Hyperfine, Inc. (NASDAQ:HYPR) reported an EPS of -$0.06, beating the estimated EPS of -$0.08, indicating better-than-expected performance.The company's revenue was $5.29 million, slightly below the estimated $5.3 million, showing a minor shortfall in sales expectations.Hyperfine's financial metrics, including a current ratio of 4.34 and a price-to-sales ratio of approximately 7.13, reflect a strong liquidity position and high investor confidence.Hyperfine, Inc. (NASDAQ:HYPR), a leading name in the health te ...

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $5.3 million, up 128% from $2.3 million in Q4 2024 [21] - Full year 2025 revenue was $13.6 million, a 5% increase from $12.9 million in 2024 [22] - Gross profit for Q4 2025 was $2.7 million, up 226% compared to Q4 2024 [22] - Gross margin for Q4 2025 was 50.9%, representing a 1,530 basis points increase from Q4 2024 [23] - Net loss for Q4 2025 was $5.9 million, compared to a net loss of $10.4 million in Q4 2024 [25] - Full year net loss was $35.6 million, down from $40.7 million in 2024 [26] Business Line Data and Key Metrics Changes - Sold 16 units in Q4 2025 compared to 9 units in Q4 2024, indicating increased demand across all business lines [21] - Significant revenue growth in the second half of 2025, generating $8.7 million compared to $4.8 million in the first half [22] - R&D expenses decreased by 25% in Q4 2025 compared to Q4 2024, reflecting a transition to a commercial growth stage [24] Market Data and Key Metrics Changes - FDA clearance for the updated Swoop system in December 2025, enhancing its clinical utility in stroke workflows [6] - Approval of the first-generation Swoop system in India opens a new market opportunity [7] - Positive market feedback on the Swoop system with Optive AI software, indicating readiness for broad adoption [17] Company Strategy and Development Direction - Focus on continuous innovation and market development, with plans for one to two software releases per year [9] - Expansion into neurology offices and international markets as key growth vectors [14][17] - Emphasis on generating clinical and economic evidence to support sales and adoption [6][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future of the Swoop system and its unique position in the ultra-low field MRI market [5] - Anticipated revenue growth for 2026 between $20-$22 million, representing a 55% increase at the midpoint [28] - Expected gross margin for 2026 to be in the range of 50%-55% [29] Other Important Information - The company raised over $20 million in equity and $15 million in long-term debt to strengthen its capital position [19][20] - Cash burn for Q4 2025 was $5.7 million, down 30% from Q4 2024 [26] - Cash runway extended into 2028 due to recent financing [30] Q&A Session Summary Question: Key assumptions surrounding 2026 guidance - Management indicated that guidance is tied to growth catalysts across three business verticals, with multi-unit systems and IDNs playing a significant role [35][37] Question: Pipeline status and strength - Management confirmed that the pipeline remains strong and diversified, with multiple IDN deals in progress [41][42] Question: Service revenue trends - Management acknowledged that service revenue was lower in Q4 due to accounting adjustments but expects long-term growth in this area [55]

Financial Data and Key Metrics Changes - Fourth quarter revenue was over $5 million, representing a 128% increase compared to $2.3 million in Q4 2024 [23] - Full year revenue for 2025 was $13.6 million, up 5% from $12.9 million in 2024 [24] - Gross profit for Q4 2025 was $2.7 million, a 226% increase from Q4 2024 [24] - Gross margin for Q4 2025 was 50.9%, marking a 1,530 basis points expansion from Q4 2024 [25] - Net loss for Q4 2025 was $5.9 million, compared to a net loss of $10.4 million in the same period of the prior year [27] - Full year net loss was $35.6 million, down from $40.7 million in 2024 [28] - Cash burn for Q4 2025 was $5.7 million, a 30% reduction from $8.2 million in Q4 2024 [28] Business Line Data and Key Metrics Changes - Sold 16 units in Q4 2025 compared to 9 units in Q4 2024, indicating increased demand across all business lines [23] - The introduction of the next-generation Swoop system and Optive AI software has led to significant traction in hospitals and neurology offices [6][10] Market Data and Key Metrics Changes - FDA clearance for the updated Swoop system in December 2025 enhances its clinical utility, particularly in stroke workflows [7] - The approval of the first-generation Swoop system in India opens a new market opportunity [8] - Positive market feedback on the Swoop system with Optive AI software supports broader adoption [19] Company Strategy and Development Direction - The company aims to expand its market presence through continuous innovation and the introduction of new software releases [9] - Focus on leveraging clinical data to support adoption and drive sales in hospitals and neurology offices [10][15] - Plans to launch the next-generation Swoop scanner in international markets in the second half of 2026 [31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future of the Swoop system and its unique position in the ultra-low field MRI market [6] - The company anticipates a progressive strengthening of revenue throughout 2026, driven by multi-unit hospital deals and international expansion [30] - Management highlighted the importance of maintaining spending discipline while investing in growth opportunities [32] Other Important Information - The company raised over $20 million in equity and $15 million in long-term debt to strengthen its capital position [21][22] - The device's MSRP was increased to $590,000, which is expected to enhance ROI for hospitals [41] Q&A Session Summary Question: Key assumptions surrounding 2026 guidance - Management indicated that guidance is based on growth catalysts across three business verticals, with expectations for progressive revenue strengthening throughout 2026 [38][39] Question: Pipeline status and strength - Management confirmed that the pipeline remains strong and diversified, with multiple IDN deals in progress, although larger deals may take longer due to budget cycles [43][44] Question: Service revenue trends - Management acknowledged that service revenue was lower in Q4 due to accounting adjustments related to technology upgrades, but expects long-term growth in this area [57]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $5.3 million, up 128% from $2.3 million in Q4 2024 [19] - Full year 2025 revenue was $13.6 million, a 5% increase from $12.9 million in 2024 [21] - Gross profit for Q4 2025 was $2.7 million, up 226% compared to Q4 2024 [21] - Gross margin for Q4 2025 was 50.9%, representing a 1,530 basis points increase from Q4 2024 [22] - Net loss for Q4 2025 was $5.9 million, compared to a net loss of $10.4 million in Q4 2024 [24] - Full year net loss was $35.6 million, down from $40.7 million in 2024 [25] Business Line Data and Key Metrics Changes - The company sold 16 units in Q4 2025 compared to 9 units in Q4 2024, indicating increased demand across all business lines [20] - The introduction of the next-generation Swoop system and Optive AI software has led to significant growth in the second half of 2025 [21][28] Market Data and Key Metrics Changes - The FDA clearance of the updated Swoop software in December 2025 has enhanced the system's capabilities, particularly in stroke workflows [6] - The approval of the first-generation Swoop system in India opens a new market opportunity for the company [7] Company Strategy and Development Direction - The company aims to expand its market presence in neurology offices and international markets, leveraging the strong clinical and economic value of its technology [4][16] - Continuous innovation and the introduction of new software releases are central to the company's strategy for growth [9][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future of the Swoop system, citing strong market feedback and the potential for broader adoption [5][16] - The company anticipates revenue growth between $20 million and $22 million for 2026, representing a year-over-year growth of approximately 55% [27] Other Important Information - The company has strengthened its capital position by raising over $20 million in equity and $15 million in debt, extending its cash runway into 2028 [18][26] - The company is focused on reducing cash burn, which was down 30% in Q4 2025 compared to the previous year [25][26] Q&A Session Summary Question: Key assumptions surrounding 2026 guidance - Management indicated that the guidance is based on growth catalysts across three business verticals, with expectations for progressive strengthening of revenue throughout 2026 [33][35] Question: Pipeline status and multi-unit orders - Management confirmed that the pipeline remains strong and diversified, with several IDN deals in progress, although larger deals may take longer to finalize due to budget cycles [40][41] Question: Service revenue trends - Management acknowledged that service revenue was lower in Q4 due to accounting adjustments related to core technology upgrades, but expects growth in the long term [53][54]

AI-POWERED, PORTABLE BRAIN MRI The MRI You Know The Swoop® Portable MR Imaging System is Driving the Future of Brain Health Corporate Investor Deck – March 2026 The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. The Swoop logo is a trademark of Hyperfine, Inc. PROPERTY OF HYPERFINE. ©2026. All rights reserved. Forward-Looking Statements This presentation includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securi ...

Washington, D.C. 20549 UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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, 2025 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 ...

Product Overview - The Swoop® Portable MR Imaging System is significantly less expensive and requires no high-cost site shielding, making it accessible at any healthcare facility [3]. - The Swoop system's image quality is approaching that of conventional MRI, with a comparison showing 0.064T for the Swoop system versus 1.5T for conventional MRI [9]. - The AI-enabled imaging software enhances image clarity and consistency, providing sharper anatomical detail to support confident diagnoses at the point of care [11]. - The Swoop system qualifies for existing reimbursement (CPT 70551), providing a strong economic value proposition for medical offices [15]. - The next-generation system is designed for multiple brain imaging applications, indicating a broad FDA clearance for imaging patients of all ages [24]. Market Opportunity - The total addressable market (TAM) for MRI in multiple sites of care is estimated to exceed $16 billion, with specific segments like outpatient settings projected to grow substantially [5]. - A typical neurologist orders 500-600 MRIs annually, and 90% of private neurology practices do not have on-site MR imaging, indicating a strong market opportunity for the Swoop system [15]. - The company has a first-mover advantage in the U.S. hospital market with proprietary patents and a global footprint through partnerships with leading distributors [24]. Business Strategy - The hospital business segment aims to increase access to MRI, improve patient progress, and reduce transportation wait times, with a focus on critical care and emergency departments [12]. - The international business strategy includes launching Optive AI software in 10 European languages and obtaining clearance for the next generation Swoop system in Europe and Canada by the end of 2026 [16]. - The company is actively engaged with several Integrated Delivery Networks (IDNs) to standardize care in adult and pediatric critical care settings, indicating strong market expansion efforts [19]. - The recent international launch of Optive AI is expected to enhance the company's product offerings and market reach, with a focus on lead generation in office settings [19]. Sales and Implementation - The company has installed over 200 Swoop systems globally, supported by a dedicated sales and implementation team of approximately 15 full-time equivalents (FTEs) and 10+ markets [18]. - The company has established a network of reference sites and key opinion leaders globally through partnerships, enhancing its market presence [16]. Future Growth - The next-generation Swoop system has received overwhelmingly positive feedback from the radiology community, with a robust pipeline of multiple deals and inbound requests for quotes and product demos [19]. - The next-generation system is expected to be commercially available in the U.S. by May 2025, with reimbursement already validated under existing CPT codes [24]. - Future opportunities include expansion into new anatomies and interventions, such as diabetic foot applications and teleradiology integration, which are expected to drive additional growth [22]. - The company is focusing on product segmentation to optimize pricing strategies in office settings, enhancing revenue potential [19]. Leadership - Leadership team has a proven track record of success, which is expected to support the company's strategic initiatives and growth plans [23].

Core Insights - Strong evidence supports the use of AI-powered portable MRI for stroke detection in various clinical settings, particularly in emergency departments [1] Industry Implications - The integration of AI technology in portable MRI systems could enhance diagnostic capabilities and improve patient outcomes in stroke management [1] - The adoption of such technology may lead to increased efficiency in emergency medical services and potentially reduce the time to treatment for stroke patients [1]

Core Insights - Hyperfine, Inc. has announced results from the NEURO PMR study, showcasing the effectiveness of its portable MRI system, Swoop®, in clinical settings [1][5]. Clinical Study Results - The NEURO PMR study is the first prospective, multi-center study evaluating the clinical utility of portable MRI compared to standard MRI in outpatient neurology clinics, enrolling 125 patients with common neurological conditions [2][3]. - Portable MRI demonstrated 92% concordance with standard MRI in identifying intracranial pathology during blinded reviews, increasing to 98% in unblinded reviews [3]. Patient Experience - Patients preferred the portable MRI, being four times more likely to choose it over standard MRI, with superior ratings across comfort, anxiety, claustrophobia, noise, and overall satisfaction [3][4]. - The Swoop® system can be operated by trained clinical staff without the need for specialized MR technologists, indicating a safe and simple workflow [3][4]. Technological Innovation - The Swoop® system is portable, fits in an exam room, requires no specialized sitting or shielding, and can be plugged into a standard outlet, addressing historical challenges in bringing MRI on-site [4][5]. - The system is FDA-cleared for brain imaging and is designed to provide clinically relevant diagnostic imaging [6][7]. Market Impact - The NEURO PMR results validate the potential of portable MRI to expand imaging capabilities beyond traditional hospital settings, benefiting physicians, patients, and the healthcare system [5].

Core Insights - The article discusses a prospective study aimed at evaluating the feasibility and visualization benefits of contrast-enhanced ultra-low-field portable MRI [1] Group 1 - The study is designed to assess the practicality of using ultra-low-field portable MRI technology in clinical settings [1] - It focuses on the visualization advantages that contrast enhancement may provide in MRI imaging [1]