• Innovative approaches in MRI technology demonstrate the potential of portable ultra-low-field brain imaging to assist in improving brain health

GUILFORD, Conn. / Nov 20, 2023 / Business Wire / Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system—the Swoop® system—today announced that three scientific sessions highlighting ultra-low-field imaging data will be presented at the Radiological Society of North America (RSNA) 2023 Annual Meeting in Chicago. These studies analyzed how portable MR brain imaging may assist physicians in the diagnosis and management of neurological conditions in critical care settings.

Conference attendees can learn more during the presentations listed below.

Name: Longitudinal Relaxivity Estimation of Gadolinium-based Contrast Agents at 64 mT
Presented by: Sudarshan Ragunathan, PhD
Session: Physics Tuesday Poster Discussions II | T5B-SPPH
Date and time: Tuesday, November 28, 12:45 PM–1:15 PM CST
Location: Learning Center

Name: A Generative Adversarial Network Approach for Low-field to High-field Image Translation
Presented by: Alfredo Lucas
Session: Neuroradiology (Techniques and Methods: AI for Image Acquisition) | W3-SSNR10
Date and time: Wednesday, November 29, 9:30 AM–10:30 AM CST
Location: E353C

Name: Point-of-care Brain MRI: Update on Preliminary Results from a Single-center Retrospective Study in the Neurocritical Care Setting
Presented by: Brian Gerard Yep, MD
Session: Neuroradiology (Techniques and Methods: Diffusion, Perfusion, and Other Techniques) | W7-SSNR12
Date and time: Wednesday, November 29, 3:00 PM–4:00 PM CST
Location: E353B

“At Hyperfine, Inc., we strive to push the boundaries of medical technology to make MR brain imaging more accessible, and our presence at RSNA 2023 underscores the promise of expanded use cases for portable MR brain imaging technology,” said Chip Truwit, MD, Hyperfine, Inc. vice president of scientific affairs. “We’ll continue to prioritize clinical application research for the Swoop system because expanding access to portable MR brain imaging is critical in improving how patient care is delivered.”

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 medical 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. It is a portable ultra-low-field magnetic resonance 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.