Nuwellis successfully completed a pre-submission meeting with the FDA to expand the Aquadex SmartFlow System's label to include pediatric patients weighing as little as 5 kg, down from the current 20 kg. This expansion addresses a critical need for safer fluid management in low-weight children, supported by clinical evidence and real-world use. The company plans to submit the formal 510(k) application by the end of 2026, aiming to improve treatment options for pediatric patients requiring controlled ultrafiltration without full renal replacement therapy.
Nuwellis, a medical technology company focused on cardiorenal conditions, has closed a public offering raising approximately $6 million. The offering included common stock, pre-funded warrants, and Series C and D warrants, with proceeds aimed at supp...
Nuwellis, Inc., a medical technology company focused on cardiorenal conditions, has closed a public offering raising approximately $6 million. The offering included common stock and warrants, priced around $0.30 per share and warrant. Proceeds will s...
Nuwellis, Inc. announced a public offering of 20 million shares of common stock and accompanying warrants priced at $0.30 each, aiming to raise approximately $6 million. The offering includes Series C and Series D warrants with exercise prices set at...
