• Portable ultra-low-field MR brain imaging provides affordable and accessible technology that may help physicians monitor ARIA and Alzheimer's disease progression in diverse professional care settings.

GUILFORD, Conn. / Jun 25, 2024 / Business Wire / Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced that two presentations on the clinical utility of portable ultra-low-field MRI for Alzheimer's disease monitoring have been accepted in the developing topics poster sessions at the upcoming 2024 Alzheimer’s Association International Conference, July 28–August 1 in Philadelphia.

These presentations, submitted by clinicians from Washington University in St. Louis, Massachusetts General Hospital, and Yale University, highlight promising applications of portable ultra-low-field MR imaging within the Alzheimer's care continuum.

Conference attendees can learn more during these select presentations:

Title: Advanced Imaging Modalities for ARIA Detection and Treatment Efficacy Monitoring in Lecanemab Therapy for Alzheimer's Disease: A Collaborative Prospective Study
Authors: Jude-Patrick Nnamdi Okafor, MD, et al.

Title: Portable, Low-field MRI for Alzheimer’s Disease
Authors: W. Taylor Kimberly MD PhD, et al.

“With the recent developments in Alzheimer’s therapies and care, the medical community has shown tremendous interest in incorporating portable ultra-low-field MR brain imaging into the continuum of care for Alzheimer’s patients, taking advantage of the system’s versatility to scan in diverse professional care settings. We are very excited to be attending the AAIC conference for the first time this year in Philadelphia,” said Maria Sainz, President and CEO of Hyperfine, Inc.

Hyperfine, Inc. is committed to delivering clinical value across the continuum of care for patients suffering from some of the most devastating neurodegenerative diseases like Alzheimer’s and reducing the complexity of the treatment and care management cycle many patients face. Earlier this year, the company announced that the first patients had been scanned in the CARE PMR (Capturing ARIA Risk Equitably with Portable MR) study. The observational study assesses the clinical utility and workflow benefits of acquiring the Swoop® system images at infusion centers and clinics to help physicians detect amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients receiving amyloid-targeting therapy.

For more information about the Swoop® Portable MR Imaging® system, please visit hyperfine.io.

About the Swoop® Portable MR Imaging® System

The Swoop® Portable MR Imaging® system is U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device 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 certification in the European Union and UKCA certification in the United Kingdom. The Swoop® system is commercially available in a select number of international markets.

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 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.

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, 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.