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Nuwellis Inc (NUWE) is a leader in developing medical devices for fluid overload management and renal monitoring. This page serves as the definitive source for verified news and official announcements about the company’s innovations in critical care technology.
Access real-time updates on Aquadex SmartFlow System deployments, RenalSense Clarity RMS clinical validations, and strategic partnerships. Investors and healthcare professionals will find essential information about regulatory milestones, research findings, and operational developments directly impacting patient care standards.
Our curated collection includes earnings reports, product launch details, and peer-reviewed study outcomes. All content is rigorously verified to ensure accuracy while maintaining accessibility for both medical experts and general investors.
Bookmark this page for streamlined access to NUWE’s latest advancements in ultrafiltration therapy and kidney function monitoring technologies. Return regularly to stay informed about developments shaping the future of fluid management solutions.
Nuwellis (Nasdaq: NUWE) has secured U.S. Patent No. 12,280,007 for an innovative self-emptying fluid bag design that enhances clinical workflow efficiency. The patent, issued on April 22, 2025, features a novel siphon mechanism that enables automatic drainage without disconnecting from the scale, maintaining precise weight-based measurements.
The technology aims to reduce manual intervention requirements while preserving system accuracy in treating fluid overload in critically ill patients. While not planned for immediate implementation, the design could be incorporated into future Aquadex SmartFlow system updates, including the Vivian pediatric-focused CRRT device under development.
The patent received a 224-day extension to its standard term from the USPTO, representing one of several initiatives by Nuwellis to expand its intellectual property portfolio and advance fluid management innovation.
Nuwellis (NUWE), a commercial-stage medical technology company specializing in fluid overload solutions, has scheduled its first quarter 2025 financial results announcement for May 13, 2025. The company will host a conference call and webcast at 9:00 AM ET to discuss the results and provide a business update.
Investors can access the live webcast through the company's investor relations website at ir.nuwellis.com, or join the conference call by dialing 1-800-579-2543 (U.S.) or 1-785-424-1789 (international) using conference ID: NUWEQ1. An audio recording will be available on the company's investor website after the call.
Nuwellis (NUWE) reported Q4 and full year 2024 financial results, showing mixed performance. Q4 revenue decreased 9% year-over-year to $2.3 million, while consumables utilization grew 21% and Critical Care revenue increased 35%. The company achieved a gross margin of 58.4%, up from 54.4% in the prior year quarter.
Notable highlights include a four-fold CMS payment increase to $1,639 for Aquadex Ultrafiltration Therapy in outpatient settings, effective January 2025. New clinical data showed Aquadex reduced heart failure events by 60% compared to IV diuretics. The company successfully reduced operating costs by $5.9 million (26%) year-over-year.
Q4 operating loss improved to $2.4 million from $3.6 million, with net loss per share of $0.44. As of December 31, 2024, Nuwellis had no debt and $5.1 million in cash and cash equivalents.
Nuwellis Inc (Nasdaq: NUWE) announced that Nestor Jaramillo, Jr. has retired as President, CEO, and director, effective February 18, 2025. John Erb, the current Chairman of the Board, has been appointed as Interim President and CEO.
The company plans to engage an executive search firm to identify a permanent CEO. Erb, who has served as a director since September 2012 and chairman since October 2012, previously served as president and CEO of Nuwellis from November 2015 to January 2021. He was also executive chairman and CEO of CHF Solutions, Inc., the previous owner of the Aquadex™ system.
Nuwellis (NUWE) announced promising findings from an updated analysis of the AVOID-HF study, published in JACC: Heart Failure. The study, led by Dr. Sean P. Pinney and Dr. Maria V. DeVita, revealed that patients treated with Aquadex SmartFlow ultrafiltration therapy showed a 60% reduction in heart failure events at 30 days compared to traditional IV diuretics.
The reanalysis of the AVOID-HF study included a broader dataset and demonstrated trends toward fewer hospitalizations and improved quality of life for patients using Aquadex therapy. Nuwellis plans to continue research through its REVERSE-HF trial to further establish the clinical and economic benefits of ultrafiltration therapy versus conventional treatments.
Nuwellis (Nasdaq: NUWE), a commercial-stage medical technology company specializing in fluid overload solutions, has announced it will release its Q4 and full year 2024 financial results on March 11, 2025. The company will host a conference call and webcast at 9:00 AM ET to discuss the results and provide a business update.
Investors can access the live webcast through the company's investor relations website at ir.nuwellis.com, or join the conference call by dialing 1-800-245-3047 (U.S) or 1-203-518-9765 (international) using conference ID: NUWEQ4. An audio archive will be available after the call on the company's investor website.
Nuwellis (Nasdaq: NUWE) has announced a new partnership with a nationally ranked hospital in Utah, marking its 44th pediatric account for the Aquadex SmartFlow® system. The hospital will use the system to treat children with fluid overload caused by kidney and heart disease. This expansion represents significant growth from 13 accounts in 2020 when FDA clearance was granted.
The collaboration integrates Nuwellis' technology into a prominent western U.S. healthcare network, offering advanced fluid management therapy for pediatric patients. The Aquadex SmartFlow® system is an ultrafiltration therapy device that safely removes excess fluid from the body, providing a gentler alternative to conventional CRRT therapy for children with fluid overload conditions resulting from disease, injury, or surgery.
Nuwellis (NUWE) has successfully regained compliance with Nasdaq's listing requirements, including both the minimum bid price and stockholders' equity requirements. The company will continue trading on the Nasdaq Capital Market under 'NUWE'. This achievement follows strategic financial moves including raising $5.1 million in gross proceeds through warrant exercises and a warrant inducement transaction in November. The company implemented a 1:35 reverse stock split on June 26, 2024, and has improved its balance sheet by raising new equity and reducing liabilities. Nuwellis now exceeds Nasdaq's stockholders' equity requirement of $2.5 million. The company will be subject to a mandatory panel monitor for one year from December 17, 2024.
Nuwellis (NUWE) reported Q3 2024 financial results with revenue of $2.4 million, showing a 2% decrease from the prior year. Notable highlights include a 297% CMS reimbursement increase to $1,639 for Aquadex facility fee effective January 2025, 28% growth in pediatrics revenue, and improved gross margin of 70% compared to 57.3% last year. The company achieved a 30% reduction in operating costs and reported net income of $2.4 million. A new study showed significant reduction in Heart Failure readmissions using Aquadex. The company added three new pediatric and two new adult accounts, while receiving $5.1 million through warrant exercises.
Nuwellis announced the exercise of warrants generating $5.1 million in gross proceeds. This includes $3.8 million from the immediate exercise of warrants issued on April 30, 2024, at $2.10 per share, plus $1.3 million from warrant exercises over the last week. In exchange for the immediate exercise, the company will issue new Series I and Series II warrants to purchase up to 3,665,034 shares. The new warrants will have an exercise price of $1.94, with Series I having a 5-year term and Series II a 2-year term, both exercisable after 6 months. Ladenburg Thalmann & Co. Inc. served as the exclusive warrant inducement agent.
