Hemanext Announces CE Mark Submission for the HEMANEXT ONE Red Blood Cell Processing System
Regulatory filing is a major step toward commercialization of transfusion-medicine innovation
LEXINGTON, Mass., November 1, 2019
Hemanext Inc., a privately held medical technology company dedicated to improving patient outcomes through fewer and better red blood cell (RBC) transfusions, today announced CE Mark submission for HEMANEXT ONE®, the company’s initial product offering that is designed to provide a higher-quality blood product for transfusion patients.
The HEMANEXT ONE processing system reduces the fuel for oxidative damage prior to and during storage, and converts a unit of conventional, leukoreduced RBC into a transfusion-ready unit of HEMANEXT ONE RBC.
“We have seen a growing body of scientific evidence that oxidative damage to RBCs could have a negative impact on clinical outcomes for many acute and chronic patient populations that require large volumes of transfusions,” said Paul M. Ness, MD, Senior Director, Division of Transfusion Medicine and Professor of Pathology, Johns Hopkins University School of Medicine; Editor, Transfusion, the peer-reviewed journal of the American Association of Blood Banks (AABB) (2003-2018); Past President, AABB. “Improving the quality of RBCs could enhance patient care and simultaneously reduce the quantity of RBC units required to treat many diseases and conditions.”
Hemanext anticipates receiving CE Mark approval in the first half of 2020, with commercialization initiatives for the HEMANEXT ONE system in Europe commencing in the second half of the year. Hemanext also expects to submit a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) in 2020.
“Our CE Mark submission is a significant milestone for Hemanext. It is the culmination of years of research and collaborations with the transfusion medicine community in Europe,” said Hemanext President and CEO Martin Cannon. “We are grateful for the partnerships that have brought us another step closer to creating a world with fewer and better transfusions.”
ABOUT HEMANEXT
Hemanext is a privately held medical technology company dedicated to improving the quality, safety, efficacy and cost of transfusion therapy. The company’s research and development efforts center on the study and future commercialization of hypoxically stored red blood cells (RBCs). HEMANEXT ONE®, our initial product offering, is designed to improve the quality of life for chronic and high-volume acute transfusion patients while reducing costs.
Visit Hemanext.com to learn more.
Dr. Ness serves as a clinical advisor to Hemanext.