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Nuwellis reported promising results for its Aquadex FlexFlow system in treating acutely decompensated heart failure (ADHF) patients. A study presented at the 2021 American College of Cardiology conference involved 30 patients, where 83% showed clinical symptom improvement. The mean fluid removal was 9.40L, with significant reductions in heart failure-related readmissions (p=0.017 at 60 days). These findings align with prior trials, affirming Aquadex's effectiveness without adverse renal impact. The company emphasizes its commitment to addressing heart failure challenges through innovative ultrafiltration therapy.
Nuwellis, Inc. (Nasdaq: NUWE) has expanded the availability of its Aquadex SmartFlow® System to Driscoll Children’s Hospital in Corpus Christi, Texas, aimed at pediatric patients experiencing fluid overload. This system allows for precise fluid removal using only 35 mL of blood, making it particularly advantageous for smaller patients. The technology is clinically proven for children weighing 20 kg or more, helping alleviate complications from conditions like heart and kidney failure. CEO Nestor Jaramillo emphasized their commitment to enhancing access to vital therapies.
Nuwellis, Inc. (Nasdaq: NUWE) reported its first-quarter results for 2021, showing revenue of $1.9 million, an 18% increase year-over-year. The company completed a rebranding from CHF Solutions, Inc. on April 27, 2021. Key highlights include increased Aquadex therapy utilization, the enrollment of the first pediatric patient in a clinical registry, and strong endorsements for a Category III CPT code application. Nuwellis ended the quarter with $27.9 million in cash and no debt, despite a net loss of $5.2 million.
Nuwellis, Inc. (NASDAQ:NUWE), formerly known as CHF Solutions, will announce its first quarter 2021 financial results on May 11, 2021, followed by a conference call at 9:00 AM ET. The session will include discussions on financial outcomes and business overview. Investors can access the live webcast through the company's website. Nuwellis specializes in developing medical devices aimed at alleviating fluid overload through innovative solutions, primarily focused on the Aquadex SmartFlow® system.
CHF Solutions (Nasdaq: CHFS) has announced the availability of its Aquadex SmartFlow® system at two new pediatric hospitals in Texas, enhancing access to vital fluid management therapies for children suffering from fluid overload. The Aquadex device is designed for pediatric use, allowing gradual fluid removal with minimal extracorporeal fluid required. This expansion reflects CHF's commitment to addressing fluid overload challenges in pediatric patients, known for complications related to heart and kidney conditions. The technology aims to improve treatment outcomes and reduce hospitalizations.
CHF Solutions has announced the initiation of the ULTRA-Peds Registry at Joe DiMaggio Children’s Hospital to gather clinical data on the Aquadex SmartFlow® system for pediatric patients suffering from fluid overload. The registry aims to collect data from approximately 500 patients concerning treatment effects on survival rates, ICU stays, kidney function, and complications. This initiative underscores the company's commitment to enhancing pediatric care and advancing its technology.
CHF Solutions announced a new clinical abstract highlighting the lifesaving potential of the Aquadex SmartFlow system during the National Kidney Foundation Spring Clinical Meeting. The case study, presented by Dr. Maria DeVita, illustrates how ultrafiltration therapy effectively supported a critically ill 74-year-old patient, helping to manage severe multi-organ failure. Key highlights include the removal of 1.5L of excess fluid during a lengthy transit to surgery, showcasing the device's portability and its crucial role in patient stabilization.
CHF Solutions, Inc. (NASDAQ:CHFS) announced the successful closing of its underwritten public offering of 3,795,816 shares at $5.50 per share, generating gross proceeds of approximately $20.9 million, including the underwriters' over-allotment option. The company plans to utilize the net proceeds for general corporate purposes and to support commercialization efforts. Following the offering, CHF Solutions anticipates a proforma cash balance of around $35.2 million to further advance its strategic goals in providing innovative care solutions for patients with cardio-kidney disease.
CHF Solutions, Inc. (NASDAQ:CHFS) has priced an underwritten public offering of 3,300,710 shares of common stock at $5.50 per share, aiming to raise approximately $18.1 million, excluding underwriting fees. The offering includes an option for underwriters to purchase an additional 495,106 shares within 45 days. Proceeds will support general corporate purposes, particularly commercialization efforts. The closing is expected around March 19, 2021, following the completion of customary conditions. This offering is registered under SEC regulations with effective registration statements.
