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Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company dedicated to transforming the lives of patients suffering from fluid overload through innovative solutions. The company's flagship products include the Aquadex SmartFlow System and the RenalSense Clarity RMS. The Aquadex SmartFlow System is designed for patients who have not responded to diuretics, offering a clinically proven method to remove excess fluid safely. The RenalSense Clarity RMS is a continuous kidney monitoring system that provides real-time data to medical staff, enhancing patient care.
Recently, Nuwellis announced promising results from new clinical data analyses from the AVOID-HF trial. These studies highlight the effectiveness of the Aquadex System in reducing heart failure readmissions within 30 days, presenting a potential superior therapy compared to traditional diuretics. The re-analysis of the AVOID-HF data demonstrates significant benefits in managing heart failure events and hospitalizations.
Nuwellis is also advancing in pediatric care with a new, fully integrated pediatric continuous renal replacement therapy (CRRT) device. This initiative is partly funded by a $1.7 million grant from the National Institutes of Health (NIH), indicating the company's commitment to addressing the needs of young patients with limited kidney function.
The company has a robust intellectual property portfolio, including a recent patent that allows for seamless transitions between stationary and mobile operation modes, enhancing patient flexibility and care. This technology, along with ongoing clinical trials and collaborations, positions Nuwellis as a leader in fluid management and ultrafiltration therapy.
Nuwellis is headquartered in Minneapolis, with a subsidiary in Ireland, and continues to push the boundaries of medical technology to improve patient outcomes worldwide. For more information, visit www.nuwellis.com.
Nuwellis Inc (Nasdaq: NUWE) reported Q2 2024 financial results, showing revenue growth and improved margins. Key highlights include:
- Revenue of $2.2 million, up 6% year-over-year
- Critical Care revenue growth of 28%
- Heart Failure consumables utilization growth of 35%
- Gross margin improved to 67.2% from 55.3%
- Total operating cost reduction of 38%
The company expanded its Aquadex® therapy to pediatric patients in Florida and secured a purchase agreement with a 50-hospital network in Texas. Nuwellis also introduced QUELIMMUNE™ for pediatric acute kidney injury and sepsis treatment. Despite revenue growth, the company reported a net loss of $7.7 million or $18.85 per share. Post-quarter, Nuwellis raised $2.0 million through a registered direct offering and private placement.
Nuwellis, Inc. (Nasdaq: NUWE) has been granted continued listing on the Nasdaq Stock Market by the Nasdaq Hearings Panel, subject to specific conditions. The decision follows a hearing on July 23, 2024. The company must meet the following requirements by November 19, 2024:
- File a Form 10-Q for Q3 2024, detailing transactions to achieve compliance with the minimum stockholder Equity Rule
- Provide 12-month income projections with clear assumptions
- Demonstrate compliance with the minimum Bid Price Rule
Nuwellis must promptly notify Nasdaq of any significant events affecting compliance during the exception period. The Panel reserves the right to reconsider the terms of the exception based on any developments that may make continued listing inadvisable or unwarranted.
Nuwellis, Inc. (Nasdaq: NUWE) announced the first commercial use of QUELIMMUNE™ therapy at Cincinnati Children's hospital. QUELIMMUNE, manufactured by SeaStar Medical (Nasdaq: ICU) and exclusively distributed by Nuwellis in U.S. pediatric hospitals, is designed to treat pediatric patients with acute kidney injury (AKI) and sepsis requiring kidney replacement therapy. Dr. Stuart Goldstein, who led the multi-center studies for FDA clearance, oversaw the treatment.
The therapy aims to mitigate cytokine storms caused by AKI and sepsis, potentially improving outcomes for critically ill children. Approximately 4,000 pediatric patients are hospitalized with AKI annually in the U.S. This milestone aligns with Nuwellis' pediatric business development strategy and their partnership with SeaStar Medical to bring innovative treatments to healthcare providers.
Nuwellis (Nasdaq: NUWE) has announced a $2.0 million registered direct offering priced at-the-market under Nasdaq rules. The company will sell 469,340 shares of common stock at $4.24 per share to institutional investors. Additionally, in a concurrent private placement, Nuwellis will issue warrants to purchase up to 938,680 shares of common stock at an exercise price of $3.99 per share, exercisable immediately with a five-year term.
The offering is expected to close around July 25, 2024. Roth Capital Partners is acting as the exclusive placement agent. Nuwellis plans to use the net proceeds for working capital and general corporate purposes. The offering is made pursuant to a shelf registration statement, with the warrants being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933.
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.
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