Hyperfine Announces Promising Interim Findings on the Value of Portable, Ultra-low-field MR Imaging for Acute Stroke Care

The Swoop® Portable MR Imaging® system shows faster time-to-scan compared to conventional MRI and good specificity in emergency stroke care

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 the presentation of interim data supporting the role portable ultra-low-field MRI can play in acute stroke workup in a hospital emergency department setting.

The findings from the study, titled Interim Analysis from Single Centre Observational Study of Ultra-Low Field Portable MRI in Acute Stroke Diagnostic Workup, were presented by Keith Muir, MD, of the University of Glasgow, during a scientific session at the 2024 European Society of Neuroradiology (ESNR) Annual Meeting.

This study, which includes a subset of patients from phase one of the prospective, international, multi-site ACTION PMR (Acute Ischemic Stroke Detection with Portable MR) study, analyzed images from the ultra-low-field Swoop® MR brain imaging system to assess the system's performance in acute care stroke workup as compared to the current standard of care. The analysis compared time-to-scan, diagnostic performance, specificity, and patient experience between ultra-low-field MRI, conventional MRI, and head CT.

Key findings showed that the Swoop® system was dramatically faster than conventional MRI, with a median time-to-scan of 2.5 hours compared to 27.7 hours. The data also demonstrated reliability in acute stroke diagnosis with comparable diagnostic performance compared to head CT and good specificity when compared to routine clinical MRI (1.5T). Further, nearly all patients reported a positive experience with the Swoop® system.

The conclusion states, "This interim analysis demonstrates that the portable [ultra-low-field] MRI system is a promising tool for the acute stroke diagnostic workup in an emergency department setting. The improved time to imaging compared to routine MRI could facilitate quicker decision-making in acute stroke management. Additionally, the high tolerance rate among patients underscores its potential usability in a clinical environment. The findings suggest that portable [ultra-low-field] MRI could enhance stroke diagnosis accessibility and efficiency, particularly in settings where conventional MRI availability is limited."

Dr. Edmond Knopp, Vice President of Medical Affairs at Hyperfine, commented, "Being at ESNR in Paris this year and showcasing our Swoop® system, we witnessed the growing interest and enthusiasm across the European neuroradiology community. This excitement was most notable when the attendees had the opportunity to see the system up close and personal. We were very pleased with Dr. Muir and his team's participation in the ACTION PMR stroke study, and it was great to have Dr. Muir share exceptional data acquired during the study. Their findings highlight the potential of the Swoop® system's clinical impact in improving stroke diagnosis and treatment."

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 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 hyperfine.io.

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

Forward-Looking Statements

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