New dementia study actively enrolling and new data to be presented at the 2025 Alzheimer's Association International Conference.

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—today announced two significant advancements highlighting the potential of its innovative MRI technology to expand dementia screening, enhance monitoring, and improve care.

Globally, over 57 million people live with dementia, with Alzheimer’s disease accounting for 60–80% of cases (Centers for Disease Control, World Health Organization). Limited access to conventional MRI, particularly in underserved and rural areas, often delays diagnosis and treatment. The Swoop® system addresses these barriers by delivering portable, accessible brain imaging in outpatient settings, including neurology clinics and infusion centers.

A new study conducted by the University of Kansas Alzheimer’s Disease Research Center is exploring the use of the next-generation Swoop® system to expedite dementia diagnosis in a memory clinic. Led by Dr. Jeffrey Burns, the Accelerated Clinical Evaluations for Alzheimer’s Disease (ACE-AD) pioneers an innovative approach that combines in-office MR imaging, cognitive testing, and blood biomarkers into a single nurse-led clinic visit, aimed to improve patient care and ease healthcare system burdens. Dr. Burns highlights the importance of accessibility, stating, "The shortage of cognitive specialists limits our ability to meet growing demand for dementia care. Tools like the Swoop® system could enable scalable, timely diagnoses and earlier treatment, particularly for patients in rural and underserved areas."

Additionally, two poster presentations from researchers in the Benzinger Lab at Washington University School of Medicine in St. Louis will be presented at this year’s Alzheimer’s Association International Conference, including interim results from the CARE PMR study, which evaluates the use of the Swoop® system for ARIA-E monitoring.

• Title: The Use of Portable MRI in the Detection and Monitoring of Amyloid-Related Imaging Abnormalities
  
  Authors: J. Hu, K. Sharifi, H. Alkelani, et al.

• Title: Assessing Low-field MRI Volumetric and White Matter Hyperintensity Lesion Measures using WMH-SynthSeg
  
  Authors: H. Shimony, S. Keefe, H. Alkelani, et al.

“These studies underscore how the Swoop® system is transforming brain imaging by bringing MRI to serve patients and clinicians across brain conditions where MRI access can significantly improve care,” said Maria Sainz, President and CEO of Hyperfine, Inc. “Neurodegenerative conditions represent immense clinical and economic burdens for patients, caregivers, and health systems globally. The work that leading clinicians are doing with the Swoop® system in dementia screening and Alzheimer’s drug therapy monitoring sets the stage for very large expansion opportunities for Hyperfine.”

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

Centers for Disease Control and Prevention. About Alzheimer’s. Alzheimer’s Disease & Dementia. Updated August 15, 2024. Accessed July 22, 2025. https://www.cdc.gov/alzheimers‑dementia/about/index.html

World Health Organization. Dementia. World Health Organization News‑Room Fact Sheets. Published March 31, 2025. Accessed July 22, 2025. https://www.who.int/news-room/fact-sheets/detail/dementia

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.

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A new study conducted by the University of Kansas Alzheimer’s Disease Research Center is exploring the use of the next-generation Swoop® system to expedite dementia diagnosis in a memory clinic.