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Publication of Hypoxic Blood Storage Study in Blood Advances

Research shows that hypoxic storage preserves faster oxygen unloading from red blood cells compared to standard conditions.1

Hypoxic storage preserves faster oxygen unloading from red blood cells. The results of a strategic research collaboration between Hemanext Inc (“Hemanext”), the University of Oxford’s Department of Physiology, Anatomy and Genetics (“DPAG”), the United Kingdom National Health Service Blood and Transplant (“NHSBT”), and the University of Colorado have been published in Blood Advances, a journal of the American Society of Hematology. The aim of the work was to investigate the effect of hypoxic storage on the oxygen-handling properties of red blood cells (RBCs) as compared to standard conditions.

Read the study

The Hemanext ONE® RBC Processing and Storage System (“Hemanext ONE®”) was used to process and store the hypoxic RBCs at NHSBT, and its performance was benchmarked against standard blood-banking conditions. At various points during storage, samples of RBCs were obtained for testing using advanced imaging methods developed in DPAG. Under standard storage conditions, RBCs undergo biochemical changes that reduce their ability to release oxygen. This so-called storage lesion reduces the quality of transfused blood products because slower oxygen release can impact negatively on tissues. In contrast, faster oxygen-handling properties were preserved for longer in blood units stored under hypoxia. This beneficial effect of Hemanext ONE® can be attributed to the preservation of key metabolites present in RBCs. These findings identify a key mechanism through which Hemanext ONE® can contribute to the improvement of RBCs processed and stored with the device. Hemanext ONE has not been cleared or approved by the United States Food and Drug Administration (“FDA”). The product is the subject of a pending De Novo submission to FDA and is currently not commercially available in the United States. Hemanext ONE received CE Mark certification in April 2021 and is currently available in the European Union.

Pawel Swietach, Professor of Physiology at Corpus Christi College Oxford, said “The maintenance of rapid gas exchange is critical for ensuring the high efficacy of transfusions, and our collaborative work published in Blood Advances explains how hypoxic storage can achieve this. I am delighted that the single-cell oxygen saturation imaging method developed at Oxford’s DPAG has found a timely application in verifying the protective effect of hypoxic storage on red blood cell physiology. Working with the premier NHSBT, we showed that the innovative technology developed by Hemanext can significantly improve the oxygen-release properties of stored blood units. A key purpose of blood transfusions is to improve oxygen delivery to tissues, but our earlier work revealed that standard storage conditions impair oxygen-release kinetics. I believe that our findings will have major impact on blood banking practice worldwide.”

“This study illustrates that hypoxic storage prevents oxidative damage and maintains high physiologic levels of the metabolites 2,3-DPG and ATP which are important mechanisms for physiologic function of RBCs,” said Samuel Sowemimo-Coker, PhD, Senior Principal Scientist at Hemanext who initiated the study with Professor Swietach and helped in the design and measurement of 2,3-DPG and ATP in the RBCs.

About Hemanext

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 by limiting oxygen and carbon dioxide levels in the storage environment.

About Hemanext ONE®

In the European Union, the Hemanext ONE® system is CE Marked for the processing and storage 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. In the United States, the product remains available for investigational use only, pending marketing authorization from the FDA.

Hemanext Media Contact
Stacy Smith
Associate Director Marketing Communications
stacy.smith@hemanext.com

  1. Rabcuka J, Blonski S, Meli A, Sowemimo-Coker S, Zaremba D, Stephenson D, Dzieciatkowska M, Nerguizian D, Cardigan RA, Korczyk P, Smethurst PA, D’Alessandro A, Swietach P. Metabolic reprogramming under hypoxic storage preserves faster oxygen unloading from stored red blood cells. Blood Adv. 2022 Jun 23:bloodadvances.2022007774. doi: 10.1182/bloodadvances.2022007774. Epub ahead of print. PMID: 35736672.
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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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