Part I [Business](index=5&type=section&id=Item%201.%20Business) Nuwellis, Inc. commercializes the Aquadex System for ultrafiltration therapy, focusing on critical care, pediatrics, and heart failure markets [Overview and Market Opportunity](index=5&type=section&id=Item%201.%20Business%23Overview) Nuwellis commercializes the Aquadex System for fluid overload, targeting critical care, pediatrics, and heart failure markets - The company's Aquadex System is indicated for adult and pediatric patients (**20 kg or more**) with fluid overload unresponsive to diuretics[14](index=14&type=chunk) 2024 Revenue Breakdown and Market Opportunity by Segment | Clinical Area | 2024 Revenue Contribution | Estimated U.S. Market Size | | :--- | :--- | :--- | | Critical Care | ~40% | ~$900 million | | Pediatrics | ~40% | ~$130 million | | Heart Failure | ~20% | ~$1 billion | - The company is aware of off-label use of the Aquadex System for neonatal patients weighing less than **20 kg** due to an unmet medical need, which has prompted the development of a dedicated pediatric device[47](index=47&type=chunk)[48](index=48&type=chunk) [Clinical Evidence and Product Development](index=13&type=section&id=Item%201.%20Business%23Clinical%20Evidence%20and%20Product%20Development) Nuwellis builds clinical evidence for Aquadex and develops new products, notably the pediatric CRRT device Vivian - The REVERSE-HF trial is ongoing, with **155 of a targeted 372 patients enrolled** as of Feb 28, 2025. The company hopes to complete enrollment by mid-2026[52](index=52&type=chunk)[53](index=53&type=chunk) - A re-analysis of the AVOID-HF trial data demonstrated that adjustable ultrafiltration (AUF) led to a **60% reduction in heart failure events at 30 days** compared to intravenous diuretics[56](index=56&type=chunk) - The company is developing a pediatric CRRT device, 'Vivian', for patients **2.5kg and above**, with an IDE submission to the FDA planned for Q3 2026 and commercialization expected in Q2 2028[61](index=61&type=chunk) [Strategy, Sales, and Competition](index=16&type=section&id=Item%201.%20Business%23Strategy%2C%20Sales%2C%20and%20Competition) Nuwellis focuses on driving revenue growth in critical care, pediatrics, and heart failure, facing competition primarily from diuretics - The strategic focus is on driving revenue growth by targeting acute needs in critical care and pediatrics, while continuing to support heart failure patients[64](index=64&type=chunk)[66](index=66&type=chunk)[67](index=67&type=chunk) - The company's largest customer represented **14.4%** of its 2024 annual revenue[74](index=74&type=chunk) - The main competition is pharmacological treatment with diuretics. Indirect device competitors include Baxter's Prismaflex, Medtronic's Carpediem, and the newly formed Mozarc Medical (Medtronic/DaVita JV)[89](index=89&type=chunk)[90](index=90&type=chunk) [Reimbursement and Regulation](index=21&type=section&id=Item%201.%20Business%23Reimbursement%20and%20Regulation) U.S. reimbursement for Aquadex is facilitated by CPT code 0692T, with the system regulated by FDA 510(k) clearance and EU CE Mark - A dedicated CPT code, **0692T**, is available for therapeutic ultrafiltration. As of January 1, 2025, this code was reassigned to a level II APC code, providing substantial daily reimbursement in the outpatient setting[93](index=93&type=chunk) - The Aquadex SmartFlow system received **510(k) clearance** on February 4, 2020, for use in adult and pediatric patients weighing **20 kg or more**[99](index=99&type=chunk) - The company's CE Mark certificate for the Aquadex SmartFlow® System under MDD/93/42 EEC has been extended to **December 31, 2028**, as it works towards certification under the new Medical Device Regulation (MDR)[108](index=108&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including operating losses, capital needs, going concern doubt, single product reliance, and internal control weaknesses - The company will need to raise additional capital to fund operations beyond **May 31, 2025**. This condition raises substantial doubt about the Company's ability to continue as a going concern[126](index=126&type=chunk) - A **material weakness** in internal control over financial reporting was identified due to insufficient headcount for segregation of duties and lack of contemporaneous documentation[130](index=130&type=chunk)[132](index=132&type=chunk) - The company's near-term prospects are highly dependent on revenues from the Aquadex System. The ten largest customers represented **49.4%** of revenues in 2024[134](index=134&type=chunk)[135](index=135&type=chunk) - The company faces delisting risk from Nasdaq. While it regained compliance with the Minimum Bid Price and Stockholder's Equity requirements in 2024, it is subject to a one-year Mandatory Panel Monitor[194](index=194&type=chunk)[199](index=199&type=chunk) - On **December 11, 2024**, the company initiated a voluntary **Class 1 recall** of specific lots of its AquaFlexFlow UF 500 Plus blood circuit due to mismatch alarms that could lead to excess fluid removal[150](index=150&type=chunk) [Cybersecurity](index=45&type=section&id=Item%201C.%20Cybersecurity) Nuwellis maintains a cybersecurity program with board oversight, third-party support, and employee training to manage risks - The company has a cross-departmental approach to cybersecurity, with oversight from the board of directors and the Audit Committee[232](index=232&type=chunk)[236](index=236&type=chunk) - Cybersecurity protocols include software programs, company-wide policies, and mandatory employee training. The company also leverages a **3rd party IT service provider**[232](index=232&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk) - Although threats have been experienced, cybersecurity risks have not materially affected the company's business strategy, results of operations, or financial condition to date[238](index=238&type=chunk) [Properties](index=46&type=section&id=Item%202.%20Properties) The company leases a 23,000 sq. ft. facility in Eden Prairie, Minnesota, serving as its corporate headquarters and manufacturing space - The company's principal facility is a **23,000 sq. ft.** leased space in Eden Prairie, MN, used for corporate headquarters, office, and manufacturing[239](index=239&type=chunk) - The current operating lease for this facility was extended and now expires in **March 2027**[239](index=239&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=47&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Nuwellis common stock trades on Nasdaq under 'NUWE', with 4.37 million shares outstanding as of March 2025, and no cash dividends are expected - The company's common stock trades on the Nasdaq Capital Market under the symbol '**NUWE**'[244](index=244&type=chunk) - As of **March 7, 2025**, there were **4,373,968 shares** of common stock outstanding[245](index=245&type=chunk) - The company has not paid and does not expect to pay cash dividends[246](index=246&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=48&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Nuwellis reported **$8.74 million** net sales in 2024, reduced operating loss, and needs capital beyond May 2025 due to going concern Results of Operations (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | % Change | | :--- | :--- | :--- | :--- | | Net Sales | $8,740 | $8,864 | (1.4)% | | Gross Profit | $5,676 | $4,983 | 13.9% | | Loss from Operations | $(10,988) | $(17,630) | (37.7)% | | Net Loss | $(11,165) | $(20,209) | (44.7)% | - The company believes its existing capital resources will be sufficient to fund operations only through **May 31, 2025**, raising substantial doubt about its ability to continue as a going concern[270](index=270&type=chunk)[273](index=273&type=chunk) - Net cash used in operating activities decreased to **$9.6 million** in 2024 from **$17.9 million** in 2023, primarily reflecting a lower net loss and changes in working capital[312](index=312&type=chunk) - Net cash provided by financing activities was **$11.0 million** in 2024, sourced from several public offerings and warrant exercises throughout the year[314](index=314&type=chunk) [Financial Statements and Supplementary Data](index=57&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited 2024 financials show a **$11.2 million** net loss; auditor highlights going concern and warrant liability as critical audit matters - The independent auditor's report expresses substantial doubt about the Company's ability to continue as a going concern due to recurring losses and the need for additional working capital[321](index=321&type=chunk) - The auditor identified the valuation of the warrant liability as a **Critical Audit Matter** due to the complexity and subjective judgment involved in the Monte Carlo simulation model used for fair value measurement[328](index=328&type=chunk)[329](index=329&type=chunk) Key Financial Data (Consolidated, in thousands) | Metric | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Balance Sheet:** | | | | Cash and cash equivalents | $5,095 | $3,800 | | Total Assets | $9,864 | $9,770 | | Total Liabilities | $3,334 | $6,559 | | Total Stockholders' Equity | $6,528 | $2,990 | | **Statement of Operations:** | | | | Net Sales | $8,740 | $8,864 | | Net Loss | $(11,165) | $(20,209) | | Basic and Diluted Loss Per Share | $(8.41) | $(360.06) | [Controls and Procedures](index=82&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective due to material weaknesses in internal control over financial reporting, specifically insufficient headcount and documentation - Management concluded that disclosure controls and procedures were **not effective** as of **December 31, 2024**[440](index=440&type=chunk) - Two **material weaknesses** were identified: 1) Insufficient headcount leading to inadequate segregation of duties in accounting and IT. 2) Lack of contemporaneous documentation for controls related to balance sheet reconciliations, journal entries, and user access[447](index=447&type=chunk) - The company is developing remediation plans to address the material weaknesses, which will be subject to senior management and audit committee oversight[448](index=448&type=chunk)[449](index=449&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=84&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The report lists the company's six directors and key executive officers, including interim CEO John L. Erb, with five directors deemed independent under Nasdaq rules - On **February 23, 2025**, Nestor Jaramillo, Jr. retired as President and CEO, and **John L. Erb** was appointed as Interim President and CEO[453](index=453&type=chunk) - The Board of Directors is composed of six members, **five of whom have been determined to be independent**: Dr. Costanzo, Dr. Georgiou, Mr. McCormick, Mr. McDonald, and Mr. Waller[454](index=454&type=chunk)[521](index=521&type=chunk) - The Audit Committee members are Mike McCormick, Dave McDonald, and Greg Waller, with Mr. Waller designated as the '**audit committee financial expert**'[471](index=471&type=chunk) [Executive Compensation](index=90&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation for 2024 included salaries and bonuses, with cost-saving measures implemented due to liquidity concerns, and no equity awards for non-employee directors 2024 Summary Compensation Table | Name and Principal Position | Salary ($) | Non-equity Incentive Plan Compensation ($) | All Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | | Nestor Jaramillo, Jr. (President & CEO) | 349,676 | 47,723 | 12,009 | 409,408 | | Robert B. Scott (CFO) | 245,000 | 20,580 | 4,376 | 269,956 | | Neil P. Ayotte (SVP, General Counsel) | 271,420 | 25,645 | 9,922 | 306,987 | - In **2024**, the company undertook cost-reduction measures, including temporary salary reductions for senior management and suspension of the 401k match, which were later restored in Q4 2024[497](index=497&type=chunk) - Non-employee directors receive annual cash compensation of **$45,000**, plus additional retainers for the Chair and committee service. The Board agreed not to receive annual stock option awards in 2024[479](index=479&type=chunk)[480](index=480&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=96&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Directors and executive officers beneficially owned **1.6%** of common stock as of March 2025, primarily through options and preferred stock conversion - As of **March 7, 2025**, all current directors and executive officers as a group beneficially owned **71,171 shares**, representing **1.6%** of the class[514](index=514&type=chunk) - Chairman John L. Erb's beneficial ownership of **69,028 shares** (**1.6%** of the class) consists almost entirely of **68,961 shares** issuable upon conversion of his Series F Convertible Preferred Stock[514](index=514&type=chunk)[515](index=515&type=chunk) Equity Compensation Plan Information (as of Dec 31, 2024) | Plan Category | Securities to be issued upon exercise () | Weighted-average exercise price ($) | Securities available for future issuance () | | :--- | :--- | :--- | :--- | | Approved by security holders | 3,761 | $474.35 | 40,964 | | Not approved by security holders | 112 | $2,022.71 | 1,211 | | **Total** | **3,873** | **$519.12** | **42,175** | [Certain Relationships and Related Transactions, and Director Independence](index=99&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The Board determined a majority of its members are independent, with no related party transactions requiring disclosure in 2023 or 2024 - The Board has determined that **five of its six directors are independent**: Dr. Costanzo, Dr. Georgiou, Mr. McCormick, Mr. McDonald, and Mr. Waller[521](index=521&type=chunk) - The company engaged in no related party transactions requiring disclosure under Item 404 of Regulation S-K for fiscal years **2024** and **2023**[524](index=524&type=chunk) [Principal Accountant Fees and Services](index=99&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Baker Tilly US, LLP served as the independent auditor, with total fees of **$749,608** in 2024, primarily for audit services, all pre-approved by the Audit Committee Accountant Fees (2024 vs 2023) | Fee Category | 2024 | 2023 | | :--- | :--- | :--- | | Audit Fees | $715,550 | $657,525 | | Tax Fees | $34,058 | $32,800 | | **Total** | **$749,608** | **$690,325** | - **100%** of the services provided by the independent auditor, Baker Tilly, were pre-approved by the Audit Committee[527](index=527&type=chunk) Part IV [Exhibits, and Financial Statement Schedules](index=100&type=section&id=Item%2015.%20Exhibits%2C%20and%20Financial%20Statement%20Schedules) This section lists documents filed as part of the Annual Report on Form 10-K, including financial statements, corporate governance, and material contracts - The Exhibit Index lists key corporate documents, including the Certificate of Incorporation, Bylaws, and various forms of Warrants[530](index=530&type=chunk)[532](index=532&type=chunk) - Material contracts filed as exhibits include the Patent License Agreement with Gambro (Baxter), various equity incentive plans, and employment agreements with executive officers[535](index=535&type=chunk)[536](index=536&type=chunk)[537](index=537&type=chunk) - Certifications by the CEO and CFO under Sections 302 and 906 of the Sarbanes-Oxley Act are filed as exhibits, along with XBRL data files[541](index=541&type=chunk)

Nuwellis, Inc. (NASDAQ:NUWE) Q4 2024 Earnings Conference Call March 11, 2025 9:00 AM ET Company Participants Vivian Cervantes - Gilmartin Group, Investor Relations John Erb - Interim President and Chief Executive Officer Rob Scott - Chief Financial Officer Conference Call Participants Jonathan Aschoff - Roth Anthony Vendetti - Maxim Group Operator Good morning. And welcome to Nuwellis Earnings Conference Call for the Fourth Quarter and Full Year ended December 31, 2024. All participants will be in a listen- ...

Financial Performance - Nuwellis, Inc. reported a quarterly loss of $0.65 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.43, representing an earnings surprise of -51.16% [1] - The company's revenues for the quarter ended December 2024 were $2.32 million, missing the Zacks Consensus Estimate by 7.12%, and down from $2.55 million in the same quarter last year [2] - The current consensus EPS estimate for the upcoming quarter is -$0.30 on revenues of $2.65 million, and for the current fiscal year, it is -$0.89 on revenues of $12.13 million [7] Stock Performance - Nuwellis shares have increased approximately 13.5% since the beginning of the year, contrasting with a decline of -4.5% in the S&P 500 [3] - The company currently holds a Zacks Rank 2 (Buy), indicating expectations for the stock to outperform the market in the near future [6] Industry Outlook - The Medical - Instruments industry, to which Nuwellis belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Nuwellis' stock performance [5]

Financial Data and Key Metrics Changes - Nuellis generated $2,300,000 in revenue for Q4 2024, a 9% decrease year over year due to a decline in U.S. console sales and international sales, partially offset by a 21% increase in consumables utilization [8][15] - Gross margin improved to 58.4% for Q4 2024 compared to 54.4% in the prior year quarter, driven by higher manufacturing volumes of consumables and lower fixed overhead manufacturing expenses [16] - Net loss attributable to common shareholders in Q4 was $1,500,000 or a loss of $0.44 per share, an improvement from a net loss of $7,900,000 or a loss of $54.48 per share for the same period in 2023 [18] Business Line Data and Key Metrics Changes - Critical care customer category posted a 35% year-over-year revenue growth, benefiting from higher console sales and consumable utilization [9][15] - Heart failure and pediatric customer categories experienced declines of 36% and 20% respectively due to lower console sales [9][15] Market Data and Key Metrics Changes - The company reported nine new account wins throughout 2024, indicating positive market penetration [7] - The reimbursement for Aquadex Ultrafiltration therapy increased nearly fourfold from $413 to $16,390 per day effective January 1, 2025, allowing entry into the outpatient market [11] Company Strategy and Development Direction - The company aims to build its clinical evidence to make Aquadex Ultrafiltration Therapy a standard of care and integrate it into medical society guidelines [10] - The focus remains on driving market penetration of Aquadex Ultrafiltration Therapy, leveraging the increased reimbursement in the outpatient setting [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, highlighting the positive impact of new reimbursement changes and clinical data supporting Aquadex therapy [7][10] - The management acknowledged the importance of the recent publication in JACC Heart Failure, which demonstrated a 60% reduction in heart failure events for patients treated with Aquadex compared to traditional IV diuretics [10][12] Other Important Information - The company had $5,100,000 in cash and cash equivalents with no debt on the balance sheet as of December 31, 2024 [18] - A voluntary recall of specific lots of blood circuit units occurred in December 2024, which included a non-recurring expense of approximately $150,000 [16] Q&A Session Summary Question: Initial traction in the outpatient setting for Aquadex - Management noted that traction is beginning with several existing accounts needing to set up permanent outpatient facilities, with more activity expected in the coming month [21] Question: Number of Aquadex units sold in Q4 2024 - Three units were sold in Q4 2024, compared to eleven units in Q3 2024 [23] Question: Timing for REVERSE HF trial completion - Management indicated that it is difficult to gauge the timing for enrollment completion and initial top-line data [24] Question: Timing for the start of the VIVIAN clinical trial - Similar to the REVERSE HF trial, management stated that predicting the start timing is also difficult [25] Question: Changes in leadership and search for a new CEO - Management confirmed that a search firm has been hired for the CEO search, and there are several candidates being considered [33]

Financial Performance - Fourth quarter 2024 revenue was $2.3 million, a 9% decrease compared to the prior year quarter[5] - Net loss attributable to common shareholders for Q4 2024 was $1.5 million, significantly improved from a net loss of $7.9 million in the prior year quarter[11] - Net loss for 2024 was $11,165 million, a decrease from $20,209 million in 2023, indicating improved financial performance[23] - Net cash used in operating activities decreased to $9,591 million in 2024 from $17,937 million in 2023, reflecting better cash flow management[23] Cost Management - The company achieved a full year operating cost reduction of $5.9 million, or 26%, compared to the previous year[7] - Total operating expenses for Q4 2024 were $3.7 million, a 25% decrease compared to $5.0 million in the prior year quarter[9] - Research and development expenses decreased to $831 thousand in Q4 2024, down from $1.4 million in the prior year quarter[9] Cash Position - The company had cash and cash equivalents of approximately $5.1 million as of December 31, 2024[12] - Cash and cash equivalents at the end of the period increased to $5,095 million from $3,800 million, showing a positive cash position[23] - Net cash provided by financing activities rose significantly to $10,962 million in 2024 compared to $3,683 million in 2023, highlighting strong capital raising efforts[23] - Proceeds from April 2024 common stock offerings amounted to $2,403 million, up from $2,109 million in the previous year, indicating robust investor interest[23] Inventory and Liabilities - Inventory net decreased to $279 million in 2024 from $697 million in 2023, reflecting improved inventory management[23] - Accounts payable and accrued expenses improved to $(626) million in 2024 from $(1,500) million in 2023, indicating better payment practices[23] Other Financial Metrics - Gross margin improved to 58.4% in Q4 2024, up from 54.4% in the prior year quarter[6] - The company reported a significant one-time gain of $900,000 from the termination of the SeaStar Medical distribution agreement[11] - The company recorded a change in fair value of warrant liability of $(4,615) million in 2024, compared to $(758) million in 2023, suggesting increased volatility in warrant valuations[23] - Depreciation and amortization expenses decreased to $310 million in 2024 from $362 million in 2023, indicating potential asset efficiency improvements[23] Revenue Growth - Consumables utilization grew by 21% year-over-year, while revenue in the Critical Care customer category increased by 35%[4] - A four-fold payment increase to $1,639 for Aquadex Ultrafiltration Therapy in the outpatient setting is effective January 1, 2025[7]

Financial Data and Key Metrics Changes - Nuellis generated $2,300,000 in revenue for Q4 2024, a 9% decrease year over year due to a decline in U.S. console sales and international sales, partially offset by a 21% increase in consumables utilization [8][15] - Gross margin improved to 58.4% for Q4 2024 compared to 54.4% in the prior year, driven by higher manufacturing volumes of consumables and lower fixed overhead manufacturing expenses [16] - Net loss attributable to common shareholders in Q4 was $1,500,000 or a loss of $0.44 per share, an improvement from a net loss of $7,900,000 or a loss of $54.48 per share in the same period in 2023 [18] Business Line Data and Key Metrics Changes - The critical care customer category posted a 35% year-over-year revenue growth, benefiting from higher console sales and consumable utilization [9][15] - Heart failure and pediatric customer categories experienced declines of 36% and 20% respectively due to lower console sales [9][15] Market Data and Key Metrics Changes - The company reported nine new account wins throughout 2024, indicating positive market penetration [7] - A new reimbursement change effective January 1, 2025, increased the facility reimbursement fee for Aquadex Ultrafiltration therapy nearly fourfold, from $413 to $1,639 per day, allowing entry into the outpatient market [11] Company Strategy and Development Direction - The company aims to build its clinical evidence to make Aquadex Ultrafiltration Therapy a standard of care and integrate it into medical society guidelines [10] - The focus remains on driving market penetration of Aquadex Ultrafiltration Therapy, leveraging clinical evidence and increased reimbursement in the outpatient setting [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, highlighting the positive impact of new reimbursement changes and clinical data supporting Aquadex therapy [7][10] - The management acknowledged the importance of the recent publication in JACC Heart Failure, which demonstrated significant clinical benefits of Aquadex over traditional IV diuretics [10][31] Other Important Information - The company had $5,100,000 in cash and cash equivalents with no debt on the balance sheet as of December 31, 2024 [18] - A voluntary recall of specific lots of blood circuit units incurred a non-recurring expense of approximately $150,000 [16] Q&A Session Summary Question: Initial traction in the outpatient setting for Aquadex - Management noted that traction is beginning with several existing accounts needing to set up permanent outpatient facilities, with more activity expected in the coming month [21] Question: Number of Aquadex units sold in Q4 2024 - Three units were sold in Q4 2024, compared to eleven units in Q3 2024 [23] Question: Timing for completion of the REVERSE HF trial enrollment - Management indicated that it is difficult to gauge the timing for completion of enrollment but is pleased with investigator engagement [24] Question: Search for a new CEO - The search for a new CEO is actively underway, with a search firm hired and potential candidates being considered [33]

Core Insights - Nuwellis, Inc. reported a 9% decrease in revenue for Q4 2024, totaling $2.3 million, primarily due to a decline in US console and international sales, despite a 21% increase in consumables utilization [4][10] - The company achieved a 35% revenue growth in its Critical Care customer category, indicating strong demand for its Aquadex system [3][10] - A significant improvement in gross margin to 58.4% was noted, up from 54.4% in the prior year, driven by higher manufacturing volumes and lower fixed overhead costs [5][10] Financial Performance - Total operating expenses for Q4 2024 decreased by 25% to $3.7 million, down from $5.0 million in the prior year, reflecting cost-saving initiatives [7][10] - The operating loss for Q4 2024 was reduced to $2.4 million from $3.6 million in the previous year [8] - The net loss attributable to common shareholders improved significantly to $1.5 million, or $0.44 per share, compared to a net loss of $7.9 million, or $54.48 per share, in the prior year [9][10] Strategic Developments - The company anticipates growth in 2025, supported by increased awareness of clinical evidence for the Aquadex system and favorable changes in CMS reimbursement policies [3][10] - A four-fold increase in CMS payment for Aquadex Ultrafiltration Therapy to $1,639 in the outpatient setting is expected to create new expansion opportunities [10] - The company reported a full-year operating cost reduction of $5.9 million, or 26%, compared to the previous year [10] Balance Sheet Highlights - As of December 31, 2024, Nuwellis had cash and cash equivalents of approximately $5.1 million and no debt [11] - Total assets increased slightly to $9.864 million from $9.770 million in the prior year [18][19] - Current liabilities decreased to $2.559 million from $3.172 million, indicating improved financial health [18][19]

Company Leadership Change - Nestor Jaramillo, Jr. has retired as President and CEO of Nuwellis, effective February 18, 2025, with John Erb appointed as Interim President and CEO [1][2] - John Erb has been with Nuwellis since September 2012, serving as a director and chairman of the board, and previously held the role of president and CEO from November 2015 to January 2021 [2] Company Overview - Nuwellis, Inc. is a commercial-stage medical device company focused on addressing fluid overload in patients through innovative solutions [3] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] Product Information - The Aquadex SmartFlow system is designed for ultrafiltration therapy, 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]

Core Insights - Nuwellis, Inc. has highlighted promising findings from the updated analysis of the AVOID-HF study, indicating that Aquadex® SmartFlow ultrafiltration therapy led to a 60% reduction in heart failure events compared to standard diuretic therapy [1][2][3] Group 1: Study Findings - The updated AVOID-HF study included a broader dataset, allowing for a more comprehensive analysis of patient outcomes, which suggests potential improvements in patient management strategies [2][4] - The reanalysis demonstrated significant clinical advantages of ultrafiltration therapy, supporting its broader clinical adoption [4] Group 2: Expert Commentary - Dr. Sean P. Pinney emphasized the compelling evidence supporting ultrafiltration over conventional diuretics, highlighting the need for further investigation to validate the therapy's benefits [3] - Megan Cotts, Vice President of Clinical Research and Reimbursement at Nuwellis, noted that the updated results contribute valuable insights into the Aquadex SmartFlow system's role in heart failure therapy [3] Group 3: Future Research and Development - Nuwellis plans to continue research efforts under the current REVERSE-HF trial to further establish the clinical and economic benefits of ultrafiltration therapy compared to conventional IV diuretics [3][5] - The complete analysis of the AVOID-HF study will be published in the February 2025 issue of JACC: Heart Failure, reinforcing the company's commitment to advancing patient care [3][4]

Company Overview - Nuwellis, Inc. is a commercial-stage medical technology company focused on transforming the lives of patients suffering from fluid overload through innovation and collaboration [3] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] Product Information - Nuwellis is focused on commercializing the Aquadex SmartFlow® system, which is designed for ultrafiltration therapy to remove excess fluid from patients with hypervolemia [3][4] - The Aquadex SmartFlow system is indicated for temporary use (up to 8 hours) or extended use (longer than 8 hours) in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [4] Financial Results Announcement - Nuwellis will release its financial results for the fourth quarter and full year 2024 on March 11, 2025 [1] - A conference call and webcast will be held at 9:00 AM ET to discuss the financial results and provide a general business update [1]