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Hyperfine Announces Alzheimer’s Research with Promising Swoop® System Data and Advanced Image Quality

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Hyperfine announced new research data supporting the use of its Swoop® Portable MR Imaging System in monitoring Alzheimer's patients. Presented at CTAD conference in Madrid, the research from Washington University in St. Louis demonstrated the system's capability to detect amyloid-related imaging abnormalities (ARIA-E) in patients receiving Lecanemab therapy. The Swoop® system's AI-processed images showed promising quality comparable to 3 tesla MRI scanners, positioning it as a cost-effective alternative for Alzheimer's patient monitoring. The CARE PMR study continues to collect data from multiple sites to assess the clinical utility of Swoop® in detecting ARIA in patients receiving amyloid-targeting therapy.

Hyperfine ha annunciato nuovi dati di ricerca a sostegno dell'uso del suo Swoop® Portable MR Imaging System nel monitoraggio dei pazienti affetti da Alzheimer. Presentata alla conferenza CTAD a Madrid, la ricerca della Washington University di St. Louis ha dimostrato la capacità del sistema di rilevare le anomalie di imaging correlate all'amiloide (ARIA-E) nei pazienti in trattamento con Lecanemab. Le immagini elaborate dall'IA del sistema Swoop® hanno mostrato una qualità promettente comparabile a quella degli scanner MRI da 3 tesla, posizionandolo come un'alternativa economica per il monitoraggio dei pazienti affetti da Alzheimer. Lo studio CARE PMR continua a raccogliere dati da più siti per valutare l'utilità clinica dello Swoop® nel rilevare ARIA nei pazienti in trattamento con terapie mirate all'amiloide.

Hyperfine anunció nuevos datos de investigación que apoyan el uso de su Swoop® Portable MR Imaging System para el monitoreo de pacientes con Alzheimer. Presentada en la conferencia CTAD en Madrid, la investigación de la Universidad de Washington en St. Louis demostró la capacidad del sistema para detectar anomalías de imagen relacionadas con amiloides (ARIA-E) en pacientes que reciben terapia con Lecanemab. Las imágenes procesadas por IA del sistema Swoop® mostraron una calidad prometedora comparable a la de escáneres de MRI de 3 teslas, posicionándolo como una alternativa rentable para el monitoreo de pacientes con Alzheimer. El estudio CARE PMR continúa recopilando datos de múltiples sitios para evaluar la utilidad clínica de Swoop® en la detección de ARIA en pacientes que reciben terapia dirigida al amiloide.

Hyperfine은 알츠하이머 환자 모니터링을 위한 Swoop® Portable MR Imaging System의 사용을 지원하는 새로운 연구 데이터를 발표했습니다. 마드리드에서 열린 CTAD 회의에서 세인트루이스의 워싱턴 대학교 연구는 Lecanemab 치료를 받고 있는 환자에서 아밀로이드 관련 영상 이상(ARIA-E)을 탐지하는 시스템의 능력을 입증했습니다. Swoop® 시스템의 AI 처리 이미지 품질은 3테슬라 MRI 스캐너에 해당하는 유망한 품질을 보여주어 알츠하이머 환자 모니터링을 위한 비용 효율적인 대안으로 자리 잡았습니다. CARE PMR 연구는 아밀로이드 표적 치료를 받는 환자에서 ARIA를 탐지하기 위한 Swoop®의 임상 유용성을 평가하기 위해 여러 장소에서 데이터를 계속 수집하고 있습니다.

Hyperfine a annoncé de nouvelles données de recherche soutenant l'utilisation de son Swoop® Portable MR Imaging System pour le suivi des patients atteints d'Alzheimer. Présentée lors de la conférence CTAD à Madrid, la recherche de l'Université de Washington à St. Louis a démontré la capacité du système à détecter les anomalies d'imagerie liées à l'amiloïde (ARIA-E) chez les patients recevant la thérapie par Lecanemab. Les images traitées par IA du système Swoop® ont montré une qualité prometteuse comparable à celle des scanners IRM de 3 teslas, le positionnant comme une alternative rentable pour le suivi des patients atteints d'Alzheimer. L'étude CARE PMR continue de collecter des données dans plusieurs sites pour évaluer l'utilité clinique de Swoop® dans la détection de l'ARIA chez les patients recevant une thérapie ciblant les amiloïdes.

Hyperfine hat neue Forschungsdaten veröffentlicht, die die Verwendung seines Swoop® Portable MR Imaging System zur Überwachung von Alzheimer-Patienten unterstützen. Auf der CTAD-Konferenz in Madrid präsentiert, zeigte die Forschung der Washington University in St. Louis die Fähigkeit des Systems, amiloidbezogene Bildanomalien (ARIA-E) bei Patienten zu erkennen, die eine Lecanemab-Therapie erhalten. Die KI-verarbeiteten Bilder des Swoop®-Systems zeigten vielversprechende Qualität, die mit 3 Tesla-MRT-Scannern vergleichbar ist, wodurch es sich als kostengünstige Alternative für das Monitoring von Alzheimer-Patienten positioniert. Die CARE PMR-Studie sammelt weiterhin Daten an mehreren Standorten, um die klinische Nützlichkeit von Swoop® bei der Erkennung von ARIA bei Patienten, die amiloidzielgerichtete Therapien erhalten, zu bewerten.

Positive
  • Promising research data shows Swoop® system's effectiveness in detecting ARIA-E
  • System demonstrates comparable image quality to high-field 3 tesla MRI scanners
  • Potential cost-effective alternative to conventional MRI systems
  • Growing international exposure through presentations at major Alzheimer's conferences
Negative
  • None.

Insights

The research data presented on the Swoop® portable MR imaging system shows promising potential in monitoring Alzheimer's patients receiving amyloid-targeting therapy. The system's ability to detect ARIA-E (amyloid-related imaging abnormalities) comparable to high-field 3T MRI scanners is technically significant. However, this remains early-stage research without immediate revenue impact.

The key value proposition lies in the system's potential to democratize brain imaging by enabling monitoring at infusion centers and clinics. This could expand the addressable market significantly if clinical validation continues to be positive. The CARE PMR multi-site study will be important in determining commercial viability for Alzheimer's applications. While the technology shows promise, investors should note that widespread adoption would require additional validation, regulatory approvals and reimbursement pathway development.

Today’s presentation at CTAD, a leading international Alzheimer's conference, expands research supporting the value of ultra-low-field MRI in monitoring amyloid-related imaging abnormalities (ARIA).

MADRID--(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 announced the presentation of additional research data and images using the Swoop® system to image patients with Alzheimer’s disease who are part of the observational, investigator-initiated CARE PMR study.

The Swoop® Portable MR Imaging® System (Photo: Business Wire)

The Swoop® Portable MR Imaging® System (Photo: Business Wire)

The Swoop® system is gaining international exposure, with growing evidence supporting the use of Swoop® system images to help in the detection of amyloid-related imaging abnormalities (ARIA-E) when monitoring Alzheimer’s patients receiving amyloid-targeting therapy. Recent presentations at significant Alzheimer’s meetings, including the Alzheimer’s Association International Conference (AAIC) in Philadelphia, AAIC in Tokyo, and the Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid (presented on October 31st), have showcased the potential value of the Swoop® system in Alzheimer’s patient management.

The presentation today at CTAD featured research from Washington University in St. Louis, a leading center in Alzheimer’s disease research using ultra-low-field MR imaging with the Swoop® system and an actively enrolling center in the CARE PMR study. The authors shared their experiences using Swoop® system images to detect ARIA-E in patients undergoing Lecanemab therapy. The presentation showcased multiple cases comparing images obtained with the ultra-low-field Swoop® portable MR brain imaging system with images from a high-field 3 tesla MRI scanner. The Swoop® system images, processed using the latest advancements in AI-driven research software, demonstrated impressive image quality that shows promise for use in assisting physicians in detecting ARIA-E.

The presentation conclusions stated that the Swoop system “presents a promising and cost-effective alternative to the conventional 3T MRI, with the added advantage of workflow optimization.” Further, the authors noted, “This study highlights the potential of innovative imaging technologies to advance patient care and monitor neurodegenerative conditions.”

The CARE PMR (Capturing ARIA Risk Equitably with Portable MR) study is a collection of data from multiple sites assessing the clinical utility and workflow benefits of using Swoop® system images to detect amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients receiving amyloid-targeting therapy.

Dr. Edmond Knopp, Chief Medical Officer at Hyperfine, expressed his enthusiasm for the ongoing research. He stated, “I want to congratulate Washington University for their leadership in Alzheimer’s research, particularly with the use of portable MR brain imaging. The impressive image quality achievable with our ultra-low-field MRI technology opens up the potential to enable the ability to provide critical diagnostic information for patients with Alzheimer’s disease across many sites of professional care, including infusion centers and clinics that currently cannot offer on-site imaging capabilities. These presentations provide early evidence that portable MRI could transform Alzheimer’s disease management.”

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 did the CTAD conference presentation reveal about Hyperfine's (HYPR) Swoop system?

The presentation showed that the Swoop system can effectively detect ARIA-E in Alzheimer's patients receiving Lecanemab therapy, with image quality comparable to 3 tesla MRI scanners, presenting a cost-effective alternative to conventional MRI.

What is the CARE PMR study investigating for Hyperfine (HYPR)?

The CARE PMR study is collecting data from multiple sites to assess the clinical utility and workflow benefits of using Swoop system images to detect amyloid-related imaging abnormalities in Alzheimer's patients receiving amyloid-targeting therapy.

Where has Hyperfine (HYPR) presented its Swoop system research in 2024?

Hyperfine has presented research at major Alzheimer's conferences including AAIC in Philadelphia, AAIC in Tokyo, and most recently at the CTAD conference in Madrid on October 31st.

Hyperfine, Inc.

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