Hemanext Signs Agreement with Hemara Bio in the U.A.E., Marking the Initiation of Commercialization Activities in the GCC Region
Hemanext Inc., a leading innovator in blood processing, storage, and transfusion technology, announced that it has entered into an exclusive distribution agreement with Hemara Bio in Dubai, United Arab Emirates (UAE) to bolster its sales capabilities across the Gulf Countries strengthening its relationships with key blood centers and clinicians in the region.
Lexington, MA, October 31, 2024 --(PR.com)-- Hemanext has entered into an exclusive distribution agreement with Hemara Bio to bring the Hemanext ONE® Red Blood Cell (RBC) Processing and Storage System to UAE, Qatar, Kuwait and the Kingdom of Saudi Arabia (Gulf Cooperation Council (GCC) Region). This agreement is in response to the increasing need for safe and efficient blood transfusions, especially for patients who rely on frequent transfusions due to chronic diseases or trauma.
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 thalassemia4, 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)
Pr. Mohamed Yassin, Professor of Hematology and Head of Hematology at Hamad Medical Corporation, Doha (Qatar), stated, “I am pleased to see the partnership between Hemanext and Hemara Bio, which will bring the innovative hypoxic transfusion system to the GCC Region. This technology addresses a significant unmet need, particularly for patients suffering from hemoglobinopathies, such as sickle cell disease and thalassemia. For these patients, traditional transfusion methods have limitations in optimizing red blood cell efficacy. Hypoxic RBCs processed from The Hemanext ONE RBC Processing and Storage system offers a potential new way to improve oxygen delivery and overall patient outcomes, which is essential in this region where hemoglobinopathies are prevalent. I look forward to seeing the impact this will have on our patients and on transfusion practices throughout the GCC.”
“We are excited about our partnership with Hemara Bio as it opens a pathway towards access to Hemanext ONE and hypoxic red blood cells for patients throughout the GCC Region. Our Hemanext ONE system has the potential to help improve cost of care and overall quality of life for those living with the burden of transfusion therapy. In Hemara Bio, we are confident to have found a partner that will be able to swiftly bring Hemanext ONE to blood banks,” stated Andrew Dunham, CEO of Hemanext.
Mohamed Algamal, CEO of Hemara Bio, said, “We are thrilled to be working alongside the Hemanext team to bring this exciting innovation in blood transfusion therapy to clinicians and patients in the GCC Region. We have deep experience bringing innovative therapies to patients in need throughout the GCC Region and see the Hemanext ONE® system as such a unique innovation that we would like to make available to patients.”
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 Hemara Bio
Hemara Bio specializes in providing advanced hematological solutions tailored for the Middle East and Africa region. With a focus on rare genetic diseases and cutting-edge therapies, the company is dedicated to improving healthcare standards and ensuring access to innovative treatments.
Visit Hemarabio.com to learn more about the Company.
About Hemanext ONE®
In Europe, Hemanext ONE is CE marked for the processing and storage of CPD/ PAGGSM Red Blood Cells, Leukocytes Reduced (LR RBC) that have been prepared and processed with the HEMANEXT ONE® system within 24-hours of collection. In the GCC Region, marketing authorization for Hemanext ONE is in preparation for submittal for approval by the local regulatory authorities. 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 RBC.(3)
Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration.
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 CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced) [EU 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 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 thalassemia4, 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)
Pr. Mohamed Yassin, Professor of Hematology and Head of Hematology at Hamad Medical Corporation, Doha (Qatar), stated, “I am pleased to see the partnership between Hemanext and Hemara Bio, which will bring the innovative hypoxic transfusion system to the GCC Region. This technology addresses a significant unmet need, particularly for patients suffering from hemoglobinopathies, such as sickle cell disease and thalassemia. For these patients, traditional transfusion methods have limitations in optimizing red blood cell efficacy. Hypoxic RBCs processed from The Hemanext ONE RBC Processing and Storage system offers a potential new way to improve oxygen delivery and overall patient outcomes, which is essential in this region where hemoglobinopathies are prevalent. I look forward to seeing the impact this will have on our patients and on transfusion practices throughout the GCC.”
“We are excited about our partnership with Hemara Bio as it opens a pathway towards access to Hemanext ONE and hypoxic red blood cells for patients throughout the GCC Region. Our Hemanext ONE system has the potential to help improve cost of care and overall quality of life for those living with the burden of transfusion therapy. In Hemara Bio, we are confident to have found a partner that will be able to swiftly bring Hemanext ONE to blood banks,” stated Andrew Dunham, CEO of Hemanext.
Mohamed Algamal, CEO of Hemara Bio, said, “We are thrilled to be working alongside the Hemanext team to bring this exciting innovation in blood transfusion therapy to clinicians and patients in the GCC Region. We have deep experience bringing innovative therapies to patients in need throughout the GCC Region and see the Hemanext ONE® system as such a unique innovation that we would like to make available to patients.”
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 Hemara Bio
Hemara Bio specializes in providing advanced hematological solutions tailored for the Middle East and Africa region. With a focus on rare genetic diseases and cutting-edge therapies, the company is dedicated to improving healthcare standards and ensuring access to innovative treatments.
Visit Hemarabio.com to learn more about the Company.
About Hemanext ONE®
In Europe, Hemanext ONE is CE marked for the processing and storage of CPD/ PAGGSM Red Blood Cells, Leukocytes Reduced (LR RBC) that have been prepared and processed with the HEMANEXT ONE® system within 24-hours of collection. In the GCC Region, marketing authorization for Hemanext ONE is in preparation for submittal for approval by the local regulatory authorities. 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 RBC.(3)
Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration.
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 CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced) [EU 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
Daan Kok, Head of Business Development and Strategy
+41782061460
https://hemanext.com
Daan Kok, Head of Business Development and Strategy
+41782061460
https://hemanext.com
Contact
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