BETHESDA, Md., June 12, 2017 /PRNewswire/ -- New Health Sciences, Inc. (NHSi), a medical technology company focused on improving transfusion therapy, is proud to announce the initiation of their clinical trial to support CE mark approval for the Hemanext RBC Processing System. Hemanext is designed for the removal of oxygen, the fuel for oxidative damage, from red blood cells (RBC). Accumulating evidence suggests this management of oxygen levels may provide a more consistent, higher quality RBC product for transfusion patients.
The CE mark study for Hemanext will enroll up to 40 donors at Héma-Québec in Quebec City and will demonstrate leukoreduced RBC processed and stored using Hemanext meet the critical acceptance criteria defined in international guidelines and directives for blood quality. Obtaining the CE mark will be a huge step forward in the commercialization of the Hemanext RBC Processing System which we expect to launch in Europe in early 2018.
Andrew Dunham, PhD, and NHSi's Chief Scientific Officer commented: "There is wide and growing recognition in the scientific community that oxidative damage is a key factor in determining RBC quality across the storage cycle. Attaining this CE mark will enable physicians and researchers across Europe to adopt and evaluate the first technology to regulate the amount of oxygen present in stored RBC units and to radically reduce the extent of oxidative damage inflicted on stored RBC."
About New Health Sciences, Inc:
New Health Sciences, Inc. (NHSi) is a medical technology company with headquarters in Bethesda MD, with an R&D center of excellence in Cambridge MA. Our corporate mission is to support the transfusion medicine community in its efforts to save lives and improve patient outcomes. Our distinctive focus is on innovations that promote radical improvements in the quality, safety, efficacy and cost of transfusion therapy. For more information, visit www.newhealthsciences.com.
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SOURCE New Health Sciences, Inc.