Partnering to Advance the Future of Blood Management

Hemanext collaborates with blood establishments to bring next-generation, oxygen-controlled red blood cell storage to hospitals and patients with a goal of improving quality, reliability, and value across the transfusion chain.

Blood establishments play a vital role in ensuring that every transfusion is a safe and effective therapy.

Blood establishments can offer hospitals oxygen-controlled blood cells (RBC) by utilizing the Hemanext ONE® System, a validated, FDA authorized and CE Marked innovation.

Hemanext ONE preserves the quality, functionality and viability of RBC throughout their shelf life.1-7

Hemanext partnerships are built on collaboration, data, and shared commitment to improving blood transfusions. Together, we can respond to the call for improved blood management in transfusion medicine: decreasing donor variability in oxygen saturation and improving the quality of the stored RBC that patients receive.

Why Blood Establishments Choose Hemanext

Hemanext is redefining red blood cell preservation through oxygen-controlled storage. For blood establishments, partnering with Hemanext represents an opportunity to offer a new generation of quality transfusion.

  • Validated Innovation: Proven performance of oxygen-controlled RBC across multiple centers, meeting stringent quality standards and hemolysis limits.7
  • Regulatory Confidence: First in class FDA and CE-marked system with FDA De Novo Authorization establishing Hemanext as the first globally to market and commercialize oxygen-controlled blood processing and storage.
  • Reimbursement: The Centers for Medicare & Medicaid Services (CMS)-recognized Healthcare Common Procedure Coding System (HCPCS) Level II reimbursement code (P9027) for “Red blood cells, leukocytes reduced, oxygen/carbon dioxide reduced, each unit” in the U.S.
  • Operational Compatibility: Designed to fit into existing blood processing workflows and compatible with systems from Fresenius Kabi, Haemonetics, and Macopharma.
  • Commercial Advantage: Enables blood establishments to differentiate their product offerings with a premium, evidence-based solution that supports hospitals’ clinical and financial goals.
  • Collaborative Approach: Scientific, operational, and training support tailored to each partner’s workflow including validation study design, implementation guidance, and data analysis.
Collaboration that Drives Change

Hemanext partners with leading blood establishments and transfusion centers expand the use of oxygen-controlled red blood cell (RBC) storage. Recent multicenter validation studies conducted in Italy, Germany, Norway, and Switzerland confirmed that RBC processed using the Hemanext ONE System consistently met or exceeded regulatory quality standards, including hemolysis levels below 0.8% for European standards and 1.0% for the U.S. requirements at day 42.7 These collaborations demonstrate the reproducibility and scalability of Hemanext ONE across diverse processing environments strengthening confidence in real-world implementation.

Let's Redefine Blood Storage — Together

Hemanext is building a network of forward-thinking blood establishments committed to improving transfusion care through science and innovation. Whether your center is exploring validation studies, pilot programs, or full adoption, our team is ready to support you—from training and implementation to data analysis and publication collaboration.

Join us in shaping the future of blood storage and ensuring that every transfusion delivers the highest possible quality of care.

Get in Touch
Preserving What's Vital to Life — Through Partnership and Innovation
  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. Agostini V, Henschler R, Felli Lunde HT, et al. A validation study of the in vitro performance of hypoxic red blood cells for transfusion across centers in Europe. Transfusion. 2025:1-10. Doi: 10.1111/trf.18408.

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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