Hemanext is a privately held medical technology company based in Lexington, MA that is dedicated to improving the quality, safety, efficacy, and cost of transfusion therapy. The company's research and development efforts center on the study of hypoxically stored red blood cells (RBCs). The company's aim is to significantly improve the quality of stored RBCs by limiting oxygen and carbon dioxide levels in the storage environment. Since its founding in 2008, Hemanext has envisioned a world with fewer and better transfusions. In its early years, multiple grants from the U.S. National Institutes of Health (NIH) enabled the company to demonstrate the feasibility of hypoxic RBC storage, develop its first prototype system, and conduct in vivo research. To date, the company has raised more than $100 million. On April 13, 2021, Hemanext announced that it had received CE Mark certification for Hemanext ONE, clearing the way for the medical device to be sold in European markets. In the EU, the system is CE Marked for the processing and storage CPD/ PAGGSM Red Blood Cells, Leukocytes Reduced (LR RBC) that have been prepared and processed with the HEMANEXT ONE system within 24-hours of collection. The HEMANEXT ONE system limits the O2 and CO2 levels in the storage environment. Red Blood Cells Leukocytes Reduced, O2 /CO2 Reduced may be stored for up to 42 days at 1-6°C. HEMANEXT ONE is used for volumes no greater than 350 ml of LR RBC.5 In the United States, the company is preparing for a Q4 submission of its FDA application for U.S. market authorization; the product remains available for investigational use only in the U.S. Preclinical data show that the medical device can maintain RBCs at or below 20% oxygen saturation for up to 42 days, thereby creating hypoxic RBCs. Clinical studies are underway to measure the impact of hypoxic RBCs on patient outcomes and the potential cost savings. Visit Hemanext.com to learn more about the Company.