News Release Details

GUILFORD, Conn.--(BUSINESS WIRE)--Nov. 13, 2025-- 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 third quarter 2025 financial results and provided a business update.

“In the third quarter, we began to reap the benefits of two key growth catalysts with the launches of our next generation Swoop® system and Optive AI^TM software and our entrance into the neurology office market. Feedback from the first 100 days following the launch of our next generation Swoop® system bolsters our belief that this system will drive broad-based adoption of our portable Swoop® system across multiple sites of care, diversifying and accelerating our growth and improving our financial performance,” said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc.

Recent Achievements and Business Highlights

• Successfully initiated commercial launch of the next generation Swoop® system powered by Optive AI™ software in the United States with strong market activation.
• Placed next generation Swoop® systems across all sites of care we call on in the United States, including adult and pediatric critical care units, emergency departments and neurology offices.
• Converted entirety of our U.S. hospital pipeline to next generation Swoop® system.
• Initiated full-scale commercial launch in the neurology office setting to unlock new revenue opportunity.
• Obtained both CE Mark and UKCA Mark approvals for Optive AI™ software.
• Commenced commercial roll out of Optive AI™ software to installed base of Swoop® scanners in the United States, Canada, United Kingdom, Australia, and New Zealand markets.
• Raised $20.1 million in gross proceeds through an underwritten public offering in October 2025, significantly bolstering the balance sheet to support continued investments in commercial expansion and growth.

Third Quarter 2025 Financial Results

• Revenues for the third quarter of 2025 were $3.4 million, increasing 27% compared to the second quarter of 2025.
• Sold 8 commercial Swoop® systems in the third quarter of 2025, 5 of which were next generation Swoop® systems.
• Gross margin for the third quarter of 2025 was $1.8 million, compared to $1.3 million in the second quarter of 2025, representing 53.8% gross margin in the third quarter of 2025, a record quarter for gross margin and up 450 basis points compared to the second quarter of 2025.
• Research and development expenses for the third quarter of 2025 were $4.0 million, compared to $4.5 million in the second quarter of 2025.
• Sales, marketing, general, and administrative expenses for the third quarter of 2025 were $6.7 million, compared to $6.4 million in the second quarter of 2025.
• Net loss for the third quarter of 2025 was $11.0 million, equating to a net loss of $0.14 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 third quarter 2025 net loss and the second quarter 2025 net loss includes a change in fair value of warrant liabilities of $2.3 million and $0 million, respectively.

2025 Financial Guidance

• Management expects revenue for the fourth quarter of 2025 to be approximately $5 to $6 million, which at the mid-point represents sequential and year-over-year quarterly growth of 60% and 137%, respectively. Accordingly, revenue for the full year 2025 is now expected to be approximately $13 to $14 million.
• Management now expects cash burn for the full year 2025 to be in the range of $29 to $31 million, representing a 22% decline at the midpoint as compared to full year 2024.

Conference Call

Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Thursday, November 13, 2025, to discuss its third quarter 2025 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 fourth quarter and full year 2025, the Company’s goals and commercial plans, including the Company’s commercial rollout of the Company’s Optive AI^TM software and next generation Swoop® system, the Company’s office pilot and commercial launch, 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; anticipated National Institutes of Health funding pressures; the expected effect 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, 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/20251113003277/en/

Investor Contact
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com

Source: Hyperfine, Inc.