Advancing the Quality of Blood Storage

Hemanext ONE® is the first and only FDA-authorized and CE-marked blood storage system that processes and stores red blood cells under oxygen-controlled conditions, protecting them from oxygen-driven degradation. By minimizing oxidative stress during storage, Hemanext ONE preserves red cell function, flexibility, and metabolism—resulting in blood that shows few differences from freshly donated RBC.1–7

The system integrates easily into existing blood processing workflows, offering hospitals and blood establishments a simple, evidence-based innovation that enhances transfusion quality without changing clinical practice.

Why RBC Quality Matters

The Storage Lesion: How Oxygen Undermines Blood Quality

Conventional (normoxic) storage exposes RBC to oxygen, accelerating oxidative damage and metabolic decline.3,8 In only a few days, stored RBC lose adenosine triphosphate (ATP) and 2,3-diphosphoglycerate (2,3-DPG), become less deformable, and release free iron upon transfusion.9–12 These effects reduce post-transfusion survival and oxygen delivery, subsequently increasing the need for transfusion and escalating iron burden, especially in chronically transfused patients.1,9

What's going on in the bag during storage?

See a depiction of the degradation process that occurs during RBC storage, how it impacts the major functions of RBCs, and the Hemanext ONE innovation.

How Hemanext ONE Works

Oxygen Reduced. Quality Preserved.

Hemanext Inc. has developed the Hemanext ONE System, an innovative system that deoxygenates red blood cells (RBC). The Hemanext ONE technology is a medical device designed to reduce oxygen (O2) and carbon dioxide (CO2) levels at the onset of storage and maintain low oxygen levels throughout the storage period. By lowering these gases, oxidative damage is minimized and RBC are preserved in a more physiologically relevant state, improving the overall quality of stored RBC for transfusion.2,5

The system includes two main components:

  • Oxygen Reduction Bag (ORB)
    A double-layered processing bag that reduces O2 and CO2 from red blood cells in about 3 to 3.5 hours.* 13,14 Gases diffuse out of the blood and into an iron-based sorbent layer, creating the low-oxygen environment needed for oxygen-controlled storage.
  • Hemanext Storage Bag (HSB)
    A compact storage bag designed to prevent oxygen ingress during refrigerated storage. Its double-wall design maintains the oxygen-reduced environment, helping preserve red cell quality for the full 42-day shelf life.

Through this simple yet scientifically advanced design, Hemanext ONE delivers oxygen-controlled storage that preserves red blood cell metabolism (ATP and 2,3-DPG), membrane flexibility, and faster oxygen-offloading, producing RBC that remain viable, deformable, and functionally closer to freshly donated RBC at transfusion.2,5,15

Watch How it Works

See how the Hemanext ONE system integrates into existing blood processing and transfusion workflows.

Better Blood. Better Value.

For blood establishments, Hemanext ONE enables the production of a premium, higher-quality RBC that can differentiate offerings to hospitals. Hospitals benefit from a higher outpatient reimbursement rate which is currently set by CMS at nearly three times that of conventional RBC, helping align innovation with our goal for cost-effective care.16

Find out about our reimbursement code

A Simple Change. A Meaningful Impact.

By addressing oxygen-driven damage at its source, Hemanext ONE delivers red blood cells that are biochemically and functionally of higher quality, potentially helping every transfusion do more, for every patient.

See the Science Behind Hemanext ONE
Preserving What's Vital to Life
  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. D’Alessandro 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, D’Alessandro A. Red blood cell storage lesion: causes and potential clinical consequences. Blood Transfus. 2019;17(1):27-52.
  4. Yoshida T, 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. Muller C, Courelli V, Govender K, et al. Hypoxically stored RBC resuscitation in a rat model of traumatic brain injury and severe hemorrhagic shock. Life Sciences. 2024. Doi: https://doi.org/10.1016/j.lfs.2024.122423.
  8. Hess JR. Measures of stored red blood cell quality. Vox Sang. 2014;107(1):1-9. Doi: 10.1111/vox.12130.
  9. Yoshida T, Shevkoplyas SS. Anaerobic storage of red blood cells. Blood Transfus. 2010;8(4):220-36.
  10. Burns JM, Yoshida T, Dumont LJ, et al. Deterioration of red blood cell mechanical properties is reduced in anaerobic storage. Blood Transfus. 2016;14(1):80-88.
  11. Rapido F, Brittenham G, Bandyopadyay S, et l. Prolonged red cell storage before transfusion increases extravascular hemolysis. J Clin Invest. 2017;127(1):375-382. Doi:10.1172/JCI90837.
  12. Hod EA, Zhang N, Sokol SA, et al. Transfusion of red blood cells after prolonged storage produces harmful effects that are mediated by iron and inflammation. Blood. 2010;115(21):4284-92. Doi: 10.1182/blood-2009-10-245001.
  13. 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.
  14. 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].
  15. 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.
  16. HCPCS Level II Coding Decisions. CMS.gov. Published October 7, 2024. Accessed December 12, 2025. https://www.cms.gov/files/document/2024-hcpcs-application-summary-biannual-1-2024-non-drug-and-non-biological-items-and-services.pdf.

* In the USA Instructions for Use, the Hemanext ONE system should be left on the agitator shelf for at least 3 hours but no longer than 3 hours 15 minutes for O2/CO2 reduction at 72 cycles/min. In the OUS Instructions for Use, the agitation time for the Hemanext ONE system should be 3 hours ± 15 minutes at 72 cycles/min or 3 hours 30 minutes ± 15 minutes at 60 cycles/min.

By producing higher quality RBCs, the Hemanext ONE system has the potential to enable fewer and more effective transfusions for patients. I am truly excited by the possibility of bringing this improved red blood cell replacement therapy to populations in the U.S. that have been waiting for a transformative technology like this one.

Dr. Philip C. Spinella
Professor, Department of Surgery and Department of Critical Care Medicine at University of Pittsburgh

We value our partnership with Hemanext to enhance blood product quality and availability. Hemanext ONE has the potential to strengthen the resiliency of the blood supply, and this FDA authorization is a significant milestone to that end.

Ralph Vassallo, MD, FACP
Executive Vice President, Chief Medical and Scientific Officer of Vitalant

The Hemanext ONE system offers promise to improve the treatment landscape for patients burdened by transfusions and could be an essential step towards performing fewer and better transfusions. Having long championed Hemanext’s transformative initiatives, I eagerly anticipate witnessing the positive influence, right here in the United States, on the advancement of transfusion therapy quality.

Paul M. Ness, MD
Former Director, Division of Transfusion Medicine at Johns Hopkins University and board member of Hemanext

By deoxygenating red cells and maintaining them in their hypoxic state throughout storage, the resulting red cells experience less oxidative stress and oxidative damage, have improved metabolism, and are also more deformable leading to improved micro vascular profusion and less hemolysis.

Dr. Steven Spitalnik, MD
Co-Director of the Laboratory of Transfusion Biology, Colombia University

The preclinical data by Williams et al. show anaerobically stored RBCs achieve multiple clinically important functional resuscitation goals, with a smaller volume of fluid and the FDA benchmark of 24-hour RBC recovery. I look forward to the clinical trials in bleeding patients.

John Holcomb, MD, FACS
University of Alabama at Birmingham

I have had several patients who have received Hemanext hypoxic blood, and several of the patients have personally said thanks for having been given the opportunity and also that they have felt better after transfusion with hypoxic blood compared to conventional transfusion. One must of course be careful not to attach too much importance to such observations, but I would still like to mention that there has been a remarkable tendency towards this.

Håkon Reikvam, MD, PhD
Professor, Department of Clinical Science, University of Bergen, Norway

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This website may contain information on products or uses of those products that are not authorized in all countries or regions. Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration. In Europe Hemanext ONE is CE marked which allows the medical device to be placed in the market in the EEA. Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Hemanext, Hemanext ONE, and the logos are registered trademarks of Hemanext, Inc. © 2026 Hemanext, Inc. All rights reserved.

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