Business Description

Overview Nuwellis is dedicated to advancing cardiorenal care by enabling earlier, safer, and more controlled fluid management for patients. The company is focused on developing, manufacturing, and commercializing medical devices used in ultrafiltration therapy, including the Aquadex FlexFlow® and the Aquadex SmartFlow® systems (collectively the “Aquadex System”). The Aquadex SmartFlow® system is indicated for temporary (up to eight hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. Please note that selected authors in the citations below are either current consultants to the Company or were previously compensated consultants. Each author typically is required to disclose any actual or potential conflicts of interest at the time they submitted their written manuscript to the potential publication. Dr. Sean Pinney for example, was the principal investigator under the Company’s former REVERSE-HF heart failure clinical study. Additionally, Dr. Maria Rosa Costanzo, joined the Company’s Board of Directors in September 2019, though many of her cited publications preceded her membership on the Board of Directors. She resigned from the Board of Directors on January 21, 2026, which was not the result of any disagreement with Nuwellis regarding its operations, policies, or practices. Since joining the Company’s Board, Dr. Costanzo has declined any equity ownership in the Company, although she has accepted cash remuneration for her Board and Committee participation. Fluid Overload Fluid overload, also known as hypervolemia, is a condition in which there is too much fluid in the blood, vital organs, and interstitial space, and generally refers to the expansion of the extracellular fluid volume. Although the body does need some amount of fluid to remain healthy, too much can cause an imbalance and damage to an individual’s health. 1 The signs and symptoms of fluid overload are not always the same in each patient and may vary. However, possible signs and symptoms of fluid overload include pulmonary edema/pleural effusion, peripheral edema, anasarca (swelling of the skin) ascites, jugular vein distention and dyspnea. 2 Medical conditions or diseases where excess fluid accumulates in the body are heart failure, kidney failure, nephrotic syndrome, cirrhosis, and burn injuries/trauma. Individuals may also suffer from temporary fluid overload following certain surgical procedures, such as cardiac surgery. 3 The diagnosis of fluid overload can be made through a variety of tests/exams such as a physical exam (weight, presence of pulmonary rales, and edema), blood chemistry, natriuretic peptides, liver enzymes, hemoglobin and hematocrit, blood volume analysis, and/or bioimpedance analysis. 4 Fluid overload has a significant association with the combined events of death, infection, bleeding, arrhythmia, and pulmonary edema 5 and is a leading cause of hospital readmissions with patients suffering from heart failure and patients following cardiac surgery. 6 1 Murugan R et al. Nature Rev Nephrol. 2020; 1-14. 2 Koratala A et al. Cardiorenal Med. 2022;12(4):141-154. 3 Vaara ST et al. Crit Care .2012; 16: 1-11. 4 Koratala A et al Cardiorenal Med. 2022;12(4):141-154 5 Stein, A, et. al. Critical Care, 2012:16:R99. 6 Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80. 7 Table of Contents The condition of fluid overload is often observed in patients with heart failure and secondary oliguric states, 7 although in pediatric patients, fluid overload is associated with significant increases in mortality. 8 9 Congestion or fluid overload, the hallmark of decompensated heart failure (HF), is the primary reason for hospitalization in 90% of these patients. 10 11 For this reason, diuretics have been the cornerstone of heart failure treatment for more than 50 years. 12 Over the past 20 years, approaches to treatment have changed dramatically. 13 These dramatic improvements include new medications and new technologies, such as ultrafiltration, to help treat fluid overload.…