GUILFORD, Conn., Feb. 09, 2023 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop^® system, the world's first FDA-cleared portable MRI system, today announced the presentation of new data regarding the use of the Swoop^® system in stroke patient follow-up at the 2023 International Stroke Conference (ISC) in Dallas, Texas. In this study, conducted between December 2021 and August 2022 at Yale-New Haven Hospital, researchers performed bedside portable magnetic resonance imaging (pMRI) exams in a standard non-magnetically shielded interventional radiology suite following mechanical thrombectomy procedures, with clinical and research staff present. Mechanical thrombectomy is a minimally-invasive procedure in which a clot is removed from the brain when a patient has experienced an acute ischemic stroke.

In the presentation titled Low-Field Portable MRI for Routine Post-Thrombectomy Assessment of Ongoing Brain Injury, researchers found that ultra-low-field pMRI can facilitate a post-treatment baseline for post-thrombectomy stroke patients to evaluate the impact of potential changes in blood pressure and heart rate that may impact ongoing brain injury. These findings are significant as brain imaging is not routinely available, particularly with conventional magnetic resonance imaging, following mechanical thrombectomy. The lack of post-mechanical thrombectomy imaging can preclude accurate infarction assessment¹.

“We believe these observations set the stage for using portable MRI in the dynamic environment of acute stroke intervention, where patients are at high risk for ongoing injury,” said Kevin Sheth, M.D., Professor of Neurology and Neurosurgery at Yale School of Medicine, one of the leading investigators.

“The data presented at ISC by the Yale team demonstrate that the Swoop^® system delivers diagnostic images and fills a critical gap where traditional imaging methods are unavailable,” said Hyperfine, Inc. President and CEO Maria Sainz, who was also at the ISC meeting. “We are excited about the work we are doing to capture the stroke opportunity with the Swoop^® system and even more encouraged given the progress we have made on image quality since the Yale data was collected.”

For more information about the Swoop^® Portable MR Imaging^® System, please visit http://www.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, and is also available in New Zealand and Pakistan. 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. (“Company”, or “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, expectations about the Company’s financial and operating results, the benefits of Company’s products and services, and 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 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 Company 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 Company business; the inability to maintain the listing of Company’s Class A common stock on the Nasdaq; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition and Company’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of Company to raise financing in the future; the inability of 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 Company to identify, in-license or acquire additional technology; the inability of Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of Company to compete with other companies currently marketing or engaged in the development of products and services that Company is currently marketing or developing; the size and growth potential of the markets for Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of Company’s products and services and reimbursement for medical procedures conducted using Company’s products and services; Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; 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. 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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¹ Sujijantarat, et al. Low-field Portable MRI For Routine Post-thrombectomy Assessment of Ongoing Brain Injury – International Stroke Conference 2023