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 ...

Reimbursement rate to increase 397% per day effective January 1, 2025 New rate expected to encourage adoption of ultrafiltration therapy in the outpatient setting MINNEAPOLIS, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical device company committed to transforming the lives of people with fluid overload, is pleased to announce that the Centers for Medicare and Medicaid Services (CMS) will reassign the Aquadex ultrafiltration code to the outpatient reimbursement le ...

MINNEAPOLIS, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical device company dedicated to transforming the lives of patients suffering from fluid overload, today announced certain preliminary, unaudited results for the quarter ended September 30, 2024. The company plans to report its complete results and host its earnings conference call for the third quarter of 2024 on November 11, 2024. Based on preliminary, unaudited results, management expects the Company to report the followin ...

MINNEAPOLIS, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced that it will release financial results for the third quarter of 2024 on Monday, November 11, 2024. Nuwellis will host a conference call and webcast at 9:00 AM ET to discuss its financial results and provide a general business update. To access the live webcast, please visit the Investors page of the Nuwellis website at htt ...

MINNEAPOLIS, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients with fluid overload, is pleased to announce that President and Chief Executive Officer Nestor Jaramillo will participate in ROTH Capital Partners' third annual ROTH Healthcare Opportunities Conference on Wednesday, October 9, 2024. Investor presentations and other materials used at the conference will be available on the investor relations section of Nuw ...

MINNEAPOLIS, Aug. 23, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) ("Nuwellis" or the "Company"), a medical technology company focused on transforming the lives of people with fluid overload, today announced that it has entered into a definitive securities purchase agreement with certain institutional investors for the purchase and sale of 496,901 shares of the Company's common stock at a price of $1.8450 per share of common stock in a registered direct offering priced at-the-market under Nasdaq r ...