Hemanext Inc. Announces First Patients Treated in a Clinical Trial Investigating the Efficacy of the Hemanext ONE® Red Blood Cell Processing and Storage System
Lexington, MA, December 20, 2024 --(PR.com)-- Hemanext Inc., a leading innovator in blood processing, storage, and transfusion technology, announces that the first two patients enrolled have begun receiving transfusions in a multi-center, randomized, controlled cross-over study to evaluate the safety and effectiveness of hypoxic red blood cells processed with the Hemanext ONE® System versus conventional red blood cells in patients with transfusion-dependent hematological malignancies.
Collectively, hematological malignancies refer to various disorders of the bone marrow which result in abnormal blood cell production. In all cases, anemia can result from the overcrowding or ineffective production of normal red blood cells, leading to inadequate oxygen delivery and requiring blood transfusion therapy. Chronic transfusion therapy impacts the lives of patients, disrupting their daily life with required blood transfusions every 2-4 weeks to manage their condition. This study aims to observe a decrease in the volume of RBCs transfused with an overall decrease in the number of units consumed, which in turn can result in an increase in time (number of days) between transfusions.
“Starting this clinical trial is an exciting and pivotal moment in our research. We are taking a crucial step toward understanding how this treatment can make a difference in patients’ lives. I’m proud to lead this effort alongside an outstanding team and look forward to the insights we’ll gain from this trial and the potential impact on patient outcomes.,” 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 the Primary Investigator.
Andrew Dunham, Chief Executive Officer of Hemanext, stated, “We are beyond thrilled to reach this monumental milestone of treating patients with hypoxic RBCs. This treatment study is a testament to the hard work, dedication, and innovation of our entire team. We’re proud to see our vision become a reality and can’t wait to witness the impact on patient care.”
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.
Collectively, hematological malignancies refer to various disorders of the bone marrow which result in abnormal blood cell production. In all cases, anemia can result from the overcrowding or ineffective production of normal red blood cells, leading to inadequate oxygen delivery and requiring blood transfusion therapy. Chronic transfusion therapy impacts the lives of patients, disrupting their daily life with required blood transfusions every 2-4 weeks to manage their condition. This study aims to observe a decrease in the volume of RBCs transfused with an overall decrease in the number of units consumed, which in turn can result in an increase in time (number of days) between transfusions.
“Starting this clinical trial is an exciting and pivotal moment in our research. We are taking a crucial step toward understanding how this treatment can make a difference in patients’ lives. I’m proud to lead this effort alongside an outstanding team and look forward to the insights we’ll gain from this trial and the potential impact on patient outcomes.,” 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 the Primary Investigator.
Andrew Dunham, Chief Executive Officer of Hemanext, stated, “We are beyond thrilled to reach this monumental milestone of treating patients with hypoxic RBCs. This treatment study is a testament to the hard work, dedication, and innovation of our entire team. We’re proud to see our vision become a reality and can’t wait to witness the impact on patient care.”
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.
Contact
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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