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Hyperfine, Inc. (Nasdaq: HYPR) is committed to revolutionizing the field of medical imaging with its pioneering Swoop® Portable MR Imaging System™. By making MRI accessible to every patient, regardless of income or location, Hyperfine is bridging the gap in medical imaging. The Swoop system addresses the limitations of conventional MRI scanners by providing portable, bedside imaging capabilities. This breakthrough technology plugs into a standard electrical outlet and is controlled using an Apple iPad®, displaying images within minutes. This efficiency aids critical decision-making in diverse clinical settings such as neurointensive care units, emergency departments, and pediatric wards.
Designed to complement traditional MRI systems, the Swoop Portable MR Imaging System can be operated by new users with just 30 minutes of training, streamlining workflows and enhancing patient care. The system is cost-effective, with the complete Swoop package costing less than the annual service contract of most fixed MRI systems.
Since receiving FDA clearance in August 2020 for brain and head imaging, Hyperfine has achieved significant milestones. The company has expanded its market reach, gaining approvals in several countries including Canada, Australia, the United Kingdom, and the European Union. Hyperfine’s recent achievements include the successful enrollment in the CARE PMR study for Alzheimer’s and the introduction of its 8th generation AI-powered software.
In the first quarter of 2024, Hyperfine reported strong commercial progress and financial results, demonstrating their ability to meet critical milestones while maintaining spending discipline. The company remains focused on its core values of commercialization, clinical evidence, and innovation. Under the leadership of CEO Maria Sainz, Hyperfine continues to push the boundaries of medical imaging technology, aiming to provide accessible and clinically relevant diagnostic imaging solutions globally.
For more information, visit Hyperfine's Investor Relations.
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) announced promising interim findings on the value of its Swoop® Portable MR Imaging® system for acute stroke care at the 2024 European Society of Neuroradiology Annual Meeting. The study, presented by Dr. Keith Muir of the University of Glasgow, compared the ultra-low-field Swoop® system to conventional MRI and head CT in emergency stroke workup.
Key findings include:
- Faster time-to-scan: 2.5 hours median for Swoop® vs. 27.7 hours for conventional MRI
- Comparable diagnostic performance to head CT
- Good specificity compared to 1.5T MRI
- Positive patient experience reported
The study concludes that the portable ultra-low-field MRI system shows promise in enhancing stroke diagnosis accessibility and efficiency, particularly where conventional MRI availability is
Hyperfine, Inc. (Nasdaq: HYPR) has announced a collaboration with the Medical University of South Carolina to assess astronaut brain health using the Swoop® Portable MR Imaging® system. The research will focus on the Polaris Dawn mission, acquiring brain images of astronauts before and after spaceflight. The study aims to assess intracranial volume changes and gain insights into spaceflight-associated neuro-ocular syndrome (SANS).
Dr. Donna Roberts, the principal investigator, emphasized the importance of understanding how human physiology adapts to spaceflight and zero-gravity environments. The Swoop® system will capture MR brain images of the four Polaris Dawn crewmembers at key points: seven days before launch, within hours of return, and one day after return. This research could provide valuable data on intracranial venous congestion during spaceflight and brain re-adaptation to Earth.
Hyperfine (Nasdaq: HYPR), the company behind the first FDA-cleared portable MR brain imaging system, announced its participation in upcoming investor conferences. Management will present at the H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, at 7:00 am ET. They will also host in-person meetings at the 2024 Wells Fargo Healthcare Conference in Boston on September 5th, 2024.
A live webcast of the H.C. Wainwright event and an archived recording will be available on the company's website. The webcast will be accessible for at least 90 days after the event. Hyperfine's groundbreaking Swoop® system has redefined brain imaging with its portability and FDA clearance.
Hyperfine, Inc. (HYPR) reported record quarterly revenue of $3.63 million in Q2 2024, up 7.4% year-over-year. The company achieved a 50% gross margin and sold 13 commercial Swoop® systems. Hyperfine raised its FY 2024 revenue guidance to $13-16 million, reflecting 31% growth at the midpoint. Key achievements include FDA clearance of 9th generation AI-powered brain imaging software and initiation of the CARE PMR study for Alzheimer's patients. The company expanded internationally, appointing distributors in 12 EU markets and India. Despite progress, Hyperfine reported a net loss of $10.16 million for Q2 2024, slightly improved from $10.64 million in Q2 2023.
Hyperfine (Nasdaq: HYPR) presented initial data from observational clinical studies evaluating the use of its Swoop® Portable MR Imaging® system for Alzheimer's patients at the 2024 Alzheimer's Association International Conference (AAIC). The CARE PMR study, involving multiple sites, assesses the clinical utility of Swoop® images in detecting amyloid-related imaging abnormalities (ARIA) in patients receiving amyloid-targeting therapy.
Key findings include:
- Evidence of ARIA-E detection in one patient using low-field strength imaging
- Strong agreement between low-field and high-field MR images in brain morphometry evaluation
- Potential for portable MRI to transform Alzheimer's disease management across various care settings
Hyperfine (Nasdaq: HYPR) has received FDA clearance for its ninth-generation AI-powered Swoop® system software, significantly reducing scan times for brain imaging without compromising image quality. This advancement positions Hyperfine as a leader in AI-powered health technology, potentially speeding up diagnoses in acute care settings, particularly for time-sensitive conditions like stroke. The software update may also help mitigate the impact of patient motion on image quality.
Professor Adnan Siddiqui from the University of Buffalo highlighted the importance of this development for stroke diagnosis workflows. Hyperfine's commitment to AI innovation is evident in its leading position on the FDA's AI/ML-Enabled Medical Devices list. Tom Teisseyre, Chief Operating Officer at Hyperfine, emphasized the company's focus on balancing speed and image quality to inform better patient care decisions in acute settings.
Hyperfine (Nasdaq: HYPR) highlights results from a multi-site study demonstrating the value of its Swoop® Portable MR Imaging® System in acute stroke diagnosis. The study, to be published in the August 2024 issue of Annals of Neurology, shows promising results for using Swoop® system images to assess stroke patients and guide critical treatment decisions. The study included 71 patients and was conducted by teams from Massachusetts General Hospital and the University at Buffalo.
This publication marks the first to include a subset of data from the ACTION PMR stroke study, which has already enrolled over 100 patients at four institutions. The study aims to compare stroke detection capabilities between ultra-low-field MRI, conventional high-field MRI, and CT. A workflow phase evaluating the Swoop® system's ease of access and versatility in emergency departments and stroke centers is set to begin later this year.
Hyperfine is set to announce its second-quarter 2024 financial results on August 8, 2024. The company, known for its FDA-cleared portable MR brain imaging system, the Swoop system, will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET. The call will be accessible via a live audio webcast on the Investors page of Hyperfine's corporate website. Participants are encouraged to register at least 15 minutes early.
Hyperfine (Nasdaq: HYPR), a leading health technology company, announced new distribution partnerships in Germany, Austria, Switzerland, and Nordic markets for its FDA-cleared portable MR brain imaging system, the Swoop®. This strategic move expands Hyperfine's reach to twelve European countries, complementing previous agreements in France, the UK, and Italy. The Swoop® system, known for its affordability, accessibility, and high performance, aims to enhance brain imaging services globally. Hyperfine's strong track record in securing international approvals supports its commercial growth, with plans for further expansion into Asian markets, including India.
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