Hyperfine, Inc. Launches Observational Study to Define New Imaging Paradigm in Stroke Care

In addition to the study, the company appoints a world-class stroke advisory board as part of its acute ischemic stroke initiatives

GUILFORD, Connecticut – July 11, 2023 – Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance brain imaging system, has announced the commencement of an international, multi-site observational study, ACTION PMR (ACuTe Ischemic strOke detectioN with Portable MR). To support its acute stroke care initiatives, Hyperfine Inc. has formed an advisory board of world-renowned stroke experts.

As a prospective, international, multi-site observational study, ACTION PMR aims to examine the integration of brain imaging with the Swoop® system into the stroke diagnosis and treatment workflow. The goal is to use point-of-care brain imaging to identify strokes and viable brain tissue that can be saved.

MRI scans, which are more precise than CT scans, are recommended for diagnosing acute ischemic stroke within twelve hours of symptom onset by the American Academy of Neuroradiology. However, the limited availability of MRI scanners near acute care settings in many hospitals highlights the need for point-of-care MR brain imaging.

“The ACTION PMR study has the potential to improve stroke treatment all over the world, with the Swoop® system assisting clinicians in imaging brain tissue and making timely diagnoses which could lead to the implementation of more effective treatments and help to facilitate better patient outcomes,” says Dr. Khan Siddiqui, Hyperfine, Inc. Chief Medical Officer and Chief Strategy Officer.

Four investigators from leading institutions will lead the study: Dr. W. Taylor Kimberly of Massachusetts General Hospital, Dr. Adnan Siddiqui of the University at Buffalo, Dr. Vivien Lee of the Ohio State University Wexner Medical Center, and Dr. Keith Muir of the University of Glasgow.

“Refining stroke diagnosis and care is central to all we do; as such, our research will focus on patients who don’t immediately qualify for thrombectomy,” says Dr. Taylor Kimberly of Massachusetts General Hospital. “We hope this study may contribute to timelier diagnoses, paving the way for improved patient outcomes.”

Alongside the ACTION PMR study, the newly formed stroke advisory board, comprised of experts in the field, will provide insights and experiences to guide and define the impact the Swoop® system can have in the fast-evolving field of acute stroke care.

Maria Sainz, Hyperfine, Inc. President and CEO, adds, "There is a significant unmet need in stroke imaging and workflow representing a very compelling incremental opportunity for Hyperfine, Inc. Our ambition is to enable innovative and readily accessible brain imaging solutions that enhance the chances of recovery for every patient. ACTION PMR is an important project for us, and we are honored to be working with our distinguished clinical investigators and stroke advisors to navigate the challenges and opportunities in stroke care and formulate the role the Swoop® system can play in acute stroke workflow.”

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 created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing brain imaging at the point of care. The Swoop® system received initial U.S. Food and Drug Administration (FDA) clearance in 2020 as a bedside magnetic resonance 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

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