• Data on the company’s portable MR imaging system show it can acquire brain images at the point of care that may assist physicians with screening and monitoring for Alzheimer’s and multiple sclerosis biomarkers

GUILFORD, Conn. / Apr 23, 2024 / Business Wire / Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced the acceptance of seventeen ultra-low-field MRI-related abstracts that will be presented at the 2024 International Society for Magnetic Resonance in Medicine (ISMRM) annual meeting, being held from May 4–9 in Singapore. These seventeen abstracts span a wide variety of use cases, including two that highlight the utility of brain images acquired with the ultra-low-field Swoop^® Portable MR Imaging® system to aid physicians screening for various biomarkers and monitoring disease progression unique to neurodegenerative diseases, including Alzheimer’s and multiple sclerosis (MS).

Conference attendees can learn more during these select presentations:

Title: Unpaired Image-to-Image Translation of ULF-MRI using Vision Transformers to Advance Volumetric Analyses
Authors: Peter Hsu et al.
Session: Power Pitch: AI-Empowered Image Analysis & Processing (PP-25)
Date and time: Thursday, May 9, 8:15–9:15 AM SGT
Location: Power Pitch Theater 1

Title: Subtraction Map Pipeline to Assess Longitudinal Changes in Multiple Sclerosis at Portable Ultra-Low Field MRI
Authors: Corinne Donnay et al.
Session: Digital Poster: Emerging Methods for Imaging Multiple Sclerosis I (D-128)
Date and time: Tuesday, May 7, 3:45–4:45 PM SGT
Location: Exhibition Hall (Hall 403)

“These abstracts are very encouraging. The scientific and clinical data supports the potential of portable ultra-low-field MR imaging to assist physicians screening for and monitoring neurodegenerative diseases like Alzheimer’s and MS,” said Maria Sainz, President and CEO of Hyperfine, Inc. “The data shows that ultra-low-field Swoop® system images can effectively help physicians track a patient’s disease progression and highlights the transformative and vast opportunity that fits the unique characteristics of our portable imaging system, which can be readily available across healthcare and resource settings.”

Hyperfine, Inc. is committed to delivering clinical value across the continuum of care for patients suffering from some of the largest and most devastating neurodegenerative diseases like Alzheimer’s and MS and improving the complex treatment and care management cycle many patients face. Earlier this month, the company announced that the first patients have been scanned in the CARE PMR (Capturing ARIA Risk Equitably with Portable MR) study. The observational study assesses the clinical utility and workflow benefits of acquiring the Swoop® system images at infusion centers and clinics to help physicians detect amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients receiving amyloid-targeting therapy.

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

About the Swoop® Portable MR Imaging® System

The Swoop® Portable MR Imaging® 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. The Swoop® system also has CE certification in the European Union and UKCA certification in the United Kingdom. The Swoop® system is commercially available in a select number of international markets.

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 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 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.