Hemanext Inc. announced today it has received a CE Certificate of Conformity for the CE Mark for its 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 the 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.1 It limits the O2 and CO2 levels in the storage environment.1 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 transfusions,4 related complications,5 and adverse events,6 thereby improving the quality of life7 for patients while reducing costs.7,8,9
Due to their need for chronic transfusions, people with thalassaemia, sickle cell disease (SCD), 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.
« CE Mark certification is an important milestone for this product. 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, » 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 in Norway.
« 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.
The company anticipates that physicians throughout Europe will seek to publish their findings in medical journals. It encourages investigators to consider potential studies with RBCs processed and stored by Hemanext ONE.
« 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.
« Physicians in Italy can now use Hemanext ONE to capture real-world evidence in patients who will receive [RBCs processed with] this innovative product, » said Giuliano Grazzini, MD, Transfusion Medicine Specialist and former director of the Italian National Blood Centre of the Istituto Superiore di Sanità (ISS). « These outcomes can be shared with prescribing and transfusing physicians around the world for a rigorous review of the data. »
ABOUT HEMANEXT ONE
The novel Hemanext ONE RBC Processing and Storage System, our initial product offering, is a prescription medical device designed to limit oxygen and carbon dioxide levels in the storage environment. It is CE-marked 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. 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.
The European Instructions for Use, which include a visual depiction of the device, are available at HemanextONE.com.
Hemanext ONE remains an investigational device that has not been cleared or approved by the FDA. It is not available for sale in the United States.
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).
Visit Hemanext.com to learn more about the company.
1 HemanextONE, Instructions for Use (April 2021).
2 Whitley et al. ISBT 2018 [Meeting Abstract].
3 D’Alessandro et al. Transfusion 2020;9999:1-13., Yoshida et al. Blood Transfus 2019;17:27-52.
4 D’Alessandro et al. Transfusion 2020;60:786-798.
5 D’Alessandro et al. Transfusion 2020;60:786-798., Yoshida et al. Blood Transfus 2019; 17(1):27-52.
6 D’Alessandro et al. Transfusion 2020;60:786-798., Yoshida et al. Blood Transfus 2019; 17(1):27-52.
7 Stegenga KA, Ward-Smith P, Hinds PS, et al. Quality of life among children with sickle cell disease receiving chronic transfusion therapy. J Pediatr Oncol Nurs 2004; 21 (4): 207-13.
8 Platzbecker U, Hofbauer LC, Ehninger G, et al. The clinical, quality of life, and economic consequences of chronic anemia and transfusion support in patients with myelodysplastic syndromes. Leukemia Research 2012; 36(5): 525-36.
9 Jansen AJ, Essink-Bot ML, Beckers EA, et al. Quality of life measurement in patients with transfusion-dependent myelodysplastic syndromes. Br J Haematol 2003; 121 (2): 270-4.
10 Howard. Hematology Am Soc Hematol Educ Program. 2016; 2016(1):625-631., Galanello et al. Orphanet J Rare Dis. 2010; 5:11., Bennett. Am J Hematol. 2008; 83(11):858-61.