• Strategic focus on India aims to make the Swoop® portable MR brain imaging system commercially available in a vast and underserved MRI market

GUILFORD, Conn. / May 28, 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 it has entered into a distribution agreement with Radiosurgery Global, Ltd. to develop the market in India. The distribution agreement also includes the countries of Malaysia, Indonesia, and Singapore through future expansion, offering Hyperfine, Inc. a significantly increased presence in Asia.

The clinical value of the Swoop® system is applicable globally as Hyperfine, Inc. aims to expand overall access and availability of MRI. In India, where there are fewer than 5,000 MRI scanners for a population exceeding 1.4 billion (approximately 3.5 MRI scanners per million inhabitants as compared to 38 per million in the U.S.), there is a growing need for specialized healthcare facilities and advanced diagnostic tools due to the increasing prevalence of chronic diseases like stroke and brain tumors. The current healthcare infrastructure, particularly in critical care and emergency settings, is under-equipped, with only fifteen percent of existing trauma centers having MRI capabilities. This gap highlights a substantial opportunity for introducing portable MR brain imaging systems that can meaningfully improve adult and pediatric care in urban and remote sites of care.

“Expanding commercially to Asia with a focus on India is an important element of our international strategy. We have begun preparing for the regulatory approval process through the CDSCO and are excited to partner with an experienced and capable group like Radiosurgery Global, Ltd. to drive commercial impact in 2025 and beyond,” said Maria Sainz, President and CEO of Hyperfine, Inc. “We believe that by expanding into global markets, we are not only revolutionizing healthcare delivery but also significantly impacting patient outcomes. We are committed to leveraging our expertise and partnerships to drive positive change in global brain health.”

“This partnership marks a significant crossroads for the entire region as we bring state-of-the-art portable MR brain imaging technology within reach of vast, underserved populations,” said Kapil Kalra, Managing Director of Radiosurgery Global, Ltd.

“The innovative Swoop® system aligns perfectly with our mission to democratize healthcare access in over 69,000 public and private hospitals across India, providing clinicians with unprecedented diagnostic imaging capabilities even in the most remote areas. We are excited about its enormous potential to enhance patient care nationwide,” said Timon Dressler, Managing Director of Radiosurgery Global, Ltd.

The expansion into global markets is supported by the company’s strong track record of securing international approvals for the Swoop® system. In 2023, Hyperfine, Inc. obtained CE certification under the EU MDR and UKCA certification in the United Kingdom for its latest hardware and eighth-generation AI-powered software. In May of 2024, the company announced the appointment of distributors in France, the United Kingdom, and Italy. Hyperfine, Inc. plans to continue its commercial expansion in partnership with Radiosurgery Global, Ltd. supporting future marketing submissions in India.

The system the company is introducing to the European and Indian markets is commercialized in the U.S. and uses the highest performing Swoop® system software to date in terms of image quality and usability. Introducing the Swoop® system into international markets is a significant step in supporting the commercial growth of Hyperfine, Inc. The Swoop® system could expand the existing imaging market with its transformative, affordable, and accessible platform to serve more clinicians and patients needing brain imaging. The versatility of the Swoop^® system across multiple sites of care offers a solution to patients in varied settings who may not have access to the latest MRI technologies.

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.

The Hyperfine logo, 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.