Nuwellis Inc Stock Price, News & Analysis

Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company specializing in fluid overload solutions, has announced its plans to release second quarter 2024 financial results on August 13, 2024. The company will host a conference call and webcast at 9:00 AM ET to discuss the results and provide a general business update.

Investors and interested parties can access the live webcast through the Investors page on the Nuwellis website. Alternatively, they can join the conference call by dialing 1-800-267-6316 (U.S) or 1-203-518-9783 (international) using the conference ID: NUWEQ2. An audio archive of the webcast will be available on the company's Investors page following the call.

Nuwellis, Inc. (Nasdaq: NUWE) has announced its first commercial sale of QUELIMMUNE™ therapy to Cincinnati Children's. QUELIMMUNE, developed by SeaStar Medical, is a novel treatment for pediatric patients with acute kidney injury (AKI) due to sepsis requiring kidney replacement therapy. The therapy, accessible under an FDA Humanitarian Device Exemption, has shown a 77% survival rate in early clinical data.

This milestone marks a significant advancement in pediatric critical care. Dr. Stuart Goldstein, Director of the Center for Acute Care Nephrology at Cincinnati Children's Hospital and Principal Investigator of the multi-center studies leading to FDA clearance, expressed enthusiasm for integrating QUELIMMUNE into their treatment arsenal. Nuwellis' exclusive U.S. license and distribution agreement with SeaStar Medical enables the commercialization of this innovative therapy.

Nuwellis (Nasdaq: NUWE) will present new clinical evidence on its Aquadex ultrafiltration therapy at the HFSA 2024 conference. The study, led by Dr. Wayne Old of Sentara Health, highlights Aquadex's efficacy for heart failure patients unresponsive to diuretics. The findings suggest that Aquadex effectively manages fluid levels, offering a vital alternative therapy. The REVERSE-HF trial, also involving Sentara Health, compares Aquadex to IV diuretics for fluid overload in worsening heart failure. Dr. Amin Yehya leads this pivotal study, aiming to validate Aquadex’s economic and clinical benefits. Nuwellis emphasizes the potential of Aquadex to reduce hospitalization duration and healthcare costs, underscoring a significant shift in heart failure management.

Nuwellis announced a 1-for-35 reverse stock split of its common stock, effective June 27, 2024. Post-split, trading will commence on June 28, 2024, under the symbol NUWE on The Nasdaq Capital Market. Approved by shareholders on June 6, 2024, the reverse split will consolidate every thirty-five shares into one, while maintaining the total authorized shares at 100 million. Any fractional shares resulting from this will be rounded down, with shareholders receiving cash equivalent for the market value of the fractional share. The new CUSIP number for the common stock post-split is 67113Y603. More details are available in the proxy statement filed with the SEC on May 17, 2024, and on the company's Investor Relations page.

Nuwellis has announced the issuance of a new patent for its pediatric continuous renal replacement therapy (CRRT) device, Vivian™, from the USPTO. The patent includes innovations such as self-centering fluid bag hangers, density compensation mechanisms, and self-sealing access ports, enhancing fluid management accuracy, ease of use, and system reliability. Vivian™'s new features streamline dialysis modes and secure seals, reducing leak risks. This is the second of several patents for Vivian™, underscoring Nuwellis' dedication to improving treatment for critically ill children. Nestor Jaramillo, President and CEO, highlighted this development as a significant milestone in pediatric CRRT.

Nuwellis has announced the extension of its pilot collaboration with DaVita for the Aquadex® ultrafiltration therapy, aimed at adult patients with congestive heart failure, until August 31, 2024. This partnership allows further evaluation of the Aquadex SmartFlow system in high-need patients within select U.S. markets. DaVita, a leading kidney care provider, may extend the agreement for up to 10 years, signifying a potential long-term collaboration in inpatient and outpatient ultrafiltration services. The goal is to enhance patient care through innovative medical solutions.

Nuwellis, a medical tech firm, announced on May 14, 2024, the expansion of its pediatric ultrafiltration program using the Aquadex SmartFlow System at a major hospital network in Florida. This initiative expands their current service, which caters to adult heart failure and critical care patients, to include pediatric patients.

Currently, seven hospitals within this network use Nuwellis' technology. This expansion enhances fluid management strategies across the healthcare system for all age groups.

The Aquadex system, FDA-cleared for both adults and pediatric patients over 20 kg, safely removes excess fluid from patients unresponsive to conventional diuretics. The device features customizable fluid removal rates and real-time hematocrit monitoring, important for pediatric care.

Nuwellis, Inc. (Nasdaq: NUWE) has announced a purchase agreement with a top 25 integrated delivery network in the U.S., involving 50 hospitals, to provide Aquadex Ultrafiltration Therapy. This agreement aims to expand access to advanced ultrafiltration technology for heart failure, critical care, and pediatric patients, demonstrating a commitment to innovative treatment options.

Nuwellis, Inc. reported financial results for Q1 2024 with revenue of $1.9 million, a 2% increase over the prior year. Consumables sales grew by 11%, pediatric revenue increased by 40%, and gross margin improved to 64.1%. The company received FDA clearance for a new catheter and launched Aquadex ultrafiltration therapy. Expense reductions of nearly 50% are expected for the rest of the year.