LEXINGTON, Mass., January 24, 2022, PR NEWSWIRE – 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.
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.
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
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.
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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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