Awarded grant supports dedicated pediatric continuous renal replacement therapy (CRRT) device in development for patients between 2.5 and 20 kg where therapeutic options are scarce Company working to advance Vivian™ towards an investigational device study to support the path to US regulatory clearance MINNEAPOLIS, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Nuwellis Inc. (Nasdaq: NUWE), announced today that the National Institutes of Health (NIH) has awarded an approximately $3 million multi-year grant to its develo ...

Core Insights - Nuwellis, Inc. plans to launch a new 24-hour circuit for Aquadex therapy in the U.S. this fall, designed for single-day outpatient sessions, complementing the existing 72-hour option for multi-day therapy or inpatient care [1][3] - The introduction of the 24-hour circuit aligns with the growing trend of hospitals establishing outpatient Aquadex programs, aiming to provide predictable, scheduled care for patients needing fluid removal without hospital admission [2][3] Company Overview - Nuwellis, Inc. is a medical device company focused on transforming the lives of patients suffering from fluid overload through innovation and collaboration, with a primary focus on the Aquadex SmartFlow system for ultrafiltration therapy [5] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [5] Product Details - The Aquadex SmartFlow system is clinically proven for removing excess fluid from patients suffering from hypervolemia, indicated for temporary (up to 8 hours) or extended use in patients weighing 20 kg or more [6] - Treatments must be administered by trained healthcare providers in clinical settings under physician prescription [6]

Core Insights - Nuwellis, Inc. has received FDA 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC), enhancing its fluid management technology platform [1][2][5] Company Strategy - The clearance aligns with Nuwellis' multi-year plan to develop a comprehensive fluid management platform that integrates therapy delivery, venous access, and implementation support for hospitals and clinics [2][3] - The company's growth strategy focuses on three key areas: critical care, cardiac surgery recovery, and outpatient heart failure programs [2] Product Details - The dELC is designed for reliable peripheral venous access for up to 72 hours, supporting the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy [4][7] - The product portfolio now includes two coil-reinforced, 6F catheters with insertable lengths of 11 cm and 15 cm, catering to various patient anatomies and clinical workflows [5][9] Clinical Relevance - The dELC aims to provide dependable peripheral access across inpatient and outpatient settings, enhancing workflow efficiency and therapy delivery confidence [3][9] - The Aquadex SmartFlow system is indicated for temporary or extended use in patients with fluid overload unresponsive to medical management, emphasizing its clinical applicability [7]

Core Viewpoint - Nuwellis, Inc. has signed a non-binding letter of intent to acquire Rendiatech, Ltd., aiming to enhance its fluid management technology offerings, particularly in continuous renal health monitoring [1][3]. Company Overview - Nuwellis, Inc. is a medical technology company focused on improving patient outcomes through advanced fluid management, currently commercializing the Aquadex SmartFlow system for ultrafiltration therapy [7]. - Rendiatech, Ltd. specializes in real-time urine flow and acute kidney injury monitoring technologies, with its key product being the Clarity RMS, an FDA-cleared critical care monitoring system [6]. Proposed Acquisition Details - The acquisition will potentially add Rendiatech's Clarity RMS and the next-generation Clarity Prime system to Nuwellis' product portfolio, enhancing real-time urine monitoring capabilities [2][5]. - The transaction is expected to close in the fourth quarter of 2025, pending due diligence and final Board approval [5]. Strategic Importance - The acquisition aligns with Nuwellis' growth strategy to achieve cash flow positivity and enhance its comprehensive fluid management offerings [3]. - Real-time urine output monitoring is critical for detecting acute kidney injury (AKI), which affects 10% to 20% of emergency hospital admissions, with higher rates in ICU settings [4]. Market Impact - The integration of Rendiatech's technologies is anticipated to improve clinical outcomes through earlier detection of AKI and dehydration, particularly in complex ICU patients [4].

Company Overview - Nuwellis, Inc. is a medical technology company focused on fluid management solutions for critically ill patients [3] - 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] Upcoming Event - Nuwellis will present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech, held virtually from August 19-21, 2025 [1] - The presentation is scheduled for August 21, 2025, at 2:40 PM ET, and will be led by John Erb, President and CEO [1] - Registration for the event is available through a provided link [1] Industry Context - Webull Financial is a leading online brokerage platform that empowers self-directed investors with innovative tools and technology [2] - The platform offers low-cost trading on a wide range of assets and advanced charting tools, catering to millions of users globally [2] - Webull Financial is registered with the SEC and CFTC, and is a member of FINRA, NFA, and SIPC [2]

[PART I—FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section provides the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [ITEM 1. FINANCIAL STATEMENTS](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining the company's business, accounting policies, and significant financial events for the reported periods [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and stockholders' equity at specific points in time Condensed Consolidated Balance Sheets | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------------------------- | :----------------------------- | :----------------------------- | | Total Assets | $9,200 | $9,864 | | Total Liabilities | $18,155 | $3,334 | | Warrant Liabilities | $14,074 | $468 | | Total Stockholders' Equity (Deficit) | $(8,960) | $6,528 | - The company's financial position as of June 30, 2025, shows a decrease in total assets and a significant increase in total liabilities, primarily due to warrant liabilities, shifting stockholders' equity from a positive balance to a deficit[13](index=13&type=chunk)[14](index=14&type=chunk)[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This statement details the company's revenues, expenses, and net loss over specific reporting periods Condensed Consolidated Statements of Operations **Three Months Ended June 30:** | Metric | 2025 (in thousands) | 2024 (in thousands) | Change (2025 vs 2024) | % Change | | :--------------------------------- | :------------------ | :------------------ | :-------------------- | :------- | | Net Sales | $1,725 | $2,194 | $(469) | (21.4)% | | Gross Profit | $958 | $1,474 | $(516) | (35.0)% | | Total Operating Expenses | $3,864 | $3,794 | $70 | 1.8% | | Loss from Operations | $(2,906) | $(2,320) | $(586) | 25.3% | | Financing Expense | $(10,553) | $(5,607) | $(4,946) | 88.2% | | Change in fair value of warrant liabilities | $900 | $198 | $702 | 354.5% | | Net Loss | $(12,553) | $(7,725) | $(4,828) | 62.5% | | Basic and Diluted Loss per Share | $(60.99) | $(791.82) | $730.83 | (92.3)% | **Six Months Ended June 30:** | Metric | 2025 (in thousands) | 2024 (in thousands) | Change (2025 vs 2024) | % Change | | :--------------------------------- | :------------------ | :------------------ | :-------------------- | :------- | | Net Sales | $3,629 | $4,051 | $(422) | (10.4)% | | Gross Profit | $2,025 | $2,665 | $(640) | (24.0)% | | Total Operating Expenses | $7,991 | $9,734 | $(1,743) | (17.9)% | | Loss from Operations | $(5,966) | $(7,069) | $1,103 | (15.6)% | | Financing Expense | $(10,553) | $(5,607) | $(4,946) | 88.2% | | Change in fair value of warrant liabilities | $940 | $720 | $220 | 30.6% | | Net Loss | $(15,567) | $(12,055) | $(3,512) | 29.1% | | Basic and Diluted Loss per Share | $(100.44) | $(139.74) | $39.30 | (28.1)% | - The company's financial performance for the three and six months ended June 30, 2025, and 2024, shows a decrease in net sales and gross profit, and an increased net loss, significantly impacted by financing expenses and changes in fair value of warrant liabilities[17](index=17&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity(Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity(Deficit)) This statement tracks changes in the company's equity over time, reflecting net income/loss, stock transactions, and other comprehensive income Condensed Consolidated Statements of Stockholders' Equity (Deficit) | Metric | Balance Dec 31, 2024 (in thousands) | Net Loss (in thousands) | Stock-based Compensation (in thousands) | Issuance of Common Stock, net (in thousands) | Balance June 30, 2025 (in thousands) | | :------------------------------------ | :---------------------------------- | :---------------------- | :-------------------------------------- | :------------------------------------------- | :----------------------------------- | | Total Stockholders' Equity (Deficit) | $6,528 | $(15,567) | $84 | $3 | $(8,960) | - The statements outline changes in stockholders' equity (deficit) for the periods ended June 30, 2024, and June 30, 2025, reflecting net losses, stock-based compensation, and significant adjustments related to preferred stock and common stock issuances[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows **Six Months Ended June 30:** | Activity | 2025 (in thousands) | 2024 (in thousands) | | :--------------------------------- | :------------------ | :------------------ | | Net Cash Used in Operating Activities | $(4,633) | $(5,616) | | Net Cash Used in Investing Activities | $(4) | $(53) | | Net Cash Provided by Financing Activities | $3,999 | $2,903 | | Net Decrease in Cash and Cash Equivalents | $(645) | $(2,777) | | Cash and Cash Equivalents - End of Period | $4,450 | $1,023 | - The statements provide a breakdown of cash flows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024, indicating continued cash usage in operations, minimal investing, and reliance on financing activities[22](index=22&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the condensed consolidated financial statements, covering the nature of business, accounting policies, significant financial instruments, and recent corporate events - This section provides detailed explanations and disclosures for the condensed consolidated financial statements, covering the nature of business, accounting policies, significant financial instruments, and recent corporate events[24](index=24&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) [Note 1 – Nature of Business and Basis of Presentation](index=7&type=section&id=Note%201%20%E2%80%93%20Nature%20of%20Business%20and%20Basis%20of%20Presentation) This note describes the company's core business, its financial condition, and the basis for preparing the financial statements - Nuwellis, Inc. is a medical technology company focused on commercializing the Aquadex SmartFlow system for ultrafiltration therapy for fluid overload[24](index=24&type=chunk)[25](index=25&type=chunk) - The company has an accumulated deficit of **$314.4 million** as of June 30, 2025, and expects to incur losses, raising substantial doubt about its ability to continue as a going concern[28](index=28&type=chunk) - In 2024, the company reduced its monthly cash burn rate by approximately **40%** through various cost-cutting measures, but some reductions were restored in late 2024[30](index=30&type=chunk) - Existing capital resources are believed to be sufficient into Q4 2025, but additional capital will be sought through debt or equity[31](index=31&type=chunk) [Note 2 – Revenue Recognition](index=9&type=section&id=Note%202%20%E2%80%93%20Revenue%20Recognition) This note outlines the company's policies for recognizing revenue from its product sales - Revenue is primarily generated from the sale of disposable blood filters and catheters for the Aquadex System in the U.S. (direct salesforce) and internationally (specialty distributors)[39](index=39&type=chunk) International Revenue as Percentage of Net Sales | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | International Revenue % of Net Sales | 3% | 3% | 4% | 4% | - One customer represented **20% of net sales** for the three months ended June 30, 2025, and **16%** for the six months ended June 30, 2025[33](index=33&type=chunk) [Note 3 – Stockholders' Equity](index=10&type=section&id=Note%203%20%E2%80%93%20Stockholders'%20Equity) This note details the components of stockholders' equity, including preferred stock, common stock, and related transactions - The Series F convertible preferred stock has full ratchet price-based anti-dilution protection, with its conversion price recalculated to **$397.00** as of July 7, 2025[45](index=45&type=chunk)[46](index=46&type=chunk) - In June 2025, the company closed a public offering of common stock and pre-funded warrants, along with Series A and Series B Warrants, raising approximately **$5.0 million** in gross proceeds[50](index=50&type=chunk) - A one-for-forty-two reverse stock split became effective on July 3, 2025, adjusting share and per-share amounts retroactively[53](index=53&type=chunk) [Note 4 - Stock-Based Compensation](index=12&type=section&id=Note%204%20-%20Stock-Based%20Compensation) This note outlines the accounting for stock-based compensation expenses Total Stock-Based Compensation Expense (in thousands) | Period | 2025 | 2024 | | :------------------- | :--- | :--- | | Three months ended June 30 | $17 | $115 | | Six months ended June 30 | $84 | $273 | - The total number of stock options outstanding as of June 30, 2025, was **4,471**, significantly higher than **79** as of June 30, 2024[56](index=56&type=chunk) [Note 5—Fair Value of Financial Instruments](index=13&type=section&id=Note%205%E2%80%94Fair%20Value%20of%20Financial%20Instruments) This note describes the valuation methods and fair value measurements for the company's financial instruments, particularly warrant liabilities Warrant Liabilities (in thousands) | Type | June 30, 2025 | December 31, 2024 | | :-------------------- | :-------------- | :---------------- | | Warrant liability Series A | $9,991 | $— | | Warrant liability Series B | $3,674 | $— | | Warrant liability Series J | $409 | $468 | | Total warrant liabilities | $14,074 | $468 | - The Series A and B warrants from the June 2025 offering were classified as a liability, with an initial valuation of **$14.5 million**, exceeding the **$5.0 million** gross proceeds, resulting in a 'Financing expense' for the difference[51](index=51&type=chunk) [Note 6 – Income Taxes](index=14&type=section&id=Note%206%20%E2%80%93%20Income%20Taxes) This note discusses the company's income tax position, including deferred tax assets and valuation allowances - The company has a full valuation allowance for its U.S. and foreign deferred tax assets due to uncertainty of generating sufficient taxable income[60](index=60&type=chunk) - The company is evaluating ASU No. 2023-09, 'Improvements to Income Tax Disclosures,' and anticipates adopting it for the annual period ending December 31, 2025[37](index=37&type=chunk)[61](index=61&type=chunk) [Note 7—Operating Leases](index=14&type=section&id=Note%207%E2%80%94Operating%20Leases) This note provides information on the company's operating lease commitments - The company leases a 23,000 sq ft facility in Eden Prairie, Minnesota, for its headquarters and manufacturing, with the lease expiring in March 2027[62](index=62&type=chunk) [Note 8—Commitments and Contingencies](index=14&type=section&id=Note%208%E2%80%94Commitments%20and%20Contingencies) This note discloses the company's significant commitments and potential contingent liabilities - The company offers a 401(k) retirement plan to eligible U.S. employees, with discretionary matching contributions[63](index=63&type=chunk) [Note 9—Segment Reporting](index=14&type=section&id=Note%209%E2%80%94Segment%20Reporting) This note provides information about the company's operating segments and key expense categories - Nuwellis operates as a single reportable segment focused on fluid overload, with the CEO as the chief operating decision maker[64](index=64&type=chunk) Key Expense Categories (in thousands) | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | General and administrative | $1,347 | $1,405 | $3,189 | $3,510 | | Sales and marketing | $1,598 | $1,495 | $3,028 | $3,576 | | Development | $327 | $246 | $533 | $1,116 | | Clinical, Quality, Regulatory | $575 | $533 | $1,157 | $1,259 | [Note 10—Subsequent Events](index=15&type=section&id=Note%2010%E2%80%94Subsequent%20Events) This note reports significant events that occurred after the balance sheet date but before the financial statements were issued - The company received a Nasdaq deficiency notice in May 2024 for not meeting the minimum stockholders' equity requirement, but was granted continued listing subject to compliance by Q3 2024[69](index=69&type=chunk)[70](index=70&type=chunk) - A June 2025 offering and subsequent reclassification of Series A and Series B warrants from liability to equity resulted in a pro forma stockholders' equity of **$4.507 million** as of June 30, 2025, which the company believes maintains Nasdaq compliance[71](index=71&type=chunk)[72](index=72&type=chunk)[74](index=74&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=16&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's perspective on the company's financial condition, results of operations, and liquidity, discussing recent developments, critical accounting policies, and future outlook, including a detailed comparison of financial performance for the three and six months ended June 30, 2025, versus 2024 [OVERVIEW](index=16&type=section&id=OVERVIEW) This section introduces the company's business and its primary product, the Aquadex SmartFlow system - Nuwellis is a medical technology company focused on commercializing the Aquadex SmartFlow system for ultrafiltration therapy for fluid overload in adult and pediatric patients weighing 20 kg or more[77](index=77&type=chunk) - The company shifted its strategy in 2016 to focus entirely on the Aquadex Business after acquiring it from Baxter, and changed its name to Nuwellis, Inc. in 2021 to reflect expanded applications beyond congestive heart failure[78](index=78&type=chunk) [Recent Developments](index=17&type=section&id=Recent%20Developments) This section highlights key corporate actions and strategic shifts impacting the company's operations and financial standing - Nuwellis resolved a Nasdaq bid price deficiency in July 2025, following a 2025 Reverse Stock Split, ensuring continued listing on the Nasdaq Capital Market[79](index=79&type=chunk) - The company completed a public offering on June 10, 2025, raising approximately **$5.0 million** in gross proceeds through the sale of common stock and warrants[80](index=80&type=chunk) - The REVERSE-HF clinical trial was terminated on July 17, 2025, to reallocate resources to outpatient heart failure, pediatric, and critical care, expecting to save approximately **$4.0 million** over 2.5 years[85](index=85&type=chunk) - The company decided to exit international operations on August 7, 2025, to focus exclusively on the U.S. market, where it sees the strongest growth and clinical demand[86](index=86&type=chunk) [CRITICAL ACCOUNTING POLICIES AND ESTIMATES](index=19&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20ESTIMATES) This section discusses the significant accounting policies and estimates that require management's judgment and can materially affect financial reporting - The company's financial statements are prepared assuming it continues as a going concern, despite an accumulated deficit of **$314.4 million** as of June 30, 2025, and expected future losses[96](index=96&type=chunk) - The company accounts for warrants as liabilities or equity based on ASC 480, with liability-classified warrants remeasured at fair value each balance sheet date using a Monte Carlo simulation model[90](index=90&type=chunk)[91](index=91&type=chunk) - Long-lived assets are reviewed for impairment whenever circumstances indicate carrying value may not be recoverable, with fair value determined using expected discounted cash flows or replacement cost[93](index=93&type=chunk)[95](index=95&type=chunk) [NEW ACCOUNTING PRONOUNCEMENTS](index=21&type=section&id=NEW%20ACCOUNTING%20PRONOUNCEMENTS) This section outlines recently issued accounting standards and their potential impact on the company's financial statements - The company is evaluating ASU No. 2023-09, 'Income Taxes (Topic 740): Improvements to Income Tax Disclosures,' and plans to adopt it for the annual period ending December 31, 2025[101](index=101&type=chunk) [FINANCIAL OVERVIEW](index=22&type=section&id=FINANCIAL%20OVERVIEW) This section provides a summary of the company's business model and its overall financial position - Nuwellis is a medical technology company commercializing the Aquadex System for ultrafiltration treatment of fluid overload, with activities focused on sales, marketing, R&D, and clinical studies since acquiring the Aquadex business in 2016[103](index=103&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$304.7 million** and expects to incur future losses, relying on public and private equity financings for funding[103](index=103&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance for the three and six months ended June 30, 2025, compared to the prior year, detailing changes in net sales, cost of goods sold, and operating expenses - This section analyzes the company's financial performance for the three and six months ended June 30, 2025, compared to the prior year, detailing changes in net sales, cost of goods sold, and operating expenses[104](index=104&type=chunk)[105](index=105&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk) [Comparison of three months ended June 30, 2025 to three months ended June 30, 2024](index=22&type=section&id=Comparison%20of%20three%20months%20ended%20June%2030%2C%202025%20to%20three%20months%20ended%20June%2030%2C%202024) This subsection compares the company's financial performance for the three-month periods, highlighting key revenue and expense trends Three Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Increase (Decrease) | % Change | | :-------------------------- | :--- | :--- | :------------------ | :------- | | Net Sales | $1,725 | $2,194 | $(469) | (21.4)% | | Cost of Goods Sold | $767 | $720 | $47 | 6.5% | | Selling, General and Administrative | $3,189 | $3,236 | $(47) | (1.5)% | | Research and Development | $675 | $558 | $117 | 21.0% | - The decrease in net sales was primarily due to a **21% decrease** in circuit sales and a temporary backorder of approximately **$400,000** in circuit revenue due to an industry-wide sterilization vendor issue[104](index=104&type=chunk) - Cost of goods sold increased due to unfavorable manufacturing variances and under-absorption of fixed overhead from lower production volumes[106](index=106&type=chunk) [Comparison of six months ended June 30, 2025 to six months ended June 30, 2024](index=23&type=section&id=Comparison%20of%20six%20months%20ended%20June%2030%2C%202025%20to%20six%20months%20ended%20June%2030%2C%202024) This subsection compares the company's financial performance for the six-month periods, detailing changes in sales and operating expenses Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Increase (Decrease) | % Change | | :-------------------------- | :--- | :--- | :------------------ | :------- | | Net Sales | $3,629 | $4,051 | $(422) | (10.4)% | | Cost of Goods Sold | $1,604 | $1,386 | $218 | 15.7% | | Selling, General and Administrative | $6,766 | $7,842 | $(1,076) | (13.7)% | | Research and Development | $1,225 | $1,892 | $(667) | (35.3)% | - The decrease in net sales was primarily due to a **9% decrease** in circuit sales, console sales, and International sales[109](index=109&type=chunk) - Selling, general and administrative expenses decreased due to reduced headcount, compensation, and professional services fees[112](index=112&type=chunk) - Research and development expenses decreased due to reduced headcount, compensation, and R&D project spend[113](index=113&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to generate and manage cash flow to meet its financial obligations and fund operations - Cash and cash equivalents were **$4.5 million** as of June 30, 2025, down from **$5.1 million** at December 31, 2024[116](index=116&type=chunk) - Net cash used in operating activities was **$4.6 million** for the six months ended June 30, 2025, an improvement from **$5.6 million** in the prior year period[117](index=117&type=chunk) - Net cash provided by financing activities was **$4.0 million** for the six months ended June 30, 2025, primarily from the June 2025 public offering[119](index=119&type=chunk) - The company expects existing capital resources to support operations into Q4 2025 but will seek additional financing to support growth or strategic initiatives[100](index=100&type=chunk)[116](index=116&type=chunk) [Forward-Looking Statements and Risk Factors](index=24&type=section&id=Forward-Looking%20Statements%20and%20Risk%20Factors) This section cautions readers about forward-looking statements and highlights the inherent risks and uncertainties affecting the company's future performance - The discussion contains forward-looking statements based on management's beliefs and expectations, which are subject to risks and uncertainties that could cause actual results to differ materially[121](index=121&type=chunk) - The company operates in an evolving environment, and new risk factors and uncertainties may emerge, making it impossible to predict all potential impacts[121](index=121&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=25&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) This section states that quantitative and qualitative disclosures about market risk are not applicable to the company [ITEM 4. CONTROLS AND PROCEDURES](index=25&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) This section details the evaluation of the company's disclosure controls and procedures, concluding that they were not effective as of June 30, 2025, due to identified material weaknesses in internal controls over financial reporting - Management concluded that the company's disclosure controls and procedures were not effective at a reasonable assurance level as of June 30, 2025, due to two identified material weaknesses in controls over financial reporting[126](index=126&type=chunk) - No material changes occurred in internal control over financial reporting during the quarter, but changes are expected as a result of the identified material weaknesses[127](index=127&type=chunk) [PART II—OTHER INFORMATION](index=25&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits [ITEM 1. LEGAL PROCEEDINGS](index=25&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) This section states that there are no legal proceedings to report for the company [ITEM 1A. RISK FACTORS](index=25&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section updates the company's risk factors, primarily focusing on the potential delisting of common stock from Nasdaq due to non-compliance with stockholders' equity requirements, risks related to off-label use of products, and potential impacts from changes in trade policies and supply chain disruptions - Nasdaq may delist the company's common stock if it fails to maintain compliance with minimum financial and other requirements, including the stockholders' equity requirement[132](index=132&type=chunk)[133](index=133&type=chunk) - As of June 30, 2025, the company's reported stockholders' equity was below the Nasdaq requirement, but a pro forma adjustment for warrant reclassification results in **$4.507 million**, which the company believes maintains compliance[139](index=139&type=chunk) - The company faces risks related to off-label use of its products, which could lead to substantial civil and criminal penalties, regulatory actions, and lawsuits if communications are deemed impermissible promotion[143](index=143&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk) - Disruptions in supply from sole source suppliers, changes in U.S. tariffs/import/export regulations, and changes in U.S. federal government funding for regulatory agencies could adversely impact the business[150](index=150&type=chunk)[155](index=155&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=29&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section reports that there were no unregistered sales of equity securities during the quarter ended June 30, 2025, that were not previously reported on a Current Report on Form 8-K [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=29&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) This section states that there are no defaults upon senior securities to report for the company [ITEM 4. MINE SAFETY DISCLOSURES](index=29&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This section states that mine safety disclosures are not applicable to the company [ITEM 5. OTHER INFORMATION](index=29&type=section&id=ITEM%205.%20OTHER%20INFORMATION) This section reports that no directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended June 30, 2025 [ITEM 6. EXHIBITS](index=29&type=section&id=ITEM%206.%20EXHIBITS) This section provides a comprehensive list of exhibits filed as part of the Quarterly Report on Form 10-Q, including corporate governance documents, agreements, and certifications - The exhibit index lists various corporate documents, including amendments to the Certificate of Incorporation, Bylaws, Certificates of Designation for preferred stock, supply agreements, employment agreements, and certifications[165](index=165&type=chunk)[167](index=167&type=chunk)

[Q2 2025 Financial Results and Business Highlights](index=1&type=section&id=Q2%202025%20Financial%20Results%20and%20Business%20Highlights) Nuwellis reported Q2 2025 revenue of **$1.7 million**, a decline from **$2.2 million** in Q2 2024, with increased operating and net losses, while strategically realigning its business focus [Q2 2025 Business Highlights](index=1&type=section&id=Second%20Quarter%202025%20and%20Recent%20Business%20Highlights) Nuwellis strategically realigned in Q2 2025, focusing on high-impact growth areas and completing a **$5 million** capital raise despite a temporary revenue disruption - Strategic realignment focused on high-impact growth areas in pediatric and cardiac surgery care, laying the foundation for expansion in outpatient heart failure[3](index=3&type=chunk) - Faced a temporary revenue disruption due to an industry-wide sterilization vendor issue, but took swift action to prioritize patient care[3](index=3&type=chunk)[4](index=4&type=chunk) - Executed a transition plan to outsource manufacturing to KDI Precision Manufacturing[8](index=8&type=chunk) - Completed a **$5 million** gross capital raise during the quarter[8](index=8&type=chunk) - Successfully grew to **47 pediatric centers** that adopted Aquadex therapy, with the addition of two new centers across the Southeastern United States[8](index=8&type=chunk) - Expanded IP portfolio with the granting of a new U.S. patent covering the fluid bag design[8](index=8&type=chunk) [Q2 2025 Financial Overview](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) Nuwellis reported Q2 2025 revenue of **$1.7 million**, a decline from **$2.2 million** in Q2 2024, with increased operating and net losses, but maintained a debt-free status Q2 2025 Financial Highlights (in millions, except per share and percentage) | Metric | Q2 2025 ($) | Q2 2024 ($) | Change (YoY) | | :------------------------------------ | :------ | :------ | :----------- | | Revenue | $1.7 | $2.2 | -22.7% | | Gross Margin | 55.5% | 67.2% | -11.7 pp | | SG&A Expenses | $3.2 | $3.2 | 0% | | R&D Expenses | $0.675 | $0.558 | +20.9% | | Total Operating Expenses | $3.9 | $3.794 | +2.8% | | Operating Loss | $(2.9) | $(2.3) | -26.1% | | Net Loss Attributable to Common Shareholders | $(12.6) | $(7.7) | -63.6% | | Basic and Diluted Loss Per Share | $(60.99) | $(791.82) | +92.3% (less negative) | | Cash and Cash Equivalents (as of June 30, 2025) | $4.5 | N/A | N/A | | Debt Status | Debt-free | N/A | N/A | - Revenue decline was primarily due to a product backorder caused by an industry-wide sterilization delay[4](index=4&type=chunk) - Gross margin contraction was primarily driven by under-absorption of fixed overhead because of lower production volumes[5](index=5&type=chunk) [Company and Investor Information](index=2&type=section&id=Company%20and%20Investor%20Information) This section provides details on Nuwellis's corporate profile, the Aquadex SmartFlow® system, investor communication, and forward-looking statement disclaimers [Conference Call and Webcast Information](index=2&type=section&id=Conference%20Call%20and%20Webcast%20Information) Nuwellis hosted a conference call and webcast on August 14, 2025, at 9:00 AM ET to discuss Q2 results and business developments - Conference call and webcast held on August 14, 2025, at 9:00 AM ET to discuss Q2 results and recent business developments[10](index=10&type=chunk) - Access via the Investors page of the Nuwellis website (https://ir.nuwellis.com) or dial-in (1-800-245-3047 U.S. / 1-203-518-9765 International) using conference ID: NUWEQ2[10](index=10&type=chunk) [About Nuwellis](index=2&type=section&id=About%20Nuwellis) Nuwellis, Inc. is a commercial-stage medical device company focused on transforming care for fluid overload patients through the Aquadex SmartFlow® system - Nuwellis, Inc. (Nasdaq: NUWE) is a commercial-stage medical device company[11](index=11&type=chunk) - Dedicated to transforming the lives of patients suffering from fluid overload[11](index=11&type=chunk) - Focuses on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy[11](index=11&type=chunk) [About the Aquadex SmartFlow® System](index=2&type=section&id=About%20the%20Aquadex%20SmartFlow%C2%AE%20System) The Aquadex SmartFlow® system provides clinically proven ultrafiltration therapy for fluid overload in adult and pediatric patients unresponsive to medical management - Delivers clinically proven therapy using a simple, flexible, and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload)[12](index=12&type=chunk) - Indicated for temporary (up to 8 hours) or extended (longer than 8 hours in hospitalized patients) use in adult and pediatric patients weighing **20 kg** or more[12](index=12&type=chunk) - Applicable to patients whose fluid overload is unresponsive to medical management, including diuretics[12](index=12&type=chunk) - Treatments must be administered by a healthcare provider within an outpatient or inpatient clinical setting, under physician prescription, with training in extracorporeal therapies[12](index=12&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) The release contains forward-looking statements based on current assumptions, involving risks and uncertainties, with no obligation for Nuwellis to update them - Statements in the release may be considered forward-looking, including those regarding future growth and market opportunities[13](index=13&type=chunk) - Forward-looking statements are based on current assumptions and expectations and involve risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission[13](index=13&type=chunk) - Nuwellis undertakes no obligation to update any forward-looking statements[13](index=13&type=chunk) [Contacts](index=3&type=section&id=Contacts) Contact information for investor relations and media inquiries is provided for Nuwellis, Inc - Investors contact: Robert Scott, Chief Financial Officer (ir@nuwellis.com)[14](index=14&type=chunk) - Media contact: Leah McMullen, Director of Communications (Leah.mcmullen@nuwellis.com)[14](index=14&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents Nuwellis's Q2 2025 condensed consolidated balance sheets, statements of operations, and cash flows, highlighting key financial performance and position metrics [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Nuwellis reported total assets of **$9.2 million**, a significant increase in total liabilities to **$18.155 million**, and a shift to negative stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 ($) | Dec 31, 2024 ($) | Change ($) | | :-------------------------- | :------------ | :----------- | :----- | | Cash and cash equivalents | $4,450 | $5,095 | $(645) | | Total current assets | $8,416 | $8,855 | $(439) | | Total assets | $9,200 | $9,864 | $(664) | | Total current liabilities | $3,892 | $2,559 | $1,333 | | Warrant liabilities | $14,074 | $468 | $13,606 | | Total liabilities | $18,155 | $3,334 | $14,821 | | Total stockholders' equity | $(8,960) | $6,528 | $(15,488) | - Significant increase in warrant liabilities from **$468 thousand** at December 31, 2024, to **$14,074 thousand** at June 30, 2025[16](index=16&type=chunk) - Total stockholders' equity shifted from positive **$6,528 thousand** to negative **$(8,960) thousand**[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Nuwellis reported Q2 2025 net sales of **$1.725 million**, a wider operating loss of **$(2.906) million**, and a significantly increased net loss of **$(12.552) million** due to substantial financing expense Q2 2025 and YTD June 30, 2025, Statements of Operations Highlights (in thousands, except per share) | Metric | Three months ended June 30, 2025 ($) | Three months ended June 30, 2024 ($) | Six months ended June 30, 2025 ($) | Six months ended June 30, 2024 ($) | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net sales | $1,725 | $2,194 | $3,629 | $4,051 | | Gross profit | $958 | $1,474 | $2,025 | $2,665 | | Total operating expenses | $3,864 | $3,794 | $7,991 | $9,734 | | Loss from operations | $(2,906) | $(2,320) | $(5,966) | $(7,069) | | Financing expense | $(10,553) | $(5,607) | $(10,553) | $(5,607) | | Net loss attributable to common shareholders | $(12,552) | $(7,725) | $(15,565) | $(11,514) | | Basic and diluted loss per share | $(60.99) | $(791.82) | $(100.44) | $(139.74) | - Net sales decreased by **21.3%** for the three months ended June 30, 2025, compared to the same period in 2024[18](index=18&type=chunk) - Financing expense significantly increased to **$(10,553) thousand** in Q2 2025 from **$(5,607) thousand** in Q2 2024[18](index=18&type=chunk) - Basic and diluted loss per share decreased from **$(791.82)** to **$(60.99)** despite a larger net loss, due to a substantial increase in weighted average shares outstanding (from **9,755** to **205,839**)[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, Nuwellis saw improved net cash used in operating activities and increased cash from financing, resulting in a **$(645) thousand** net decrease in cash Six Months Ended June 30, 2025, Cash Flow Highlights (in thousands) | Metric | Six months ended June 30, 2025 ($) | Six months ended June 30, 2024 ($) | | :------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(4,633) | $(5,616) | | Net cash used in investing activities | $(4) | $(53) | | Net cash provided by financing activities | $3,999 | $2,903 | | Net decrease in cash and cash equivalents | $(645) | $(2,777) | | Cash and cash equivalents - end of period | $4,450 | $1,023 | - Net cash used in operating activities decreased by **17.5%** year-over-year[20](index=20&type=chunk) - Net cash provided by financing activities increased by **37.7%** year-over-year, driven by the issuance of common stock and warrants from offering[20](index=20&type=chunk)

Financial Data and Key Metrics Changes - Revenue for the second quarter was CAD1.7 million, a year-over-year decline of 21% [5][13] - Gross margin for the quarter was 55.5%, down from 67.2% in Q2 2024 [14] - Operating loss for Q2 was $2.9 million compared to $2.3 million in Q2 2024 [15] - Net loss attributable to common shareholders was $12.6 million, or a loss of $60.99 per share, compared to a net loss of $7.7 million, or a loss of $791.22 per share for the same period in 2024 [15] Business Line Data and Key Metrics Changes - Pediatric revenues increased by 23% compared to 2024 [13] - Heart failure and critical care revenues declined by 53% and 35% respectively, significantly impacted by the temporary backorder [13] Market Data and Key Metrics Changes - The pediatrics business remains strong with ongoing interest from new centers [7] - The outpatient heart failure opportunity is expected to grow due to increased reimbursement rates [23] Company Strategy and Development Direction - The company is focused on strengthening fundamentals, operational discipline, and strategic investments in high-impact growth areas [5] - Key growth areas identified include cardiac surgery, pediatrics, and outpatient heart failure [11][17] - The transition to KDI precision manufacturing is planned for October, expected to yield operational efficiencies and cost savings [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating temporary setbacks and emphasized a commitment to delivering value to patients and shareholders [16] - The company aims to progress towards being cash flow positive and deepen outpatient engagement with heart failure programs [17] Other Important Information - The company ended the REVERSE HF clinical trial to reallocate approximately $4 million towards higher impact growth areas [10] - The company ended the quarter with $4.5 million in cash and cash equivalents and remains debt-free [15] Q&A Session Summary Question: Resolution of sterilization vendor issue and impact on Q3 - The issue was resolved in July, and the company is no longer in backorder, rapidly building finished goods inventory [20][21] Question: Largest opportunity among pediatrics, critical care, and heart failure - Management sees growth opportunities in all three areas, with heart failure expected to grow the fastest due to outpatient opportunities and increased reimbursement [22][23]

MINNEAPOLIS, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical technology company dedicated to transforming care for fluid overload patients, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. Second Quarter 2025 and Recent Business Highlights Nuwellis continued to advance its strategic realignment during the second quarter, sharpening focus on high-impact growth areas in pediatric and cardiac surgery care w ...

MINNEAPOLIS, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company delivering fluid management solutions for critically ill patients, today announced its decision to exit international operations in order to focus exclusively on the U.S. market—where the company is seeing the strongest growth and clinical demand. This strategic realignment supports Nuwellis’ core business strategy: investing in the markets driving revenue growth. With expanding traction in U.S. cardia ...