Hyperfine Expands Global Market Reach with New Distribution Partnerships in European and Middle Eastern Markets
Hyperfine (NASDAQ: HYPR) announced expansion of its commercial operations through new distribution agreements in Turkey, Israel, and Saudi Arabia for its Swoop® system, the first FDA-cleared AI-powered portable MR brain imaging system. These partnerships follow earlier 2024 agreements covering thirteen European markets, India, Malaysia, and Indonesia.
The company received CE approval in Europe for its ninth-generation AI-powered software in October 2024. The expansion targets regions with large populations and low MRI penetration, positioning Hyperfine for significant growth in 2025. The Swoop® system's portability and cost-effectiveness aim to address healthcare gaps in remote and emergency settings.
Hyperfine (NASDAQ: HYPR) ha annunciato l'espansione delle sue operazioni commerciali attraverso nuovi accordi di distribuzione in Turchia, Israele e Arabia Saudita per il suo sistema Swoop®, il primo sistema di imaging cerebrale portatile con intelligenza artificiale approvato dalla FDA. Queste partnership seguono accordi precedenti del 2024 che coprono tredici mercati europei, India, Malaysia e Indonesia.
La società ha ricevuto l'approvazione CE in Europa per il suo software di nona generazione alimentato da intelligenza artificiale nell'ottobre 2024. L'espansione punta su regioni con grandi popolazioni e bassa penetrazione di risonanza magnetica, posizionando Hyperfine per una crescita significativa nel 2025. La portabilità e il costo contenuto del sistema Swoop® mirano a colmare le lacune nel settore sanitario in contesti remoti e di emergenza.
Hyperfine (NASDAQ: HYPR) anunció la expansión de sus operaciones comerciales a través de nuevos acuerdos de distribución en Turquía, Israel y Arabia Saudita para su sistema Swoop®, el primer sistema portátil de imagen cerebral impulsado por IA aprobado por la FDA. Estas asociaciones siguen a acuerdos anteriores de 2024 que cubren trece mercados europeos, India, Malasia e Indonesia.
La compañía recibió la aprobación CE en Europa para su software de novena generación impulsado por inteligencia artificial en octubre de 2024. La expansión tiene como objetivo regiones con grandes poblaciones y baja penetración de resonancia magnética, posicionando a Hyperfine para un crecimiento significativo en 2025. La portabilidad y costo efectivo del sistema Swoop® buscan abordar las brechas en la atención médica en entornos remotos y de emergencia.
Hyperfine (NASDAQ: HYPR)는 터키, 이스라엘, 사우디 아라비아에서 Swoop® 시스템에 대한 새로운 유통 계약을 통해 상업 운영 확장을 발표했습니다. Swoop®는 FDA 승인을 받은 최초의 AI 기반 휴대용 뇌 이미징 시스템입니다. 이러한 파트너십은 2024년 유럽의 13개 시장, 인도, 말레이시아 및 인도네시아를 포함하는 이전 계약에 이어 이루어졌습니다.
회사는 2024년 10월에 아홉 번째 세대 AI 기반 소프트웨어에 대해 유럽에서 CE 승인을 받았습니다. 이 확장은 인구가 많지만 MRI 침투율이 낮은 지역을 목표로 하며, Hyperfine의 2025년 중요한 성장을 위한 준비를 하고 있습니다. Swoop® 시스템의 휴대성과 비용 효율성은 원격 및 응급 상황에서의 건강 관리 격차를 해소하기 위해 설계되었습니다.
Hyperfine (NASDAQ: HYPR) a annoncé l'expansion de ses opérations commerciales grâce à de nouveaux accords de distribution en Turquie, Israël et Arabie Saoudite pour son système Swoop®, le premier système d'imagerie cérébrale portable alimenté par IA approuvé par la FDA. Ces partenariats font suite à des accords précédents de 2024 couvrant treize marchés européens, l'Inde, la Malaisie et l'Indonésie.
La société a obtenu l'approbation CE en Europe pour son logiciel de neuvième génération alimenté par IA en octobre 2024. L'expansion cible des régions avec de grandes populations et une faible pénétration de l'IRM, positionnant Hyperfine pour une croissance significative en 2025. La portabilité et le coût abordable du système Swoop® visent à combler les lacunes en matière de soins de santé dans des contextes éloignés et d'urgence.
Hyperfine (NASDAQ: HYPR) kündigte die Expansion seiner Geschäftstätigkeit durch neue Vertriebsvereinbarungen in Türkei, Israel und Saudi-Arabien für sein Swoop®-System an, das erste von der FDA zugelassene tragbare MRT-Gehirnbildgebungssystem mit KI. Diese Partnerschaften folgen früheren Vereinbarungen aus dem Jahr 2024, die dreizehn europäische Märkte, Indien, Malaysia und Indonesien abdecken.
Das Unternehmen erhielt im Oktober 2024 die CE-Zulassung in Europa für seine KI-unterstützte Software der neunten Generation. Die Expansion zielt auf Regionen mit großen Bevölkerungen und geringer MRT-Durchdringung ab und positioniert Hyperfine für ein signifikantes Wachstum im Jahr 2025. Die Tragbarkeit und Kosteneffizienz des Swoop®-Systems sollen dabei helfen, Gesundheitslücken in abgelegenen und Notfallsituationen zu schließen.
- Secured new distribution agreements in Turkey, Israel, and Saudi Arabia
- Obtained CE approval in Europe for ninth-generation AI-powered software
- Expanded market reach to regions with over 100 million people
- Established distribution network across North America, Europe, Asia, Oceania, and Middle East
- None.
Insights
The expansion into Turkey, Israel and Saudi Arabia represents a significant market opportunity for Hyperfine. These regions, with a combined population of over 100 million people and low MRI penetration rates, offer substantial growth potential. The CE approval for the 9th generation AI-powered software strengthens the company's competitive position in Europe, while the broader distribution network spanning multiple continents positions HYPR for accelerated market penetration.
The timing of these partnerships aligns with increasing global demand for point-of-care diagnostics and decentralized healthcare solutions. With conventional MRI systems being cost-prohibitive and infrastructure-dependent, Hyperfine's portable Swoop® system addresses a critical market gap. The focus on emerging markets with underdeveloped healthcare infrastructure could drive significant unit sales growth in 2025.
The Swoop® system's AI-powered portable design represents a paradigm shift in neurological diagnostics. Traditional MRI installations require dedicated facilities, extensive infrastructure and significant capital investment. By contrast, the Swoop® system's portability and lower cost structure enable point-of-care brain imaging in previously underserved settings. The ninth-generation AI software upgrade demonstrates continued technological advancement, potentially improving diagnostic capabilities and clinical utility.
The expansion into markets with MRI access could revolutionize stroke diagnosis and emergency neurological care in these regions. The system's ability to deliver imaging at the bedside particularly benefits time-critical conditions where rapid diagnosis impacts patient outcomes.
Strategic agreements set the stage for further global adoption of portable MR brain imaging technology, fueling expansion plans for 2025.
The Swoop® Portable MR Imaging® System (Photo: Business Wire)
“We have achieved several milestones throughout 2024 that have positioned us for significant growth in international markets in 2025,” said David Castiglioni, Hyperfine Chief Commercial Officer. “Agreements with these new partners build on our existing distribution networks, giving Hyperfine robust global reach. The interest from international clinicians and healthcare facilities reflects the growing global enthusiasm for portable MR brain imaging and its potential to bridge critical healthcare gaps.”
The new distribution agreements in
The new distribution partnerships ensure efficient market entry and afford Hyperfine strong local support for adopting the Swoop® system. These areas, home to over 100 million people, face challenges in providing timely neurological care, particularly in remote and emergency settings lacking access to advanced imaging equipment. With its portability and cost-effectiveness, the Swoop® system eliminates barriers posed by conventional MRI systems, enabling clinicians to deliver high-quality imaging at the point of care.
“We feel the Swoop® system can play a very valuable role in advancing neurological care globally,” added Castiglioni. “International markets have significantly lower penetration of conventional MRI, and a portable and affordable MR brain imaging option is a valuable solution to serve large areas of unmet need in those markets.”
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241217074637/en/
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Health+Commerce
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Source: Hyperfine, Inc.
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