Hyperfine, Inc. Receives FDA Clearance for Updated Software to Further Improve Diffusion-Weighted Imaging

Swoop® Portable MR Imaging® system positioned to offer even greater clinical utility in neurocritical care

GUILFORD, Conn., Feb. 28, 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 U.S. Food and Drug Administration (FDA) 510(k) clearance of the latest update of its Swoop® system software. This updated software, which significantly improves diffusion-weighted imaging (DWI), highlights the company’s commitment to continuously improving image quality.

In this clearance, Hyperfine, Inc. achieved a significant 42% increase in the signal-to-noise ratio (SNR) for the DWI sequence compared to the previous software version. This increase in SNR, coupled with more robust compensation for subtle patient motion, yields substantially improved image quality for the DWI sequence. The updated software also provides enhanced image uniformity for all sequences.

The DWI sequence in MRI is important for patient care because it provides images that can be useful in diagnosing a wide range of neurological conditions, allowing for prompt and accurate treatment. The American Stroke Association guidelines recommend brain imaging be conducted 24 to 36 hours after ischemic stroke treatmentⁱ. For follow-up imaging of stroke patients, DWI imaging is crucial for monitoring stroke progression and evaluating the effectiveness of primary treatment, enabling healthcare professionals to make more informed decisions regarding ongoing patient care.

“We are committed to continuously improving the provider and patient experience with the Swoop^® system, with the goal of enabling more-confident patient diagnosis in the neurocritical care setting. With this latest software, Swoop^® system images provide increasingly valuable diagnostic images that can aid clinicians in caring for neurocritical patients,” said Edmond Knopp, M.D., senior medical director of Hyperfine, Inc.

“We are ecstatic about the FDA clearance of our latest software,” stated Tom Teisseyre, the chief product officer of Hyperfine, Inc. “Our focus remains on enhancing the image quality of all sequences through better image acquisition and advanced AI-powered image reconstruction. I take immense pride in the considerable image quality that our team has achieved across the Swoop^® system’s T1, T2, FLAIR, and DWI sequences and delivering that to the point of care.”

The updated Swoop^® system software is expected to roll out to customers in March 2023.

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 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, CE certification in the European Union, 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. (“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 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 inability to recognize the anticipated benefits of the business combination, which may be 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 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, future 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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ⁱ Powers WJ, Rabinstein AA, Ackerson T, et al. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association [published correction appears in Stroke. 2018 Mar;49(3):e138] [published correction appears in Stroke. 2018 Apr 18;:]. Stroke. 2018;49(3):e46-e110. doi:10.1161/STR.0000000000000158