Hyperfine Announces First Patients Enrolled in PRISM PMR to Evaluate the Use of Next-Generation Swoop® System in the Operating Room Setting

With several patients already enrolled in the study, PRISM PMR is designed to evaluate the Swoop® system's clinical utility in the operating room.

Hyperfine, Inc. (NASDAQ:HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced plans for clinical use expansion into the operating room environment, advancing its mission to make brain MRI more accessible across a diversity of care settings. The company plans to establish a foothold in the neurosurgical operating setting by launching a new study to build a body of clinical evidence for Swoop® system use in neurosurgical procedures.

PRISM PMR (PRe- and post-operatIve Study of iMaging with Portable MR) is designed to further collect data and optimize the Swoop® system's real-world clinical utility in the operating room. The study will evaluate the pre- and post-procedure use of portable MRI across a diverse range of neurosurgical procedures, including its ability to detect post-operative complications, such as stroke and bleeding, and how it can be best integrated into the surgical workflow to accelerate discharge and recovery. The study has enrolled its first patients and is led by the principal investigator, Dr. Elad Levy, MD, MBA, a globally recognized pioneer in the field of neurovascular disease. It is being conducted over three months at the Atlas Surgery Center in Buffalo, New York.

"The operating room is an exciting new setting and use case for the portable MRI market. Having a high-field MRI right in the OR is not practical. The PRISM PMR study and Dr. Levy's pioneering work illustrates how the Swoop® system can potentially reshape neurosurgical care, bringing valuable clinical insights and workflow benefits," said Hyperfine President and Chief Executive Officer Maria Sainz. "By enabling neurosurgeons to obtain critical imaging immediately before and after a procedure, the Swoop® system can help improve patient safety, reduce costs, and transform how surgical centers think about imaging infrastructure."

Dr. Levy commented, "MRI is a cornerstone in imaging patients undergoing neurovascular procedures, and having the ability to perform imaging immediately after surgery in the operating room is transformative," said Dr. Elad Levy, neurosurgeon at Atlas Surgery Center. "Portable brain MRI allows us to confirm results, rule out major complications, and potentially safely discharge patients on the same day. This technology has the potential to redefine surgical workflows and change how we care for patients. It's also helping us eliminate bottlenecks by shifting appropriate patients to the ambulatory setting, which in turn frees up valuable surgical capacity in the hospital."

In addition to being part of the PRISM PMR study, Dr. Levy recently highlighted the value of having post-operative MRI on a live surgery case at the Congress of Neurological Surgeons, demonstrating the growing clinical interest and relevance of portable brain MRI in a surgical setting. Using the Swoop® system post-procedure allowed Dr. Levy and his team to assess the intracranial environment, rule out complications, and support the possibility of same-day discharge—capabilities traditionally limited to hospitals equipped with large, costly intraoperative MRI systems requiring specialized siting and infrastructure.

For more information about the Swoop® system, please visit HyperfineMRI.com.

About the Swoop® Portable MRI Systems

The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices 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.

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 HyperfineMRI.com.

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