Hyperfine has appointed Roots Pharmaceutical as exclusive distributor of the Swoop® system for Kuwait and the United Arab Emirates

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—today announced the appointment of Roots Pharmaceutical Co. W.L.L. as its exclusive distribution partner for Kuwait and the United Arab Emirates (UAE). Under the agreement, Roots Pharmaceutical will support market development, local regulatory activities, product education, demonstrations, customer engagement, and, following any applicable regulatory clearances, commercial and service activities for the Swoop system across both countries.

The partnership represents an important step in Hyperfine’s international growth strategy and reflects the company’s commitment to expanding access to brain imaging technologies globally, from low- and middle-income countries to advanced healthcare markets. The neurological conditions for which the Swoop system may be used, including stroke and neurodegenerative diseases, represent major global health challenges in which faster, decentralized access to MRI can make a meaningful difference. Kuwait and the UAE continue to invest significantly in healthcare infrastructure, digital transformation, and advanced diagnostic capabilities, creating strong opportunities for innovative technologies that can improve patient access and clinical efficiency.

"Expanding into new countries is one of the growth vectors for our international business at Hyperfine, and we are excited to partner with Roots Pharmaceutical to support the introduction and drive the future adoption of the Swoop system across these markets," said Eric Willis, Vice President, International at Hyperfine. "Roots brings strong customer relationships and a deep understanding of the healthcare landscape throughout the Gulf Cooperation Council (GCC) Region. Together, we look forward to supporting clinicians and healthcare institutions as they seek new ways to deliver high-quality imaging closer to the patient."

Roots Pharmaceutical is a Kuwait-based healthcare company with extensive experience commercializing innovative healthcare technologies and specialty medical products across the GCC region. The company has built a reputation for successfully launching and supporting novel therapies and technologies in collaboration with global healthcare partners.

"We are honored to be selected as Hyperfine’s distribution partner for Kuwait and the UAE," said Islam Zayed, Chief Executive Officer of Roots Pharmaceutical. "The Swoop system represents a significant advancement in diagnostic brain imaging and aligns closely with our mission of bringing innovative healthcare solutions to the region. We believe this portable brain MRI technology can help hospitals improve access to critical diagnostic information while supporting better patient care across a variety of clinical settings."

The appointment of Roots Pharmaceutical further strengthens Hyperfine’s global distribution network and supports the company’s mission of making brain imaging more accessible worldwide.

For more information about the Swoop® 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.

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

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, including its entrance into new markets. 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 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 progress on product advancements and improvements; 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; existing and potential future National Institutes of Health funding pressures; existing and potential future effects from U.S. export controls and tariffs; 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 the 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260928146537/en/

Media Contact

Devin Zell

Hyperfine

dzell@hyperfine.io

Investor Contact

Webb Campbell

Gilmartin Group LLC

webb@gilmartinir.com