Nuwellis Inc - NUWE STOCK NEWS

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.

Nuwellis (Nasdaq: NUWE) announces a significant reimbursement rate increase for its Aquadex SmartFlow therapy from the Centers for Medicare and Medicaid Services (CMS). Effective January 1, 2025, the payment rate will increase by 397% from $413 to $1,639 per day. This change involves reassigning the therapeutic ultrafiltration CPT code 0692T from APC 5241 to APC 5242, creating a better reimbursement pathway for outpatient treatment. The decision aims to expand patient access to ultrafiltration therapy and improve fluid management care in outpatient settings.

Nuwellis (NUWE) reported preliminary Q3 2024 results with revenue of approximately $2.4 million. The company achieved 28% revenue growth in the Pediatric category year-over-year and improved gross margin to 70%, up 12.7% from 57.3% in Q3 2023. Operating costs were reduced by approximately 30% compared to the same period. The company ended the quarter with $1.9 million in cash, with quarterly cash burn of $2.5 million. Nuwellis acquired five new accounts and received a $900,000 settlement from SeaStar Medical, with $500,000 already paid.

Nuwellis announces that University of Iowa Health Care Stead Family Children's Hospital has adopted the Aquadex SmartFlow® system for treating pediatric patients with fluid overload due to heart and kidney disease. The system provides adjustable ultrafiltration therapy for critically ill children experiencing excess fluid buildup. Dr. Kyle Merrill, Associate Medical Director of Pediatric Dialysis, highlights that fluid overload increases ICU time, ventilator dependency, and mortality rates. The hospital previously relied on diuretics and conventional dialysis methods. The Aquadex therapy offers a new solution for managing fluid overload in their most critical pediatric patients, aiming to improve outcomes and quality of life.