• The publication includes a subset of data from the ACTION PMR stroke study and provides early evidence that the Swoop^® system is a promising tool for enabling critical stroke treatment choices in urgent care settings.

GUILFORD, Conn. / Jul 15, 2024 / Business Wire / Hyperfine (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 highlights the results from a multi-site observational study that showed the value of using Swoop^® system images to quickly assess stroke patients and help guide physicians making critical treatment decisions. This publication marks the first to include a subset of ACTION PMR study data and shows encouraging results.

The study, entitled "Diffusion-Weighted Imaging and Fluid-Attenuated Inversion Recovery Mismatch on Portable, Low-Field Magnetic Resonance Imaging Among Acute Stroke Patients,” will be published in the August 2024 issue of the Annals of Neurology. It included 71 patients and was conducted by a team from several institutions, including Massachusetts General Hospital and the University at Buffalo, two of the centers in the ACTION PMR study.

"Our goal is to assess whether portable, ultra-low-field MRI can be used as a tissue clock to characterize acute stroke, which has the potential to inform treatments and improve outcomes. Thus far, we have convincing data on FLAIR showing that this is, in fact, the case," said Dr. Taylor Kimberly, Chief of the Division of Neurocritical Care at Massachusetts General Hospital, one of the lead authors.

“We would like to congratulate Dr. Kimberly and all the authors on this elegant study demonstrating the Swoop^® system’s utility in stroke management,” said Edmond A. Knopp, MD, Hyperfine Vice President of Medical Affairs. “We eagerly await additional analysis of the entire ACTION PMR dataset, which we believe will show the benefit that Swoop^® system images can bring to the overall care and management of patients presenting with symptoms of acute cerebral ischemic disease.”

The Acute Ischemic Stroke Detection with Portable MR (ACTION PMR) study is a prospective, international, multi-site observational study that aims to examine the integration of brain imaging with the portable Swoop^® system into the stroke diagnosis and treatment workflow. ACTION PMR has already enrolled over 100 patients at four institutions and is composed of a series of investigator-sponsored studies. The initial 100 patients allow for a direct comparison of stroke detection between ultra-low-field MRI, conventional high-field MRI, and CT as a means to assess the capability of stroke detection of the Swoop^® system. The study will continue into a workflow phase starting later this year, evaluating the ease of access and versatility of using the Swoop^® system in emergency departments and stroke centers within hospital networks.

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.

The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc.

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