15 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this company would post a loss of $0.14 per share when it actually produced a loss of $0.14, delivering no surprise.Over the last four quarters, the company has surpassed consensus EPS estimates just once.Hyperfine, which belongs to the Zacks Medical - Ins ...

GUILFORD, Connecticut, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced third quarter 2024 financial results and provided a business update. “The Hyperfine team delivered yet another strong quarter of financial performance across revenue growth, gross margin expansion, and disciplined cash management ...

Hyperfine, Inc. (HYPR) recently announced a publication by investigators at Johns Hopkins Hospital and the University of Texas-Houston on using the Swoop system for patients on extracorporeal membrane oxygenation (ECMO) support. The study is titled "Clinical Use of Bedside Portable Ultra-Low-Field Brain Magnetic Resonance Imaging in Patients on Extracorporeal Membrane Oxygenation: Results From the Multicenter SAFE MRI ECMO Study." It was published in the September issue of Circulation. HYPR's Likely Stock T ...

Hyperfine, Inc. (HYPR) , a pioneer in health technology, recently announced promising interim data on the Swoop Portable magnetic resonance (MR) Imaging for acute stroke diagnosis. These findings, presented at the 2024 European Society of Neuroradiology (ESNR) Annual Meeting, underline how the portable ultra-low-field MRI could revolutionize stroke care, particularly in emergency department settings. HYPR's Likely Stock Trend Following the News Following the news, shares of HYPR rose 1.5% at yesterday's clo ...