Hemanext Inc. Announces Completion of Cancer and Burn Safety Study, a Significant Milestone for the Hemanext ONE® Innovative Red Blood Cell Processing and Storage System
The post-market clinical study in Bergen, Norway, that was designed to assess the safety of transfusing hypoxic red blood cells (RBCs) in patients with acute burns and hematological malignancies, has been completed.
Lexington, MA, August 20, 2024 --(PR.com)-- Hemanext Inc., a leading innovator in blood processing, storage, and transfusion technology, marks a significant milestone for the company’s innovative blood processing and storage system, Hemanext ONE. The post-market clinical study in Bergen, Norway, that was designed to assess the safety of transfusing hypoxic red blood cells (RBCs) in patients with acute burns and hematological malignancies, has been completed.
The study investigated the safety of a single administration of 2 units of hypoxic RBCs to 10 patient participants with transfusion-dependent hematologic malignancies and 10 patient participants with acutely bleeding burns as a prelude to larger studies. Safety and tolerance data up to 24 hours and up to 7 days following the transfusion event were recorded. Secondary objectives included adverse events (AEs) up to the subsequent transfusion event or 28 days post-transfusion. Additionally, changes in hemoglobin (Hgb) levels post-transfusion were assessed.
“It has been interesting and exciting to participate in the first clinical study involving the use of hypoxic blood transfusion. The study has provided us with interesting and educational results. Both personnel and patient participants have been eager and curious to take part in the study, which will hopefully provide a foundation for further research on the use of hypoxic blood transfusion,” said Håkon Reikvam, MD, PhD, Professor, Department of Clinical Science at University of Bergen in Norway, and Department of Medicine, Hematology Section at Haukeland University Hospital, and a study investigator.
Andrew Dunham, Chief Executive Officer of Hemanext, expressed his enthusiasm for the conclusion of the post-market clinical study, stating, “As we continue our mission to improve the standard of care for patients who rely on transfusions, we recognize the vital importance of delivering a safe RBC product. Designed to enhance the clinical value of red blood cells, Hemanext ONE aims to reduce the burden of transfusions on patients and the healthcare system and is well-positioned to make a significant impact in transfusion medicine. Reaching this milestone and completing the safety study is a remarkable accomplishment for Hemanext. It represents a critical stride toward making our groundbreaking technology, which creates hypoxic red blood cells, available to patients worldwide.”
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 transfusion for chronic conditions, such as thalassemia[4], sickle cell disease (SCD)[5], and myelodysplastic syndromes (MDS),[6] as well as those in need of critical transfusions during post-traumatic surgery 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 center 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 the medical device to be placed in the market in the European Economic Area (EEA).
HEMANEXT ONE creates hypoxic RBCs, RBCs that have been processed to reduce oxygen and carbon dioxide content of RBCs and to maintain this level 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.
The study investigated the safety of a single administration of 2 units of hypoxic RBCs to 10 patient participants with transfusion-dependent hematologic malignancies and 10 patient participants with acutely bleeding burns as a prelude to larger studies. Safety and tolerance data up to 24 hours and up to 7 days following the transfusion event were recorded. Secondary objectives included adverse events (AEs) up to the subsequent transfusion event or 28 days post-transfusion. Additionally, changes in hemoglobin (Hgb) levels post-transfusion were assessed.
“It has been interesting and exciting to participate in the first clinical study involving the use of hypoxic blood transfusion. The study has provided us with interesting and educational results. Both personnel and patient participants have been eager and curious to take part in the study, which will hopefully provide a foundation for further research on the use of hypoxic blood transfusion,” said Håkon Reikvam, MD, PhD, Professor, Department of Clinical Science at University of Bergen in Norway, and Department of Medicine, Hematology Section at Haukeland University Hospital, and a study investigator.
Andrew Dunham, Chief Executive Officer of Hemanext, expressed his enthusiasm for the conclusion of the post-market clinical study, stating, “As we continue our mission to improve the standard of care for patients who rely on transfusions, we recognize the vital importance of delivering a safe RBC product. Designed to enhance the clinical value of red blood cells, Hemanext ONE aims to reduce the burden of transfusions on patients and the healthcare system and is well-positioned to make a significant impact in transfusion medicine. Reaching this milestone and completing the safety study is a remarkable accomplishment for Hemanext. It represents a critical stride toward making our groundbreaking technology, which creates hypoxic red blood cells, available to patients worldwide.”
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 transfusion for chronic conditions, such as thalassemia[4], sickle cell disease (SCD)[5], and myelodysplastic syndromes (MDS),[6] as well as those in need of critical transfusions during post-traumatic surgery 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 center 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 the medical device to be placed in the market in the European Economic Area (EEA).
HEMANEXT ONE creates hypoxic RBCs, RBCs that have been processed to reduce oxygen and carbon dioxide content of RBCs and to maintain this level 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.
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Hemanext
Robert Haime, Vice President, Commercial
781-301-7474
https://hemanext.com
Robert Haime, Vice President, Commercial
781-301-7474
https://hemanext.com
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