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European Patients Have Begun Receiving Transfusions with Hemanext ONE

Hemanext Inc., a leading innovator in blood processing, storage, and transfusion technology, today announced that it has initiated the rollout of its Hemanext ONE® RBC (Red Blood Cell) Processing and Storage System in Europe.

Doctors have begun transfusing patients suffering from hematological malignancies using RBCs processed and stored with the Hemanext ONE® system, as part of a post-market clinical study in Bergen, Norway. This is a study designed to assess the initial safety effects of transfusing hypoxic RBCs in patients with acute burns and hematological malignancies, including MDS.

Hemanext received CE Mark Certification for its RBC Processing & Storage System in April 2021 and plans to roll out Hemanext ONE® across additional European markets in the coming months. As part of this commercialization and sales ramp-up program, Hemanext has been strengthening its relationships with distributors, healthcare institutions and blood establishments across Europe.

The Company has recently submitted a De Novo classification request to the US FDA. The De Novo submission is currently pending, and the product is not commercially available in the United States at this time.

Martin Cannon, Co-Founder and CEO of Hemanext, said: “Successfully beginning the treatment of patients in Europe with hypoxically stored RBCs is a tremendous milestone, both for our company and for transfusion patients globally. We believe the road to improved patient transfusions begins with storing RBCs under hypoxic conditions to limit oxidative damage and storage lesions. Our technology has the potential to facilitate efficient treatment of patients in need. We look forward to continuing to expand our presence into additional European markets over the course of 2022.”

Geir Hetland, MD, PhD, group leader, Department of Immunology and Transfusion Medicine, Oslo University Hospital said: “As a physician, it is thrilling to have a powerful new tool available that could improve transfusions. We look forward to seeing the data that results from this clinical study, as we believe these real-world improvements in technology have the potential to transform blood and transfusion therapy.”

Janice Frey-Angel, CEO of Aplastic Anemia & MDS International Foundation (AAMDSIF), said: “This announcement marks a concrete step forward for transfusion patients everywhere. AAMDSIF is proud to partner with companies like Hemanext that work tirelessly with the mission to improve the quality of life for patients who are burdened by chronic blood disorders. We are eager to learn more about the data from the study, as we look to further our support for patients searching for tools to navigate their chronic illnesses.”

Håkon Reikvam, MD, PhD, Professor, Department of Clinical Science, University of Bergen in Norway, and a study investigator, said: “The commencement of this study marks an important step forward in the journey to innovate on behalf of patients suffering from severe blood disorders. As a clinician, I am well-aligned with Hemanext’s mission to provide safer transfusions. I believe this study represents a key stride towards a world with fewer and better transfusions.”

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.

Since its founding in 2008, Hemanext has envisioned a world with fewer and better transfusions. In its early years, multiple grants from the U.S. National Institutes of Health (NIH) enabled the company to demonstrate the feasibility of hypoxic RBC storage, develop its first prototype system, and conduct in vivo research. To date, the company has raised more than $100 million in private equity capital from major US and international investors.

On April 13, 2021, Hemanext announced that it had received CE Mark certification for Hemanext ONE® system, clearing the way for the medical device to be sold in European markets.

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.1

In the United States, the product remains available for investigational use only, pending marketing authorization from the FDA.

Preclinical data show that the medical device can maintain RBCs at or below 20% oxygen saturation for up to 42 days2, thereby creating hypoxic RBCs. Clinical studies are underway to measure the impact of hypoxic RBCs on patient outcomes and the potential cost savings.3,4

Hemanext Media Contact
Nathan Riggs / Hallie Wolff
nathan.riggs@kekstcnc.com / Hallie.Wolff@kekstcnc.com

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

  1. Hemanext ONE®, Instructions for Use for the European Union (April 2021), DOF
  2. Brouard, D et al. Vox Sang 2018; 113: 153.2018.
  3. Frank, S et al. Anesthesiology 2017;127(5):754-764.
  4. DOF. Document.Calculation.2021
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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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