MINNEAPOLIS, June 10, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) (“Nuwellis” or the “Company”), a commercial-stage medical device company dedicated to transforming care for fluid overload patients, today announced the closing of a public offering of 2,580,667 shares of its common stock (“Common Stock”), pre-funded warrants to purchase 14,085,998 shares of Common Stock, in each case with accompanying Series A Warrants to purchase up to 49,999,995 shares of Common Stock and Series B Warrants to pu ...

MINNEAPOLIS, June 09, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) (“Nuwellis” or the “Company”), a commercial-stage medical device company dedicated to transforming care for fluid overload patients, today announced the pricing of a public offering of 406,755 shares of its common stock (“Common Stock”), pre-funded warrants to purchase 14,085,998 shares of Common Stock, in each case with accompanying Series A Warrants to purchase up to 43,478,259 shares of Common Stock and Series B Warrants to purc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-35312 NUWELLIS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware No. 68-0533453 (State or Other Jur ...

Revenue and Financial Performance - Revenue for Q1 2025 was $1.9 million, a 3% increase compared to Q1 2024[3] - Gross margin for Q1 2025 was 56.0%, down from 64.1% in the prior-year quarter[4] - Operating loss improved to $3.1 million in Q1 2025, compared to a loss of $4.7 million in Q1 2024[7] - Net loss attributable to common shareholders was $3.0 million, or a loss of $0.69 per share, compared to a net loss of $3.8 million, or $24.11 per share, in the prior-year period[8] Expenses - SG&A expenses decreased by 22% to $3.6 million from $4.6 million in Q1 2024[5] - R&D expenses were $550 thousand, a significant reduction from $1.3 million in the prior-year quarter[7] Cash Position - As of March 31, 2025, cash and cash equivalents were $2.6 million, with no debt[9] Market and Reimbursement - Effective January 1, 2025, CMS increased the outpatient reimbursement rate for Aquadex nearly four-fold to $1,639 per day[6] - The company is focusing on expanding outpatient opportunities driven by favorable reimbursement and clinical data[6] Utilization and Growth - Consumables utilization grew by 4% year-over-year, with pediatric revenue increasing by 38%[6]

Nuwellis (NUWE) Q1 2025 Earnings Call May 13, 2025 09:00 AM ET Company Participants Louisa Smith - PrincipalJohn Erb - Chairman, Interim President & CEORob Scott - CFO Conference Call Participants Jonathan Aschoff - Managing Director, Senior Research Analyst Operator Good day, everyone, and welcome to Newellis First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. Later, you will have an opportunity to ask questions during the question and answer ...

Financial Data and Key Metrics Changes - Newellis generated $1.9 million in revenue for Q1 2025, representing a 3% increase year over year, supported by a 4% increase in consumables utilization and an increase in U.S. console sales, partially offset by a decrease in international sales [6][13] - Gross margin for Q1 was 56%, down from 64.1% in the same period last year, primarily due to unfavorable manufacturing variances and lower fixed overhead absorption [14] - Operating loss narrowed to $3.1 million compared to an operating loss of $4.7 million in the prior year quarter [15] Business Line Data and Key Metrics Changes - Pediatric and heart failure revenues increased by 3828% year over year, driven by growth in consumables utilization [6][13] - Critical care revenue declined by 25% year over year, primarily due to one of the largest customers building excess inventory in the previous quarter [7][13] Market Data and Key Metrics Changes - The company has built a growing pipeline of target outpatient facilities, representing an addressable market opportunity of approximately $717 million [12] - The recent reassignment of OXWAD X to a new outpatient reimbursed level by CMS increased the facility reimbursement fee for the therapy by nearly four times to $16.39 per day [11] Company Strategy and Development Direction - Newellis is focusing on critical care, pediatrics, and outpatient heart failure, with critical care representing approximately 40% of current business [18] - The company aims to position Aquadex as a standard of care within fluid management, expanding into the outpatient market as hospital accounts complete logistical challenges [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stabilization of critical care business volume in the upcoming quarter after a temporary decline [7][24] - The company is actively working with hospitals to implement outpatient clinics, expecting to see revenue growth in the second quarter and more rapid growth in the third and fourth quarters [28] Other Important Information - Newellis ended the quarter with $2.6 million in cash and cash equivalents and operates with no debt on the balance sheet [16] - The company has signed an agreement with KDI Precision Manufacturing to move manufacturing, which is expected to result in meaningful expense reductions over the next twelve months [22] Q&A Session Summary Question: Was the drop in adult revenue entirely due to lower international sales? - The drop in critical care was primarily due to a large customer building inventory in the previous quarter, and they have begun repurchasing in the second quarter [24] Question: Is the drop in the first quarter seasonal? - Management indicated that there is not a lot of seasonality in the business, attributing the drop to a specific incident rather than a recurring pattern [25][26] Question: What does expanding the outpatient pipeline mean for Aquadex? - The company is currently working with four hospitals to implement outpatient clinics, identifying locations and nursing resources necessary to support these clinics [27] Question: Can you provide an update on the Phase three trial enrollment with Aquadex? - Enrollment for the REVERSE HF trial is ongoing, and the company is about halfway to its goal of 372 patients [30] Question: What is the timeline for the VIVIAN clinical trial? - The clinical trial will not start until later this year or early next year, pending further development of the device [31]

Nuwellis, Inc. (NUWE) came out with a quarterly loss of $0.69 per share versus the Zacks Consensus Estimate of a loss of $0.45. This compares to loss of $20.98 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -53.33%. A quarter ago, it was expected that this company would post a loss of $0.43 per share when it actually produced a loss of $0.65, delivering a surprise of -51.16%.Over the last four quarters, the company has surpas ...

The Company has 47 Pediatric Centers utilizing AquadexMINNEAPOLIS, May 08, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on fluid management solutions for patients with fluid overload, today announced a meaningful step forward for children facing fluid overload with the recent expansion of its Aquadex SmartFlow® therapy into two additional pediatric centers across the Southeastern United States. The company now has 47 pediatric centers that have adopted Aquadex ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended: December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission file number 001-35312 NUWELLIS, INC. (Exact name of registrant as specified in its charter) Delaware 68-0533453 (State or other jurisdiction of incorporation o ...

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- ...