Hyperfine Announces Completion of Enrollment in the Contrast PMR Study to Support the Submission to Expand Indications for Use of the Swoop® System with Contrast Agents

Hyperfine has finished enrolling the Contrast PMR study, a key step toward an FDA 510(k) submission to add contrast-enhanced use for Swoop.

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The anticipated indication expansion would position Hyperfine to drive adoption in outpatient neurology and establish new opportunities for portable MRI in post-procedural imaging in operating room workflows.

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 that it has completed enrollment of the Contrast PMR study, a prospective, multi-center clinical study designed to evaluate the feasibility and visualization benefits of contrast-enhanced ultra-low-field portable MRI using the Swoop system. The study is intended to support the first expansion of the Swoop system's indications for use since its original FDA clearance and represents an important step toward broadening the clinical utility of portable MRI.

Contrast-enhanced MRI represents a meaningful portion of brain MRI examinations performed today and plays a critical role in the evaluation of brain tumors, inflammatory disorders, and other conditions associated with blood-brain barrier disruption. The primary objective of the Contrast PMR study is to evaluate the visualization of brain lesions, including those associated with blood-brain barrier disruption, using contrast agents with ultra-low-field portable MRI. Visualization is assessed across three endpoints related to lesion appearance, with the study specifically evaluating the Swoop system’s ability to visualize common contrast-enhancing brain lesions using commonly administered gadolinium-based contrast agents.

“The completion of enrollment of the Contrast PMR study is an important milestone in expanding the use of portable MRI across clinically relevant imaging modalities across a broader range of neurological applications,” said W. Taylor Kimberly, MD, PhD, Chief, Division of Neurocritical Care, Neurology, Mass General Brigham. “Contrast-enhanced imaging is fundamental to the evaluation of many brain lesions, including tumors and other conditions associated with blood-brain barrier disruption. This study is designed to assess whether portable MRI can provide meaningful visualization of the types of lesions neurologists and neurosurgeons routinely evaluate using contrast-enhanced MRI. If successful, contrast-enhanced portable MRI could meaningfully expand the role of point-of-care imaging across a wide range of clinical settings.”

“We believe contrast-enhanced imaging can be a powerful catalyst for expanding adoption of the Swoop system and extending its value across the diverse care settings we serve,” said Maria Sainz, President and Chief Executive Officer of Hyperfine. “In addition to supporting critical diagnostic and treatment decisions across a broad range of clinical settings, contrast-enhanced brain imaging benefits from established dedicated reimbursement pathways, creating a strong foundation for adoption and long-term value for providers. We see this unlocking expanded use in outpatient settings and opening new applications for post-procedural imaging in surgical environments, including assessment of residual tumor after resection. I want to congratulate the Hyperfine team and our clinical collaborators on completing enrollment in this study as an important milestone in pursuit of an indication expansion for the Swoop system to include contrast-enhanced brain imaging, broadening its clinical utility

Following completion of enrollment, Hyperfine will proceed with image review, data analysis, and preparation of a planned FDA 510(k) submission, which the company plans to submit by the end of 2026. FDA clearance for the use of contrast would represent the first expansion of the Swoop system's indications for use since its original FDA clearance.

Additional information about the study is available through ClinicalTrials.gov (NCT07296263). The expanded use of the Swoop system with contrast agents remains subject to FDA clearance.

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, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260915575730/en/

Media Contact
Devin Zell
Hyperfine
dzell@hyperfine.io

Investor Contact
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com

Source: Hyperfine, Inc.

Key Terms

ultra-low-field portable mri technical

A portable ultra-low-field MRI is a medical imaging device that produces magnetic resonance images using a much weaker magnetic field than conventional hospital MRIs and is designed to be moved or used outside traditional imaging suites. It matters to investors because its smaller size, lower cost and reduced infrastructure needs can open new markets and change how and where imaging is delivered—altering potential sales, regulatory paths, and reimbursement compared with standard MRI systems.

blood-brain barrier disruption medical

A change that makes the blood-brain barrier — the brain’s protective layer that normally blocks many substances in the bloodstream — more permeable so molecules, cells, or fluids can enter brain tissue. It can occur unintentionally from disease or injury, or be induced intentionally to help drugs reach the brain; either way it matters to investors because it affects drug delivery, safety, clinical trial outcomes, regulatory review, and potential market value of related therapies.

gadolinium-based contrast agents medical

Gadolinium-based contrast agents are injectable substances used during MRI scans to make blood vessels and tissues show up more clearly, like adding a highlighter to a map so doctors can spot abnormalities. Investors care because safety signals, regulatory reviews, manufacturing supply, or changes in clinical use can affect demand, product approvals, legal risk and revenue for companies that make or use these imaging agents.

fda 510(k) regulatory

A FDA 510(k) is a premarket notification a medical device maker files to show a new device is similar enough to an already approved device that it can be marketed without a lengthy review. For investors it matters because a cleared 510(k) offers a faster, lower-cost path to sell a product and reduces regulatory uncertainty—think of it like proving you’re using an approved recipe rather than inventing a brand-new one.

indications for use regulatory

Indications for use are the specific medical conditions, patient groups, or purposes that a drug, device, or diagnostic test is approved or proposed to treat, diagnose, prevent, or monitor. They are like a product’s stated target customer and allowed uses on the label, and they determine what doctors can prescribe and how regulators and payers evaluate the product. Investors watch indications because they define the potential market size, regulatory requirements, and reimbursement landscape.