LEXINGTON, Mass., July 12, 2022 – PR NEWSWIRE – Hemanext Inc., a leading innovator in blood processing, storage, and transfusion technology, today announced a significant milestone in the rollout of its Hemanext ONE® RBC (Red Blood Cell) Processing and Storage System in Europe.
Physicians in Norway have initiated recruitment of chronically transfused patients with hematological malignancies, including myelodysplastic syndrome (MDS), to receive transfusions using RBCs processed and stored with the Hemanext ONE® system. This will be followed by enrollment and transfusion of acutely bleeding burn patients. Hemanext expects these transfusions, which are part of a post-market clinical study in Bergen, Norway, to begin later this summer.
Martin Cannon, Co-Founder, and CEO of Hemanext said: “After receiving European CE mark certification last year, beginning the treatment of patients in Europe with hypoxically stored RBCs will mark a significant milestone, both for our company and for transfusion patients globally. We believe the road to improved patient transfusions begins with storing RBCs under hypoxic conditions to limit oxidative damage and storage lesions. Our technology has the potential to facilitate efficient treatment of patients in need, and we look forward to continuing to expand our presence into additional European markets over the course of 2022.”
Hemanext plans to roll out Hemanext ONE® across additional European markets in the coming months. As part of its commercialization and sales ramp up program, Hemanext has been strengthening its relationship with distributors, healthcare institutions, and blood establishments across Europe.
Hemanext is a privately held medical technology company based in Lexington, MA that is dedicated to improving the quality, safety, efficacy, and cost of transfusion therapy. The company’s research and development efforts center on the study of hypoxically stored red blood cells (RBCs). The company’s aim is to significantly improve the quality of stored RBCs.
About Hemanext ONE®
In the EU, the system is CE Marked for the processing and storage of CPD/ PAGGSM Red Blood Cells, Leukocytes Reduced (LR RBC) that have been prepared and processed with the HEMANEXT ONE® system within 24 hours of collection. The HEMANEXT ONE® system limits the O2 and CO2 levels in the storage environment. Red Blood Cells Leukocytes Reduced, O2 /CO2 Reduced may be stored for up to 42 days at 1-6°C. HEMANEXT ONE® is used for volumes no greater than 350 ml of LR RBC.1
In the United States, the product remains available for investigational use only, pending marketing authorization from the FDA.
Preclinical data show that the medical device can maintain RBCs at or below 20% oxygen saturation for up to 42 days,2 thereby creating hypoxic RBCs. Clinical studies are underway to measure the impact of hypoxic RBCs on patient outcomes and the potential cost savings.3
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1 Hemanext ONE, Instructions for Use for the European Union (April 2021), DOF.
2 Brouard, D et al. Vox Sang 2018; 113: 153.2018.
3 Frank, S. et al. Anesthesiology 2017;127(5):754-764. DOF calculation.