• Program seeks to increase neuroimaging clinical research and knowledge transfer between high-income and low- and medium-income countries

TORONTO / Jun 08, 2023 / 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 brain imaging system, is proud to be the first magnetic resonance imaging technology partner in an education-centric collaboration between the International Society for Magnetic Resonance in Medicine (ISMRM) and the Bill & Melinda Gates Foundation.

The ISMRM, a non-profit organization, has long promoted MR research and its translation into clinical practice, fostering dialogue among scientific and clinical professionals and driving the development and application of MR techniques. Under the newly formed collaboration, the ISMRM aims to enhance global access to MR imaging and knowledge. The goal is to address the disparities in MR access and utilization by providing local neuroimaging capabilities in low- and medium-income countries (LIMC) by enabling access to ISMRM’s educational programs and establishing a global mentorship program for LIMC clinicians.

A critical component of the ISMRM’s initiative involves the deployment of MR brain imaging equipment, made possible by an existing partnership between Hyperfine, Inc. and the UNITY project, a Bill & Melinda Gates Foundation-funded initiative allowing leading researchers to study environmental factors affecting early brain development, focusing on neurodevelopment patterns in Sub-Saharan Africa and South Asia. The Hyperfine, Inc., Swoop^® Portable MR Imaging^® system will play a vital role in revolutionizing global access to brain imaging technology. Through the UNITY project, Hyperfine, Inc. has already deployed Swoop^® systems in Bangladesh, Ethiopia, Ghana, Kenya, Malawi, Pakistan, South Africa, and Uganda.

The first significant initiative of the ISMRM-Gates Foundation partnership, “The Toronto 100,” involves funding for one hundred participants, including members of the UNITY project and the newly formed Africa chapter of the ISMRM, to attend this year’s annual ISMRM meeting in Toronto. Each participant will pair with a long-term mentor who will lend expertise, guidance, and support throughout the participant’s MR career journey. Three Hyperfine, Inc. team members will lend their expertise to this initiative as mentors, including Chief Medical Officer and Chief Strategy Officer Khan Siddiqui, MD, Senior Research Scientists Megan Poorman, PhD, and Francesco Padormo, PhD.

“The ISMRM’s collaboration with Hyperfine, Inc. is a significant milestone in our efforts to level the playing field and to democratize access to MR imaging,” said ISMRM Vice President Derek Jones. “Their portable brain imaging system will be an invaluable resource in enhancing the efforts of our international community.”

“We at Hyperfine, Inc. are incredibly honored to work side by side with luminaries in the field and contribute to this transformative global initiative with our Swoop^® Portable MR Imaging^® system,” says Dr. Khan Siddiqui. “Our technology was designed with a vision to transform access to MR imaging. We believe the Swoop^® system, with its portability and affordability, will play a pivotal role in this project, particularly in regions where access to MR imaging has traditionally been limited. Our partnerships with the ISMRM and the UNITY project emphasize our shared commitment to reducing the access gap, and we look forward to witnessing the potentially profound impact this project will have on global patient care.”

For more information about ISMRM’s initiatives, the collaboration with Hyperfine, Inc., and the impact of the UNITY project, please visit ISMRM’s President’s Corner Blog.

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 brain imaging 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 the Bill & Melinda Gates Foundation, 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.