Peer-reviewed clinical results and strong patient preference support growing use across neurology practices and emerging brain health applications

GUILFORD, Conn.: 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 peer-reviewed publication of the NEURO PMR study in the Journal of Neuroimaging. The publication comes as real-world use of the Swoop system continues to grow, with more than 3,000 brain MRI scans completed across a broad range of physician practices within the first year of Hyperfine’s office-market launch.

NEURO PMR, or Neurological Evaluation in the Office with Portable MR, is the first prospective, multicenter, real-world study to evaluate the clinical performance and patient experience of portable MRI compared with high-field MRI in outpatient neurology clinics. With respect to clinical performance, portable MRI demonstrated 92% concordance with high-field MRI in identifying the presence or absence of structural abnormality in blinded neuroradiology review, and 98% with clinical information. In addition, patients preferred portable MRI over high-field MRI by a four-to-one margin, rating it superior on all dimensions assessed in the study, including comfort, anxiety, claustrophobia, noise and overall experience.

“Point-of-care brain imaging is an important part of the future of outpatient neurology,” said Laszlo Mechtler, MD, President of DENT Neurologic Institute, past president of the American Society of Neuroimaging, and principal investigator of the NEURO PMR study. “Portable MRI brings imaging directly to the clinic, giving neurologists diagnostic information sooner, offering patients a more comfortable experience, and enabling an efficient and economical care model. As access to on-site imaging expands, I believe it can become a routine part of neurological practice.”

Because in-office MRI is rare in neurology practices, most rely on external imaging referrals that can fragment the diagnostic process and delay clinical decision-making. Unlike conventional high-field MRI, the Swoop system fits in a standard exam room without specialized shielding, runs on standard electrical power, and can be operated by any trained clinical staff. These advantages create a practical and accessible point-of-care imaging model for independent practices.

Real-world use of the Swoop system now spans across diverse types of outpatient practices, including general neurology, headache specialists, memory clinics, pediatric neurology offices, concierge medicine, and longevity clinics. Physicians are using portable brain MRI to support neurological evaluation and disease surveillance while providing patients with more timely access to imaging in a familiar and convenient environment.

Beyond established clinical applications, greater access to brain MRI may support emerging applications in proactive brain health. “Neurology is moving toward a more proactive model of care,” said Madhureeta Achari, MD, principal neurologist at Integrated Neurology and past president of the Texas Neurological Society. “Having brain MRI available in the practice creates the opportunity to establish a baseline and evaluate meaningful change over time, rather than relying solely on a single snapshot after symptoms emerge.”

“One year into our office-market launch, we are seeing meaningful early commercial traction. More than 3,000 in-office brain MRI scans demonstrate real-world utilization and workflow fit, while the NEURO PMR results show strong clinical value and patient acceptance,” said Chi Nguyen, Senior Vice President of Office & Community Business at Hyperfine. “But we are just at the beginning. The Swoop system is taking brain MRI where it has not been before, beyond hospitals and imaging centers, and closer to where patients receive their everyday care. By making brain MRI more accessible, Hyperfine is helping redefine the role imaging can play in lifelong brain health.”

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.

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

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, expectations regarding adoption, utilization, clinical utility, and the potential use of the Swoop® system in outpatient neurology practices, brain health applications, disease surveillance, and other care settings, and the Company’s future performance and its ability to implement its strategy, including its entrance into new markets. 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 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 progress on product advancements and improvements; 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; existing and potential future National Institutes of Health funding pressures; existing and potential future effects from U.S. export controls and tariffs; 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 the 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.

Fonte: Business Wire