Observational Study Finds That Hyperfine, Inc. Portable MR Brain Imaging System Assists Clinicians in Early Detection of Acute Brain Injury in ECMO Patients

Results from study presented at the 2023 Asia-Pacific Extracorporeal Life Support Organization (APELSO) meeting

Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system—the Swoop® system—today announced initial findings from the multicenter observational study Assessing Brain Injury Using Portable Magnetic Resonance Imaging in Patients With Extracorporeal Membrane Oxygenation.

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Hyperfine, Inc. has redefined brain imaging with the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system—the Swoop® system (Photo: Business Wire)

The primary investigator of the study, which explored the use of portable MR brain images in assessing acute brain injury (ABI) in 46 adult extracorporeal membrane oxygenation (ECMO) patients at two major US medical institutions, presented the results on November 2, 2023, at the APELSO 2023 meeting. ECMO patients are typically unable to be transported to the conventional high-field MRI suite due to their unstable condition. The study evaluated the feasibility of using portable MR brain imaging for monitoring patients during ECMO use, highlighting its potential advantage in providing early visualization of ischemic stroke compared to computerized tomography (CT) scans.

The initial findings of this study demonstrate the feasibility of using portable MR brain imaging with adult ECMO patients. It concludes that the incidence of acute brain injury was high, with ischemic stroke being the most common type of injury. The study further underscores the role of MR-based neuroimaging in ABI detection and the potential for allowing improvement in neurological outcomes.

“This study signals the potential benefit of portable MR brain imaging over conventional CT scans during ECMO, especially in detecting early ischemic injuries,” said Edmond A. Knopp, MD, Hyperfine, Inc. vice president of medical affairs. “This may be particularly important when you consider mortality rates due to acute brain injury in ECMO patients and emphasizes the need for early and accurate neuromonitoring.”

“The study’s findings are very encouraging, especially as they relate to the benefits of using the Swoop® portable brain imaging system for early assessment of acute brain injury in patients being treated with ECMO. Without the Swoop® system, these patients, who are too unstable to transport, would not have access to the benefits of MR brain imaging,” said Maria Sainz, Hyperfine, Inc. president and CEO. “This data further supports yet another use case for the Swoop® system where timely access to MR brain imaging for patients and their clinical teams can make a profound impact on mitigating care delays.”

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

About Hyperfine, Inc. and the Swoop® Portable MR Imaging® System

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking medical technology company that has redefined brain imaging with the Swoop® system—the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care. The Swoop® system received initial U.S. Food and Drug Administration (FDA) clearance in 2020 as a portable magnetic resonance brain imaging device for producing images that display the internal structure of the head where a 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 has been approved for brain imaging in several countries, including Canada and Australia, has UKCA certification in the United Kingdom, CE certification in the European Union, and is also available in New Zealand.

The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging and data solutions. 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. Traditionally, access to costly, stationary, conventional MRI technology can be inconvenient or not available when needed most. With the portable, ultra-low-field Swoop® system, Hyperfine, Inc. is redefining the neuroimaging workflow by bringing brain imaging to the patient’s bedside. 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.

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