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Hemanext® Inc. Receives CE Mark Certification for Innovative Red Blood Cell (RBC) Processing & Storage SystemCompany to launch Hemanext ONE® RBC Processing and Storage System in select European markets in 2021, with wider distribution in Europe and the Americas in 2022 and future years Hemanext ONE is now commercially available in Norway LEXINGTON, Mass., April 13, 2021 /PRNewswire/ -- Hemanext Inc., a privately held medical technology company, today announced it has received a CE Certificate of Conformity for the CE Mark for the Hemanext ONE Red Blood Cell (RBC) Processing and Storage System, allowing the innovative medical device to be sold in European markets. Blood center validations required for local adoption of the Hemanext ONE RBC Processing and Storage System were completed in Norway in 2020. The company expects blood centers in Italy, Switzerland, and France to complete validations in 2021. Hemanext plans to secure additional validations and approvals in order to make the device available to healthcare professionals in other select European markets and in the Americas in future years. The Hemanext ONE RBC Processing and Storage System is indicated for the processing and storage of CPD/PAGGSM Red Blood Cells, Leukocytes Reduced (LRRBC) that have been prepared and processed with the HEMANEXT ONE system within 24-hours of collection. It limits the O2 and CO2 levels in the storage environment.1 reduces the fuel for oxidative damage prior to and during hypoxic storage. Blood centers can utilize the device to convert a unit of conventional, leukoreduced RBCs into a transfusion-ready unit of RBCs that based on pre-clinical data, offloads oxygen better than conventional blood2 and reduces progressive damage that occurs naturally during storage.3 CE marking will allow the initiation of clinical studies and real-world experience in Europe to evaluate the potential of the technology. Researchers anticipate that RBCs with limited oxygen and carbon dioxide may fill an unmet medical need by potentially reducing the number of transfusions4, related complications5, and adverse events6, thereby improving the quality of life7 for patients while reducing costs.7,8,9 Due to their need for chronic transfusions, people with thalassaemia and myelodysplastic syndromes (MDS) are among the patient populations that could benefit from RBCs with limited oxygen and carbon dioxide,10 like Hemanext ONE. European physicians now can generate and publish real-world data about the potential impact of this innovative technology. "We look forward to exploring [Hemanext ONE], including its potential ability to achieve clinically important endpoints," said Geir Hetland, MD, group leader, Department of Immunology and Transfusion Medicine, Oslo University Hospital. The company anticipates that physicians throughout Europe will seek to publish their findings in medical journals. It encourages investigators to discuss potential studies with RBCs processed and stored by Hemanext ONE. "By obtaining CE Mark certification, Hemanext ONE promises to make available a red blood cell transfusion therapy to help patients who are in need of lifelong and regular blood transfusions. We, as TIF, are excited about another treatment option for our patients with thalassaemia and other hemoglobin disorders," said Dr. Androulla Eleftheriou, Executive Director, Thalassaemia International Federation (TIF), when asked about the impact of this announcement in Europe. "For more than a decade, Hemanext has committed its resources to the continuing effort of the transfusion medicine community to save lives and improve patient outcomes. We are eager to offer physicians and their patients throughout Europe an innovation that intends to advance the quality and cost of transfusion therapy," said Hemanext President and CEO Martin Cannon. "We achieved this critical regulatory milestone which is an important step toward delivering on this promise. This is thanks to the dedication of expert researchers across Europe and around the world and our superb multidisciplinary Hemanext teams. I would also like to acknowledge the contribution of our world class clinical advisors and our distinguished investors and Board of Directors. We are now in a position to introduce Hemanext technology to the European market beginning with France, Italy, Norway, and Switzerland. We are preparing our application to submit to FDA for authorization in the US." "For many years, transfusion medicine physicians have been reviewing published preclinical data that highlighted the potential benefits of hypoxically stored RBCs. We have eagerly awaited the ability to validate those findings through clinical studies. Now, with the availability of Hemanext ONE, my peers in Europe can examine and report their findings in patients across multiple therapeutic areas," said Paul M. Ness, MD, senior director, Division of Transfusion Medicine, Professor of Pathology, Johns Hopkins University School of Medicine, former editor of Transfusion—the Journal of the American Association of Blood Banks (AABB) and past president of AABB. "Based on the body of pre-clinical data published in many peer-reviewed journals, we are eager to start using Hemanext ONE with our patients in Norway," said Tor Hervig, MD, PhD; founding member of the Traumatic Hemostasis and Oxygenation Research (THOR) Network; Chief Medical Officer, Blood bank, Haugesund Hospital: Senior Consultant, Haukeland University Hospital. ABOUT HEMANEXT ONE The Hemanext ONE remains an investigational device that has not been cleared or approved by the FDA and is not available for sale in the United States. ABOUT HEMANEXT Since its founding in 2008, Hemanext has envisioned a world with fewer and better transfusions.
Visit Hemanext.com to learn more about the company. 1 HemanextONE, Instructions for Use (April 2021). Logo - https://mma.prnewswire.com/media/1486352/Hemanext_Logo.jpg |