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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 (NASDAQ: HYPR) has announced a $6.0 million registered direct offering through the sale of 4,511,278 shares of Class A common stock and accompanying warrants. Each share and warrant combination is priced at $1.33, with warrants exercisable immediately at $1.33 per share and expiring in five years.
Lake Street Capital Markets is serving as the exclusive placement agent. The offering is expected to close around February 12, 2025, subject to customary conditions. The company plans to use the proceeds for working capital and general corporate purposes, including commercial, manufacturing, and R&D activities.
The securities are being offered through an effective shelf registration statement on Form S-3 previously filed with the SEC on November 9, 2023 and declared effective on November 22, 2023.
Hyperfine (NASDAQ: HYPR) presented two significant studies at the 2025 International Stroke Conference demonstrating the effectiveness of their Swoop® system, an AI-powered portable MR brain imaging system, in stroke diagnosis. The ACTION PMR study, conducted across four leading institutions in the US and Europe, showed that physicians using Swoop® system images could diagnose 90% of acute infarcts compared to conventional high-field MRI.
Research from Ohio State University and Massachusetts General Hospital demonstrated the system's ability to differentiate between stroke and stroke mimics, with strong agreement to high-field MRI results. The study highlighted faster time-to-scan compared to conventional MRI and good specificity in emergency stroke care. The ACTION PMR study, which began in July 2023, included one hundred patients and has shown substantial agreement between Swoop® system diagnoses and standard-of-care imaging in detecting acute ischemic strokes.
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) showcased eleven clinical studies at RSNA 2024 demonstrating the effectiveness of their Swoop® system, an FDA-cleared AI-powered portable MR brain imaging system. The presentations highlighted the system's applications in stroke diagnosis, intracerebral hemorrhage monitoring, and multiple sclerosis imaging.
Washington University School of Medicine presented the largest study to date, analyzing over 350 exams in acute neurological care settings. The ACTION PMR study, involving multiple institutions including Massachusetts General Brigham and Ohio State Hospitals, evaluated the system's accuracy in detecting acute ischemic stroke, demonstrating promising results for hyperacute stroke detection and potential to increase MRI accessibility.
Hyperfine (Nasdaq: HYPR) announced the appointment of Chi Nguyen as VP of Office Strategy and Partnerships and Rafael Donnay as VP of Hospital Strategy and Health Economics. These roles aim to drive the adoption of the Swoop® system in hospitals and neurology offices, targeting significant growth in 2025 and beyond. Nguyen will lead office strategy, leveraging new MRI standards for CMS reimbursement, targeting 2,400 U.S. neurology offices. Donnay will focus on hospital strategy, aiming to integrate the Swoop® system into 9,600 U.S. sites, including critical care units and emergency departments. Additionally, Hyperfine plans international expansion, supported by recent CE approval for European markets. CEO Maria Sainz highlighted the strategic importance of these appointments for Hyperfine's growth and market development.
Hyperfine (Nasdaq: HYPR) announces that the Intersocietal Accreditation Commission (IAC) has issued new MRI standards that now include portable MR scanning at point of care. This update enables IAC-accredited facilities to qualify for CMS reimbursement for brain scans performed using the Swoop® system. The Swoop® Portable MR Imaging® system operates at 0.064T ultra-low field strength, eliminating the need for shielded MRI rooms, and features plug-and-scan functionality with a tablet interface for easy operation in any healthcare setting.
Hyperfine (Nasdaq: HYPR) announced that ten scientific abstracts featuring ultra-low-field imaging will be presented at the Radiological Society of North America (RSNA) 2024 Annual Meeting in Chicago. This represents the company's largest number of RSNA presentations to date, demonstrating growing interest in the Swoop® Portable MR Imaging® System. The abstracts cover diverse applications including emergency department workflow, neuro ICU implementation, intracerebral hemorrhage monitoring, acute ischemic stroke detection, and advanced imaging techniques for multiple sclerosis. The presentations highlight the system's versatility across multiple care settings and its potential to transform brain imaging and enhance patient care.
Hyperfine (Nasdaq: HYPR), creator of the first FDA-cleared portable magnetic resonance brain imaging system - the Swoop® system, has announced its participation in two upcoming investor conferences. The company will present at the BTIG Digital Health Forum on November 25, 2024, and the Mizuho Healthcare Conference in New York on December 11, 2024. Interested parties can schedule one-on-one meetings with management through their BTIG or Mizuho representatives.
Hyperfine (HYPR) reported strong Q3 2024 financial results with record revenues of $3.64 million, up 56% year-over-year. Gross margin improved to 52% from 48% in Q3 2023. The company posted a net loss of $10.33 million ($0.14 per share), compared to $10.76 million ($0.15 per share) in Q3 2023.
Key achievements include CE approval and FDA clearance of 9th generation AI-powered brain imaging software, and significant clinical data presentations for Alzheimer's and stroke applications. Management expects full-year 2024 revenue of $14-14.5 million, representing 27-31% growth, with projected cash burn of $37-40 million.
Hyperfine (Nasdaq: HYPR) has received CE approval for its latest generation of AI-powered Swoop® system software under European Medical Device Regulation. This milestone follows the initial CE certification in 2023 and enables broader European commercial expansion of their portable MR brain imaging system. The company has already established distribution partnerships in thirteen European countries, including the five major European markets. The latest software improvements focus on reducing scan times, which is important for time-sensitive conditions like stroke, and minimizing the impact of patient motion on image quality.
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