Core Insights - Nuwellis, Inc. has reinforced its leadership in precision ultrafiltration for patients with acute kidney injury and fluid overload through new real-world data presented at the 2025 ASN Kidney Week [1][2] Group 1: Study Findings - A retrospective analysis reviewed 69 cases treated with Aquadex from 2018 to 2024, demonstrating effective fluid removal in patients with various underlying conditions [2] - The analysis revealed an average of 6.4 liters of ultrafiltrate removed over a mean duration of 78 hours, with stable hemodynamics even among patients on vasopressor support [3] - The study emphasizes that Aquadex can be safely applied across a wide range of complex patients, aiding clinicians in achieving euvolemia when other measures are insufficient [4] Group 2: Clinical Relevance - The findings support precision ultrafiltration as a complement to traditional kidney replacement therapy, with moderate and individualized ultrafiltration rates linked to improved outcomes in critically ill patients [5] - Aquapheresis is increasingly relevant in nephrology and critical care, where controlled fluid removal can stabilize hemodynamics and support renal recovery [6] - The study reflects a shift in fluid management practices, highlighting its importance as a vital sign of patient stability [7] Group 3: Company Overview - Nuwellis, Inc. is dedicated to advancing cardio-renal care by enabling earlier, safer, and more controlled fluid management for patients [8] - The Aquadex SmartFlow system is designed for ultrafiltration therapy, indicated for patients with fluid overload unresponsive to medical management [9]

Core Insights - Nuwellis, Inc. has announced the initiation of an Aquadex Ultrafiltration Program at a leading children's hospital in the Northeastern U.S., indicating a growing adoption of the therapy in pediatric nephrology and cardiology [1][2] - The Aquadex system is being integrated into care pathways for complex cardiac and critical care cases, highlighting its clinical value and strategic importance in Nuwellis' long-term growth plan [2][3] - The company's growth in the pediatric market is driven by clinicians seeking reliable solutions for fluid management, with Aquadex becoming a trusted option in pediatric care [3][4] Company Overview - Nuwellis, Inc. is focused on transforming the lives of patients suffering from fluid overload through innovative medical technology, specifically the Aquadex SmartFlow® system for ultrafiltration therapy [6][7] - The Aquadex SmartFlow system is indicated for use in both adult and pediatric patients weighing 20 kg or more, providing a method for removing excess fluid in cases unresponsive to traditional medical management [7] Market Dynamics - The adoption of Aquadex is accelerating in high-acuity pediatric settings across the nation, with children's hospitals recognizing its value in managing fluid-sensitive patients [2][3] - The integration of Aquadex into pediatric care reflects a broader trend of hospitals seeking controlled and predictable approaches to fluid management, which is essential for fragile pediatric patients [4]

Financial Performance - For the three months ended September 30, 2025, net sales were $2.217 million, a decrease of 6.3% compared to $2.367 million for the same period in 2024 [106]. - The cost of goods sold for the three months ended September 30, 2025, increased by 8.6% to $772,000 from $711,000 in the prior year [107]. - Selling, general and administrative expenses rose by 31.0% to $3.539 million for the three months ended September 30, 2025, compared to $2.702 million in the same period in 2024 [107]. - Research and development expenses increased by 24.1% to $603,000 for the three months ended September 30, 2025, from $486,000 in the prior year [107]. - For the nine months ended September 30, 2025, net sales were $5.846 million, down 8.9% from $6.418 million in the same period in 2024 [111]. - The cost of goods sold for the nine months ended September 30, 2025, increased by 13.3% to $2.376 million from $2.097 million in the prior year [112]. - Selling, general and administrative expenses decreased by 2.3% to $10.305 million for the nine months ended September 30, 2025, compared to $10.544 million in the same period in 2024 [112]. - Research and development expenses decreased by 23.1% to $1.828 million for the nine months ended September 30, 2025, from $2.378 million in the prior year [112]. - As of September 30, 2025, the company reported an accumulated deficit of $313.9 million and expects to incur losses for the foreseeable future [98]. Financing Activities - The company completed a public offering on June 10, 2025, raising approximately $5.0 million by selling 61,444 shares of Common Stock and warrants, with the public offering price set at $12.60 per share [78]. - An At The Market Offering Agreement was established on September 3, 2025, allowing the company to sell shares with an initial aggregate offering price of up to $4,650,000, resulting in net proceeds of approximately $1.9 million from 447,288 shares sold by September 30, 2025 [86]. - The Company plans to seek additional financing in the future, primarily through offerings of equity securities [119]. - Net cash provided by financing activities was $5.8 million for the nine months ended September 30, 2025, compared to $6.2 million for the same period in 2024 [122]. - The Company is obligated to pay a sales agent commission of up to 3.0% on gross proceeds from the sale of Common Stock under the Sales Agreement [118]. Operational Changes - Nuwellis announced the termination of its REVERSE-HF clinical trial, expecting to save approximately $4.0 million over the next 2.5 years by reallocating resources to areas with greater potential for impact [83]. - The company decided to exit selected international operations to focus on the U.S. market, where it is experiencing the strongest growth and clinical demand [84]. - Nuwellis entered into a non-binding letter of intent to acquire Rendiatech, Ltd., aiming to expand its technology platform into continuous renal health monitoring technologies [85]. - The company made a contractual payment of $240,000 to KDI Precision Manufacturing to enhance manufacturing capabilities and streamline operations [81]. Stock and Warrant Information - The Series A and B warrants from the public offering were valued at $10.6 million and $3.9 million at issuance, respectively, with a decrease in warrant liability of $0.8 million reported by June 30, 2025 [79]. - As of September 30, 2025, the fair value of unexercised Series B warrants was $21,004, with the majority of the liability associated with these warrants removed due to their exercise into Common Stock [80]. - As of September 30, 2025, the Company sold 447,288 shares of Common Stock, generating total net proceeds of approximately $1.9 million [118]. Cash Flow and Liquidity - As of September 30, 2025, the Company had cash and cash equivalents of $3.1 million, down from $5.1 million as of December 31, 2024 [119]. - Net cash used in operating activities was $7.7 million for the nine months ended September 30, 2025, compared to $8.1 million for the same period in 2024 [120]. - Net cash used in investing activities was $102,000 for the nine months ended September 30, 2025, an increase from $37,000 in the prior year [121]. - The cash used in investing activities in 2025 was primarily for the purchase of loaner and demo console units and office equipment [121]. - The Company has no material commitments for capital expenditures as of September 30, 2025 [123]. Management Changes - Robert B. Scott resigned as Chief Financial Officer on October 24, 2025, with John L. Erb appointed as interim CFO [88]. Regulatory and Compliance Issues - Nuwellis, Inc. received a Deficiency Notice from Nasdaq due to the closing bid price of its Common Stock being below $1.00 for 30 consecutive trading days, leading to potential delisting unless a hearing is requested [77]. - Forward-looking statements indicate potential risks related to funding and regulatory approvals that could impact future operations [124].

Financial Performance - Total revenue for Q3 2025 was $2.2 million, a decrease of 6% year-over-year but an increase of 29% sequentially[4] - Pro-forma revenue grew approximately 7% year-over-year after excluding one-time SeaStar medical revenue of $0.2 million from the prior year[5] - Gross margin was 65.2%, down from 70.0% in the prior year quarter due to unfavorable manufacturing utilization[6] - Operating expenses totaled $4.1 million, up 30% year-over-year, reflecting increased investment in rebuilding the U.S. sales force[7] - Operating loss was $2.7 million, compared to a loss of $1.5 million in the previous year[8] - Net loss for the nine months ended September 30, 2025, was $15,099,000, compared to a net loss of $9,697,000 for the same period in 2024, representing a 55.5% increase in losses[23] Cash Flow and Liquidity - The company ended the quarter with $3.1 million in cash and cash equivalents and remains debt-free[9] - Net cash used in operating activities was $7,780,000 for the nine months ended September 30, 2025, slightly improved from $8,087,000 in 2024[23] - Cash and cash equivalents at the end of the period were $3,094,000, up from $1,907,000 at the end of the same period in 2024, indicating a 62.3% increase[23] - Net cash provided by financing activities was $5,888,000, compared to $6,246,000 in the previous year, showing a decrease of 5.7%[23] - The company raised $1.9 million through an ATM facility during the quarter[4] - The company issued common stock and warrants from offerings, netting $3,999,000, an increase from $2,403,000 in 2024[23] - The company experienced a net decrease in cash and cash equivalents of $2,001,000, compared to a decrease of $1,893,000 in the prior year[23] Expense Management - Depreciation and amortization expenses decreased to $166,000 from $227,000, reflecting a 26.9% reduction[23] - Stock-based compensation expense decreased significantly to $103,000 from $374,000, a decline of 72.5%[23] Product Development and Market Expansion - All customer categories achieved year-over-year growth in circuit sales, indicating broader adoption across critical care, heart failure, and pediatrics[4] - The U.S. launch of a new 24-hour circuit and dual-lumen extended-length catheter enhances provider flexibility[4] - Pediatric product development accelerated through an NIH-funded collaboration and a newly issued U.S. patent[4] Warrant Liabilities - The change in fair value of warrant liabilities improved to a loss of $4,101,000 from a loss of $4,602,000, indicating a 10.9% improvement[23] - The reclassification of April 2024 warrants to equity was recorded as $0, down from $4,217,000 in 2024[23]

Core Viewpoint - Nuwellis is conducting a conference call to discuss its financial results for the third quarter of 2025, highlighting the importance of the information shared during the call [2][3]. Financial Results - The financial results for the third quarter ended September 30, 2025, were released earlier, and details can be found on the company's Investor page [3]. Leadership - The call features key executives including John Erb, Chairman of the Board and CEO, and Lynn Blake, the Interim Head of Finance [2].

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $2.2 million, a 6% decrease from Q3 2024, primarily due to one-time prior year Seastar Medical Quellimune sales and a decrease in international revenues [9] - On a proforma basis, revenue grew approximately 7% year-over-year after excluding the Seastar Medical revenue and the decrease in international revenue [9] - Gross margin for the quarter was 65.2%, down from 70% in Q3 2024, primarily due to underabsorption of fixed overhead from lower production volumes earlier in the year [10] - Operating loss for the quarter was $2.7 million compared to an operating loss of $1.5 million in Q3 2024 [11] - Net income attributable to common shareholders was $469,000 or $0.56 per share, compared to $2.4 million or $73.23 per share in the prior year quarter [11] Business Line Data and Key Metrics Changes - Heart failure and critical care customer categories saw revenue increases of 41% and 15% year-over-year, respectively, while pediatrics declined by 7% [10] - There was a 15% year-over-year increase in consumables utilization, which partially offset the revenue decline [9] - All customer categories experienced year-over-year growth in circuit sales, with heart failure and critical care benefiting from stronger console demand [10] Market Data and Key Metrics Changes - The company is focusing on three growth areas: critical care, pediatrics, and hospital-based outpatient heart failure therapy, which are expected to define a new standard for precision fluid management [13] - The introduction of new products, such as the 24-hour Aquadex circuit and dual-lumen extended length catheter, is aimed at expanding access and compatibility across care environments [6] Company Strategy and Development Direction - The company is transitioning manufacturing to KDI Precision Manufacturing and exiting European operations to sharpen focus on the U.S. market [7] - The strategy emphasizes clinical value, scalability, and growth in precision fluid management across the cardiorenal continuum [8] - The company aims to build a sustainable growth model centered on technology, evidence, and access to improve patient outcomes [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made in Q3, highlighting the growing adoption of Aquadex therapy and its impact on fluid management in hospitals [5] - The company anticipates realizing incremental cost efficiency from the manufacturing transition beginning next year, which should support margin expansion [10] Other Important Information - The company ended the quarter with $3.1 million in cash and cash equivalents and remained debt-free [12] - A net equity raise of $1.9 million in Q3, combined with a $4 million raise in June, provides flexibility for continued execution of the U.S. revenue growth strategy [12] - Recognition was given to Rob Scott for his contributions as Chief Financial Officer during his tenure [13] Q&A Session Summary Question: No questions were asked during the Q&A session - There were no questions from participants during the Q&A session [15]

Core Insights - Nuwellis, Inc. reported steady performance and key milestones in critical care, pediatrics, and hospital-based outpatient therapy, focusing on cardiorenal conditions [1][3] Financial Performance - Total revenue for Q3 2025 was $2.2 million, a decrease of 6% year-over-year but an increase of 29% sequentially from Q2 2025 [4][7] - On a pro-forma basis, revenue grew approximately 7% year-over-year after excluding one-time revenue from SeaStar Medical [4][7] - Gross margin was 65.2%, down from 70.0% in the prior year quarter, attributed to unfavorable manufacturing utilization [5] - Operating expenses totaled $4.1 million, up 30% year-over-year, reflecting investments in rebuilding the U.S. sales force and sustaining engineering [6] - The operating loss was $2.7 million, compared to $1.5 million in the previous year [6][19] Business Developments - The company launched a new 24-hour circuit and dual-lumen extended-length catheter, enhancing provider flexibility in therapy delivery [7] - The first Aquadex therapies were delivered in a hospital-based outpatient setting, marking a significant step in expanding access to ultrafiltration therapy [7] - Pediatric product development accelerated through an NIH-funded collaboration for the Vivian™ pediatric CRRT system [7] - Nuwellis initiated a manufacturing transition to KDI Precision Manufacturing and began winding down international operations to focus on U.S. market growth [7] Cash Position - The company ended the quarter with $3.1 million in cash and cash equivalents and remains debt-free [6][19]

Core Insights - Nuwellis, Inc. has received a notice of allowance for a new patent related to advanced safety mechanisms for blood return line clamps in extracorporeal blood filtration systems, specifically for the Vivian Pediatric Continuous Renal Replacement Therapy (CRRT) System [1][3] - The patented technology enhances safety by dynamically adjusting clamping force based on environmental factors and improving material stability through thermal insulation [2] - The company emphasizes its commitment to pediatric innovation and safety, with a growing portfolio of intellectual property supporting the Vivian system [3][4] Company Overview - Nuwellis, Inc. is a medical technology company focused on solutions for patients with cardio-renal conditions, headquartered in Minneapolis with a subsidiary in Ireland [6] - The company is dedicated to transforming the lives of patients suffering from fluid overload through innovative therapies, including the Aquadex SmartFlow system [6][7] Product Details - The Aquadex SmartFlow system is designed for ultrafiltration therapy in patients with fluid overload, indicated for both temporary and extended use in adults and pediatric patients weighing 20 kg or more [7] - The Vivian system is a pediatric CRRT platform designed for neonates and children, featuring integrated sensors for real-time monitoring and multiple therapy options [8]

Earnings Reports Overview - The earnings season is slowing down, but several retail-favorite companies are set to report this week [1] - Key companies reporting include Barrick Mining Corp., Plug Power Inc., Oklo Inc., Cisco Systems Inc., Walt Disney Co., and Applied Materials Inc. [2][3][5][10][11] Company-Specific Insights - Barrick Mining Corp. reported its third-quarter results before the market opened on November 10 [2] - Plug Power Inc. is expected to report losses of 12 cents per share and revenue of $179.54 million, having missed earnings expectations for the last 18 quarters [3] - Oklo Inc. is anticipated to report losses of 13 cents per share and revenue of $17.01 billion, with stock volatility noted ahead of the report [5] - Cisco Systems Inc. is expected to be a focal point for investors, particularly regarding management's guidance and updates on AI and cybersecurity business momentum [10] - Walt Disney Co. and JD.com Inc. will release earnings reports before the market opens on November 13 [11] - Applied Materials Inc. is set to release its Q4 results after the market closes on November 13 [11] Additional Companies Reporting - Other companies reporting this week include Workhorse Group Inc., Beyond Meat Inc., Microvision Inc., and Virgin Galactic Holdings Inc. [4][6][12]

Core Insights - Nuwellis, Inc. will release its financial results for Q3 2025 on November 12, 2025, 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 solutions for patients with cardio-renal conditions, particularly addressing the relationship between the heart and kidneys [1] - The company is dedicated to transforming the lives of patients suffering from fluid overload through innovation and collaboration [3] - Nuwellis is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] Product Information - The Aquadex SmartFlow system is designed for ultrafiltration therapy, effectively removing excess fluid from patients suffering from hypervolemia [4] - The system is indicated for temporary or extended use in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [4] - Treatments must be administered by trained healthcare providers in clinical settings under physician prescription [4]