Co-Investigator of Clinical Safety Study Presents at EHA
The full clinical study was designed to evaluate the safety profile of hypoxic red blood cells (RBCs) in chronically transfused patients with hematologic malignancies and acutely bleeding burn patients. The study, that was completed in Q4 2024, has been submitted for publication.
Håkon Reikvam, Professor at University of Bergen, Bergen, Norway, states, 'We are thrilled to share our safety findings with the medical community. This cohort analysis serves as a foundational pillar for our upcoming efficacy trials. It not only strengthens the scientific rationale behind our approach but also lays the groundwork for the next phase of our research.'
The HEMANEXT ONE RBC Processing and Storage system limits oxygen, the fuel for oxidative damage, providing a higher quality blood product (1,2,3). It has the potential to benefit all patients requiring transfusions for chronic conditions, such as thalassemia (4), sickle cell disease (5), and myelodysplastic syndromes (6), as well as those in need of critical transfusions during acute bleeding in surgery, trauma and other medical procedures (7).
About Hemanext
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 focus on the study of hypoxically stored RBCs. The company's aim is to significantly improve the quality of stored RBCs worldwide.
Visit Hemanext.com to learn more about the Company.
About Hemanext ONE
Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration. It is intended to process and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC) that have been prepared within the standard 8-hour hold time. Processing of Red Blood Cells processed with the HEMANEXT ONE system must be initiated within 8 hours of collection and completed within 12 hours of collection. The Red Blood Cells must be processed at room temperature (20-26°C). The HEMANEXT ONE system limits 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.
In Europe, Hemanext ONE is CE marked, which allows its commercial distribution within the market of the European Economic Area.
HEMANEXT ONE creates hypoxic RBCs, RBCs that have been processed to reduce oxygen and carbon dioxide content of RBCs and to maintain these levels throughout storage up to 42 days (3). Hypoxic RBCs have demonstrated positive impacts on multiple in vitro metrics of RBC quality in preclinical studies (8,9). Clinical studies are underway to determine the impact of hypoxic RBCs on patient outcomes and estimate potential cost savings from expected improvements in care and reductions in transfusion volumes (10).
References
1. Rabcuka J, Blonski S, Meli A, et al. Metabolic reprogramming under hypoxic storage preserves faster oxygen unloading from stored red blood cells. Blood Adv. 2022;6(18):5415-5428. doi: 10.1182/bloodadvances.2022007774
2. Reisz JA, Wither MJ et al. Oxidative modifications of glyceraldehyde 3-phosphate dehydrogenase regulate metabolic reprogramming of stored red blood cells. 2016;128(12): e32-42.
3. HEMANEXT ONE® (Blood container set used to process and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced) [US Instructions for Use]. Lexington, MA: Hemanext Inc.
4. Farmakis D, Porter J, Taher A, et al. 2021 Thalassemia International Federation Guidelines for the management of transfusion-dependent thalassemia. 2022;6:8.
5. Chou S, Alsawas M, Fasano R, et al. American Society of Hematology 2020 guidelines for sickle cell disease: transfusion support. Blood Adv. 2020;4:2.
6. Germing U, Oliva E, Hiwase D, and Almeida A. Treatment of anemia in transfusion-dependent and non-transfusion-dependent lower-risk MDS: current and emerging strategies. 2019;3(6). doi: 10.1097/HS9.0000000000000314
7. American College of Surgeons. ACS TQIP massive transfusion in trauma guidelines. ACS TQIP. 2014; https://www.facs.org/media/zcjdtrd1/transfusion_guildelines.pdf.
8. Yoshida T, Blair A, D'Alessandro A, et al. Enhancing uniformity and overall quality of red cell concentrate with anaerobic storage. Blood Transfus. 2017;15(2):172-81.
9. Yoshida T, McMahon E, Croxon H, et al. The oxygen saturation of red blood cell concentrates: The basis for a novel index of red cell oxidative stress. Transfusion. 2022;62(1):183-193. doi: 10.1111/trf.16715.
10. Reikvam H, Hetland G, Ezligini F, et al. Safety of hypoxic red blood cell administration in patients with transfusion-dependent hematological malignancies: An interim analysis. Transfus Apher Sci. 2023; doi: 10.1016/j.transci.2023.103755.
Contact Information:
Hemanext
Robert Haime, Vice President, Commercial
(781) 301-7474
Contact via Email
https://hemanext.com
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