1. Karafin MS, Field J, Ilich A, et al. Hypoxic storage of donor red cells preserves deformability after exposure to plasma from adults with sickle cell disease. Transfusion. 2022;1-10. Doi: 10.1111/trf.17163. 2.DʼAlessandro A, Yoshida T, Nestheide S, et al. Hypoxic storage of red blood cells improves metabolism and post-transfusion recovery. Transfusion. 2020;60(4):786-798. 3. Yoshida T, Prudent M, and D’Alessandro A. Red blood cell storage lesion: causes and potential clinical consequences. Blood Transfus. 2019;17(1):27-52. 4.Yoshida T and Shevkoplyas SS. Anaerobic storage of red blood cells. Blood Transfus. 2010;8(4):220-36.

Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration and has CE Mark Certification for the EU.

Reducing oxidative damage improved the quality of the red blood cell.

Yoshida et al, data revealed the oxygen content of Leukoreduced RBC (LR-RBC) increases during 6-week storage as seen in figure 1. Hemanext ONE was found to tightly control the oxygen levels which are represented in the dashed line in figure 2.

Hemanext ONE Overview

The product displayed below is the version for use in the USA that has been granted marketing authorization by the FDA. This version has slight differences but is representative of the CE Mark version for use in the European Economic Area.

1. Karafin MS, Field J, Ilich A, et al. Hypoxic storage of donor red cells preserves deformability after exposure to plasma from adults with sickle cell disease. Transfusion. 2022;1-10. Doi: 10.1111/trf.17163. 2. DʼAlessandro A, Yoshida T, Nestheide S, et al. Hypoxic storage of red blood cells improves metabolism and post-transfusion recovery. Transfusion. 2020;60(4):786-798. 3. Yoshida T, Prudent M, and D’Alessandro A. Red blood cell storage lesion: causes and potential clinical consequences. Blood Transfus. 2019;17(1):27-52. 4. Yoshida T and Shevkoplyas SS. Anaerobic storage of red blood cells. Blood Transfus. 2010;8(4):220-36. 5. Rabcuka J, Blonski S, Meli A, et al. Metabolic reprograming under hypoxic storage preserves faster oxygen unloading from stored red blood cells. Blood Adv. 2022; 6(18):5415-5428. doi: 10.1182/bloodadvances.2022007774. 6. Dumont LJ, Yoshida T, AuBuchon JP. Anaerobic storage of red blood cells in a novel additive solution improves in vivo recovery. Transfusion. 2009;49(3):458-64. 7. Sharma RR and Marwaha N. Leukoreduced blood components: advantages and strategies for its implementation in developing countries. Asian J Transfus Sci. 2010; 4(1):3-8. 8. Wortham S, Ortolao G, and Wenz B. A brief history of blood filtration: clot screens, microaggregate removal and leukocyte reduction. Transfusion Medicine Reviews. 2003; 17(3):216-222. 9. Association for the advancement of blood and biotherapies. Highlights of transfusion medicine history. Accessed January 30, 2024. https://www.aabb.org/news-resources/resources/transfusion-medicine/highlights-of-transfusion-medicine-history 10. American Red Cross. History of blood transfusion. Accessed January 30, 2024. https://www.redcrossblood.org/donate-blood/blood-donation-process/what-happens-to-donated-blood/blood-transfusions/history-blood-transfusion.html. 11. Orlov D and Karkouti K. The pathophysiology and consequences of red blood cell storage. Anesthesia. 2015;70 (Suppl. 1). 12. Yoshida T, Blair A, D’Alessandro A, et al. Enhancing uniformity and overall quality of red cell concentrate with anaerobic storage. Blood Transfus. 2017;15(2):172-181. 13. Zimring JC. Established and theoretical factors to consider in assessing the red cell storage lesion. Blood. 2015; 125 (14): 2185-2190. 14. Hess Jr. Measures of stored red blood cell quality. Vox Sanguinis. 2014; 107:1-9. 15. HEMANEXT ONE® (Blood container set used to process and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced) [US Instructions for Use]. Lexington, MA: Hemanext Inc. 16. HEMANEXT ONE® (Blood container set used to process and store CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced) [OUS Instructions for Use]. Lexington, MA: Hemanext Inc. 17. Williams AT, Jani VP, Nemkov T, et al. Transfusion of anaerobically or conventionally stored blood after hemorrhagic shock. Shock. 2020;53(3):352-362. 18. DOF. Report Document. Test Report CLIN-0001.2019. 19. DOF.Report Document.Test Report CLIN-0002.2019. 20. Whitley P, Wellington M, Sawyer S, et al. 2,3 Diphosphoglycerate content and oxygen affinity of Hemanext red blood cells. Poster presented at: The International Society of Blood Transfusion; June, 2018; Toronto, Canada. 21. Centers for Disease Control and Prevention (CDC). “Complications and Treatments of Sickle Cell Disease.” https://www.cdc.gov/ncbddd/sicklecell/treatments.html. Accessed October 2020. 22. Inusa Baba, Atoyebi W, Andermariam B, Hourani J, and Omert L. Global burden of transfusion in sickle cell disease. Transfusion and Apheresis Science. 2023. Doi: https://doi.org/10.1016/j.transci.2023.103764. 23. American Cancer Society. “Supportive Therapy for Myelodysplastic Syndromes.” https://www.cancer.org/cancer/myelodysplasticsyndrome/treating/supportive-therapy.html. Accessed October 2020. 24. Mayo Clinic. “Thalassemia, Diagnosis & Treatment.” https://www.mayoclinic.org/diseases-conditions/thalassemia/diagnosis-treatment/drc-20355001. Accessed October 2020. 25. Reikvam H, Hetland G, Ezligini F, et al. Safety of hypoxic red blood cell administration in patients with transfusion-dependent hematological malignancies: an interim analysis. Transfusion and Apheresis Science. 2023. Doi: 10.1016/j.transci.2023.103755. 26. DOF.Calculator.Budget Impact Model.2024. 27. Odom SR, Howell MD, Silva GS, et al. Lactate clearance as a predictor of mortality in trauma patients. J Trauma Acute Care Surg. 2013;74(4):999-1004. Doi: 10.1097/TA.0b013e3182858a3e.