Core Insights - Nuwellis, Inc. plans to launch a new 24-hour circuit for Aquadex therapy in the U.S. this fall, designed for single-day outpatient sessions, complementing the existing 72-hour option for multi-day therapy or inpatient care [1][3] - The introduction of the 24-hour circuit aligns with the growing trend of hospitals establishing outpatient Aquadex programs, aiming to provide predictable, scheduled care for patients needing fluid removal without hospital admission [2][3] Company Overview - Nuwellis, Inc. is a medical device company focused on transforming the lives of patients suffering from fluid overload through innovation and collaboration, with a primary focus on the Aquadex SmartFlow system for ultrafiltration therapy [5] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [5] Product Details - The Aquadex SmartFlow system is clinically proven for removing excess fluid from patients suffering from hypervolemia, indicated for temporary (up to 8 hours) or extended use in patients weighing 20 kg or more [6] - Treatments must be administered by trained healthcare providers in clinical settings under physician prescription [6]

Core Insights - Nuwellis, Inc. has received FDA 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC), enhancing its fluid management technology platform [1][2][5] Company Strategy - The clearance aligns with Nuwellis' multi-year plan to develop a comprehensive fluid management platform that integrates therapy delivery, venous access, and implementation support for hospitals and clinics [2][3] - The company's growth strategy focuses on three key areas: critical care, cardiac surgery recovery, and outpatient heart failure programs [2] Product Details - The dELC is designed for reliable peripheral venous access for up to 72 hours, supporting the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy [4][7] - The product portfolio now includes two coil-reinforced, 6F catheters with insertable lengths of 11 cm and 15 cm, catering to various patient anatomies and clinical workflows [5][9] Clinical Relevance - The dELC aims to provide dependable peripheral access across inpatient and outpatient settings, enhancing workflow efficiency and therapy delivery confidence [3][9] - The Aquadex SmartFlow system is indicated for temporary or extended use in patients with fluid overload unresponsive to medical management, emphasizing its clinical applicability [7]

Financial Data and Key Metrics Changes - Revenue for the second quarter was CAD1.7 million, a year-over-year decline of 21% [5][13] - Gross margin for the quarter was 55.5%, down from 67.2% in Q2 2024 [14] - Operating loss for Q2 was $2.9 million compared to $2.3 million in Q2 2024 [15] - Net loss attributable to common shareholders was $12.6 million, or a loss of $60.99 per share, compared to a net loss of $7.7 million, or a loss of $791.22 per share for the same period in 2024 [15] Business Line Data and Key Metrics Changes - Pediatric revenues increased by 23% compared to 2024 [13] - Heart failure and critical care revenues declined by 53% and 35% respectively, significantly impacted by the temporary backorder [13] Market Data and Key Metrics Changes - The pediatrics business remains strong with ongoing interest from new centers [7] - The outpatient heart failure opportunity is expected to grow due to increased reimbursement rates [23] Company Strategy and Development Direction - The company is focused on strengthening fundamentals, operational discipline, and strategic investments in high-impact growth areas [5] - Key growth areas identified include cardiac surgery, pediatrics, and outpatient heart failure [11][17] - The transition to KDI precision manufacturing is planned for October, expected to yield operational efficiencies and cost savings [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating temporary setbacks and emphasized a commitment to delivering value to patients and shareholders [16] - The company aims to progress towards being cash flow positive and deepen outpatient engagement with heart failure programs [17] Other Important Information - The company ended the REVERSE HF clinical trial to reallocate approximately $4 million towards higher impact growth areas [10] - The company ended the quarter with $4.5 million in cash and cash equivalents and remains debt-free [15] Q&A Session Summary Question: Resolution of sterilization vendor issue and impact on Q3 - The issue was resolved in July, and the company is no longer in backorder, rapidly building finished goods inventory [20][21] Question: Largest opportunity among pediatrics, critical care, and heart failure - Management sees growth opportunities in all three areas, with heart failure expected to grow the fastest due to outpatient opportunities and increased reimbursement [22][23]

Core Insights - Nuwellis, Inc. has successfully treated the first patients with Aquadex ultrafiltration therapy in a hospital-based outpatient setting, marking a significant advancement in fluid management access and care [1][2][3] - The transition to outpatient therapy is supported by a recent increase in reimbursement rates, which enhances the economic viability for healthcare systems [3][4] Company Developments - The treatments were conducted at a leading healthcare institution in the southeastern United States, utilizing the Aquadex SmartFlow system and established clinical protocols [2] - Nuwellis is actively collaborating with healthcare providers to develop hospital-based outpatient programs, focusing on training, protocols, and workflow integration [5] Economic Impact - Outpatient reimbursement rates have increased from approximately $413 to $1,639 per treatment day, providing a sustainable model for health systems to manage complex patients and reduce readmissions [3] - The outpatient setting allows for treatment without hospitalization, optimizing resource management for healthcare systems [4] Product Information - The Aquadex SmartFlow system is designed for patients suffering from fluid overload, offering a clinically proven method for fluid removal [7] - The system is indicated for both temporary and extended use in adult and pediatric patients, requiring administration by trained healthcare providers [7]

Financial Data and Key Metrics Changes - Newellis generated $1.9 million in revenue for Q1 2025, representing a 3% increase year over year, supported by a 4% increase in consumables utilization and an increase in U.S. console sales, partially offset by a decrease in international sales [6][13] - Gross margin for Q1 was 56%, down from 64.1% in the same period last year, primarily due to unfavorable manufacturing variances and lower fixed overhead absorption [14] - Operating loss narrowed to $3.1 million compared to an operating loss of $4.7 million in the prior year quarter [15] Business Line Data and Key Metrics Changes - Pediatric and heart failure revenues increased by 3828% year over year, driven by growth in consumables utilization [6][13] - Critical care revenue declined by 25% year over year, primarily due to one of the largest customers building excess inventory in the previous quarter [7][13] Market Data and Key Metrics Changes - The company has built a growing pipeline of target outpatient facilities, representing an addressable market opportunity of approximately $717 million [12] - The recent reassignment of OXWAD X to a new outpatient reimbursement level by CMS increased the facility reimbursement fee for the therapy by nearly four times to $16.39 per day [11] Company Strategy and Development Direction - Newellis is focusing on critical care, pediatrics, and outpatient heart failure, with critical care representing approximately 40% of current business [17] - The company aims to position Aquadex as a standard of care within fluid management, expanding into the outpatient market as hospital accounts complete logistical challenges [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stability of critical care business volume, expecting it to return to normal levels in the upcoming quarter [23] - The company is actively working with hospitals to implement outpatient clinics, anticipating revenue growth in the second quarter and more rapid growth in the third and fourth quarters [26] Other Important Information - Newellis ended the quarter with $2.6 million in cash and cash equivalents and operates with no debt on the balance sheet [16] - The company is focused on disciplined expense management, achieving a 31% reduction in operating expenses [20] Q&A Session Summary Question: What caused the drop in adult revenue? - The drop in critical care was primarily due to a large customer building inventory in the previous quarter, leading to lower purchases in Q1 [23] Question: Is the drop in Q1 revenue seasonal? - Management indicated that the drop was not typical seasonality but rather specific to a recall incident affecting inventory management [24] Question: What does expanding the outpatient pipeline mean for Aquadex? - The company is working with four hospitals to implement outpatient clinics, focusing on logistical changes and nursing resources [25] Question: Update on Phase three trial enrollment and VIVIAN clinical trial timeline? - Enrollment for the REVERSE HF trial is ongoing, with efforts to increase enrollment resuming after previous issues [28] - The VIVIAN clinical trial will not start until later this year or early next year, pending further device development [29]

Core Viewpoint - Nuwellis, Inc. has received U.S. Patent No. 12,280,007 for a novel self-emptying fluid bag design that enhances nursing workflow and maintains measurement accuracy in fluid management for patients with fluid overload [1][5]. Company Overview - Nuwellis, Inc. is a medical technology company focused on fluid management solutions, particularly for patients suffering from fluid overload [6]. - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [6]. Patent Details - The patent was officially issued on April 22, 2025, and includes a 224-day extension to its standard term granted by the USPTO [5]. - The patented design features a siphon mechanism that allows the fluid bag to automatically empty without disconnecting from the scale, thus preserving measurement integrity [2]. Impact on Healthcare - Fluid overload is a significant complication in critically ill patients, and the new design aims to improve the accuracy and efficiency of ultrafiltration therapy [3]. - The innovation is expected to simplify routine tasks for clinicians, enhancing both care and workflow in critical care settings [4]. Future Developments - The design may be integrated into future enhancements of the Aquadex SmartFlow system, including a pediatric-focused CRRT device currently under development [4]. - This patent represents a step towards expanding Nuwellis' product portfolio and advancing innovation in fluid management [4]. Product Information - The Aquadex SmartFlow system is indicated for temporary or extended use in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [7]. - Treatments must be administered by trained healthcare providers in clinical settings under physician prescription [7].