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]

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 ...