Hyperfine Announces Extensive Clinical Study Coverage at RSNA 2024, Showcasing the Body of Evidence Supporting the Use of the Swoop® System Across Different Sites of Care
Hyperfine (NASDAQ: HYPR) showcased eleven clinical studies at RSNA 2024 demonstrating the effectiveness of their Swoop® system, an FDA-cleared AI-powered portable MR brain imaging system. The presentations highlighted the system's applications in stroke diagnosis, intracerebral hemorrhage monitoring, and multiple sclerosis imaging.
Washington University School of Medicine presented the largest study to date, analyzing over 350 exams in acute neurological care settings. The ACTION PMR study, involving multiple institutions including Massachusetts General Brigham and Ohio State Hospitals, evaluated the system's accuracy in detecting acute ischemic stroke, demonstrating promising results for hyperacute stroke detection and potential to increase MRI accessibility.
Hyperfine (NASDAQ: HYPR) ha presentato undici studi clinici al RSNA 2024 dimostrando l'efficacia del loro Swoop® system, un sistema di imaging cerebrale MR portatile alimentato da intelligenza artificiale e approvato dalla FDA. Le presentazioni hanno evidenziato le applicazioni del sistema nella diagnosi dell'ictus, nel monitoraggio dell'emorragia intracerebrale e nell'imaging della sclerosi multipla.
La Washington University School of Medicine ha presentato il più grande studio mai realizzato, analizzando oltre 350 esami in contesti di cura neurologica acuta. Lo studio ACTION PMR, che ha coinvolto più istituzioni tra cui il Massachusetts General Brigham e gli Ohio State Hospitals, ha valutato l'accuratezza del sistema nella rilevazione dell'ictus ischemico acuto, dimostrando risultati promettenti per la rilevazione dell'ictus iperacuto e il potenziale di aumentare l'accessibilità della risonanza magnetica.
Hyperfine (NASDAQ: HYPR) presentó once estudios clínicos en RSNA 2024 que demuestran la efectividad de su Swoop® system, un sistema de imagen cerebral MR portátil impulsado por IA y aprobado por la FDA. Las presentaciones destacaron las aplicaciones del sistema en diagnóstico de ictus, monitoreo de hemorragias intracerebrales y obtención de imágenes en esclerosis múltiple.
La Escuela de Medicina de la Universidad de Washington presentó el estudio más grande hasta la fecha, analizando más de 350 exámenes en entornos de atención neurológica aguda. El estudio ACTION PMR, que involucra a múltiples instituciones, incluyendo el Massachusetts General Brigham y los hospitales de Ohio State, evaluó la precisión del sistema en la detección de ictus isquémico agudo, demostrando resultados prometedores para la detección de ictus hiperagudo y la posibilidad de aumentar la accesibilidad a la resonancia magnética.
Hyperfine (NASDAQ: HYPR)는 RSNA 2024에서 Swoop® 시스템의 효능을 입증하는 11개의 임상 연구를 발표했습니다. 이 시스템은 FDA 승인을 받은 AI 기반의 휴대용 MR 뇌 이미지 시스템입니다. 발표에서는 뇌졸중 진단, 뇌내 출혈 모니터링 및 다발성 경화증 이미지 촬영에서의 시스템의 적용이 강조되었습니다.
워싱턴 대학교 의과대학은 지금까지의 최대 연구를 발표하며, 급성 신경학적 치료 환경에서 350건 이상의 검사를 분석했습니다. ACTION PMR 연구는 매사추세츠 종합병원과 오하이오 주립병원을 포함한 여러 기관이 참여하여 시스템이 급성 허혈성 뇌졸중을 탐지하는 정확성을 평가했으며, 급성 뇌졸중 탐지에 대한 유망한 결과를 보여주었고 MRI 접근성을 높일 수 있는 가능성을 보여주었습니다.
Hyperfine (NASDAQ: HYPR) a présenté onze études cliniques à la RSNA 2024 démontrant l'efficacité de leur Swoop® system, un système d'imagerie cérébrale par résonance magnétique portable, alimenté par IA et approuvé par la FDA. Les présentations ont mis en lumière les applications du système dans le diagnostic des AVC, le suivi des hémorragies intracérébrales et l'imagerie de la sclérose en plaques.
La Washington University School of Medicine a présenté l'étude la plus vaste à ce jour, analysant plus de 350 examens dans des contextes de soins neurologiques aigus. L'étude ACTION PMR, impliquant plusieurs institutions dont le Massachusetts General Brigham et les hôpitaux d'Ohio State, a évalué la précision du système dans la détection des AVC ischémiques aigus, démontrant des résultats prometteurs pour la détection des AVC hyperaigus et un potentiel d'augmentation de l'accessibilité à l'IRM.
Hyperfine (NASDAQ: HYPR) stellte auf der RSNA 2024 elf klinische Studien vor, die die Wirksamkeit ihres Swoop® Systems demonstrieren, eines tragbaren MR-Gehirnbildgebungssystems, das von der FDA genehmigt wurde und KI-gestützt ist. Die Präsentationen hoben die Anwendungen des Systems in der Schlaganfalldiagnose, der Überwachung intrazerebraler Blutungen und der Bildgebung bei Multipler Sklerose hervor.
Die Washington University School of Medicine präsentierte die bisher größte Studie, in der über 350 Untersuchungen in akuten neurologischen Behandlungsszenarien analysiert wurden. Die ACTION PMR-Studie, an der mehrere Institutionen wie das Massachusetts General Brigham und die Ohio State Hospitals beteiligt waren, bewertete die Genauigkeit des Systems bei der Erkennung von akutem ischämischem Schlaganfall und zeigte vielversprechende Ergebnisse für die Erkennung von hyperakuten Schlaganfällen sowie das Potenzial zur Erhöhung der Zugänglichkeit von MRT-Untersuchungen.
- Multiple clinical studies validate Swoop® system's effectiveness in stroke diagnosis
- Large-scale study with 350+ exams demonstrates clinical utility
- System shows capability to detect hyperacute stroke
- Growing adoption across leading medical institutions
- None.
Insights
The extensive clinical study coverage at RSNA 2024 represents significant validation for Hyperfine's Swoop® system, particularly in acute stroke diagnosis. The presentation of eleven clinical studies from leading institutions, including a landmark study with over 350 exams from Washington University School of Medicine, demonstrates growing clinical acceptance and utility.
The multi-site ACTION PMR study's interim findings are particularly noteworthy, showing promising capabilities in hyperacute stroke detection when compared to conventional high-field MRI and CT scans. This could significantly impact stroke care workflows, especially in settings where traditional MRI access is or patient transport is challenging.
The system's ability to provide diagnostic imaging in neurocritical ICU settings without patient transfer represents a substantial operational advantage. However, investors should note that while the study results are encouraging, broader market adoption and revenue impact will depend on continued clinical validation and healthcare facility implementation rates.
The Swoop® system's AI-powered technology represents a significant advancement in portable MR imaging. The system's ability to operate at ultra-low-field strengths while maintaining diagnostic utility for critical conditions like acute stroke is technically impressive. The integration of AI for image processing helps overcome traditional limitations of low-field MRI.
What's particularly notable is the system's versatility across different clinical settings - from emergency departments to neuro ICUs. The successful implementation across multiple institutions suggests robust technical reliability and user-friendly operation. For a medical device company with a relatively modest market cap of
Eleven clinical studies presented at RSNA 2024 highlighted the growing clinician experience with the Swoop® system for imaging diverse patient groups in emergency departments and neuro ICUs.
The Swoop® Portable MR Imaging® System (Photo: Business Wire)
The clinical studies presented clinician experience using Swoop® system images for intracerebral hemorrhage monitoring, acute ischemic stroke detection, and advanced imaging techniques for multiple sclerosis. These studies highlighted the potential of the Swoop® system to expand access to critical diagnostic imaging for acute ischemic stroke and other neurological conditions, providing actionable insights where conventional high-field MRI may not be viable.
A team from Washington University School of Medicine in
One of the authors, Cyrus A. Raji, MD, PhD, commented, "Our experience with the portable MR imaging system has shown it to be a valuable addition to acute neurological care in our facility. It allows for follow-up of large strokes and intracranial hemorrhage in the neurocritical ICU without the need for transfer of acutely ill patients to the MRI suites.”
In another study, Dr. Nandor Pinter of the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo presented data from the prospective, international, multi-site ACTION PMR (Acute Ischemic Stroke Detection with Portable MR) study. Massachusetts General Brigham and Ohio State Hospitals also participated in this study, which evaluated the accuracy of images acquired with AI-powered portable MRI in detecting acute ischemic stroke. The presentation, titled Acute stroke detection using portable ultra low-field MRI: A multicenter outlook, demonstrated that images from the Swoop® system showed lesions and location identification capability. The authors concluded that low-field MR imaging has the potential to enable physicians to detect hyperacute stroke, which may increase access to MRI given its unique portable capabilities.
"The ACTION PMR study looked at stroke detection using Swoop® system images compared to high-field MRI and CT, and our interim findings highlight the promising role of AI-powered portable MRI in acute stroke care,” said Dr. Nandor Pinter, research assistant professor in the Department of Neurosurgery at the University at Buffalo. “Our conclusions, using the Swoop® system in the ED across four institutions, show the system’s potential to revolutionize hyperacute stroke workflow and diagnostics.”
“The eleven abstracts presented at RSNA this week not only demonstrate the Swoop® system’s ability to deliver diagnostic-quality MR brain imaging at the point of care but also reflect the growing excitement and momentum around portable MRI technology,” said Dr. Edmond Knopp, Chief Medical Officer at Hyperfine. “These results expand the evidence base for stroke applications, showcasing the system’s potential to transform care in resource-limited and high-acuity settings. The enthusiasm we’ve seen from clinicians and researchers at RSNA underscores the Swoop® system’s impact in advancing stroke diagnostics and improving patient outcomes when and where it’s needed most.”
For more information about the Swoop® Portable MR Imaging® system, please visit hyperfine.io.
About the Swoop® Portable MR Imaging® System
The Swoop® Portable MR Imaging® system is
About Hyperfine, Inc.
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. 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. For more information, visit hyperfine.io.
The Hyperfine logo, 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. Actual results of Hyperfine, Inc. (the “Company”) 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 Company’s goals and 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 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.
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Source: Hyperfine, Inc.
FAQ
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