Update: 30 September 2023
- Granted marketing authorization for commercial distribution via the De Novo process by the FDA.
Update: 30 June 2023
- As part of a post-CE mark study, enrolment of thalassaemia patients in Genoa (Italy) to receive transfusions using RBCs processed and stored with the Hemanext ONE® system has begun.The study will assess safety the safety and efficacy of transfusing hypoxic RBCs in thalassemia patients. Efficacy is defined as a reduction in the volume of RBCs transfused.
- Data was presented at the Annual ISBT Congress (Gothenberg, Sweden) held on 17-21 June 2023, from the ongoing post-market clinical study in Norway for patients with haematological malignancies that required transfusions every 2 – 3 weeks, and showed that:
– After receiving 2 units of RBCs processed and stored with the Hemanext ONE® system (i.e. hypoxic RBCs), no complications or adverse events were reported.
– Haemoglobin levels increased by 17% post-transfusion.
– The data suggests that hypoxic RBCs function appropriately.
Update: 31 March 2023
No update available.