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Hyperfine Swoop® Portable MR Imaging® System Utilized in Multicenter SAFE MRI ECMO Study Published in the September 29th Issue of Circulation

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Hyperfine, Inc. (Nasdaq: HYPR) announced the publication of a multicenter study utilizing their Swoop® Portable MR Imaging® System in the September 29th issue of Circulation. The SAFE MRI ECMO study evaluated the use of ultra-low-field portable MR imaging on ICU patients undergoing extracorporeal membrane oxygenation (ECMO) with an elevated risk of acute brain injury (ABI).

The study, conducted by investigators at Johns Hopkins Hospital and the University of Texas-Houston, demonstrated the safety and effectiveness of using the Swoop® system for bedside neuroimaging in complex clinical settings like intensive care units. This breakthrough addresses the significant barrier of conducting timely neuroimaging on ECMO patients, potentially improving patient outcomes through earlier interventions.

Dr. Edmond Knopp, Chief Medical Officer at Hyperfine, highlighted the value of the Swoop® system in clinical situations where conventional MRI is not accessible, emphasizing its ability to provide real-time insights into a patient's acute brain injury state.

Hyperfine, Inc. (Nasdaq: HYPR) ha annunciato la pubblicazione di uno studio multicentrico che utilizza il loro sistema di imaging MR portatile Swoop® nel numero del 29 settembre della rivista Circulation. Lo studio SAFE MRI ECMO ha valutato l'uso dell'imaging MR portatile a campo ultra-basso su pazienti in terapia intensiva sottoposti a ossigenazione extracorporea della membrana (ECMO) con un elevato rischio di lesioni cerebrali acute (ABI).

Lo studio, condotto da ricercatori del Johns Hopkins Hospital e dell'Università del Texas-Houston, ha dimostrato la sicurezza e l'efficacia dell'uso del sistema Swoop® per l'imaging neurodottico al letto del paziente in contesti clinici complessi come le unità di terapia intensiva. Questa innovazione affronta il significativo ostacolo di condurre indagini neuroimmagini tempestive su pazienti ECMO, migliorando potenzialmente i risultati per i pazienti attraverso interventi più precoci.

Il Dr. Edmond Knopp, Chief Medical Officer di Hyperfine, ha sottolineato il valore del sistema Swoop® in situazioni cliniche in cui la risonanza magnetica convenzionale non è accessibile, enfatizzando la sua capacità di fornire informazioni in tempo reale sullo stato delle lesioni cerebrali acute di un paziente.

Hyperfine, Inc. (Nasdaq: HYPR) anunció la publicación de un estudio multicéntrico que utiliza su sistema de imagenología MR portátil Swoop® en el número del 29 de septiembre de la revista Circulation. El estudio SAFE MRI ECMO evaluó el uso de imagenología MR portátil de campo ultra bajo en pacientes de UCI sometidos a oxigenación por membrana extracorpórea (ECMO) con un riesgo elevado de lesión cerebral aguda (ABI).

El estudio, realizado por investigadores del Johns Hopkins Hospital y la Universidad de Texas-Houston, demostró la seguridad y eficacia en el uso del sistema Swoop® para la neuroimagen bedside en entornos clínicos complejos como las unidades de cuidados intensivos. Este avance aborda la significativa barrera de llevar a cabo neuroimagen oportuna en pacientes ECMO, mejorando potencialmente los resultados de los pacientes a través de intervenciones más tempranas.

El Dr. Edmond Knopp, Director Médico de Hyperfine, destacó el valor del sistema Swoop® en situaciones clínicas donde la resonancia magnética convencional no está disponible, enfatizando su capacidad para proporcionar información en tiempo real sobre el estado de la lesión cerebral aguda del paciente.

Hyperfine, Inc. (Nasdaq: HYPR)는 9월 29일자 Circulation 저널에 자사의 Swoop® Portable MR Imaging® System을 활용한 다기관 연구의 발행을 발표했습니다. SAFE MRI ECMO 연구는 ECMO(체외막 산소공급)를 받는 집중 치료실(ICU) 환자들에 대한 초저장 MR 영상 사용을 평가했습니다. 이 환자들은 급성 뇌 손상(ABI)의 위험이 높습니다.

존스 홉킨스 병원과 텍사스 대학교 휴스턴 캠퍼스의 연구자들이 수행한 이 연구는 복잡한 임상 환경, 즉 중환자실에서 환자 옆에서 신경 이미징에 Swoop® 시스템을 안전하고 효과적으로 사용할 수 있음을 증명했습니다. 이 획기적인 연구는 ECMO 환자에 대한 적시 신경 이미징을 수행하는 데 있어 중요한 장애물을 해결하여, 더 빠른 개입을 통해 환자 결과를 개선할 수 있는 가능성을 높입니다.

Hyperfine의 최고 의료 책임자인 에드몬드 크노프 박사는 전통적인 MRI 접근이 어려운 임상 상황에서 Swoop® 시스템의 가치를 강조하며, 환자의 급성 뇌 손상 상태에 대한 실시간 통찰력을 제공할 수 있는 능력을 강조했습니다.

Hyperfine, Inc. (Nasdaq: HYPR) a annoncé la publication d'une étude multicentrique utilisant leur système d'imagerie MR portable Swoop® dans le numéro du 29 septembre de la revue Circulation. L'étude SAFE MRI ECMO a évalué l'utilisation de l'imagerie MR portable à champ ultra-bas chez des patients en soins intensifs subissant une oxygenation extracorporelle par membrane (ECMO) et présentant un risque élevé de lésion cérébrale aiguë (ABI).

L'étude, menée par des chercheurs du Johns Hopkins Hospital et de l'Université du Texas-Houston, a démontré la sécurité et l'efficacité de l'utilisation du système Swoop® pour l'imagerie neurochirurgicale au chevet des patients dans des environnements cliniques complexes tels que les unités de soins intensifs. Cette avancée vise à surmonter l'obstacle significatif que représente la réalisation d'imageries neurochirurgicales en temps opportun chez les patients sous ECMO, ce qui pourrait améliorer les résultats des patients grâce à des interventions plus précoces.

Le Dr Edmond Knopp, directeur médical de Hyperfine, a souligné la valeur du système Swoop® dans des situations cliniques où l'IRM conventionnelle n'est pas accessible, en mettant en avant sa capacité à fournir des informations en temps réel sur l'état des lésions cérébrales aiguës d'un patient.

Hyperfine, Inc. (Nasdaq: HYPR) hat die Veröffentlichung einer multizentrischen Studie angekündigt, in der ihr tragbares MR-Bildgebungssystem Swoop® im September 29. Ausgabe von Circulation verwendet wird. Die SAFE MRI ECMO-Studie bewertete die Verwendung von ultraschall-niedrigfeld tragbarer MR-Bildgebung bei Patienten auf der Intensivstation, die einer extrakorporalen Membranoxygenation (ECMO) ausgesetzt sind und ein erhöhtes Risiko für akute Hirnschäden (ABI) aufweisen.

Die Studie, die von Forschern des Johns Hopkins Hospital und der University of Texas-Houston durchgeführt wurde, zeigte die Sicherheit und Wirksamkeit des Swoop®-Systems für die Neuroimaging am Patientenbett in komplexen klinischen Umgebungen wie Intensivstationen. Dieser Durchbruch beseitigt ein erhebliches Hindernis für die zeitgerechte Durchführung von Neuroimagining bei ECMO-Patienten, was potenziell die Patientenresultate durch frühere Interventionen verbessern könnte.

Dr. Edmond Knopp, Chief Medical Officer von Hyperfine, hob den Wert des Swoop®-Systems in klinischen Situationen hervor, in denen eine herkömmliche MRT nicht verfügbar ist und betonte die Fähigkeit, Echtzeiteinblicke in den Zustand von akuten Hirnschäden eines Patienten zu liefern.

Positive
  • Publication of study in prestigious journal Circulation, potentially increasing credibility and visibility of Hyperfine's Swoop® system
  • Demonstration of Swoop® system's effectiveness in complex clinical settings like ICUs
  • Potential for improved patient outcomes through earlier interventions enabled by bedside MRI neuroimaging
Negative
  • None.

Insights

This study represents a significant advancement in the use of portable MRI technology for critically ill patients. The Hyperfine Swoop® system's ability to safely image patients on ECMO support addresses a important gap in neurological monitoring for high-risk ICU patients. Key points include:

  • The study, published in Circulation, a prestigious journal, lends credibility to the technology's potential impact.
  • It demonstrates the safety and feasibility of using ultra-low-field portable MRI in complex ICU settings.
  • The technology enables timely detection of acute brain injury (ABI) in ECMO patients, potentially improving outcomes through earlier interventions.
  • This application could expand the market potential for Hyperfine's Swoop® system in critical care settings.

While this study is promising, investors should note that it's observational and further research may be needed to fully establish clinical efficacy and cost-effectiveness. The positive results could drive adoption in ICUs, potentially boosting Hyperfine's market penetration and revenue growth in the medical imaging sector.

The SAFE MRI ECMO study evaluated the use of ultra-low-field portable MR imaging on ICU patients undergoing extracorporeal membrane oxygenation (ECMO) with an elevated risk of acute brain injury (ABI)

GUILFORD, Conn.--(BUSINESS WIRE)-- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—today congratulates investigators at Johns Hopkins Hospital and the University of Texas-Houston on the publication of an exciting study using the Swoop® system for patients on extracorporeal membrane oxygenation (ECMO) support.

(Photo: Business Wire)

(Photo: Business Wire)

The study, entitled Clinical Use of Bedside Portable Ultra-Low-Field Brain Magnetic Resonance Imaging in Patients on Extracorporeal Membrane Oxygenation: Results From the Multicenter SAFE MRI ECMO Study, was published in the September issue of Circulation. The prospective observational study evaluated the safety of using ultra-low-field portable brain MRI on patients in cardiac ICUs undergoing ECMO and investigated the frequency of acute brain injury (ABI).

The use of ECMO has dramatically increased over the past decade but carries an elevated risk of ABI, which substantially increases the risk of mortality. The inability to conduct timely neuroimaging on ECMO patients is a significant barrier to effectively detecting and treating ABI. The study cites, “ultra-low-field portable technology specifically addresses this issue, enabling clinically meaningful, sensitive imaging ... in complex clinical settings, such as intensive care units.”

“We would like to congratulate Dr. Cho and his collaborators on the publication of this exciting data in such a prestigious journal. This study highlights the value of the Swoop® system in clinical situations where conventional MRI is not accessible,” said Dr. Edmond Knopp, Chief Medical Officer at Hyperfine. “The ability to perform safe, bedside MRI neuroimaging with our ultra-low-field portable system provides clinicians with real-time insights into a patient’s acute brain injury state, potentially improving patient outcomes by enabling earlier interventions in high-risk settings. Hyperfine recommends that institutions ensure the safe use of ECMO systems when used within the Swoop® system’s 5 gauss line.”

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 U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field 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 also has CE certification in the European Union and UKCA certification in the United Kingdom. The Swoop® system is commercially available in a select number of international markets.

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.

Media Contact

Dana Schroeder

Health+Commerce

dana@healthandcommerce.com



Investor Contact

Marissa Bych

Gilmartin Group LLC

marissa@gilmartinir.com

Source: Hyperfine, Inc.

FAQ

What is the SAFE MRI ECMO study using Hyperfine's Swoop® system (HYPR)?

The SAFE MRI ECMO study is a multicenter research evaluating the use of Hyperfine's Swoop® Portable MR Imaging® System on ICU patients undergoing extracorporeal membrane oxygenation (ECMO) with an elevated risk of acute brain injury (ABI). The study was published in the September 29th issue of Circulation.

How does the Swoop® system by Hyperfine (HYPR) benefit ECMO patients?

The Swoop® system enables safe, bedside MRI neuroimaging for ECMO patients, providing real-time insights into acute brain injury states. This addresses the significant barrier of conducting timely neuroimaging on ECMO patients, potentially improving outcomes through earlier interventions in high-risk settings.

Where was the SAFE MRI ECMO study using Hyperfine's Swoop® system (HYPR) conducted?

The SAFE MRI ECMO study was conducted by investigators at Johns Hopkins Hospital and the University of Texas-Houston, as a multicenter prospective observational study evaluating the safety and effectiveness of using ultra-low-field portable brain MRI on patients in cardiac ICUs undergoing ECMO.

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