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Hyperfine Swoop® AI-Powered Portable MRI System Demonstrates 100% Sensitivity for ARIA-E Detection in New Data Presented at the 2025 Alzheimer’s Association International Conference

via Business Wire

Interim results from the CARE PMR study support the use of ultra-low-field MRI as a triage tool for monitoring patients on amyloid-targeting therapies.

Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—announced promising early results from the CARE PMR (Capturing ARIA Risk Equitably with Portable MR) study presented at the 2025 Alzheimer’s Association International Conference in Toronto, Canada.

Researchers from the Benzinger Lab at Washington University School of Medicine in St. Louis reported interim results from 31 Alzheimer’s patients undergoing Lecanemab therapy. Participants were scanned using the Swoop® system within one week of their clinical high-field MRI scans, as part of the safety monitoring protocol required by the FDA when it approved Lecanemab.

The Swoop® system achieved 100% sensitivity in detecting mild to moderate ARIA-E, a condition marked by cerebral edema. Researchers note that while ultra-low-field MRI is promising as a triage tool to screen for ARIA-E, high-field MRI may remain necessary for comprehensive evaluation in some cases.

Appropriate use guidelines for amyloid-targeting therapies, including Lecanemab and Donanemab, require MRI safety monitoring at multiple, specific intervals throughout the course of therapy. However, regular screening with conventional MRI systems is often hindered by high costs, scheduling delays, and logistical challenges for both patients and caregivers. The Swoop® system addresses these barriers by offering an affordable, portable imaging solution that is readily available to patients at the point of care, such as neurology offices and infusion clinics. Dr. Tammie Benzinger, principal investigator of the study, noted, “This research could help alleviate the burden on families and facilities and improve overall access to care. We are hoping to expand the project to Washington University’s Medical Campus to include community sites offering infusion therapy for early Alzheimer’s disease.”

These findings from the CARE PMR study underscore the potential of portable MRI to transform ARIA-E monitoring and expand access to care. The Swoop® system enables clinicians to confidently detect ARIA-E, while offering patients and caregivers the convenience of point-of-care screening, eliminating the need for separate imaging appointments. “We are proud to collaborate with leading clinicians and researchers who share our vision of advancing Alzheimer’s care through accessible innovation,” said Edmond Knopp, MD, Chief Medical Officer at Hyperfine.

The CARE PMR study is a collection of data from multiple sites assessing the clinical utility and workflow benefits of using Swoop® system images to detect amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients receiving amyloid-targeting therapy. It is funded by the Alzheimer’s Association and the American Society of Neuroradiology.

For more information about the Swoop® system, please visit HyperfineMRI.com.

About the Swoop® Portable MRI Systems

The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (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.

About Hyperfine, Inc.

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first 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 HyperfineMRI.com.

The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. The Swoop logo, Optive AI logo, and Optive AI are 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, the Company’s goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future 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 impact of COVID-19 on the Company’s business; the inability to maintain the listing of the Company’s Class A common stock on the Nasdaq; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability 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 inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability 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 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 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.

The Swoop® system achieved 100% sensitivity in detecting mild to moderate ARIA-E, a condition marked by cerebral edema.

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