Innovative approaches in MRI technology demonstrate the potential of portable ultra-low-field MR brain imaging to aid physicians in the diagnosis of acute ischemic stroke

Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced that four abstracts highlighting ultra-low-field imaging data will be presented at the 2024 International Stroke Conference (ISC), held from February 7–9 in Phoenix. These abstracts demonstrate the depth and breadth of research into the clinical utility and applications of portable ultra-low-field MR imaging.

Conference attendees can learn more during the presentations listed below.

Title: Portable, Low-Field Magnetic Resonance Imaging: Determining Mismatch Following Acute Ischemic Stroke

Presented by: Annabel Sorby-Adams, PhD, Massachusetts General Hospital and Harvard Medical School

Presentation: A16: Cerebrovascular Systems of Care Oral Abstracts II

Date and time: Thursday, February 8, 9:27 AM–9:39 AM MST

Location: North 131 A–C

Title: Multi-Direction Diffusion Weighted Imaging on Portable, Low-Field Magnetic Resonance Imaging

Presented by: Annabel Sorby-Adams, PhD, Massachusetts General Hospital and Harvard Medical School

Presentation: A25: Imaging Oral Abstracts II

Date and time: Friday, February 9, 8:18 AM–8:30 AM MST

Location: North 126 A–C

Title: Portable Bedside Low-Field Magnetic Resonance Imaging Acute Infarct Detection on Floor Level Acute Ischemic Stroke Patients

Presented by: James Shay, MD, The Ohio State University Wexner Medical Center

Presentation: P6: Imaging Posters I

Date and time: Wednesday, February 7, 7:00 PM–7:30 PM MST

Location: Board no. P120

Title: Quality Improvement Review and Practical Consideration of Hyperfine Portable Bedside Low-Field Magnetic Resonance Imaging in the Non-ICU Setting

Presented by: Jorge Morales, MD, The Ohio State University Wexner Medical Center

Presentation: P17: Health Services, Quality Improvement, and Patient-Centered Outcomes Posters II

Date and time: Thursday, February 8, 7:00 PM–7:30 PM MST

Location: Board no. P109

Maria Sainz, Hyperfine, Inc. president and CEO, said, “Acute ischemic stroke remains a large and growing global health issue. More timely diagnosis and treatment are key to addressing stroke. Evaluating the opportunity for the Swoop® system to contribute to better stroke care remains incredibly compelling for our company. The peer-reviewed abstracts at this year's conference highlight the advancements in portable, ultra-low-field MR brain imaging and underscore the potential of the Swoop® system in transforming the diagnosis and treatment of acute ischemic stroke.”

Additionally, investigators of the prospective, international, multi-site ACTION PMR (Acute Ischemic Stroke Detection with Portable MR) study, which aims to examine the integration of brain imaging with the Swoop® system into the stroke diagnosis and treatment workflow, are announcing an update on enrollment. Taylor Kimberly, MD, PhD, of Massachusetts General Hospital, the study’s principal investigator, commented on the study’s progress, “Over 70 patients across four sites have been enrolled since the study’s launch in July 2023. We look forward to determining how ultra-low-field MR imaging can help clinicians detect strokes and identify viable brain tissue that can be saved.”

For more information about the Swoop® Portable MR Imaging® system, please visit hyperfine.io.

About Hyperfine, Inc. and the Swoop® Portable MR Imaging® System

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care. The Swoop® system received initial U.S. Food and Drug Administration (FDA) clearance in 2020 as a portable, ultra-low-field magnetic resonance brain imaging device for producing images that display the internal structure of the head where a 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. The Swoop® system has been approved for brain imaging in several countries, including Canada and Australia, has UKCA certification in the United Kingdom, CE certification in the European Union, and is also available in New Zealand.

The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging and data solutions. 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. Traditionally, access to costly, stationary, conventional MRI technology can be inconvenient or not available when needed most. With the portable, ultra-low-field Swoop® system, Hyperfine, Inc. is redefining the neuroimaging workflow by bringing brain imaging to the patient’s bedside. For more information, visit hyperfine.io.

Hyperfine, Swoop, and Portable MR Imaging are registered 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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