HYPERFINE Stock Price, News & Analysis

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.

Hyperfine announced new research data supporting the use of its Swoop® Portable MR Imaging System in monitoring Alzheimer's patients. Presented at CTAD conference in Madrid, the research from Washington University in St. Louis demonstrated the system's capability to detect amyloid-related imaging abnormalities (ARIA-E) in patients receiving Lecanemab therapy. The Swoop® system's AI-processed images showed promising quality comparable to 3 tesla MRI scanners, positioning it as a cost-effective alternative for Alzheimer's patient monitoring. The CARE PMR study continues to collect data from multiple sites to assess the clinical utility of Swoop® in detecting ARIA in patients receiving amyloid-targeting therapy.

Hyperfine (Nasdaq: HYPR), developer of the Swoop® system—the first FDA-cleared portable magnetic resonance brain imaging system—has scheduled its Q3 2024 financial results announcement for November 12, 2024. Management will host a conference call at 1:30 PM PT/4:30 PM ET. The webcast will be accessible through the company's investor relations webpage, with advance registration recommended.

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.