Hyperfine, Inc. Receives Grant for an Additional Three Years to Utilize Innovative Swoop® Portable MR Imaging® System in Low and Middle-Income Countries

Clinical research, supported by funding from the Bill & Melinda Gates Foundation, has the potential to make a profound impact on global maternal and childhood health

GUILFORD, Conn.–(BUSINESS WIRE)–Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) system, today announced an expansion of clinical research to study the neurological effects of early childhood malnutrition in low and middle-income countries, with funding support from the Bill & Melinda Gates Foundation. The goal of the collaborative, multi-year global study is to address the impact of malnutrition on school readiness and academic achievement in the future development of children.

The three-year extension is covered under a new $3 million grant through which Hyperfine, Inc. plans to make enhancements to the Swoop® Portable MR Imaging® system to improve the system’s functionality, software, and data management specifically for use in remote low and middle-income settings; to continue to support the research of and optimization of neuroimaging MRI sequences for neonates and infants; and provide technical support for all Swoop® systems that are part of the global study. This work will be carried out by Hyperfine, Inc. engineers and scientists working hand-in-hand with leading MRI physicists and imaging scientists also funded by the Bill & Melinda Gates Foundation.

“This work is designed to benefit infants and young children throughout the world. Children born preterm, small for gestational age, or who face malnutrition, neglect, or other forms of adversity are at risk for delayed, impaired, or sub-optimal neurodevelopment,” said Dr. Khan Siddiqui, Chief Medical Officer at Hyperfine, Inc. “This investment will fill a critical role in providing an affordable, scalable method for directly evaluating the efficacy of interventions to improve infant and child health and neurodevelopment.”

Magnetic resonance (MR) brain imaging for newborns, infants, and young children is essential for early assessment of brain development. In a medical setting, using an MRI at the patient’s bedside can quickly help physicians diagnose and treat issues like difficulty breathing at birth, infections, brain inflammation, and other common brain-related problems. Today, high-field MRI machines are not widely available or accessible in low- and middle-income countries. There is a need for affordable, easy-to-use imaging to evaluate neurodevelopmentally focused interventions. We believe this need is a significant issue in global health.

“Hyperfine, Inc. is building a global network of Swoop® Portable MR Imaging® systems to make imaging more accessible to patients around the world. Through our collaboration with the foundation’s UNITY project, we are actively partnering and learning alongside researchers and clinicians from Uganda to Bangladesh who see the immense value of accessible and affordable MR imaging,” said Maria Sainz, President and CEO of Hyperfine, Inc. “What we are witnessing firsthand in low- and middle-income countries from this team also has implications for current and future Swoop® system clinical use cases in the United States and internationally. We are excited about the possibilities to improve global health with our Swoop® system.”

The extension of Hyperfine, Inc.’s work on the Swoop® system and continued support from the Bill & Melinda Gates Foundation, which began in March 2020, highlights the power of combining innovative technology with philanthropic efforts to address global health challenges. By equipping low- and middle-income settings with the Swoop® Portable MR Imaging® system, this initiative aims to close the gap in neurodevelopmental assessment and enable more targeted interventions, transforming the lives of children affected by malnutrition.

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 created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. The Swoop® system received initial U.S. Food and Drug Administration (FDA) clearance in 2020 as a bedside 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, 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. Hyperfine, Inc. (“the Company”)’s actual results 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 goals, plans for and potential impact of the Company’s collaboration with BMGF, the Company’s 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 availability of BMGF funding for our clinical research program with BMGF; 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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