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].