Core Insights - Nuwellis, Inc. has been granted U.S. Patent No. 12,415,021 for a technology related to hemolysis sensors in extracorporeal blood filtration systems, enhancing patient safety in fluid management [1][2]. Group 1: Patent and Technology - The patent focuses on the integration of hemolysis sensors with systems like ultrafiltration therapy and continuous renal replacement therapy (CRRT) to detect red blood cell destruction [2][4]. - This technology allows for the assessment of hemolysis origins, whether from outside the system or within the extracorporeal circuit, enabling timely responses from care teams [4][5]. Group 2: Importance of Hemolysis Monitoring - Hemolysis, the destruction of red blood cells, can significantly impact patient safety by reducing oxygen-carrying capacity and potentially leading to misinterpretation of filter issues [3]. - Standard blood-leak detectors may not effectively identify hemolyzed blood, highlighting the need for advanced monitoring solutions [3]. Group 3: Product Development - Nuwellis is developing a pediatric CRRT system named Vivian, designed specifically for neonates and children, featuring integrated sensors for real-time monitoring [6]. - Vivian supports multiple therapies on a single platform and is tailored for patients weighing between 2.5 kg and 20 kg, emphasizing safety and ease of use [6]. Group 4: Company Overview - Nuwellis, Inc. is dedicated to improving the lives of patients with fluid overload through innovative medical devices and is focused on commercializing the Aquadex SmartFlow system [8]. - The company is headquartered in Minneapolis and has a subsidiary in Ireland, indicating a global operational footprint [8].

Core Insights - Nuwellis, Inc. reported a revenue of $1.9 million for Q1 2025, marking a 3% increase compared to Q1 2024, driven by a 4% growth in consumables utilization and higher U.S. console sales, despite a decline in international sales [3][9] - The company is focusing on expanding access to Aquadex therapy, particularly in outpatient settings, supported by higher reimbursement rates and clinical data [2][3] - Nuwellis achieved a significant reduction in operating expenses, down 31% to $4.1 million, leading to an improved operating loss of $3.1 million compared to $4.7 million in the prior year [6][9] Financial Performance - Gross margin for Q1 2025 was 56.0%, down from 64.1% in the prior-year quarter, primarily due to unfavorable manufacturing variances and lower fixed overhead absorption [4] - Selling, general, and administrative (SG&A) expenses decreased by 22% to $3.6 million, driven by lower headcount and reduced professional services [5] - Research and development (R&D) expenses were $550 thousand, a significant decrease from $1.3 million in the prior-year quarter, reflecting reduced staffing and project spending [5] Cash Position - As of March 31, 2025, Nuwellis had $2.6 million in cash and cash equivalents and remained debt-free [7] Market Opportunities - Effective January 1, 2025, CMS reassigned Aquadex to a higher outpatient reimbursement level, increasing the facility fee nearly four-fold to $1,639 per day, which is expected to enhance outpatient opportunities [9]

Financial Data and Key Metrics Changes - Nuwellis generated $2.3 million in revenue for Q4 2024, a 9% decrease year-over-year due to a decline in U.S. console sales and international sales, offset by a 21% increase in consumables utilization [10][20] - Gross margin improved to 58.4% for Q4 2024 compared to 54.4% in the prior year quarter, driven by higher manufacturing volumes of consumables and lower fixed overhead manufacturing expenses [21] - Net loss attributable to common shareholders in Q4 was $1.5 million, or a loss of $0.44 per share, compared to a net loss of $7.9 million, or a loss of $54.48 per share for the same period in 2023 [24][25] Business Line Data and Key Metrics Changes - The Critical Care business, the largest customer category, saw a 35% year-over-year quarterly revenue growth, benefiting from higher console sales and consumable utilization [11][20] - Heart failure and pediatric customer categories experienced declines of 36% and 20% respectively due to lower console sales [12][20] Market Data and Key Metrics Changes - The company reported nine new account wins throughout 2024, indicating positive market penetration [9] - A favorable reimbursement change effective January 1, 2025, allows Nuwellis to enter the outpatient services market for Aquadex technology, with the facility reimbursement fee increasing nearly fourfold from $413 to $1,639 per day [14][15] Company Strategy and Development Direction - Nuwellis aims to build its body of clinical evidence to make Aquadex Ultrafiltration therapy a standard of care and integrate it into medical society guidelines [12] - The company is focused on driving market penetration of Aquadex Ultrafiltration therapy, leveraging clinical evidence and increased reimbursement rates in the outpatient setting [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, highlighting the positive impact of new account wins and reimbursement changes on growth [9] - The recent publication in JACC: Heart Failure demonstrated a 60% reduction in heart failure events for patients treated with Aquadex compared to traditional IV diuretics, which is expected to support broader adoption of the technology [13][18] Other Important Information - The company had a voluntary recall of specific lots of blood circuit units, which resulted in a non-recurring expense of approximately $150,000 [22] - Total operating expenses decreased by approximately 25% compared to Q4 2023, reflecting savings from operational efficiency initiatives [24] Q&A Session Summary Question: Initial traction in the outpatient setting for Aquadex - Management noted that traction is beginning with several existing accounts needing to set up permanent outpatient facilities, with more activity expected in the coming month [29] Question: Number of Aquadex units sold in Q4 2024 and Q3 2024 - Three units were sold in Q4 2024, compared to 11 units in Q3 2024 [33][35] Question: Timing for reverse HF trial enrollment completion - Management indicated it is difficult to gauge the timing for enrollment completion [37] Question: Timing for the start of the Vivian clinical trial - Management provided a similar response, stating it is difficult to predict [39] Question: Changes in leadership and search for a new CEO - Management confirmed that a search firm has been hired and candidates are being evaluated, with no immediate need for major changes in direction [46]