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Hemanext Continues European Rollout of Hemanext ONE

Hemanext Inc., a leading innovator in blood processing, storage, and transfusion technology, today announced that physicians in Italy have initiated enrollment of chronically transfused patients with beta thalassemia to receive transfusions using red blood cells (RBCs) processed and stored with the Hemanext ONE® system. Hemanext expects these transfusions, which are part of a post-CE mark clinical study in Genoa, Italy, to begin in June.

The study in Genoa is a single center, prospective, historical control study designed to assess the safety and efficacy of transfusing hypoxic RBCs in beta thalassemia patients undergoing chronic transfusions. Efficacy in this case is defined as a reduction in the volume of RBCs transfused. Additional endpoints such as mean change in hemoglobin and hematocrit, quality of life (QoL), serum ferritin (during first 12 months), and the impact of hypoxic RBCs on iron overload will all be evaluated and compared to this cohort’s results for the same parameters with conventionally stored RBCs.

Dr. Vanessa Agostini, Director, Unit of Transfusion Medicine, IRCCS San Martino University Hospital, and Director, Liguria Regional Blood Center, Genoa, Italy, commented on this event, “We are thrilled to commence this clinical study and are optimistic about the potential of this innovation to ease the struggles faced by those dependent on chronic transfusions, such as thalassemia patients.”

Dr. Gian Luca Forni, Past President of the Italian Society of Thalassemia and Hemoglobinopathies, Director of the Regional Center for Thalassemia and Congenital Hemoglobinopathies, Genoa, Italy, and member of Eurobloodnet, said, “I am eager to see the results from this clinical study and hopeful that transfusion-dependent patients will benefit from this promising new technology.”

Dr. Giuliano Grazzini, Hematology and Transfusion Medicine Specialist, former Director of the Italian National Blood Centre of the Istituto Superiore di Sanità, Rome, Italy, shared, “I am excited to be a part of this study and I am looking forward to seeing the impact of hypoxic RBCs on patient outcomes.”

In Bergen, Norway, a post-market clinical study designed to assess the initial safety effects of transfusing hypoxic RBCs in patients with acute burns and hematological malignancies began transfusing patients in the latter part of 2022. As the study progresses, after transfusing patients from the hematological malignancy cohort, the physicians have now transfused the first acute bleeding burn patient in April.

Martin Cannon, CEO of Hemanext said, “This announcement is a significant milestone in our European rollout and is the next step in our quest to bring this innovative RBC therapy to patients burdened by transfusion. The Hemanext technology has the potential to improve patient outcomes and facilitate efficient treatment of patients in need, and we look forward to expanding our global presence and reaching more people.”

Hemanext plans to continue its rollout of the Hemanext ONE system across additional European markets in the coming months. As part of its commercialization and sales ramp up program, Hemanext recently signed agreements with leading healthcare distributors in Italy and the Nordics.

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 $130 million.

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 system is CE Marked for the processing and storage of 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 market authorization from the FDA.

Preclinical data shows that the HEMANEXT ONE system can reduce oxygen saturation of RBCs to 20% or below and maintain this level throughout storage up to 42 days, demonstrating positive impacts on multiple in vitro metrics of RBC quality.2 Clinical studies are underway to determine the impact of hypoxic RBCs on patient outcomes and estimate potential cost savings from expected improvements in care and reductions in transfusion volumes.3,4

Hemanext Media Contact
Stacy Smith
Director of Global Marketing Communications
stacy.smith@hemanext.com
781-301-7461

  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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