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Hemanext ONE Receives Standards-Compliant Seal from AABB

Hemanext ONE becomes the first blood processing and storage system to receive the Standards-Compliant seal from AABB.

Hemanext Inc. today announced that Hemanext ONE®, its innovative blood processing and storage system, has been recognized by the Association for the Advancement of Blood & Biotherapies (“AABB”), a leading international association in transfusion medicine and biotherapies, for compliance with its industry-recognized quality and safety standards SCoPE Program. The Hemanext ONE® technology is the first system providing both blood processing and storage to receive this designation.

“The AABB SCoPE Program benefits both vendors and customers by certifying that a product is in compliance with AABB Standards,” said Melanie Sloan, MS, MT(ASCP)SBB, CQA(ASQ), AABB’s Senior Director of Accreditation and Quality. “AABB-accredited facilities must adhere to a set of rigorous standards, all of which promote optimal approaches to quality, and donor and patient safety.”

Hemanext ONE® received CE Mark certification for sale in European markets on April 13, 2021. The accreditation from AABB confirms that Hemanext’s technology meets the industry-leading requirements laid out by the association. Hemanext ONE® was submitted for marketing authorization review by the U.S. Food and Drug Administration (FDA) on December 30, 2021, and the product is currently available in the United States for investigational use only, pending market authorization from the FDA.

Martin Cannon, Co-Founder and CEO of Hemanext, said: “Receiving the ‘AABB Standards-Compliant’ seal codifies Hemanext’s absolute commitment to quality in all that we do. We are an organization that takes our duty seriously to provide innovative products that people can trust. This seal of approval is a sign of that trust, and we believe it will instill in patients and doctors an even greater confidence in our ability to provide high-quality blood processing and storage solutions.”

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.

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. On December 30, 2021, Hemanext submitted the Hemanext ONE® system for marketing authorization review by the U.S. Food and Drug Administration (FDA).

About Hemanext ONE®

In the EU, 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 show that the medical device can maintain RBCs at or below 20% oxygen saturation for up to 42 days,2 thereby creating hypoxic RBCs. Clinical studies are underway to measure the impact of hypoxic RBCs on patient outcomes and the potential cost savings.3

About AABB

AABB is an international, not-for-profit association representing individuals and institutions involved in the fields of transfusion medicine and biotherapies. The association is committed to improving health through the development and delivery of standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership includes physicians, nurses, scientists, researchers, administrators, medical technologists, and other health care providers. AABB members are located in more than 80 countries and AABB accredits institutions in more than 50 countries.

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. DOF calculation.
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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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