The FDA has not cleared or approved the Hemanext ONE system, and it is an investigational device that is not available for commercial distribution in the United States. If you are a resident of the European Union, please click below for our site for healthcare professionals.
The Hemanext ONE® system enables processing and storage of oxygen and carbon dioxide reduced red blood cells. Our system seeks to provide a more consistent and higher quality red blood cell (RBC) by removing the fuel for oxidative damage.
The Hemanext ONE® process is designed to reduce progressive damage to red blood cells during storage. This can be seen through the MicroVascular analysis (MVA), showing the effects of storage on RBCs. In an MVA test conducted by Hemanext Inc, RBCs were observed at Day 0 and at Day 42 using conventional blood bank storage techniques and the Hemanext ONE® storage system.
The Hemanext MVA Test is for Research Use Only.
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 protype system and conduct in vivo research
In 2017, NIH awarded another $3 million grant to further develop the Hemanext ONE processing system; the company also completed research that became the pivotal clinical study for obtaining CE Mark certification
In 2018, in preparation of FDA submission, Hemanext completed a clinical study for the Hemanext ONE RBC Processing System
In 2019, Hemanext and its research colleagues wrote the latest in a series of papers published in prestigious journals that added to the body of scientific evidence supporting the clinical potential of hypoxic RBC storage