Core Insights - Hyperfine, Inc. has announced results from the NEURO PMR study, showcasing the effectiveness of its portable MRI system, Swoop®, in clinical settings [1][5]. Clinical Study Results - The NEURO PMR study is the first prospective, multi-center study evaluating the clinical utility of portable MRI compared to standard MRI in outpatient neurology clinics, enrolling 125 patients with common neurological conditions [2][3]. - Portable MRI demonstrated 92% concordance with standard MRI in identifying intracranial pathology during blinded reviews, increasing to 98% in unblinded reviews [3]. Patient Experience - Patients preferred the portable MRI, being four times more likely to choose it over standard MRI, with superior ratings across comfort, anxiety, claustrophobia, noise, and overall satisfaction [3][4]. - The Swoop® system can be operated by trained clinical staff without the need for specialized MR technologists, indicating a safe and simple workflow [3][4]. Technological Innovation - The Swoop® system is portable, fits in an exam room, requires no specialized sitting or shielding, and can be plugged into a standard outlet, addressing historical challenges in bringing MRI on-site [4][5]. - The system is FDA-cleared for brain imaging and is designed to provide clinically relevant diagnostic imaging [6][7]. Market Impact - The NEURO PMR results validate the potential of portable MRI to expand imaging capabilities beyond traditional hospital settings, benefiting physicians, patients, and the healthcare system [5].

Core Viewpoint - Hyperfine, Inc. has announced preliminary, unaudited financial results for the fourth quarter and full year ended December 31, 2025, highlighting its innovative position in the health technology sector with the Swoop® system, the first FDA-cleared AI-powered portable MRI for brain imaging [1] Financial Performance - Preliminary, unaudited revenue for the fourth quarter of 2025 was reported [1] - The company also disclosed net cash burn and cash and cash equivalents for the same period [1]

GUILFORD, Conn.--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR) ("Hyperfine†or the "Company†) today announced that it has commenced an underwritten public offering of its Class A common stock or, in lieu of Class A common stock to certain investors, pre-funded warrants to purchase Class A common stock. All securities to be sold in the offering will be sold by Hyperfine. In addition, Hyperfine intends to grant the underwriters a 30-day option to purchase up to 15% of the total number of securities sold in ...

Core Insights - Hyperfine, Inc. announced its second quarter 2025 financial results and significant business updates, highlighting key advancements in its AI-powered portable MRI technology and strong financial performance [1][2]. Business Highlights - The company received FDA clearances for its Optive AI software and the next-generation Swoop® system, marking a pivotal moment in its technology development [6]. - A commercial rollout of the next-gen Swoop® system began shortly after FDA clearance, with initial shipments to U.S. hospitals [6]. - The completion of a pilot neurology office program was announced, paving the way for a full-scale commercial launch [6]. - Enrollment of the 100th patient in the NEURO PMR study was achieved, which evaluates the use of AI-powered portable MRI in neurology offices [6]. - The PRIME study was initiated at Yale School of Medicine to assess the impact of AI-driven portable MRI in emergency departments [6]. - New data presented at the 2025 Alzheimer's Association International Conference indicated that the Swoop® system showed 100% sensitivity in detecting mild and moderate ARIA-E in Alzheimer's patients undergoing Lecanemab therapy [6]. Financial Results - Revenues for Q2 2025 reached $2.7 million, a 26% increase compared to Q1 2025 [6]. - The company sold 8 commercial Swoop® systems in Q2 2025, up from 6 in Q1 2025 [6]. - Gross margin for Q2 2025 was $1.3 million, representing a gross margin of 49.3%, an increase of 800 basis points from Q1 2025 [6]. - Research and development expenses decreased to $4.5 million in Q2 2025 from $5.0 million in Q1 2025 [6]. - Sales, marketing, general, and administrative expenses also decreased to $6.4 million in Q2 2025 from $6.7 million in Q1 2025 [6]. - The net loss for Q2 2025 was $9.2 million, consistent with the net loss of $9.4 million in Q1 2025, equating to a net loss of $0.12 per share [6]. Financial Guidance - Management expects full-year 2025 revenue to be 10% to 20% higher than in 2024 [6]. - Cash burn for the full year 2025 is projected to be approximately $27 to $29 million, reflecting a 27% decline at the midpoint compared to 2024 [6].

Core Insights - Hyperfine, Inc. reported its first quarter 2025 financial results and highlighted progress in expanding its business pipeline, particularly in the neurology office setting, while facing longer sales cycles in hospitals [2][4] Business Highlights - The company has made significant advancements in its commercial efforts, focusing on both hospitals and neurology offices, which is expected to diversify its revenue profile starting in the second half of 2025 [2] - Hyperfine completed a reorganization to reduce operating costs and raised $6 million through a registered direct offering, extending its cash runway until the end of 2026 [7] - The company initiated patient enrollment in the NEURO PMR study to evaluate the use of AI-powered portable MRI in neurology offices, with completion expected by the end of Q3 2025 [7] Financial Results - Revenues for Q1 2025 were $2.1 million, down from $3.3 million in Q1 2024 [7] - Gross margin for Q1 2025 was $0.9 million, representing a gross margin of 41.3%, slightly up from 41.1% in Q1 2024 [7] - The net loss for Q1 2025 was $9.4 million, or $0.12 per share, compared to a net loss of $9.8 million, or $0.14 per share, in Q1 2024 [7][16] Financial Guidance - Management expects revenue for the first half of 2025 to be approximately $5 to $6 million and anticipates annual revenue growth of 10% to 20% over 2024 [7] - The projected cash burn for the full year 2025 is approximately $25 to $28 million, indicating a 31% decline at the midpoint compared to 2024 [7]