Welcome to our dedicated page for Nuwellis news (Ticker: NUWE), a resource for investors and traders seeking the latest updates and insights on Nuwellis stock.
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 Q3 2022 revenue of $2.1 million, marking an 11% increase year-over-year. The gross margin remained solid at 61%, consistent with last year. The company activated three additional sites for the REVERSE-HF clinical study and announced positive AVOID-HF clinical data showing ultrafiltration's superior benefits for heart failure patients. Nuwellis also closed an $11.0 million public offering on October 18. The net loss was reduced to $3.9 million from $5.3 million a year prior. Cash and equivalents total approximately $12.1 million.
Nuwellis, Inc. (NUWE) announced promising clinical data demonstrating the efficacy of kidney replacement therapy using ultrafiltration for preterm neonates with end-stage kidney disease. A retrospective study revealed that 71% of the seven neonates studied survived to hospital discharge. The company aims to address unmet needs in neonatal fluid management and is developing a new pediatric CRRT device with partial funding from a $1.7 million NIH grant, collaborating with Koronis Biomedical Technologies Corporation.
Nuwellis, Inc. (NASDAQ: NUWE) will release its third quarter 2022 financial results on November 8, 2022. A conference call and webcast are scheduled for 9:00 AM ET, featuring management's discussion on the financial results and a business overview. Interested parties can join the live webcast on Nuwellis' Investors page or call in using the provided numbers with conference ID 10172214. Founded in Minneapolis, Nuwellis focuses on developing and commercializing the Aquadex SmartFlow® system for ultrafiltration therapy to aid patients with fluid overload.
Nuwellis, Inc. (Nasdaq: NUWE) has appointed Lynn Blake as Chief Financial Officer, effective October 19, 2022. With over 20 years of financial leadership experience, including successful roles in public offerings, Blake aims to support Nuwellis in expanding its market opportunities for ultrafiltration therapies targeting fluid overload in patients. Nuwellis is focused on enhancing access to its Aquadex SmartFlow® technology for both adult and pediatric patients, signaling a strategic move towards growth in critical care and heart failure sectors.
Nuwellis, Inc. (NASDAQ: NUWE) announced the successful closing of an underwritten public offering, generating gross proceeds of approximately $11.04 million. This offering included the full exercise of the underwriter's over-allotment option. The transaction comprised 15,235,196 Class A Units at $0.25 each, and 23,157,124 Class B Units, also priced at $0.25. Each Class A Unit consists of one share of common stock and 1.5 warrants, while Class B Units consist of one share of Series I convertible preferred stock. The warrants will be exercisable contingent on stockholder approval of a reverse stock split.
Nuwellis, Inc. (Nasdaq: NUWE) announced an underwritten public offering of units, aiming to raise approximately $9.6 million before costs. The offering includes 15,235,196 Class A Units and 23,157,124 Class B Units, each priced at $0.25. Each unit consists of common stock and warrants to purchase additional shares. Stockholder approval is required for the warrants' exercise, contingent upon a reverse stock split. Closing is anticipated on October 18, 2022. Ladenburg Thalmann is acting as the sole book-running manager.
Nuwellis, Inc. (Nasdaq: NUWE) announced significant findings from the AVOID-HF clinical study at the HFSA 2022 Annual Scientific Meeting. The analysis revealed that ultrafiltration outperforms diuretics in reducing heart failure events, showcasing an 81% increase in wins at 30 days and a 109% increase at 90 days. The results support the effectiveness of the Aquadex System in managing fluid overload, promising better outcomes for patients and potential cost savings for healthcare systems. Nuwellis aims to set Aquadex therapy as the standard for fluid management in heart failure patients.
Nuwellis, Inc. (Nasdaq: NUWE) has activated three new sites for its pivotal REVERSE-HF clinical study, evaluating ultrafiltration therapy against IV diuretics for heart failure patients with fluid overload. New sites include Jefferson Abington Hospital, UCSF, and Baycare Morton Plant Hospital. The study aims to provide evidence on the clinical, economic, and quality-of-life benefits of ultrafiltration therapy, especially for patients unresponsive to traditional diuretics, amidst over 1 million annual hospitalizations for heart failure in the U.S.
Nuwellis (Nasdaq: NUWE) announced promising clinical data supporting the use of Aquadex FlexFlow® System for fluid management in high-risk postoperative coronary artery bypass grafting (CABG) patients. A study published in the Journal of Cardiac Surgery revealed a 100% 30-day survival rate among 17 patients treated with ultrafiltration, despite a high mean mortality score of 5.7%. This innovative approach addresses fluid overload, a significant risk factor for morbidity and mortality in CABG surgeries. The company aims to further research the application of Aquadex technology across more institutions.
Nuwellis, Inc. (Nasdaq: NUWE) has received a patent for a novel technology aimed at enhancing fluid balance and safety during pediatric dialysis and hemofiltration. The innovation allows healthcare providers to sense pressure changes in connected pumps, enabling timely therapeutic adjustments. Funded partly by a $1.7 million NIH grant, Nuwellis is also developing a fully integrated continuous renal replacement therapy device for infants and children, in collaboration with KBT. This advancement supports the company's mission to improve outcomes for patients with fluid overload.
FAQ
What is the current stock price of Nuwellis (NUWE)?
What is the market cap of Nuwellis (NUWE)?
What does Nuwellis, Inc. specialize in?
What is the Aquadex SmartFlow System?
What recent clinical trials have Nuwellis conducted?
What is the RenalSense Clarity RMS?
What innovations has Nuwellis introduced for pediatric patients?
Where is Nuwellis headquartered?
How does the Aquadex SmartFlow System benefit patients?
Does Nuwellis have any recent patents?
What partnerships does Nuwellis have?
What is the focus of Nuwellis' business strategy?
