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]

Core Insights - Nuwellis, Inc. has announced a new partnership with a nationally ranked pediatric hospital in Utah, marking its 44th pediatric account, to utilize the Aquadex SmartFlow system for treating fluid overload in children [1][2][3] - The Aquadex SmartFlow system is designed to provide advanced therapy for fluid management, particularly beneficial for pediatric patients suffering from severe kidney and heart conditions [2][3] - Since receiving FDA clearance in 2020, Nuwellis has significantly expanded its accounts from 13 to 44, demonstrating strong growth in its pediatric business [1][3] Company Overview - Nuwellis, Inc. is a medical technology company focused on transforming the lives of patients suffering from fluid overload through innovative solutions like the Aquadex SmartFlow system [5] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland, emphasizing its commitment to expanding access to its therapies for both pediatric and adult patients [5][4] Product Details - The Aquadex SmartFlow system is an ultrafiltration therapy device that safely and predictably removes excess fluid from patients, helping them regain fluid balance in critical care situations [3][6] - It is indicated for temporary or extended use in patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics [6]

Core Points - Nuwellis, Inc. has regained compliance with Nasdaq's minimum bid price and stockholders' equity requirements, allowing its common stock to continue trading on the Nasdaq Capital Market under the symbol "NUWE" [1][2][3] - The company improved its balance sheet by raising $5.1 million in gross proceeds from warrant exercises and a warrant inducement transaction, and it now exceeds the equity requirement of at least $2.5 million [2][3] - A reverse stock split of 1:35 was implemented on June 26, 2024, as part of the company's compliance efforts [3] Company Overview - Nuwellis, Inc. is a medical device company focused on transforming the lives of patients suffering from fluid overload through innovative therapies [4] - The company is commercializing the Aquadex SmartFlow® system, which is designed for ultrafiltration therapy in patients with hypervolemia [5] - The Aquadex SmartFlow 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 [5]

Financial Performance - Net sales for Q3 2024 were $2,367,000, a decrease of 1.9% compared to $2,412,000 in Q3 2023[5] - Gross profit increased to $1,656,000 in Q3 2024, up 19.9% from $1,381,000 in Q3 2023[5] - Operating expenses decreased from $4,545,000 in Q3 2023 to $3,188,000 in Q3 2024, a reduction of approximately 29.9%[5] - The company reported a net income of $2,358,000 for Q3 2024, compared to a net loss of $3,370,000 in Q3 2023[5] - Basic and diluted net income per share for Q3 2024 was $1.74, a significant improvement from a loss of $63.27 per share in Q3 2023[5] - For the nine months ended September 30, 2024, net sales increased to $6.418 million, up 1.7% from $6.313 million in the same period in 2023[124] - Net loss attributable to common shareholders for the nine months ended September 30, 2024, was $(9,156,000), an improvement from $(14,700,000) in the same period of 2023[33] - Basic and diluted loss per share for the three months ended September 30, 2024, was $1.74, significantly better than $(63.27) for the same period in 2023[33] Assets and Liabilities - Total current assets decreased from $8,209,000 on December 31, 2023, to $5,494,000 as of September 30, 2024, representing a decline of approximately 33.1%[4] - Total liabilities decreased from $6,559,000 on December 31, 2023, to $3,549,000 as of September 30, 2024, a reduction of approximately 45.9%[4] - The company’s accumulated deficit increased to $(297,323,000) as of September 30, 2024, from $(287,626,000) on December 31, 2023[4] - Cash and cash equivalents decreased from $3,800,000 on December 31, 2023, to $1,907,000 as of September 30, 2024, a decline of approximately 49.9%[4] - The company’s additional paid-in capital increased to $300,546,000 as of September 30, 2024, up from $290,647,000 on December 31, 2023[4] Cash Flow and Financing - Nuwellis, Inc. experienced a net cash used in operating activities of $8,087,000 for the quarter ending September 30, 2024, compared to $15,183,000 for the same period in the previous year[9] - The company reported a net decrease in cash and cash equivalents of $1,893,000 for the quarter ending September 30, 2024, with cash and cash equivalents at the end of the period totaling $1,907,000[9] - Cash provided by financing activities was $6.2 million for the nine months ended September 30, 2024, up from $2.1 million in the same period in 2023, reflecting increased financing efforts[150] - The company closed a public offering on April 30, 2024, raising approximately $2.7 million from the sale of 240,571 shares at a price of $8.40 per share[15][17] - A registered direct offering on July 24, 2024, generated approximately $2.0 million from the sale of 469,340 shares at a price of $4.24 per share[17][19] - The gross proceeds from the offering on August 26, 2024, were approximately $892,000 from the sale of 483,351 shares at a price of $1.8450 per share[23] Cost Management - The company has reduced its monthly cash burn rate by approximately 40% through various cost-cutting measures, including job eliminations and salary reductions[24] - Stock-based compensation expense for the quarter ending September 30, 2024, was $374,000, down from $513,000 in the same quarter of the previous year[9] - Selling, general, and administrative expenses decreased by 21.2% to $2.702 million for the three months ended September 30, 2024, compared to $3.428 million in the same period in 2023[122] - Research and development expenses for the three months ended September 30, 2024, were $486,000, down 56.5% from $1.117 million in the same period in 2023[122] Business Strategy and Operations - Nuwellis, Inc. has focused on developing the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy, targeting patients with fluid overload[10] - The company underwent a name change from CHF Solutions, Inc. to Nuwellis, Inc. in April 2021 to reflect its expanded customer base[11] - The company must succeed in expanding the adoption of the Aquadex System to achieve profitability, which includes training personnel and effective marketing[14] - The company is currently evaluating the impact of ASU 2023-07 on its disclosures, which requires expanded segment reporting effective for fiscal 2024[33] - The company is assessing the impact of new SEC rules on climate-related disclosures, effective for fiscal years beginning on or after January 1, 2027[35] Customer and Revenue Insights - For the three months ended September 30, 2024, two customers represented 12% and 10% of net sales, compared to 21% and 11% for the same period in 2023[27] - International revenue represented 3% of net sales for the three months ended September 30, 2024, compared to 5% for the same period in 2023[37] - Revenue from extended service plans represents less than 1% of net sales for the three and nine months ended September 30, 2024[39] - The company sells products primarily through a direct salesforce in the U.S. and through specialty healthcare distributors internationally[37] Compliance and Reporting - The company has identified two material weaknesses in controls over financial reporting as of September 30, 2024, which management plans to address[156] - The company has established a full valuation allowance for its U.S. and foreign deferred tax assets due to uncertainty in generating enough taxable income[77] - The company has not established an allowance for credit losses as of September 30, 2024, due to no write-offs or deterioration in accounts receivable[102] - The company has not experienced any write-offs or significant deterioration in accounts receivable, maintaining no allowance for doubtful accounts as of September 30, 2024[28]

Financial Results - Nuwellis, Inc. reported preliminary financial results for Q3 2024 on November 1, 2024[3] - The financial results pertain to the quarter ended September 30, 2024[3] - The report does not include specific financial figures or performance metrics[3] Company Information - The company is listed on the Nasdaq Capital Market under the trading symbol NUWE[1] - Nuwellis, Inc. is classified as an emerging growth company[2] - The company is led by President and CEO Nestor Jaramillo, Jr.[6] Regulatory Compliance - The report is filed in accordance with the Securities Exchange Act of 1934[4] - The filing does not indicate any new or revised financial accounting standards compliance[2] Additional Information - The press release detailing financial results is attached as Exhibit 99.1[2] - No information on user data, future outlook, or new product developments is provided in the current report[3]

Nuwellis, Inc. (NUWE) came out with quarterly earnings of $1.74 per share, beating the Zacks Consensus Estimate of a loss of $0.88 per share. This compares to loss of $63.29 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 297.73%. A quarter ago, it was expected that this company would post a loss of $9.49 per share when it actually produced a loss of $18.85, delivering a surprise of -98.63%.Over the last four quarters, the com ...

MINNEAPOLIS, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical device company focused on transforming the lives of people with fluid overload, today reported financial results for the third quarter ended September 30, 2024. Recent Highlights: Received a 297% CMS reimbursement increase to $1,639 for Aquadex facility fee, effective January 1, 2025.Revenue of $2.4 million.Pediatrics revenue growth of 28% compared to the prior year quarter.Gross margin of 70%, compared to 57.3% in the p ...

MINNEAPOLIS, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) (“Nuwellis” or the “Company”), a commercial-stage medical device company committed to transforming the lives of people with fluid overload, today announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants issued by the Company on April 30, 2024 (collectively, the “Existing Warrants”) to purchase up to an aggregate of 1,832,517 shares of the Company’s common stock at their current exerc ...