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 ...

Revenue and Growth - Revenue for Q2 2024 was $2.2 million, a 6% increase compared to Q2 2023[2] - Critical Care revenue grew by 28% year-over-year, while Heart Failure consumables utilization increased by 35%[2] Financial Performance - Gross margin improved to 67.2% in Q2 2024, up from 55.3% in the prior-year quarter[2] - Total operating costs decreased by 38% to $3.8 million compared to $6.2 million in Q2 2023[5] - Research and development expenses were $558 thousand, down from $1.5 million in the prior-year quarter[5] - Operating loss decreased to $2.3 million in Q2 2024 from $5.0 million in Q2 2023[6] - Net loss attributable to common shareholders was $7.7 million, or a loss of $18.85 per share, compared to a net loss of $4.8 million, or a loss of $127.65 per share in the prior-year quarter[6] Cash Flow and Liquidity - Net cash used in operating activities decreased to $5,616,000 in 2024 from $11,358,000 in 2023, indicating a reduction of about 50.6%[15] - Cash and cash equivalents at the end of the period were $1,023,000, down from $8,896,000 in 2023, reflecting a decrease of approximately 88.5%[15] - Issuance of common stock from offerings generated $2,403,000 in 2024, with net cash provided by financing activities totaling $2,903,000, compared to $2,108,000 in 2023[15] - The company experienced a net decrease in cash and cash equivalents of $2,777,000 in 2024, compared to a decrease of $8,841,000 in 2023, indicating an improvement in cash management[15] Investments and Assets - Accounts receivable increased by $659,000 in 2024, compared to an increase of $230,000 in 2023, indicating a significant rise in receivables[15] - The company reported a depreciation and amortization expense of $151,000 in 2024, slightly down from $169,000 in 2023[15] - The net cash provided by (used in) investing activities was $(53,000) in 2024, compared to $415,000 in 2023, showing a decline in investment cash flow[15] New Products and Agreements - The company expanded Aquadex® to pediatric patients in a major Florida hospital network[2] - A purchase agreement was announced with a 50-hospital network in Texas for Aquadex Ultrafiltration Therapy[2] - The company is excited to introduce QUELIMMUNE™ for pediatric patients suffering from acute kidney injury and sepsis[3] Warrant and Fair Value Changes - The company recorded a warrant financing cost of $5,607,000 in 2024, which was not present in 2023[15] - The change in fair value of warrant liability was a loss of $720,000 in 2024, contrasting with a gain of $755,000 in 2023[15] Year-to-Date Losses - Net loss for the six months ended June 30, 2024, was $12,055,000, compared to a net loss of $11,330,000 in 2023, representing an increase in loss of approximately 6.4%[15]

Nestor Jaramillo, President and CEO of Nuwellis, shared his thoughts on this milestone: "We are thrilled to introduce QUELIMMUNE to critically ill pediatric patients in need. This marks a significant step forward in Nuwellis' mission to execute our pediatric business development strategy. By partnering with SeaStar Medical, we are committed to bringing this groundbreaking therapy to U.S. healthcare providers, offering new hope to children suffering from severe immune system reactions." About QUELIMMUNE Abou ...

In addition, in a concurrent private placement, the Company will issue to the investors warrants to purchase up to 938,680 shares of common stock. The warrants have an exercise price of $3.99 per share, will be exercisable immediately following the date of issuance and will have a term of five years from the date of issuance. The gross proceeds to Nuwellis from the registered direct offering and the concurrent private placement, before deducting the placement agent fees and other offering expenses payable b ...

MINNEAPOLIS, July 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 second quarter of 2024 on Tuesday, August 13, 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. Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company dedicated to transforming th ...

MINNEAPOLIS, July 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 second quarter of 2024 on Tuesday, August 13, 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. About Nuwellis The Aquadex SmartFlow system delivers clinically proven therapy using a sim ...