Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food and Drug Administration (FDA)
LEXINGTON, Mass., September 21, 2023, –Hemanext Inc., a leading innovator in blood processing, storage, and transfusion technology, marks a significant milestone with the U.S. Food and Drug Administration for the company’s innovative blood processing and storage system, Hemanext ONE. The medical device has been granted marketing authorization for commercial distribution via the De Novo process by the FDA. This authorization sets a new standard for RBC processing and storage as the only FDA authorized RBC processing and storage system designed to limit oxygen in the storage environment.
The Hemanext ONE RBC Processing and Storage system limits oxygen, the fuel for oxidative damage, providing a higher quality blood product.1,2,3 It has the potential to benefit all patients requiring transfusion for chronic conditions such as thalassemia4, sickle cell disease (SCD)5, and myelodysplastic syndromes (MDS),6 as well as those in need of critical transfusions during post-traumatic surgery and other medical procedures.7
Andrew Dunham, Chief Executive Officer of Hemanext, expressed his enthusiasm for this groundbreaking achievement, stating, “This pivotal accomplishment underscores Hemanext’s unwavering commitment to the transfusion medicine community and our dedication to meeting patients’ needs through continuous advancements in medical technology. Patients are at the heart of our mission, and we are always seeking ways to expedite the delivery of our innovative red blood cell transfusion therapy, produced using the Hemanext ONE Processing and Storage system, to patients worldwide to potentially enhance their quality of life. The FDA’s De Novo authorization signifies that Hemanext meets the agency’s stringent regulatory standards for reasonable assurance for safety and effectiveness for its intended use. Achieving this critical regulatory milestone is an important step toward delivering on our promise and accomplishing our mission of safer transfusions and healthier patients.”
“Limiting oxygen in the storage environment has the potential to meaningfully impact healthcare outcomes for the 4-5 million American patients transfused annually. As a trauma surgeon, I have witnessed firsthand the critical unmet need in trauma and acute care surgery for higher-quality blood products to mitigate the downstream impact of massive bleeding and hemorrhagic shock. Hemanext’s innovative technology has the potential to be a game-changer in this regard. By delivering red blood cells that decrease the storage lesion and offload oxygen better than conventional blood, we aim to raise the bar in trauma care. We are honored to receive this landmark De Novo authorization from the FDA which brings us closer to fulfilling this unmet need,” said Laurel Omert, MD, FACS, Chief Medical Officer of Hemanext.
“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 with the potential to enhance patient outcomes,” said Paul M. Ness, MD, former Director, Division of Transfusion Medicine at Johns Hopkins University, board member of Hemanext.
“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,” said Ralph Vassallo, MD, FACP, Executive Vice President, Chief Medical and Scientific Officer of Vitalant.
“This is a noteworthy advancement in the field of blood and biotherapies for Hemanext, an Association for the Advancement of Blood and Biotherapies (AABB) Premium Corporate Partner. Receiving FDA authorization highlights Hemanext’s commitment to enhancing the quality and safety of blood products and underscores the company’s commitment to improving patient care,” said David Green, MSA, AABB’s ambassador to the Corporate Partner Program, and President and CEO of Vitalant.
“We congratulate Hemanext on its achievement of this major milestone in the United States. This innovative technology represents a significant step forward in improving the quality of care for individuals living with sickle cell disease. Its potential to ease the burden of transfusions provides promise and we look forward to the positive impact this will have on this community,” said Regina Hartfield, President & CEO of the Sickle Cell Disease Association of America (SCDAA).
“Hemanext’s FDA De Novo marketing authorization is a great accomplishment that excites us at the Thalassaemia International Federation (TIF). Hemanext ONE aims to offer a transformative red blood cell transfusion therapy, providing support to patients in need of lifelong and regular blood transfusions. This innovative treatment option holds great promise for individuals with thalassaemia and other hemoglobin disorders,” said Dr. Androulla Eleftheriou, Executive Director of TIF.
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 RBCs. The company’s aim is to significantly improve the quality of stored RBCs worldwide.
Visit hemanext.com to learn more about the Company.
About Hemanext ONE
Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration. It is intended to process and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC) that have been prepared within the standard 8-hour hold time. Processing of Red Blood Cells processed with the HEMANEXT ONE system must be initiated within 8 hours of collection and completed within 12 hours of collection. The Red Blood Cells must be processed at room temperature (20-26°C). The HEMANEXT ONE system limits 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 Europe, Hemanext ONE is CE marked which allows the medical device to be placed in the market in the European Economic Area (EEA).
HEMANEXT ONE creates hypoxic RBCs, RBCs that have been processed to reduce oxygen and carbon dioxide content of RBCs and to maintain this level throughout storage up to 42 days.3 Hypoxic RBCs have demonstrated positive impacts on multiple in vitro metrics of RBC quality in preclinical studies.8,9 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.10
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- 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
- Reisz JA, Wither MJ et al. Oxidative modifications of glyceraldehyde 3-phosphate dehydrogenase regulate metabolic reprogramming of stored red blood cells. 2016;128(12): e32-42.
- HEMANEXT ONE® (Blood container set used to process and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced) [US Instructions for Use]. Lexington, MA: Hemanext Inc.
- Farmakis D, Porter J, Taher A, et al. 2021 Thalassemia International Federation Guidelines for the management of transfusion-dependent thalassemia. 2022;6:8.
- Chou S, Alsawas M, Fasano R, et al. American Society of Hematology 2020 guidelines for sickle cell disease: transfusion support. Blood Adv. 2020;4:2.
- Germing U, Oliva E, Hiwase D, and Almeida A. Treatment of anemia in transfusion-dependent and non-transfusion-dependent lower-risk MDS: current and emerging strategies. 2019;3(6). doi: 10.1097/HS9.0000000000000314
- American College of Surgeons. ACS TQIP massive transfusion in trauma guidelines. ACS TQIP. 2014; https://www.facs.org/media/zcjdtrd1/transfusion_guildelines.pdf.
- 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.
- 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.
- 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.