The Princess Royal was introduced to the first FDA-cleared portable MR brain imaging system being used to test the disparities in MR access in low- and medium-resource countries

Hyperfine, Inc. (Nasdaq: HYPR), the developer of the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop^® system, today announced an exclusive demonstration of the Swoop^® system and UNITY (Ultra low-field Neuroimaging In The Young) project to The Princess Royal at the Centre for Neuroimaging Sciences, King’s College London.

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The Princess Royal watches a demonstration of the Swoop® system (Photo: Business Wire)

Her Royal Highness (HRH) met researchers and collaborators from King’s College London and Maria Sainz, president and CEO of Hyperfine, Inc., to learn about the deployment of noninvasive, accessible Hyperfine portable MR brain imaging systems to sub-Saharan African and South Asian countries as a key element of the UNITY project led by King’s College London. Her Royal Highness was shown a demonstration of the Swoop^® system to see first-hand the device’s ease of use. She spoke to researchers and clinicians who currently use the device in different clinical settings, including settings beyond the confines of a typical radiology department.

“It is a great pleasure for us to introduce HRH Princess Royal to the UNITY project. We hope that these portable MRI scanners will revolutionize neuroscience, providing global access to brain imaging,” said Professor Steve Williams, Head of the Centre and Professor of Imaging Sciences at King's College London. “This collaborative project has a common goal—to improve the quality of life for mothers and their children across the world.”

The UNITY project is an initiative funded by the Bill & Melinda Gates Foundation, which allows leading researchers to study environmental factors affecting early brain development, focusing on neurodevelopment patterns in Sub-Saharan Africa and South Asia. The project is led by Professor Steve Williams, who oversees 25 portable MRI systems distributed across fifteen countries to assess brain health and development in infants and young children.

“Since 2021, the Hyperfine, Inc. collaboration with King’s College London has further enabled our vision of making brain MRI accessible anywhere in the world to become a reality at UNITY project sites,” said Ms. Sainz. “The collaboration with global luminaries in the field of MR has augmented our portable brain MRI technology and, most importantly, has given us the incredibly rewarding experience of helping hundreds of children, their families, and clinicians in low- and medium-resource settings.”

The Centre for Neuroimaging Sciences, King’s College London, is home to the Department of Neuroimaging in the School of Neuroscience. The center also provides National Health Service (NHS) services under the South London and Maudsley NHS Foundation Trust.

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 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 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. 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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