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Hyperfine, Inc. Reports Second Quarter 2025 Financial Results

GUILFORD, Conn., Aug. 13, 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鈥攖he Swoop庐 system鈥攖oday announced second quarter 2025 financial results and provided a business update.

鈥淚n the second quarter, we executed across our key growth drivers. We received FDA clearances for our latest software, Optive AI^TM, and for the next generation Swoop庐 system powered by Optive AI^TM software, which represent a key inflection point in our technology. We also completed our pilot neurology office program. We believe these critical milestones establish a strong foundation for accelerated momentum in the second half of 2025. We did all of this while delivering strong sequential financial results and continuing to drive leverage and spending discipline as we advance our commercial profile,鈥� said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc.

Recent Achievements and Business Highlights

• Secured FDA clearance for two breakthrough innovations 鈥� the 10^th generation software for all Swoop庐 systems, Optive AI鈩�, and a next generation Swoop庐 scanner powered by Optive AI^TM software鈥� positioning Hyperfine at the forefront of accessible, AI-integrated imaging.
• Commenced commercial rollout of the next-gen Swoop庐 system powered by Optive AI^TM software, with the first commercial shipments in U.S. hospitals within weeks of receiving FDA clearance.
• Commenced commercial roll out of Optive AI^TM software to installed base of Swoop庐 scanners in the U.S., Canada, Australia and New Zealand markets.
• Successfully completed neurology office pilot and initiated a full-scale commercial launch to unlock new revenue opportunity.
• Announced enrollment of the 100th patient in the NEURO PMR study, a first-of-its-kind, multi-center study to evaluate use of AI-powered portable MRI in neurology offices.
• Initiated the PRIME study at Yale School of Medicine to evaluate the impact of AI-driven portable MRI in triaging a broad range of emergency department patients, supporting clinical validation and future use case expansion.
• Announced promising new data at the 2025 Alzheimer鈥檚 Association International Conference showing that the Swoop庐 AI-powered portable MRI system demonstrated 100% sensitivity in detecting mild and moderate ARIA-E in Alzheimer鈥檚 patients undergoing Lecanemab therapy.
  

Second Quarter 2025 Financial Results

• Revenues for the second quarter of 2025 were $2.7 million, increasing 26% compared to the first quarter of 2025.
• Hyperfine, Inc. sold 8 commercial Swoop庐 systems in the second quarter of 2025, up from 6 Swoop庐 systems in the first quarter of 2025.
• Gross margin for the second quarter of 2025 was $1.3 million, compared to $0.9 million in the first quarter of 2025, and representing 49.3% gross margin in the second quarter of 2025, up 800 basis points compared to the first quarter of 2025.
• Research and development expenses for the second quarter of 2025 were $4.5 million, compared to $5.0 million in the first quarter of 2025.
• Sales, marketing, general, and administrative expenses for the second quarter of 2025 were $6.4 million, compared to $6.7 million in the first quarter of 2025.
• Net loss for the second quarter of 2025 was $9.2 million, equating to a net loss of $0.12 per share, as compared to a net loss of $9.4 million, or a net loss of $0.12 per share, for the first quarter of 2025.

2025 Financial Guidance

• Management continues to expect revenue for the full year 2025 to be 10% to 20% over 2024.
• Management now expects cash burn for the full year 2025 to be approximately $27 to $29 million, representing a 27% decline at the midpoint as compared to 2024.

Conference Call

Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Wednesday, August 13, 2025, to discuss its second 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.鈥檚 corporate website at https://investors.hyperfine.io/.

About Hyperfine, Inc. and the Swoop庐 Portable MR Imaging庐 Systems

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop庐 system鈥攖he 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庐 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庐 Portable MR Imaging庐 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庐 system also has CE Mark in the European Union and UKCA Mark in the United Kingdom. The Swoop庐 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 鈥渇orward-looking statements鈥� within the meaning of the 鈥渟afe harbor鈥� provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the 鈥淐ompany鈥�) 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 鈥渆xpect,鈥� 鈥渆stimate,鈥� 鈥減roject,鈥� 鈥渂udget,鈥� 鈥渇orecast,鈥� 鈥渁nticipate,鈥� 鈥渋ntend,鈥� 鈥減lan,鈥� 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渃ould,鈥� 鈥渟hould,鈥� 鈥渂elieves,鈥� 鈥減redicts,鈥� 鈥減otential,鈥� 鈥渃ontinue,鈥� 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鈥檚 financial and operating results, including, the Company鈥檚 expected revenue and cash burn for the full year 2025, the Company鈥檚 goals and commercial plans, including the Company鈥檚 commercial rollout of the Company鈥檚 Optive AI^TM software and next generation Swoop庐 system and , the Company鈥檚 office pilot and commercial launch, PRIME study and NEURO PMR multi-center, prospective observational study, the benefits of the Company鈥檚 products and services, progress on improvements and advancements in the Company鈥檚 products and services and the timing of FDA clearances, and the Company鈥檚 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鈥檚 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鈥檚 product development and commercialization activities, including the degree that the Swoop庐 system is accepted and used by healthcare professionals; the Company鈥檚 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鈥檚 products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company鈥檚 products and services and reimbursement for medical procedures conducted using the Company鈥檚 products and services; the Company鈥檚 ability to successfully complete and generate positive data from the PRIME study, ACTION PMR study, CARE PMR study and NEURO PMR study; the Company鈥檚 ability to generate clinical evidence of the benefits of the Company鈥檚 products and services and to progress on product advancements and improvements; the Company鈥檚 estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company鈥檚 financial performance; and other risks and uncertainties indicated from time to time in the Company鈥檚 filings with the Securities and Exchange Commission, including those under 鈥淩isk Factors鈥� 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.

Investor Contact
Webb Campbell
Gilmartin Group LLC
[email protected]