Hyperfine Enrolls Initial Patients in NEURO PMR Study to Evaluate Use of AI-Powered Portable MRI in Neurology Offices
Hyperfine (NASDAQ: HYPR) has initiated the NEURO PMR (Neurological Evaluation in the Office with Portable MRI) study, enrolling initial patients to evaluate their AI-powered portable MRI system in neurology offices. This multi-center study compares their Swoop® system, first FDA-cleared in 2021, with conventional high-field MRI systems.
The study, conducted at the DENT Neurologic Institute and Texas Neurology, targets 100 patients and aims to conclude by year-end. It will assess pathology findings, clinical utility, and patient experience. The portable system offers significant advantages, requiring no costly siting, helium, or specialized MRI technologists.
Notably, starting November 2024, IAC Accredited medical offices using portable MRI systems will qualify for Centers for Medicare and Medicaid Services (CMS) reimbursement, potentially expanding accessibility in underserved, rural, and community centers.
Hyperfine (NASDAQ: HYPR) ha avviato lo studio NEURO PMR (Valutazione Neurologica in Studio con Risonanza Magnetica Portatile), arruolando i primi pazienti per testare il proprio sistema di risonanza magnetica portatile basato su intelligenza artificiale negli studi neurologici. Questo studio multicentrico confronta il loro sistema Swoop®, primo ad aver ricevuto l'approvazione FDA nel 2021, con i tradizionali sistemi di risonanza magnetica ad alto campo.
Lo studio, condotto presso il DENT Neurologic Institute e Texas Neurology, prevede il coinvolgimento di 100 pazienti e mira a concludersi entro la fine dell'anno. Verranno valutati i risultati patologici, l’utilità clinica e l’esperienza del paziente. Il sistema portatile offre vantaggi significativi, poiché non richiede costose installazioni, elio o tecnici specializzati in risonanza magnetica.
Da segnalare che, a partire da novembre 2024, gli studi medici accreditati IAC che utilizzano sistemi di risonanza magnetica portatili potranno beneficiare del rimborso da parte dei Centers for Medicare and Medicaid Services (CMS), ampliando così l’accessibilità soprattutto in aree svantaggiate, rurali e centri comunitari.
Hyperfine (NASDAQ: HYPR) ha iniciado el estudio NEURO PMR (Evaluación Neurológica en Consulta con Resonancia Magnética Portátil), inscribiendo a los primeros pacientes para evaluar su sistema de resonancia magnética portátil con inteligencia artificial en consultorios de neurología. Este estudio multicéntrico compara su sistema Swoop®, el primero aprobado por la FDA en 2021, con los sistemas convencionales de resonancia magnética de alto campo.
El estudio, realizado en el DENT Neurologic Institute y Texas Neurology, tiene como objetivo incluir a 100 pacientes y concluir a finales de año. Evaluará hallazgos patológicos, utilidad clínica y la experiencia del paciente. El sistema portátil ofrece ventajas importantes, ya que no requiere instalaciones costosas, helio ni técnicos especializados en resonancia magnética.
Es importante destacar que, a partir de noviembre de 2024, los consultorios médicos acreditados por IAC que usen sistemas de resonancia magnética portátiles podrán acceder al reembolso de los Centers for Medicare and Medicaid Services (CMS), lo que podría ampliar el acceso en zonas desatendidas, rurales y centros comunitarios.
Hyperfine (NASDAQ: HYPR)는 NEURO PMR(이동형 MRI를 활용한 신경학적 평가) 연구를 시작하여 신경과 진료실에서 AI 기반 이동형 MRI 시스템을 평가하기 위해 초기 환자들을 등록하고 있습니다. 이 다기관 연구는 2021년에 FDA 승인을 받은 Swoop® 시스템과 기존의 고자장 MRI 시스템을 비교합니다.
DENT Neurologic Institute와 Texas Neurology에서 진행되는 이 연구는 100명의 환자를 대상으로 연말까지 완료할 예정입니다. 병리학적 소견, 임상적 유용성 및 환자 경험을 평가합니다. 이동형 시스템은 고가의 설치 비용, 헬륨, 전문 MRI 기술자가 필요 없다는 큰 장점을 제공합니다.
특히 2024년 11월부터 IAC 인증을 받은 이동형 MRI 시스템을 사용하는 의료기관은 Centers for Medicare and Medicaid Services (CMS)의 보험 급여 대상이 되어, 의료 서비스가 부족한 농촌 및 지역사회 센터에서 접근성을 확대할 수 있을 것으로 기대됩니다.
Hyperfine (NASDAQ : HYPR) a lancé l’étude NEURO PMR (Évaluation neurologique au cabinet avec IRM portable), en recrutant les premiers patients afin d’évaluer leur système d’IRM portable alimenté par intelligence artificielle dans des cabinets de neurologie. Cette étude multicentrique compare leur système Swoop®, premier à avoir reçu l’approbation FDA en 2021, aux systèmes d’IRM conventionnels à champ élevé.
L’étude, menée au DENT Neurologic Institute et chez Texas Neurology, vise 100 patients et devrait se terminer d’ici la fin de l’année. Elle évaluera les résultats pathologiques, l’utilité clinique et l’expérience patient. Le système portable présente des avantages significatifs, ne nécessitant ni installation coûteuse, ni hélium, ni techniciens IRM spécialisés.
Il est à noter qu’à partir de novembre 2024, les cabinets médicaux accrédités par l’IAC utilisant des systèmes d’IRM portables pourront bénéficier d’un remboursement par les Centers for Medicare and Medicaid Services (CMS), ce qui pourrait améliorer l’accès dans les zones mal desservies, rurales et les centres communautaires.
Hyperfine (NASDAQ: HYPR) hat die NEURO PMR-Studie (Neurologische Untersuchung in der Praxis mit tragbarem MRT) gestartet und die ersten Patienten eingeschlossen, um ihr KI-gestütztes tragbares MRT-System in neurologischen Praxen zu evaluieren. Diese multizentrische Studie vergleicht ihr Swoop®-System, das 2021 als erstes von der FDA zugelassen wurde, mit herkömmlichen Hochfeld-MRT-Systemen.
Die Studie, die am DENT Neurologic Institute und bei Texas Neurology durchgeführt wird, zielt auf 100 Patienten ab und soll bis Jahresende abgeschlossen sein. Es werden pathologische Befunde, klinischer Nutzen und Patientenerfahrungen bewertet. Das tragbare System bietet erhebliche Vorteile, da es keine teuren Installationen, Helium oder spezialisierte MRT-Technologen benötigt.
Bemerkenswert ist, dass ab November 2024 medizinische Praxen mit IAC-Akkreditierung, die tragbare MRT-Systeme verwenden, eine Erstattung durch die Centers for Medicare and Medicaid Services (CMS) erhalten können, was die Zugänglichkeit insbesondere in unterversorgten, ländlichen und kommunalen Zentren erweitern könnte.
- CMS reimbursement approval starting November 2024 for IAC Accredited offices
- First multi-center study comparing portable MRI with conventional systems
- No requirement for costly infrastructure, helium, or specialized technologists
- Study results and commercial success not yet proven
- to 100 patients in initial study
Insights
Hyperfine's NEURO PMR study marks a strategic effort to expand their Swoop® AI-powered portable MRI system into neurology office settings. This is meaningful advancement for their commercialization strategy as they target a potentially significant opportunity - neurologists reportedly order approximately 500 MRIs annually per physician, yet in-office imaging remains inaccessible for most private practices.
The study design utilizing two premier neurology practices (DENT Neurologic Institute and Texas Neurology) will compare portable ultra-low-field MRI against conventional high-field MRI for pathology findings, clinical utility, and patient experience. While the 100-patient enrollment target is modest, it's appropriately sized for an initial validation study in this setting.
Critically, the November 2024 regulatory milestone establishing CMS reimbursement qualification for IAC Accredited medical offices using portable MRI systems removes a major financial barrier to adoption. This reimbursement pathway is essential for commercial viability in outpatient settings.
The value proposition hinges on Hyperfine's technology addressing key adoption barriers that have kept conventional MRI systems out of offices - no costly siting requirements, no helium dependency, and no need for specialized MRI technologists. The plug-and-play capabilities enable on-demand brain imaging directly in exam rooms, aligning with the broader healthcare shift toward comprehensive outpatient services.
With study completion expected by year-end, positive outcomes could accelerate penetration into neurology practices, potentially expanding Hyperfine's addressable market while generating additional clinical evidence to support adoption in other specialties.
Real-world study will assess clinical utility and patient experience across diverse neurological conditions to support adoption of AI-powered portable MRI systems in the office setting.
The NEURO PMR study is the first multi-center, prospective observational study of its kind, comparing portable ultra-low-field MRI and conventional high-field MRI with respect to pathology findings, clinical utility, and patient experience. Conducted with two premier private neurology practices—the DENT Neurologic Institute and Texas Neurology—the study utilizes the latest AI-powered portable MRI technology with advanced image quality. The study has a target enrollment of 100 patients and is expected to conclude by year-end.
“Neuroimaging has become a cornerstone of modern neurological care, with neurologists ordering an average of 500 MRIs each year. Yet, in-office imaging remains out of reach for most private practices,” explained Dr. Laszlo Mechtler, Principal Investigator of the study and Chief Medical Officer at the DENT Neurologic Institute. “This study aims to identify the best uses for portable brain MRI technology in a comprehensive neurology practice. The goal is to make advanced imaging more accessible, affordable, and convenient for both patients and healthcare providers.”
The Hyperfine AI-powered portable MRI system removes many of the barriers that have made conventional high-field MRI systems inaccessible for placement in neurology offices. Unlike conventional MRI systems, portable MRI doesn’t require costly siting, helium, or specialized MRI technologists to operate. With its simple plug-and-play design, the system enables on-demand brain imaging directly in the exam room. Furthermore, as of November 2024, IAC Accredited medical offices that use portable MRI systems qualify for reimbursement through the Centers for Medicare and Medicaid Services (CMS).
"As more healthcare moves to outpatient settings, patients increasingly expect neurology practices to offer both diagnostic and treatment services under one roof," adds Dr. Gincy Samuel, site Principal Investigator at Texas Neurology. "Portable MR technology aligns well with this trend, offering enhanced care and convenience in a single location—a shift we believe will only gain momentum. It provides a vital clinical function for centers that would not normally have immediate access to imaging, especially in underserved, rural, and community centers."
The NEURO PMR study is a key initiative in the Hyperfine office market entry strategy. It represents a significant step forward in making advanced imaging available to neurology practices of all sizes, ultimately reducing healthcare costs while improving patient access and clinical outcomes.
For more information about Hyperfine and AI-powered portable MRI technology, please visit hyperfine.io.
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, AI-powered, 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 and continue to improve 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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Media Contact
Devin Zell
Hyperfine
dzell@hyperfine.io
Investor Contact
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com
Source: Hyperfine, Inc.
FAQ
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