MINNEAPOLIS, July 23, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc., today announced that John Erb, President and Chief Executive Officer of Nuwellis, participated in the Virtual Investor “What’s Your Story” Summer Spotlight On-Demand Conference. For the event, Mr. Erb dove deeper into his dedication to the Company, how he got to where he is today, and provided insight into why he is passionate about the Company’s programs in development. The on-demand video webcast is now available on the www.virtualinvestorco.c ...

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 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].

Nuwellis (NUWE) Q1 2025 Earnings Call May 13, 2025 09:00 AM ET Company Participants Louisa Smith - PrincipalJohn Erb - Chairman, Interim President & CEORob Scott - CFO Conference Call Participants Jonathan Aschoff - Managing Director, Senior Research Analyst Operator Good day, everyone, and welcome to Newellis First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. Later, you will have an opportunity to ask questions during the question and answer ...

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 reimbursed 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 [18] - 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 [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stabilization of critical care business volume in the upcoming quarter after a temporary decline [7][24] - The company is actively working with hospitals to implement outpatient clinics, expecting to see revenue growth in the second quarter and more rapid growth in the third and fourth quarters [28] 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 has signed an agreement with KDI Precision Manufacturing to move manufacturing, which is expected to result in meaningful expense reductions over the next twelve months [22] Q&A Session Summary Question: Was the drop in adult revenue entirely due to lower international sales? - The drop in critical care was primarily due to a large customer building inventory in the previous quarter, and they have begun repurchasing in the second quarter [24] Question: Is the drop in the first quarter seasonal? - Management indicated that there is not a lot of seasonality in the business, attributing the drop to a specific incident rather than a recurring pattern [25][26] Question: What does expanding the outpatient pipeline mean for Aquadex? - The company is currently working with four hospitals to implement outpatient clinics, identifying locations and nursing resources necessary to support these clinics [27] Question: Can you provide an update on the Phase three trial enrollment with Aquadex? - Enrollment for the REVERSE HF trial is ongoing, and the company is about halfway to its goal of 372 patients [30] Question: What is the timeline for the VIVIAN clinical trial? - The clinical trial will not start until later this year or early next year, pending further development of the device [31]

Nuwellis (NUWE) Q4 2024 Earnings Call March 11, 2025 09:00 AM ET Company Participants Vivian Cervantes - Managing DirectorJohn Erb - Chairman, Interim President & CEORob Scott - CFOAnthony Vendetti - Executive Managing Director Conference Call Participants Jonathan Aschoff - Managing Director, Senior Research Analyst Operator Good morning, and welcome to the Nuelles Earnings Conference Call for the Fourth Quarter and Full Year Ended 12/31/2024. All participants will be in a listen only mode. After today's p ...

Nuwellis (NUWE) Q4 2024 Earnings Call March 11, 2025 09:00 AM ET Company Participants Vivian Cervantes - Managing DirectorJohn Erb - Chairman, Interim President & CEORob Scott - CFOAnthony Vendetti - Executive Managing Director Conference Call Participants Jonathan Aschoff - Managing Director, Senior Research Analyst Operator Good morning, and welcome to the Nuelles Earnings Conference Call for the Fourth Quarter and Full Year Ended 12/31/2024. All participants will be in a listen only mode. After today's p ...