Hemanext Inc. Receives CE Mark Certification for Innovative Red Blood Cell (RBC) Processing & Storage System
Company to launch Hemanext ONE RBC Processing and Storage System in select European markets in 2021, with wider distribution in Europe and the Americas in 2022 and future years
Hemanext ONE is now commercially available in Norway
LEXINGTON, Mass., April 13, 2021 /PRNewswire/ -- Hemanext Inc., a privately held medical technology company, today announced it has received a CE Certificate of Conformity for the CE Mark for the Hemanext ONE Red Blood Cell (RBC) Processing and Storage System, allowing the innovative medical device to be sold in European markets. Blood center validations required for local adoption of the Hemanext ONE RBC Processing and Storage System were completed in Norway in 2020. The company expects blood centers in Italy, Switzerland, and France to complete validations in 2021. Hemanext plans to secure additional validations and approvals in order to make the device available to healthcare professionals in other select European markets and in the Americas in future years.
The Hemanext ONE RBC Processing and Storage System is indicated for the processing and storage of CPD/PAGGSM Red Blood Cells, Leukocytes Reduced (LRRBC) that have been prepared and processed with the HEMANEXT ONE system within 24-hours of collection. It limits the O2 and CO2 levels in the storage environment.1 reduces the fuel for oxidative damage prior to and during hypoxic storage. Blood centers can utilize the device to convert a unit of conventional, leukoreduced RBCs into a transfusion-ready unit of RBCs that based on pre-clinical data, offloads oxygen better than conventional blood2 and reduces progressive damage that occurs naturally during storage.3
CE marking will allow the initiation of clinical studies and real-world experience in Europe to evaluate the potential of the technology. Researchers anticipate that RBCs with limited oxygen and carbon dioxide may fill an unmet medical need by potentially reducing the number of transfusions4, related complications5, and adverse events6, thereby improving the quality of life7 for patients while reducing costs.7,8,9
Due to their need for chronic transfusions, people with thalassaemia and myelodysplastic syndromes (MDS) are among the patient populations that could benefit from RBCs with limited oxygen and carbon dioxide,10 like Hemanext ONE. European physicians now can generate and publish real-world data about the potential impact of this innovative technology.