Hyperfine Announces Key Executive Appointments to Strengthen its Leadership Position in AI-Powered Portable MRI

Rafael O'Halloran, PhD, and Rob Fasciano, PhD, bring depth and breadth of experience in imaging and Medtech.

Hyperfine, Inc. (NASDAQ:HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—announced the appointments of Rob Fasciano, PhD, as Chief Regulatory and Quality Officer, and Rafael O'Halloran, PhD, as Vice President of Technology. These leadership additions were instrumental in the development of the recently FDA-cleared Optive AI™ software and the new, next-generation Swoop® scanner. Their work will greatly aid the rollout of this new technology globally and the development of future software enhancements.

Rob Fasciano, PhD, joined Hyperfine as Chief Regulatory and Quality Officer, bringing over 25 years of leadership experience in regulatory affairs, quality systems, and R&D in the medical device and diagnostics space. He has held senior roles at Abiomed, Johnson & Johnson, Orchestra BioMed, and Impulse Dynamics. Dr. Fasciano earned a PhD from Johns Hopkins University, an MBA from Purdue University, an MS from Boston University, and a BA from Dartmouth College.

Rafael O'Halloran, PhD, was appointed as Vice President of Technology. Dr. O'Halloran has over two decades of experience in MRI physics focused on innovation in sequence development and image reconstruction. Most recently, he led the development of the AI-driven image pipeline at Hyperfine. Previously, he served as an Assistant Professor of Radiology at the Mount Sinai School of Medicine, focusing on the use of diffusion-weighted imaging in neuromodulation and the study of psychiatric disorders. Prior to his work at Mount Sinai, he was a research associate at Stanford University. Dr. O'Halloran holds a PhD in medical physics from the University of Wisconsin-Madison and a BS in physics from Louisiana State University.

"These appointments further strengthen our capabilities as we scale the commercialization of our next-generation Swoop® system with Optive AI™ software," said Maria Sainz, President and Chief Executive Officer of Hyperfine. "Technology innovation is at the core of our mission and central to accelerating global adoption of the Swoop® system. Raf has been instrumental in elevating our imaging performance to the standard we deliver today. Rob joins at a pivotal time as we translate that innovation into globally cleared, commercially scalable products. I'm thrilled to have such talented and experienced leaders on the Hyperfine team as we continue to advance our mission and extend our reach to transform brain health."

For more information about the Swoop® Portable MR Imaging® system, please visit HyperfineMRI.com.

About the Swoop® Portable MRI Systems

The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices 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.

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 professional 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 HyperfineMRI.com.

The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. The Swoop logo, Optive AI logo, and Optive AI are 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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Devin Zell

Hyperfine

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