Hyperfine Enrolls Initial Patients in NEURO PMR Study to Evaluate Use of AI-Powered Portable MRI in Neurology Offices

Real-world study will assess clinical utility and patient experience across diverse neurological conditions to support adoption of AI-powered portable MRI systems in the office setting.

Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system, first approved in 2021—today announced the enrollment of initial patients in the NEURO PMR (Neurological Evaluation in the Office with Portable MRI) study.

The NEURO PMR study is the first multi-center, prospective observational study of its kind, comparing portable ultra-low-field MRI and conventional high-field MRI with respect to pathology findings, clinical utility, and patient experience. Conducted with two premier private neurology practices—the DENT Neurologic Institute and Texas Neurology—the study utilizes the latest AI-powered portable MRI technology with advanced image quality. The study has a target enrollment of 100 patients and is expected to conclude by year-end.

“Neuroimaging has become a cornerstone of modern neurological care, with neurologists ordering an average of 500 MRIs each year. Yet, in-office imaging remains out of reach for most private practices,” explained Dr. Laszlo Mechtler, Principal Investigator of the study and Chief Medical Officer at the DENT Neurologic Institute. “This study aims to identify the best uses for portable brain MRI technology in a comprehensive neurology practice. The goal is to make advanced imaging more accessible, affordable, and convenient for both patients and healthcare providers.”

The Hyperfine AI-powered portable MRI system removes many of the barriers that have made conventional high-field MRI systems inaccessible for placement in neurology offices. Unlike conventional MRI systems, portable MRI doesn’t require costly siting, helium, or specialized MRI technologists to operate. With its simple plug-and-play design, the system enables on-demand brain imaging directly in the exam room. Furthermore, as of November 2024, IAC Accredited medical offices that use portable MRI systems qualify for reimbursement through the Centers for Medicare and Medicaid Services (CMS).

"As more healthcare moves to outpatient settings, patients increasingly expect neurology practices to offer both diagnostic and treatment services under one roof," adds Dr. Gincy Samuel, site Principal Investigator at Texas Neurology. "Portable MR technology aligns well with this trend, offering enhanced care and convenience in a single location—a shift we believe will only gain momentum. It provides a vital clinical function for centers that would not normally have immediate access to imaging, especially in underserved, rural, and community centers."

The NEURO PMR study is a key initiative in the Hyperfine office market entry strategy. It represents a significant step forward in making advanced imaging available to neurology practices of all sizes, ultimately reducing healthcare costs while improving patient access and clinical outcomes.

For more information about Hyperfine and AI-powered portable MRI technology, please visit hyperfine.io.

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, AI-powered, 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 and continue to improve 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.

Forward-Looking Statements

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