Hemanext ONE®
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Product Information
Scientific name: Hypoxic RBCs
Brand name: Hemanext ONE®
RESPONSIBLE: Hemanext -
Clinical Trial/Study Information
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 countryPost-market clinical studies to demonstrate efficacy have started in: Norway (patients with acute burns and hematological malignancies) and Italy.
Update: 19 December 2024
Distribution agreement with distributor in UAE to strengthen relationships with blood centres and clinicians in the GCC region, particularly UAE, Qatar, Kuwait, Saudi Arabia.
Source: https://hemanext.com/hemanext-signs-agreements-with-healthcare-distributor-in-the-u-a-e/
Update: 30 September 2024
Information published in poster abstracts at the International Society of Blood Transfusion (ISBT) Conference held on 23 – 27 June 2024 in Barcelona, Spain, shared that:
- RBCs processed and stored under hypoxic conditions using HEMANEXT ONE® meet the acceptance criteria for safe transfusions in the four European countries participating in the study (Norway, Switzerland, Germany and Italy) regardless of collection and processing modality. This validates the use of RBCs stored under hypoxic conditions for up-to 42 days.
- No side effects have been shown to occur with the use of hypoxic RBCs in patients with acute burns and haematological malignancies, as per the interim data of a safety study conducted in Norway (full results are expected in November 2024).
- A two-arm validation study to compare standard RBC processing and storage with HEMANEXT ONE® has taken place in Germany. The results will be presented in Q4 2024.
- Investigator-led studies are being assessed in Greece and Italy to generate more clinical data.
- The Irish Blood Transfusion Society is evaluating the use of hypoxic RBCs in MDS and SCD patients with a future view to also consider trauma patients.
Sources: P214 A multicentre European validation study of hypoxic red blood cells. VAgostini1,GUbezio1,RHenschler2,THFelliLunde3,EK Kristoffersen3,4,GHetland5,EDanilova6,AMartin7,MPrudent8,9,10, GGrazzini11,Walicka12,JWagner12,LOmert https://www.isbtweb.org/events/isbt-barcelona-2024/abstracts-barcelona.html
Company correspondence
Update: 30 June 2024
No update available.
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.
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.