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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), pioneer of the Swoop® system, the first FDA-cleared portable MRI system, announced it will report its Q1 2023 financial results on May 11, 2023. The company will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET to discuss the results. Swoop® provides neuroimaging at the point of care, offering bedside imaging capabilities where traditional MRI access is limited or unavailable. Initially cleared by the FDA in 2020, it is now also approved in Canada, Australia, and other regions, enhancing patient care through accessible diagnostic imaging. Interested investors can access the live audio webcast via the company’s website.
Hyperfine, Inc. (Nasdaq: HYPR) reported fourth quarter and full year 2022 financial results, achieving revenue of $6.8 million for the year, up from $1.5 million in 2021. In Q4 2022, revenue was $1.424 million, compared to $0.436 million in Q4 2021. The net loss for the year was $73.164 million, or $1.04 per share, an increase from $64.851 million or $17.57 per share in the previous year. The company ended the year with $117.472 million in cash. 2023 guidance estimates revenue between $10 to $14 million with a cash burn of $40 to $45 million. Significant achievements included FDA clearances and the installation of 35 commercial systems.
Hyperfine, Inc. (Nasdaq: HYPR), creator of the first FDA-cleared portable MRI system, Swoop®, announced it will report financial results for Q4 and full year 2022 on March 21, 2023. The management will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET, accessible through their investor page. The Swoop® system, approved for brain imaging in multiple countries, aims to enhance patient care through accessible diagnostic imaging. Since its FDA clearance in 2020, it has revolutionized neuroimaging by bringing bedside MRI capabilities to clinicians, improving diagnosis where conventional MRI is not feasible.
Hyperfine, Inc. (Nasdaq: HYPR) announced FDA 510(k) clearance for an updated version of its Swoop® Portable MR Imaging® system software, enhancing clinical utility in neurocritical care. The new software improves diffusion-weighted imaging (DWI) with a 42% increase in signal-to-noise ratio, essential for diagnosing neurological conditions. This update aims to provide clearer images and better patient care in diagnosing and monitoring stroke progression. The improved software is expected to roll out to customers in March 2023.
Hyperfine, Inc. (Nasdaq: HYPR) has achieved CE Marking for its portable MRI system with AI-powered imaging software, confirming compliance with EU safety standards. This milestone allows the company to explore future commercial opportunities within the European Economic Area (EEA) while maintaining its focus on the U.S. market in 2023. Compliance with the EU's Medical Device Regulation (MDR) was essential for legal marketing in Europe, reflecting an increase in regulatory rigor. CEO Maria Sainz emphasized the achievement's significance in enhancing the company's market potential.
Hyperfine, Inc. announced FDA 510(k) clearance for the upgraded Swoop® software, enhancing diffusion-weighted imaging (DWI) quality with improved signal-to-noise ratios.
This release also expands the system's field of view by 10% for key MRI sequences, aiding in pathology visualization. The enhancements aim to boost diagnostic confidence and support clinical decision-making.
With a total installed base of 100 Swoop® systems globally, Hyperfine demonstrates commitment to software advancement and AI integration, focusing on accessible neuroimaging. The ongoing software updates are positioned as pivotal for commercial adoption.
Hyperfine, Inc. (Nasdaq: HYPR) announced groundbreaking data on its Swoop® portable MRI system at the 2023 International Stroke Conference. The study, conducted at Yale-New Haven Hospital, focused on stroke patient follow-ups using bedside portable magnetic resonance imaging following mechanical thrombectomy procedures. The findings suggest that low-field pMRI can assess ongoing brain injury that is typically unmonitored due to the unavailability of conventional imaging post-procedure. Hyperfine's CEO highlighted the significance of these advancements in improving patient care and diagnostics.
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