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Hemanext ONE® Receives 510(k) Clearance for Expanded Indications for Use in the US

The expanded Indications for Use enable processing of whole blood and apheresis-derived AS-3 leukocyte-reduced red blood cells.

Hemanext Inc., a leading innovator in blood processing, storage and transfusion technology, today announced that the Hemanext ONE® System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded indications for use in the United States.

The clearance enables U.S. blood establishments to use the Hemanext ONE System to process any AS-3 leukocyte-reduced red blood cells, derived from either whole blood or apheresis, processed with the Hemanext ONE System.

The Hemanext ONE System can now process whole blood-derived or apheresis-derived CP2D/AS-3 leukocyte-reduced RBCs, as well as apheresis-derived ACD-A/AS-3 leukocyte-reduced RBCs.

Oxygen exposure during conventional storage contributes to oxidative damage that drives the red blood cell storage lesion.1–3 The Hemanext ONE System removes oxygen at the start of storage and maintains hypoxic conditions throughout the storage period, helping preserve red blood cell metabolism and structure as blood ages.3–5

Hypoxic RBCs have demonstrated improvements in multiple markers of red blood cell quality and performance in preclinical studies, with clinical trials underway to evaluate potential benefits for patient outcomes and healthcare costs.6–10

“We are extremely excited about the recent 510(k) clearance expanding the processing conditions for generating hypoxic red blood cells using Hemanext ONE. This milestone reflects the dedication and persistence of our team and strengthens our ability to work alongside our blood establishment and hospital partners to advance transfusion care. By expanding access to this innovation across the United States, we are focused on delivering meaningful clinical and economic benefits to hospitals while supporting the availability of high-quality red blood cells for patients who need transfusions” stated Shane Ray, CEO of Hemanext.

For complete information, please refer to the Hemanext ONE Instructions for Use.

About Hemanext

Hemanext Inc. is a privately held medical technology company based in Lexington, Massachusetts, focused on improving the quality, safety, efficacy, and cost of transfusion therapy. The company develops technologies designed to enable the storage of hypoxic red blood cells with the goal of improving transfusion outcomes for patients worldwide.

About Hemanext ONE

Hemanext ONE is a first-in-class disposable medical device designed to improve the quality of red blood cells for transfusion by removing oxygen and maintaining hypoxic storage conditions. The system is intended to process and store whole blood- or apheresis-derived leukocyte-reduced red blood cells collected in CP2D/AS-3 or apheresis-derived LR-RBC in ACD-A/AS-3.

Hemanext ONE has received marketing authorization from the U.S. Food and Drug Administration and is CE-marked for commercial distribution in the European Economic Area and the United Kingdom.

Hemanext Media Contact
Suzanna van Straaten
EMEA Commercial Lead & Head of Global Marketing
Suzanna.vanstraaten@hemanext.com
Mobile: +31 6 12 36 54 61

  1. Mustafa I, Al Marwani A, Mamdouh Nasr K, Abdulla Kano N, and Hadwan T. Time dependent assessment of morphological changes: leukodepleted packed red blood cells stored in SAGM. BioMed Research Intl. 2016:4529434. Doi: 10.1155/2016/4529434.
  2. Orlov D and Karkouti K. The pathophysiology and consequences of red blood cell storage. Anesthesia. 2015;70 (Suppl. 1):29-37. doi:10.1111/anae.12891.
  3. Yoshida T, Shevkoplyas SS. Anaerobic storage of red blood cells. Blood Transfus. 2010;8(4):220-36.
  4. 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.
  5. 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.
  6. 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):172-81.
  7. Yoshida T, McMahon E, Croxon H, et al. The oxygen saturation of red blood cell concentrates: The basis for a novel index of red cell oxidative stress. Transfusion. 2022;62(1):183-193. doi: 10.1111/trf.16715.
  8. Rabcuka J, Blonski S, Meli A, et al. Metabolic reprogramming under hypoxic storage preserves faster oxygen unloading from stored red blood cells. Blood Adv. 2022;6(18):5415-5428. doi: 10.1182/bloodadvances.2022007774.
  9. 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. Transfus Apher Sci. 2023; doi: 10.1016/j.transci.2023.103755.
  10. Reikvam H, Kristofferson E, Felli Lunde T, et al. Transfusion of hypoxic red blood cells to hematologic malignancy patients and acutely bleeding burn patients. Poster presented at: The Association for the Advancement of Blood & Biotherapies; October 19-22, 2024; Houston, TX.
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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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