Core Insights - Nuwellis, Inc. has completed the acquisition of Rendiatech, Inc., enhancing its capabilities in automated kidney function monitoring technology for critically ill patients [1][2] Group 1: Acquisition Details - The acquisition of Rendiatech allows Nuwellis to access assets previously held by RenalSense Ltd. after its bankruptcy [1] - Rendiatech's technology focuses on automated, continuous renal monitoring, providing real-time data to support clinical decision-making [3] Group 2: Product Integration - The new technology complements Nuwellis' existing Aquadex SmartFlow System, which is designed to manage fluid overload in patients [2] - Continuous renal monitoring is crucial for assessing kidney function and acute kidney injury (AKI), enabling timely clinical interventions [3] Group 3: Strategic Implications - The acquisition aligns with Nuwellis' strategy to enhance solutions for patients in cardiac surgery, critical care, and cardiorenal populations, where effective fluid management is vital [4] - The integration of real-time kidney function monitoring with targeted fluid removal aims to improve patient outcomes by allowing earlier identification and management of fluid balance issues [4]

Financial Performance - For the year ended December 31, 2025, net sales were $8.27 million, a decrease of 5.4% from $8.74 million in 2024, primarily due to a 2% decrease in circuit sales and lower average selling prices [301]. - The gross profit for 2025 was $5.12 million, down from $5.68 million in 2024, reflecting a gross margin of 61.9% [349]. - The net loss for 2025 was $17.52 million, compared to a net loss of $11.17 million in 2024, resulting in a basic and diluted loss per share of $25.39 [349]. - Cash and cash equivalents decreased to $1.09 million as of December 31, 2025, from $5.10 million in 2024 [347]. - The Company had total current liabilities of $3.03 million as of December 31, 2025, an increase from $2.56 million in 2024 [347]. - The Company reported a net loss of $17,521,000 for the year ended December 31, 2025, compared to a net loss of $11,165,000 in 2024 [384]. - Basic and diluted loss per share for 2025 was $(25.39), significantly higher than $(353.30) in 2024, reflecting the increased net loss [384]. - The company reported net cash used in operations of $10.8 million for the year ended December 31, 2025, compared to $9.6 million for the previous year, indicating increased cash outflows [355]. - The company had an accumulated deficit of $316.3 million as of December 31, 2025, indicating ongoing financial challenges [360]. Capital Raising and Financing - Nuwellis completed a public offering on June 10, 2025, raising approximately $5.0 million by selling 61,444 shares of Common Stock and warrants [267]. - The Company raised approximately $3.1 million from a private placement on January 29, 2026, for working capital and general corporate purposes [271]. - The company has raised approximately $57.0 million in net proceeds from public and private equity offerings since 2021, which is essential for ongoing operations [293]. - The company plans to seek additional capital to support growth and strategic initiatives, with no assurance of success in raising such funds [294]. - The gross proceeds from the private placement on January 29, 2026, were approximately $3.1 million [325]. - The Company intends to use the net proceeds from various offerings for working capital and general corporate purposes [315][325]. - The Company plans to seek additional financing to support operations and growth, particularly in expanding the Aquadex Business [329]. Operational Changes and Strategy - Nuwellis plans to exit selected international operations to focus on the U.S. market, where it is experiencing the strongest growth and clinical demand [278]. - The Company announced its decision to exit substantially all international operations to focus on the U.S. market, accruing approximately $246,000 in contractual exit fees [444]. - The Company is acquiring Rendiatech primarily to gain access to certain assets following the bankruptcy of RenalSense Ltd. [460]. - On January 29, 2026, Nuwellis entered into a Securities Purchase Agreement to acquire Rendiatech Ltd., a company focused on automated kidney function monitoring [279]. Research and Development - Research and development expenses decreased by 15.5% to $2.712 million in 2025 from $3.209 million in 2024, primarily due to reduced project spending [302][305]. - A research and development collaboration agreement was established with Koronis Biomedical Corporation, involving a non-refundable technology license fee of $600,000 [445]. - Research and development costs include expenses related to the Aquadex System and clinical trials, with a collaboration agreement with Koronis Biomedical Corporation involving a $600,000 technology license fee [386][385]. Stock and Equity - The Company issued warrants to purchase up to 623,585 shares of common stock, generating approximately $1.9 million in gross proceeds [327]. - The Series A warrants were valued at $10.6 million at issuance, decreasing to $10.0 million by June 30, 2025, indicating a $0.8 million reduction in warrant liability [268]. - The Series A Warrants were reset to an exercise price of $7.00 per share following a reverse stock split on July 3, 2025, where every 42 shares converted into one share [416]. - As of December 31, 2025, there were 1,334,937 warrants outstanding, exercisable at prices ranging from $7.00 to $36,750 per share [428]. Management and Governance - The Company appointed Carisa Schultz as Chief Financial Officer effective February 2, 2026, following the resignation of Robert B. Scott [461]. - E.F. Hutton & Co. filed a lawsuit against the Company alleging breach of engagement, seeking compensatory and punitive damages [462]. Compliance and Regulatory - The Company received a Deficiency Notice from Nasdaq on June 18, 2025, due to its stock price falling below $1.00 for 30 consecutive trading days, but later resolved the deficiency [266]. - The Company has adopted new accounting standards for segment reporting and income tax disclosures, effective for fiscal years 2024 and 2025 respectively [387][388].

Exhibit 99.1 Nuwellis, Inc. Announces Fourth Quarter and Full Year 2025 Financial Results MINNEAPOLIS – March 10, 2026 –Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today reported financial results for the fourth quarter and full year ended December 31, 2025. Fourth Quarter and Recent Highlights: "2025 was a year of structural change and strategic re-focus for Nuwellis," said John Erb, Chief Executive Officer of Nuwel ...

Financial Data and Key Metrics Changes - Full-year revenue for 2025 was $8.3 million, a 5% decrease compared to 2024, primarily due to lower consumables utilization and reduced international contributions [11] - Fourth-quarter revenue was $2.4 million, representing a 4% increase year-over-year and a 9% sequential increase, driven by a 208% increase in U.S. console sales [9][10] - Gross margin for the fourth quarter improved to 68.2%, up from 58.4% in the prior year [7][10] - Full-year operating expenses were $16.2 million, slightly lower than the previous year, reflecting improved expense discipline [11] Business Line Data and Key Metrics Changes - U.S. console sales increased by 208%, with 8 units sold compared to 3 in the prior year [9] - International sales increased by 59% year-over-year, largely due to last-time buys from distributors [9] - Heart failure and pediatrics segments grew by 8% and 14% year-over-year, respectively, while critical care revenue declined by 19% [11] Market Data and Key Metrics Changes - The company reduced exposure in certain international markets, particularly in the European Union, where it had consistently lost money [16] - The strategic rationalization of international contributions was a key factor in the overall revenue decline [11] Company Strategy and Development Direction - The company focused on the cardiorenal continuum, emphasizing the interrelation between cardiac and renal conditions [6] - A significant operational change included transitioning manufacturing to KDI Precision Manufacturing to enhance reliability and scalability [5] - The company aims to concentrate resources in areas with strong clinical adoption and economic value, rather than broad-based expansion [8] Management's Comments on Operating Environment and Future Outlook - Management highlighted 2025 as a year of structural change and repositioning, with a focus on operational strengthening and strategic clarity [4][25] - The company plans to maintain financial rigor, strengthen margin consistency, and prioritize capital efficiency as it scales into 2026 [26] - The integration of the Rendiatech acquisition is expected to enhance product offerings and improve utilization within existing accounts [22][26] Other Important Information - The company ended 2025 with approximately $1.2 million in cash and no outstanding debt, having raised about $7 million in net proceeds through financing activities [11] - The appointment of Carisa Schultz as Chief Financial Officer is expected to enhance financial leadership and operational transparency [8] Q&A Session Summary Question: Discussion on operational changes and sales focus - Management reinforced the direct sales team and focused on increasing utilization within existing accounts, particularly in critical care [15][21] Question: Incorporation of Rendiatech products into the portfolio - Rendiatech's technology will enhance the measurement of renal output in critical care, providing real-time data that is crucial for kidney health [18][19]

Financial Data and Key Metrics Changes - Full-year revenue for 2025 was $8.3 million, a 5% decrease compared to 2024, primarily due to lower consumables utilization and reduced international contributions [12] - Fourth quarter revenue was $2.4 million, representing a 4% increase year-over-year and a 9% sequential increase, driven by a 208% increase in U.S. console sales [10][11] - Gross margin for the fourth quarter improved to 68.2%, up 9.9 percentage points from the prior year [11] - Full-year operating expenses were $16.2 million, slightly lower than the prior year, reflecting improved expense discipline [12] Business Line Data and Key Metrics Changes - U.S. console sales increased by 208%, with 8 units sold compared to 3 in the prior year [10] - Heart failure and pediatrics segments grew by 8% and 14% year-over-year, respectively, while critical care revenue declined by 19% [12] - International sales increased by 59% year-over-year, largely due to last-time buys from distributors [10] Market Data and Key Metrics Changes - The company reduced exposure in certain international markets, particularly in the European Union, where it had been losing money [18] - The focus has shifted towards geographies with more predictable clinical demand and commercial conversion [5] Company Strategy and Development Direction - The company has clarified its strategic focus around the cardiorenal continuum, emphasizing the interrelation between cardiac and renal conditions [6] - A significant operational change included transitioning manufacturing to KDI Precision Manufacturing to enhance reliability and scalability [5] - The company aims to concentrate resources in areas with strong clinical adoption and economic value, rather than broad-based expansion [9] Management's Comments on Operating Environment and Future Outlook - Management described 2025 as a year of structural change and repositioning, with a focus on operational strengthening and strategic clarity [4][28] - The company plans to maintain financial rigor, strengthen margin consistency, and prioritize capital efficiency as it scales [29] - The integration of the Rendiatech acquisition is expected to enhance utilization within existing accounts, particularly in critical care [25] Other Important Information - The company ended the year with approximately $1.2 million in cash and no outstanding debt, emphasizing liquidity management as a priority [5][12] - The company received a National Institutes of Health grant to support pediatric device development, reinforcing the importance of this area [7][19] Q&A Session Summary Question: Discussion on operational changes and sales focus - Management reinforced the direct sales team and focused on increasing utilization within existing accounts, particularly in critical care [17][24] Question: Inquiry about the Rendiatech acquisition - The acquisition is expected to enhance capabilities in critical care, particularly in measuring renal output and electrolytes at the bedside [20][21]

Core Insights - Nuwellis, Inc. experienced a year of structural change and strategic re-focus in 2025, with a decline in full-year revenue compared to 2024, but fourth-quarter results showed stronger utilization trends and gross margin expansion [3][4] Fourth Quarter Highlights - Revenue for Q4 2025 was $2.4 million, reflecting a 4% increase year-over-year and a 9% increase sequentially, driven by a 208% increase in U.S. console sales and an 11% increase in circuit average selling price [4][8] - Gross margin improved to 68.2% in Q4 2025 from 58.4% in the prior-year quarter, attributed to better pricing and product mix [5][8] - Operating expenses for Q4 2025 were approximately $4.1 million, up from approximately $3.7 million in the prior-year quarter, resulting in an operating loss of approximately $2.4 million, consistent with the prior-year quarter [5][6] Full Year Financial Results - Total revenue for the full year 2025 was $8.3 million, a 5% decrease from the previous year, with Heart Failure revenue increasing by 8% and Pediatrics by 14%, while Critical Care revenue declined by 19% [7][9] - The gross margin for the full year was 62.0%, down from 64.9% in the prior year [7] - The net loss attributable to common shareholders for the full year was approximately $17.5 million, which included a $6.4 million non-cash warrant valuation expense [9] Strategic Developments - The company is entering 2026 with new momentum, including the acquisition of Rendiatech, the appointment of a new Chief Financial Officer, and additional capital to support operations [3][8] - The focus for 2026 includes integrating the Rendiatech acquisition, developing Vivian, a novel pediatric solution, and enhancing commercial execution [3]

Appointment Strengthens Clinical Leadership in Precision Fluid Management and Acute Kidney InjuryMINNEAPOLIS, March 05, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announced the appointment of Stuart L. Goldstein, MD, FASN as Director of Clinical Strategy. Dr. Goldstein is internationally recognized as a pioneer in pediatric nephrology and critical care medicine. He serves as Director o ...

Core Insights - Nuwellis, Inc. has appointed David A. McDonald and Martin J. Emerson to its Board of Directors, effective February 24, 2026, enhancing the board's expertise in public company leadership, capital markets, and medical device commercialization [1][2] Group 1: Board Appointments - The appointments are aimed at reinforcing operational discipline and long-term value creation for the company [2] - Martin J. Emerson has extensive experience in leading medical device organizations and has successfully guided companies through strategic transformations and acquisitions [3][4] - David A. McDonald brings over 25 years of experience in healthcare capital markets and corporate development, having raised nearly $200 million in capital during his career [5][6] Group 2: Company Overview - Nuwellis, Inc. focuses on advancing precision fluid management technologies for cardiorenal conditions, developing solutions for patient care through monitoring, therapy, and data-informed clinical decision-making [7] - The company's portfolio includes both commercially available and development-stage technologies aimed at addressing complex cardiorenal conditions, emphasizing safety, precision, and scalability [7] Group 3: Product Highlight - The Aquadex SmartFlow system is designed to remove excess fluid from patients suffering from hypervolemia, indicated for both temporary and extended use in adult and pediatric patients [8]

Core Insights - Nuwellis, Inc. will release its financial results for Q4 and full year 2025 on March 10, 2026, and will host a conference call at 9:00 AM ET to discuss these results and provide a business update [1] Company Overview - Nuwellis, Inc. is a medical technology company focused on precision fluid management technologies for cardiorenal conditions, developing solutions for patient care through monitoring, therapy, and data-informed clinical decision-making [3] - The company's portfolio includes both commercially available and development-stage technologies aimed at addressing complex cardiorenal conditions, emphasizing safety, precision, and scalability [3] Product Information - The Aquadex SmartFlow system is designed to remove excess fluid from patients with hypervolemia, indicated for temporary or extended use in patients weighing 20 kg or more, whose condition is unresponsive to medical management [4]

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