Latest Data Demonstrate Potential of the Swoop® Portable MR Imaging® System in the Follow-up of Stroke Patients Who Have Received a Thrombectomy

Hyperfine, Inc.

Hyperfine, Inc.

New Study Uses Hyperfine, Inc.’s Wearable MRI System to Monitor Brain Injuries and Assess Physiological Effects

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

In the presentation titled Portable low-field MRI for routine Post thrombectomy assessment of persistent brain injury, Researchers found that ultra-low-field pMRI can facilitate a post-treatment baseline for post-thrombectomy stroke patients to assess the impact of potential changes in blood pressure and heart rate that may impact sustained brain injury. These findings are significant because brain imaging is not routinely available, particularly with conventional magnetic resonance imaging after mechanical thrombectomy. The lack of postmechanical thrombectomy imaging may preclude accurate infarct assessment1.

“We believe these observations set the stage for the use of handheld MRI in the dynamic acute stroke intervention setting, where patients are at high risk of injury,” said Dr. Kevin Sheth, professor of neurology and neurosurgery at the Yale School of Medicine of lead investigators.

“The data presented by the Yale team at ISC shows that the swoop® System provides diagnostic images and fills a critical gap where traditional imaging methods are unavailable,” said Maria Sainz, President and CEO of Hyperfine, Inc., who also attended the ISC meeting. “We’re excited about the work we’re doing to harness the power of stroke with the Swoop® system and even more encouraged by the progress we have made in image quality since the Yale data was collected.”

Learn more about the swoop® Portable MR imaging® system, please visit http://www.hyperfine.io.

About Hyperfineinc and the swoop® Portable MR imaging® system
Hyperfine, Inc. (NASDAQ: HYPR) is the pioneering medical device company that invented the swoop® System, the world’s first FDA-cleared handheld magnetic resonance imaging (MRI) system capable of delivering neuroimaging at the point-of-care. The swoop® System received the first US Food and Drug Administration (FDA) approval in 2020 as a bedside magnetic resonance imaging device to create images that show the internal structure of the head when a full diagnostic evaluation is clinically impractical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The swoop® The system has been approved for brain imaging in several countries including Canada and Australia, is UKCA certified in the UK and is also available in New Zealand and Pakistan. Hyperfine, Inc.’s mission is to revolutionize patient care worldwide through transformative, 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 passionate about redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. Traditionally, access to expensive, stationary, conventional MRI technology can be inconvenient or unavailable when it is needed most. Featuring the portable ultra low field swoop® System, Hyperfine, Inc. is redefining neuroimaging workflow by bringing brain imaging to the patient’s bedside. Visit hyperfine.io for more information.

Hyperfine, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc.

Forward-Looking Statements
This press release contains “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. (“Company” or “the Company”) may differ from its expectations, estimates and results projections differ and you should therefore not rely on these forward-looking statements as predictions of future events. Words like “expect”, “estimate”, “forecast”, “budget”, “forecast”, “anticipate”, “intend”, “plan”, “can”, “will”, “could”, “should”, ” “believes”, “forecast”, “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 regarding the Company’s financial and operating results, the benefits of the Company’s products and services, and the Company’s future performance and ability to execute its strategy. These forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from anticipated results. Most of these factors are beyond 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 extent to which 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 inability to realize the anticipated benefits of the business combination, which may be adversely affected by, among other things, competition and the Company’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the Company’s inability to obtain financing in the future; the inability of the company. to obtain and maintain regulatory clearances or approvals for its products and any related limitations and restrictions on approved or approved products; the Company’s inability to identify, license or acquire additional technology; the Company’s inability to maintain its existing or future licensing, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the Company’s inability to compete with other companies that currently market or develop products and services that the Company currently markets or develops; 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 performed using the Company’s products and services; the company’s estimates of expenses, future revenues, capital requirements and need for additional financing; Company financial performance; and other risks and uncertainties discussed 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 on forward-looking statements, which speak only as of the date on which they are made. The Company undertakes no obligation or undertaking to publicly release any updates or revisions to any forward-looking statement to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

media contact
Annika Pfarr
Health+Commerce
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investor contact
Marissa Bysh
Gilmartin Group LLC
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1
Sujijantarat et al. Portable low-field MRI for routine assessment of persistent brain injury after thrombectomy – International Stroke Conference 2023

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