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]

MINNEAPOLIS, July 22, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical technology company focused on transforming the lives of people with fluid overload, today announced that it will release financial results for the second quarter 2025 on August 12, 2025. Nuwellis will host a conference call and webcast at 9:00 AM ET to discuss its financial results and provide a general business update. To access the live webcast, please visit the Investors page of the Nuwellis website a ...

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]

Core Points - Nuwellis, Inc. has appointed John Erb as Chief Executive Officer, effective June 27, 2025, after serving as interim CEO since February 2025 [1][2] - Erb previously held the CEO position from 2015 to 2020, and his reappointment indicates the Board's confidence in his leadership and understanding of the company's mission [2] - Under Erb's interim leadership, the company has experienced stability and renewed momentum [2] Company Overview - Nuwellis, Inc. is a medical technology company focused on fluid management solutions, particularly the Aquadex SmartFlow system for ultrafiltration therapy [4] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [4] Product Information - The Aquadex SmartFlow system is designed to remove excess fluid from patients suffering from hypervolemia, with indications for both temporary (up to 8 hours) and extended use [5] - The system is intended for adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management, including diuretics [5]

Core Viewpoint - Nuwellis, Inc. has successfully closed a public offering, raising approximately $5.0 million through the sale of common stock and warrants, aimed at transforming care for fluid overload patients [1][2]. Summary by Sections Public Offering Details - The offering included 2,580,667 shares of common stock and pre-funded warrants to purchase 14,085,998 shares, along with Series A and Series B Warrants [1]. - The public offering price was set at $0.30 per share and accompanying warrants, while the pre-funded warrants were priced at $0.2999 [2]. Warrant Specifications - Pre-funded warrants have an exercise price of $0.0001 and are immediately exercisable until fully exercised [3]. - Series A and Series B Warrants have an exercise price of $0.30 and will be exercisable for five years post stockholder approval [3]. - Series A Warrants include a one-time reset of the exercise price in case of a reverse stock split, while Series B Warrants offer a zero cash exercise option [3]. Underwriter Information - Ladenburg Thalmann & Co. Inc. served as the sole book-running manager for the offering [4]. Regulatory Compliance - The securities are offered under a registration statement on Form S-1, which was declared effective by the SEC on June 9, 2025 [5].

Core Viewpoint - Nuwellis, Inc. has announced a public offering of common stock and warrants to raise capital for working and corporate purposes, including potential acquisitions [1][2]. Group 1: Offering Details - The public offering includes 406,755 shares of common stock priced at $0.30 per share, along with pre-funded warrants for 14,085,998 shares priced at $0.2999 each [2]. - Accompanying the common stock are Series A Warrants for up to 43,478,259 shares and Series B Warrants for up to 14,492,753 shares, both with an exercise price of $0.30 [1][3]. - The offering is expected to close on or about June 10, 2025, subject to customary closing conditions [4]. Group 2: Warrant Details - Each pre-funded warrant has an exercise price of $0.0001 and is immediately exercisable until fully exercised [3]. - Series A and Series B Warrants will be exercisable for five years following stockholder approval, with Series A Warrants including a one-time reset of the exercise price under certain conditions [3]. - Series B Warrants offer a zero cash exercise option, allowing holders to receive shares without additional cash payment [3]. Group 3: Company Overview - Nuwellis, Inc. is a commercial-stage medical device company focused on treating fluid overload patients through innovative therapies [7]. - The company is commercializing the Aquadex SmartFlow system, which is designed for ultrafiltration therapy in patients unresponsive to medical management [8]. - Nuwellis is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [7].