Hyperfine Achieves Clinical Milestone Ahead of Plan With 100th Patient Enrolled in Neurology Office Study Using the Next-Generation Swoop® System

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08/04/2025 - 08:15 AM

NEURO PMR study evaluates the clinical utility and patient experience of AI-powered portable MRI in an outpatient setting

GUILFORD, Conn.--(BUSINESS WIRE)-- 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 the successful enrollment of 100 patients in its NEURO PMR (Neurological Evaluation in the Office with Portable MRI) study just 16 weeks after the study initiation, announced on April 15, 2025. This milestone reflects strong clinician enthusiasm for accessible, point-of-care brain imaging and supports Hyperfine's market expansion into outpatient neurology offices.

The NEURO PMR study, being conducted at DENT Neurologic Institute and Texas Neurology, is the first multi-center, prospective observational study comparing portable ultra-low-field MRI with conventional high-field MRI in neurology office settings. All patients enrolled in the study have been scanned on the next-generation Swoop® system powered by OptiveAI™ software, with results expected to be announced in early 2026.

Dr. Laszlo Mechtler, Chief Medical Officer at DENT Neurologic Institute and the study's Principal Investigator, stated, “The next-generation Swoop® system delivers impressive image quality with a simplified clinic workflow and comfortable patient experience. The promise of this technology is that it puts brain imaging back into the hands of neurologists—by providing an affordable, easy-to-operate portable MRI system that fits seamlessly into a clinic setting without expensive siting costs."

This milestone supports Hyperfine’s commercial launch in the neurology office market, following the successful conclusion of its office pilot program. In the pilot, early neurology practices acquired and implemented Swoop® systems in their clinic, completed IAC accreditation, and obtained reimbursement from CMS and private insurers. To drive commercial adoption, Hyperfine has also entered into a strategic partnership with NeuroNet Pro, the largest U.S. association of independent neurology practices, to bring greater awareness and practice support for their portable MRI technology.

“Neurologists typically order between 500 and 600 brain MRIs each year, yet only 5% of private neurology offices have in-house imaging," said Maria Sainz, President and CEO of Hyperfine. "Our next-generation Swoop® system delivers an exciting opportunity for independent practices—expanding access to advanced imaging, boosting clinic efficiency, and elevating the level of patient care.”

For more information about the Swoop® system and Optive AI™ software, please visit HyperfineMRI.com.

About the Swoop® AI-Powered Portable MRI (V2) System
The Swoop® Portable MR Imaging® (V2) 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.

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.

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