2023

2023

On September 15, 2023, Hemanext ONE was granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration.
2023

2022

Transfusions have begun in EU using RBCs processed and stored with the Hemanext ONE® system in Bergen, Norway as part of a post-market clinical study.
2022

2022

On January 24, 2022, Hemanext announced that its innovative blood processing and storage system has been recognized by the Association for the Advancement of Blood & Biotherapies (“AABB”), a leading international association in transfusion medicine and...
2023

2021

On April 13, 2021, Hemanext announced that it had received CE Mark certification for Hemanext ONE® system, clearing the way for the medical device to be sold in European markets. On December 30, 2021, Hemanext submitted the Hemanext ONE® system for marketing...
2019

2019

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.