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

July 11, 2023 — Hyperfine, Inc., 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: https://hyperfine.io/