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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 (Nasdaq: NUWE), a medical technology company specializing in fluid overload solutions, has announced it will release its third quarter 2024 financial results on November 11, 2024. The company will host a conference call and webcast at 9:00 AM ET to discuss financial results and provide a business update. Investors can access the webcast through the company's investor relations website or join via telephone using the provided dial-in numbers.
Nuwellis (Nasdaq: NUWE), a medical technology company focused on treating fluid overload, has announced its participation in the Third Annual ROTH Healthcare Opportunities Conference. The event is scheduled for Wednesday, October 9, 2024.
President and CEO Nestor Jaramillo will represent Nuwellis at the conference. Investor presentations and related materials will be accessible on the company's website in the investor relations section.
Interested parties can attend the conference and meet with Nuwellis representatives by contacting their ROTH representative, submitting an online registration request, or reaching out to Vivian Cervantes at Gilmartin Group via ir@nuwellis.com.
Nuwellis, Inc. (Nasdaq: NUWE) announced the publication of a new study in Current Problems in Cardiology demonstrating the effectiveness of Aquadex® ultrafiltration therapy in reducing 60-day hospital readmission rates for patients with acutely decompensated heart failure (ADHF). The study, conducted in a community hospital setting, analyzed data from 30 patients and found:
- Significant volume loss and weight reduction without adverse renal effects
- Statistically significant reduction in rehospitalization rates at 60 days (16.7% vs. 26.7%, p=0.013)
- 40% decrease in ADHF readmissions in 30 days and 59% in 60 days following therapy
- Stable renal function post-ultrafiltration
These results highlight the potential of Aquadex therapy to improve patient outcomes and reduce healthcare costs associated with heart failure management.
Nuwellis (NUWE) has announced a $916,000 registered direct offering priced at-the-market under Nasdaq rules. The company will sell 496,901 shares of common stock at $1.8450 per share. Additionally, in a concurrent private placement, Nuwellis will issue warrants to purchase up to 496,901 shares with an exercise price of $1.72 per share. The warrants will be immediately exercisable and have a 5-year term. The offering is expected to close around August 26, 2024. Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent. Nuwellis plans to use the net proceeds for working capital and general corporate purposes.
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.
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