BLOOD TRAΝSFUSION THERAPY | FDA Approves Hemanext ONE®
Hemanext Inc. has achieved a significant milestone with the FDA marketing authorization for Hemanext ONE®, the company’s innovative red blood cell (RBC) processing and storage system.
This revolutionary technology sets a new standard in RBC processing and storage by limiting oxygen in the storage environment, thereby providing a higher quality blood product for patients requiring transfusions.
The Hemanext ONE RBC Processing and Storage system has the potential to benefit those suffering from chronic conditions such as thalassaemia, sickle cell disease (SCD), and myelodysplastic syndromes (MDS), as well as patients requiring critical transfusions during post-traumatic surgery or other medical procedures.
HEMANEXT ONE creates hypoxic RBCs, RBCs that have been processed to reduce oxygen and carbon dioxide content of RBCs and to maintain this level throughout storage up to 42 days. Hypoxic RBCs have demonstrated positive impacts on multiple in vitro metrics of RBC quality in preclinical studies. Clinical studies are underway to determine the impact of hypoxic RBCs on patient outcomes and estimate potential cost savings from expected improvements in care and reductions in transfusion volumes.
Andrew Dunham, Chief Executive Officer of Hemanext, expressed his enthusiasm for this groundbreaking achievement, stating, “This pivotal accomplishment underscores Hemanext’s unwavering commitment to the transfusion medicine community and our dedication to meeting patients’ needs through continuous advancements in medical technology. Patients are at the heart of our mission, and we are always seeking ways to expedite the delivery of our innovative red blood cell transfusion therapy, produced using the Hemanext ONE Processing and Storage system, to patients worldwide to potentially enhance their quality of life.”
Commenting on the news, Dr. Androulla Eleftheriou, TIF’s Executive Director, said: “Hemanext’s FDA De Novo marketing authorization is a great accomplishment that excites us at the Thalassaemia International Federation (TIF). Hemanext ONE aims to offer a transformative red blood cell transfusion therapy, providing support to patients in need of lifelong and regular blood transfusions. This innovative treatment option holds great promise for individuals with thalassaemia and other hemoglobin disorders.”
