HYPERFINE Stock Price, News & Analysis

Hyperfine (NASDAQ: HYPR) has initiated the NEURO PMR (Neurological Evaluation in the Office with Portable MRI) study, enrolling initial patients to evaluate their AI-powered portable MRI system in neurology offices. This multi-center study compares their Swoop® system, first FDA-cleared in 2021, with conventional high-field MRI systems.

The study, conducted at the DENT Neurologic Institute and Texas Neurology, targets 100 patients and aims to conclude by year-end. It will assess pathology findings, clinical utility, and patient experience. The portable system offers significant advantages, requiring no costly siting, helium, or specialized MRI technologists.

Notably, starting November 2024, IAC Accredited medical offices using portable MRI systems will qualify for Centers for Medicare and Medicaid Services (CMS) reimbursement, potentially expanding accessibility in underserved, rural, and community centers.

Hyperfine (HYPR) reported Q4 2024 financial results, with revenues of $2.32 million, down from $2.69 million in Q4 2023. The company sold 9 Swoop® systems in Q4 2024 versus 7 in Q4 2023.

Full year 2024 revenues increased 17% to $12.89 million, with 48 Swoop® systems sold compared to 37 in 2023. Gross margin improved to 46% from 43%. Net loss for 2024 was $40.72 million ($0.56 per share), improved from $44.24 million ($0.62 per share) in 2023.

The company strengthened its financial position through a $6.0 million registered direct offering, extending cash runway through 2026. For 2025, management projects revenue growth of 20-30% and reduced cash burn of $25-27 million, a 32% decline from 2024.

Hyperfine (Nasdaq: HYPR) has announced a strategic collaboration with NVIDIA to enhance its AI-powered portable MRI technology. The partnership focuses on advancing the Swoop® system, the first FDA-cleared AI-powered portable magnetic resonance brain imaging system.

The collaboration aims to leverage NVIDIA's AI expertise and accelerated computing to make brain MRI faster, smarter, and more affordable globally. Using NVIDIA's advanced suite of training and inference tools, including NVIDIA DALI and MONAI, the partnership will work on improving image quality, reducing scan times, and enabling faster diagnoses.

This initiative addresses a critical healthcare gap, as 90% of the global population lacks access to timely MRI diagnostics due to conventional MRI systems' high costs and infrastructure requirements. The Swoop® system is designed for point-of-care use in professional healthcare settings by trained clinicians, targeting the over three billion people worldwide affected by brain diseases.

Hyperfine (Nasdaq: HYPR), creator of the first FDA-cleared portable magnetic resonance brain imaging system—the Swoop® system, has scheduled its fourth quarter and full year 2024 financial results announcement for March 17, 2025. The company will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on the same day. Investors can access both the live audio webcast and recording through the company's investor relations website.

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.