Hyperfine Announces Zero Radiation Dose Rapid MR Imaging Test for Pediatric Hydrocephalus Patients

Groundbreaking Medical Device Company Unveils AI-Powered Software that Improves Diagnostic Imaging Experience for Young Patients

AUSTIN, Texas, July 14, 2022 (GLOBE NEWSWIRE) — Today, at HA Connect!, the 17th annual national conference on hydrocephalus, Hyperfine—creator of Swoop^®, the first FDA-cleared portable magnetic resonance imaging (MRI) device—announced a new software enhancement that enables brain scans in under three minutes with no ionizing radiation. This development is especially significant for young hydrocephalus patients, who may have difficulty staying still without sedation and have previously received a CT scan, which has radiation exposure due to lack of MRI access. Hyperfine is an official partner with the Hydrocephalus Association (HA), the nation’s most widely respected organization dedicated to research and advocacy of hydrocephalus. This complex disease accounts for over 40,000 hospital admissions each year.

Children suffering from hydrocephalus typically receive more than two brain scans per year to ensure that pressure on the brain caused by enlarged ventricles remains normal and to rule out the possibility of shunt malfunctions. Clinicians may do these brain scans with CT or MRI, but MRI is not always available. Published studies show that even a single pediatric head CT scan increases the risk of radiation-associated malignancy, potentially up to two times as much as those children that did not have a CT scan¹. In short, pediatric head CT scans pose a significant health risk to children with hydrocephalus.

“There is no way to prevent hydrocephalus, and there is no known cure. Young people diagnosed with this life-threatening neurological condition require life-long brain monitoring,” said Hyperfine Chief Medical Officer Dr. Khan Siddiqui. “Hyperfine designed the Swoop system to bring low-field MRI to the point of care. This unique ability allows young patients to be imaged sooner, avoid harmful ionizing radiation, stay close to their caregivers, and eliminates the intimidating experience of transport and lengthy wait times often associated with traditional MR imaging.”

The recent FDA clearance of this software upgrade includes a T1 Standard sequence optimized for imaging the inside of the brain and a Fast T2 sequence that provides images that can aid in the assessment of brain ventricles. This clearance supports the commitment of Hyperfine to drive innovation in portable low-field MRI and deliver product enhancements clinicians can use to improve patient care.

HA Connect!, Hydrocephalus Association’s National Conference, is the largest conference in the world for hydrocephalus and draws hundreds of families, researchers, and medical professionals annually. Hydrocephalus Association President and CEO Diana Gray shared her enthusiasm about the Swoop system stating, “We are always excited to witness progress in the care and treatment of hydrocephalus. The capacity to provide a faster, fully accessible MRI free from harmful radiation is invaluable and will transform the pathway to diagnosis and treatment.”

At HA Connect!, Hyperfine will have an interactive all-ages learning program exploring the origins of MRI, multiple images from hydrocephalus patient scans, a guessing game of scanned fruits, and LEGO® bricks to construct miniature replicas of the Hyperfine Swoop Portable MR Imaging System^™.

For more information, please visit http://www.hyperfine.io.

LEGO® is a trademark of the LEGO Group. The LEGO Group does not sponsor, endorse or authorize this display of LEGO elements.

About Hyperfine and the Swoop Portable MRI System
Hyperfine, Inc. is the groundbreaking medical device company that created Swoop, the world’s first US FDA-cleared portable MRI system. Hyperfine designed Swoop to enable rapid diagnosis and treatment of all patients regardless of income, resources, or location, pushing the boundaries of conventional imaging technology and expanding patient access to timely care. The Swoop Portable MR Imaging System produces high-quality images at a lower magnetic field strength, allowing clinicians to quickly scan, diagnose and treat patients in various point-of-care clinical settings. Swoop can be wheeled directly to the patient’s bedside, plugged into a standard electrical wall outlet, and controlled by a tablet. Designed as a complementary system to conventional MRIs at a fraction of the cost, Swoop captures images in minutes, providing critical decision-making capabilities across a variety of clinical settings. For more information about Hyperfine, please visit https://www.hyperfine.io.

Forward-Looking Statements
This presentation includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Hyperfine’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, Hyperfine’s expectations with respect to financial results, future performance, development and commercialization of products and services, the potential benefits and impact of Hyperfine’s products and services, potential regulatory approvals, and the size and potential growth of current or future markets for Hyperfine’s products and services. Most of these factors are outside of Hyperfine’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the completion and audit of Hyperfine’s financial statements for the year ended December 31, 2021; the success, cost and timing of Hyperfine product development and commercialization activities, including the degree that Swoop is accepted and used by healthcare professionals; the impact of COVID-19 on Hyperfine’s business; the inability to maintain the listing of Hyperfine’s Class A common stock on the Nasdaq following the recently completed business combination; the inability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition and Hyperfine’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of Hyperfine to raise financing in the future; the inability of Hyperfine 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 Hyperfine to identify, in-license or acquire additional technology; the inability of Hyperfine to maintain its existing or future license, manufacturing, supply and distribution agreements; the inability of Hyperfine to compete with other companies currently marketing or engaged in the development of products and services that Hyperfine is currently marketing or developing; the size and growth potential of the markets for Hyperfine’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of Hyperfine’s products and services and reimbursement for medical procedures conducted using Hyperfine’s products and services; Hyperfine’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; Hyperfine’s financial performance; and other risks and uncertainties indicated from time to time in Hyperfine’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. Hyperfine 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. Hyperfine 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.

Media Contact (US)
Aunny De La Rosa-Bathe
APCO Worldwide
abathe@apcoworldwide.com

¹https://link.springer.com/content/pdf/10.1007/s00381-019-04345-3