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 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. 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]

Company Overview - Nuwellis, Inc. is a commercial-stage medical technology company focused on transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation [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 suffering from 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, including diuretics [4] Financial Results Announcement - Nuwellis will release its financial results for the first quarter of 2025 on May 13, 2025 [1] - A conference call and webcast will be hosted at 9:00 AM ET to discuss the financial results and provide a general business update [1]