Clinical trial updates

Hemanext ONE®

  • Product Information

    Product Information

    Scientific name: Hypoxic RBCs
    Brand name: Hemanext ONE®
    RESPONSIBLE: Hemanext

  • Clinical Trial/Study Information

    Clinical Trial/Study Information

    Last update: 22/6/2023
    Trial Name: N/A – Hemanext ONE® is a medical device not a drug/medicinal product.
    Code: N/A
    Phase: N/A
    Eligible patient diagnosis: N/A
    No. of Patients enrolled: N/A
    Study Sites: N/A Sites per country

    Post-market clinical studies to demonstrate efficacy have started in: Norway (patients with acute burns and hematological malignancies) and Italy.

  • Regulatory Information

    Regulatory Information

    Status: Authorised

    Additional notable points:

    • EMA: CE approved (medical device) (2021)
    • FDA: Authorised via the De Novo process (2023)
    • MHRA: N/A

Update: 31 March 2024

  • No update available.

 

Update: 20 December 2023

  • No update available.

 

Update: 30 September 2023

  • Granted marketing authorization for commercial distribution via the De Novo process by the FDA.

Source: https://hemanext.com/hemanext-inc-announces-a-significant-milestone-with-fda-marketing-authorization-for-hemanext-one-hemanexts-innovative-red-blood-cell-rbc-processing-and-storage-system/


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.

Sources: https://hemanext.com/hemanext-continues-european-rollout-of-hemanext-one-rbcprocessing-and-storage-system/ 
Oral Presentation LD03-L04 https://onlinelibrary.wiley.com/doi/10.1111/vox.13433


Update: 31 March 2023

  • No update available.
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