Innovative Blood Processing and Storage System Received CE Mark Certification for Sale in European Markets Last Year
LEXINGTON, Mass., January 5, 2022, PR NEWSWIRE – Hemanext Inc., a leading innovator in blood processing and storage technology, announced that it submitted the Hemanext ONE® system for marketing authorization review by the U.S. Food and Drug Administration (FDA) on December 30, 2021.
The innovative Hemanext ONE® RBC Processing and Storage System is a medical device that processes and stores eligible Red Blood Cells (RBCs) with the goal of limiting oxygen and carbon dioxide exposure – two significant drivers of RBC damage1,2 – to create hypoxic RBCs. Limiting oxygen has the potential to meaningfully impact healthcare outcomes for the 4-5 million American patients transfused annually.2 It has the potential to benefit all patients requiring transfusion for chronic conditions such as thalassemia3, sickle cell disease (SCD)4, and myelodysplastic syndromes (MDS)5, as well as those in need of critical transfusions during post-traumatic surgery and other medical procedures.6
Martin Cannon, Co-Founder and CEO of Hemanext, said: “In developing innovative technologies to improve the quality of the blood supply, our singular objective has been to improve outcomes for patients with blood disorders and those in need of transfusions. Receiving CE Mark certification last year was an important milestone, which has allowed us to begin deploying our technology in Europe. Today marks the next step in our journey. We are grateful for the tireless efforts of our entire team including and especially our outstanding scientists, biochemical engineers, and research collaborators who have brought us to this point, and we are hopeful for the future of Hemanext ONE®in the U.S.”
Dr. Biree Andemariam, Director of the New England Sickle Cell Institute & Connecticut Bleeding Disorders Center, said, “Patients with chronic disorders, suffer not only from the physical consequences of the disease, but also from the negative impacts on personal, professional, and emotional aspects of daily life. Improving the quality of RBCs may lead to a reduction in the number and volume of transfusions that patients on chronic transfusions need. The Hemanext ONE® system has the potential to give patients more freedom to pursue their goals and energy to spend time with the people they love.”
Dr. Philip C. Spinella, Professor, Department of Surgery and Department of Critical Care Medicine at University of Pittsburgh, said: “I have devoted much of my career to studying the effects of blood storage conditions on the quality of red bloods cells. 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.”
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.
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.7
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,8 thereby creating hypoxic RBCs. Clinical studies are underway to measure the impact of hypoxic RBCs on patient outcomes and the potential cost savings.9
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1 D’Alessandro et al. Transfusion 2020;9999:1-13.
2 Yoshida, T et al. Blood Transfus. 2019; 17 (1): 27-52.
3 Thalassemias | NHLBI, NIH. (2014, December 9). NIH. https://www.nhlbi.nih.gov/health-topics/thalassemias
4 Complications and Treatments of Sickle Cell Disease | CDC. (2020, June 3). Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/sicklecell/treatments.html
5 Germing, U. et al. HemaSphere. 2019; 3(6): e314.
6 Massive Transfusion in Trauma. (n.d.). Facs. Retrieved August 11, 2021, from https://www.facs.org/-/media/files/quality-programs/trauma/tqip/transfusion_guildelines.ashx
7 Hemanext ONE, Instructions for Use for the European Union (April 2021), DOF
8 Brouard, D et al. Vox Sang 2018; 113: 153.2018.
9 Frank, S. et al. Anesthesiology 2017;127(5):754-764. DOF calculation