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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 the acceptance of two presentations on the clinical utility of their portable ultra-low-field MRI system, Swoop®, for Alzheimer's disease monitoring at the 2024 Alzheimer’s Association International Conference, from July 28 to August 1 in Philadelphia. These presentations, prepared by clinicians from Washington University, Massachusetts General Hospital, and Yale University, will focus on the use of the Swoop® system for detecting and monitoring treatment efficacy in Alzheimer's patients. Hyperfine aims to make brain imaging more accessible and affordable, enhancing care in diverse settings. The company is also conducting the CARE PMR study to evaluate the system's utility in detecting amyloid-related imaging abnormalities (ARIA) in patients undergoing amyloid-targeting therapy.
Hyperfine (Nasdaq: HYPR) will host an analyst and investor education webcast on June 25, 2024, at 2:00 PM ET, focusing on advancements in ultra-low-field (ULF) MR imaging.
Led by Dr. Edmond Knopp, VP of Medical Affairs, the event features key opinion leaders (KOLs) discussing the Swoop® portable MR imaging system's application in critical care, stroke, and dementia, including Alzheimer's workflows.
Guest speakers include Dr. Jamal Derakhshan from Jefferson Abington Hospital, Dr. W. Taylor Kimberly from Mass General Hospital, and Dr. Cyrus A. Raji from Barnes Jewish Hospital. The webcast will end with an interactive Q&A session. The live audio and an archive of the webcast will be accessible on Hyperfine's investor relations page.
Hyperfine (Nasdaq: HYPR) is expanding its global reach by partnering with Radiosurgery Global to distribute its portable MR imaging system, Swoop®, in India. This strategic move addresses India's significant shortage of MRI scanners, with fewer than 5,000 units for over 1.4 billion people. The Swoop® system is designed to enhance diagnostic capabilities, particularly in underserved critical care and emergency settings. Hyperfine also plans future expansions into Malaysia, Indonesia, and Singapore. The company’s expansion is bolstered by recent certifications in the EU and UK and aims for regulatory approval in India through CDSCO. This collaboration signifies a major step toward improving healthcare accessibility and patient outcomes across Asia.
Hyperfine, a health technology company known for its FDA-cleared portable MR brain imaging system, the Swoop®, will present at the Jefferies Global Healthcare Conference in New York on June 6, 2024, at 3:00 pm ET. The event will be live-streamed and archived on the company's investor relations website for 90 days. For more details about the Swoop® system, visit their official website.
Hyperfine (Nasdaq: HYPR) participated in the 2024 ASNR Annual Meeting held in Las Vegas from May 18-22, 2024. The event highlighted the use of the Swoop® Portable MR Imaging® system, particularly for Alzheimer's care. Presenters emphasized the critical role of MRI in diagnosing and managing Alzheimer's disease and the potential of portable MR imaging to fill existing gaps in diagnostic capabilities. Sessions focused on the importance of monitoring amyloid-related imaging abnormalities (ARIA) for safe Alzheimer’s treatments. Attendees expressed significant enthusiasm for the Swoop® system’s benefits in clinical settings.
Hyperfine (Nasdaq: HYPR) announced its Q1 2024 financial results on May 13, 2024. The company reported $3.30 million in revenue, a 25% increase from Q1 2023, and sold 13 Swoop® systems. Gross margin improved to $1.35 million. R&D expenses were $5.57 million, and SG&A expenses dropped to $6.43 million. Net loss decreased to $9.85 million ($0.14 per share) from $12.16 million ($0.17 per share) in Q1 2023. Key milestones include starting the CARE PMR Alzheimer’s study, enrolling over 100 patients in the ACTION PMR stroke study, and launching the 8th-gen AI-powered software. Full-year 2024 revenue is expected to be $12-$15 million with a $40 million cash burn.
Hyperfine, Inc. (Nasdaq: HYPR) has appointed distributors in France, the UK, and Italy to expand the market reach of its portable MR brain imaging system, Swoop®. The company has obtained CE certification and UKCA certification for its latest hardware and AI-powered software. The move aims to meet the global demand for accessible MR brain imaging, with a focus on Alzheimer's disease and acute stroke applications. Enrico Barini joins as International Business Development Director to lead the European market expansion.
Hyperfine, Inc. (Nasdaq: HYPR) will announce its first quarter 2024 financial results on May 13, 2024. The company, known for its FDA-cleared portable MR brain imaging system, the Swoop® system, will host a conference call on the same day. The event can be accessed via the Investors page of Hyperfine, Inc.'s website.
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