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. reported a revenue of $1.7 million for Q2 2025, down from $2.2 million in Q2 2024, primarily due to a product backorder linked to an industry-wide sterilization vendor issue [3][5][7] - The company is focusing on high-impact growth areas in pediatric and cardiac surgery care while preparing for expansion in outpatient heart failure [2][3] - Nuwellis completed a $5 million gross capital raise during the quarter and has a cash position of $4.5 million as of June 30, 2025 [5][7] Financial Performance - Gross margin decreased to 55.5% in Q2 2025 from 67.2% in Q2 2024, attributed to lower production volumes [4] - Operating loss for the quarter was $2.9 million, compared to a loss of $2.3 million in Q2 2024 [5][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 $791.82 per share in Q2 2024 [5][15] Business Developments - The pediatric category remains a key driver of sustained demand, with 47 pediatric centers adopting Aquadex therapy [7] - The company executed a transition plan to outsource manufacturing to KDI Precision Manufacturing [7] - Nuwellis expanded its intellectual property portfolio with a new U.S. patent covering a fluid bag design that passively drains once full [7]

Core Viewpoint - Nuwellis, Inc. is exiting international operations to focus exclusively on the U.S. market, where it is experiencing the strongest growth and clinical demand [1][2][3] Company Strategy - The strategic realignment supports Nuwellis' core business strategy of investing in markets that drive revenue growth, particularly in U.S. cardiac surgery and pediatric programs [2][3] - The company aims to streamline operations to prioritize investment in areas with immediate and long-term impact [2][3] Market Focus - Nuwellis is doubling down on the U.S. market, focusing on high-acuity and hospital-based outpatient settings [3] - Cardiac surgery, pediatrics, and outpatient models are identified as the strongest growth drivers, offering faster intervention and better patient outcomes [3] Operational Changes - The company will support its international partners through a structured wind-down period, aligning operations with market demand [4] - This shift emphasizes operational discipline and customer focus to deliver shareholder value [4] Product Information - Nuwellis is dedicated to transforming the lives of patients suffering from fluid overload through its Aquadex SmartFlow® system, which is indicated for ultrafiltration therapy [5][6] - The system is designed for both adult and pediatric patients and is administered in clinical settings under physician supervision [6]

Core Viewpoint - Nuwellis, Inc. has announced a postponement of its 2025 second quarter earnings release and conference call, originally set for August 12, 2025, due to the need for additional time to complete valuations and audit procedures [1] Company Overview - Nuwellis, Inc. is a medical technology company focused on fluid management, specifically targeting patients suffering from fluid overload [3] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] Product Information - The Aquadex SmartFlow® system is designed for ultrafiltration therapy, providing a clinically proven method to remove excess fluid from patients with hypervolemia [4] - The system is indicated for temporary use (up to 8 hours) or extended use (longer than 8 hours) in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [4] Upcoming Events - A conference call and webcast to discuss financial results and provide a general business update is scheduled for 9:00 AM ET on August 14, 2025 [1]

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]

Core Points - Nuwellis, Inc. announced that stockholders approved all proposals at the Special Meeting, aimed at enhancing financial flexibility and supporting strategic growth [1][2][3] Proposal Summaries - **Warrant Exercise Proposal**: Stockholders approved the issuance of common stock shares through the exercise of warrants from the June 10, 2025 financing, allowing full access to committed capital [1] - **Authorized Shares Increase Proposal**: An amendment was approved to increase the number of authorized shares of common stock from 100 million to 200 million [2] - **Reverse Split Proposal**: Stockholders approved a reverse stock split at a ratio between 1-for-5 and 1-for-70, to be enacted at the Board's discretion for Nasdaq compliance [2] Company Insights - CEO John Erb expressed appreciation for stockholder support, indicating that these approvals are crucial for strengthening the company's capital position and executing long-term strategy [3] - Nuwellis is focused on transforming the lives of patients with fluid overload through its Aquadex SmartFlow® system, which is designed for ultrafiltration therapy [4][5]

Core Insights - Nuwellis, Inc. participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference, where CEO John Erb shared his commitment to the company and its development programs [1] - The on-demand video webcast of the conference is accessible on the Virtual Investor website and Nuwellis' own website [2] - Nuwellis is a medical device company focused on addressing fluid overload in patients through innovative solutions, particularly the Aquadex SmartFlow® system for ultrafiltration therapy [3] Company Overview - Nuwellis, Inc. is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] - The company is listed on Nasdaq under the ticker symbol NUWE [3] - Nuwellis aims to transform the lives of patients suffering from fluid overload through science and collaboration [3]

Company Overview - Nuwellis, Inc. is a commercial-stage medical technology company focused on transforming the lives of patients suffering from fluid overload through innovation and collaboration [3] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] Product Information - Nuwellis is focused on commercializing the Aquadex SmartFlow® system, which is designed for ultrafiltration therapy to remove excess fluid from patients with hypervolemia [3][4] - The Aquadex SmartFlow system is indicated for temporary use (up to 8 hours) or extended use (longer than 8 hours) in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [4] Financial Results Announcement - Nuwellis will release its financial results for the second quarter of 2025 on August 12, 2025 [1] - A conference call and webcast will be held at 9:00 AM ET to discuss the financial results and provide a general business update [1]

Core Insights - Nuwellis, Inc. has announced the termination of its REVERSE-HF clinical trial to focus resources on outpatient markets with higher potential for impact and growth [1][2] - The company aims to redirect investments towards outpatient heart failure, pediatric, and critical care areas, anticipating savings of approximately $4.0 million over the next 2.5 years from this decision [2][3] Company Strategy - The decision to terminate the REVERSE-HF trial is part of a strategic commitment to prioritize areas that demonstrate the greatest potential for patient impact and business growth [1][2] - Nuwellis is experiencing increasing demand for its ultrafiltration therapy in hospital-based outpatient heart failure programs, indicating a shift in focus towards this high-potential area [2] Clinical Trial Details - The REVERSE-HF trial began enrolling patients in 2022 and had enrolled 167 patients at the time of termination [3] - The company plans to collaborate with the steering committee and biostatisticians to derive statistical value from the existing data for future clinical publications [3] Product Information - The Nuwellis SmartFlow device remains on the market as an FDA-cleared treatment for fluid overload, and the termination of the trial was not related to device performance or patient safety concerns [4][6] - The Aquadex SmartFlow system is designed for ultrafiltration therapy, indicated for both adult and pediatric patients suffering from hypervolemia [6]

Core Insights - Nuwellis, Inc. has been granted U.S. Patent No. 12,357,734 for innovations in blood filtering and fluid management, enhancing its intellectual property portfolio [1][3] - The patent addresses inaccuracies in fluid balance calculations in continuous renal replacement therapy (CRRT) systems by incorporating fluid density, which can lead to clinically relevant errors if uncorrected [2] - The CEO of Nuwellis emphasized the importance of expanding the intellectual property portfolio as a strategy for long-term value creation through innovation [3] Company Overview - Nuwellis, Inc. is a medical technology company focused on fluid management solutions, particularly the Aquadex SmartFlow system for ultrafiltration therapy [5] - The Aquadex SmartFlow system is designed for patients suffering from fluid overload, providing a clinically proven method for excess fluid removal [6] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [5] Patent Details - The newly issued patent covers methods that allow CRRT systems to account for fluid density variations, improving volumetric flow tracking accuracy [2] - This innovation is crucial for enhancing the performance of extracorporeal fluid management systems [3]