Hemanext Continues European Rollout of Hemanext ONE® RBC Processing and Storage System
Groundbreaking technology to be deployed to transfuse thalassemia patients in Italy and acute bleeding burn patients in Norway.
Lexington, MA, May 25, 2023 --(PR.com)-- Hemanext Inc., a leading innovator in blood processing, storage, and transfusion technology, today announced that physicians in Italy have initiated enrollment of chronically transfused patients with beta thalassemia to receive transfusions using red blood cells (RBCs) processed and stored with the Hemanext ONE® system. Hemanext expects these transfusions, which are part of a post-CE mark clinical study in Genoa, Italy, to begin in June.
The study in Genoa is a single center, prospective, historical control study designed to assess the safety and efficacy of transfusing hypoxic RBCs in beta thalassemia patients undergoing chronic transfusions. Efficacy in this case is defined as a reduction in volume of RBCs transfused. Additional endpoints such as mean change in hemoglobin and hematocrit, quality of life (QoL), serum ferritin (during first 12 months), and the impact of hypoxic RBCs on iron overload will all be evaluated and compared to this cohort’s results for the same parameters with conventionally stored RBCs.
Dr. Vanessa Agostini, Director, Unit of Transfusion Medicine, IRCCS San Martino University Hospital, and Director, Liguria Regional Blood Center, Genoa, Italy, commented on this event, “We are thrilled to commence this clinical study and are optimistic about the potential of this innovation to ease the struggles faced by those dependent on chronic transfusions, such as thalassemia patients.”
Dr. Gian Luca Forni, Past President of the Italian Society of Thalassemia and Hemoglobinopathies, Director of the Regional Center for Thalassemia and Congenital Hemoglobinopathies, Genoa, Italy, and member of Eurobloodnet, said, "I am eager to see the results from this clinical study and hopeful that transfusion-dependent patients will benefit from this promising new technology."
Dr. Giuliano Grazzini, Hematology and Transfusion Medicine Specialist, former Director of the Italian National Blood Centre of the Istituto Superiore di Sanità, Rome, Italy, shared, "I am excited to be a part of this study and I am looking forward to seeing the impact of hypoxic RBCs on patient outcomes.”
In Bergen, Norway, a post-market clinical study designed to assess the initial safety effects of transfusing hypoxic RBCs in patients with acute burns and hematological malignancies began transfusing patients in the latter part of 2022. As the study progresses, after transfusing patients from the hematological malignancy cohort, the physicians have now transfused the first acute bleeding burn patient in April.
Martin Cannon, CEO of Hemanext said, “This announcement is a significant milestone in our European rollout and is the next step in our quest to bring this innovative RBC therapy to patients burdened by transfusion. The Hemanext technology has the potential to improve patient outcomes and facilitate efficient treatment of patients in need, and we look forward to expanding our global presence and reaching more people.”
Hemanext plans to continue its rollout of the Hemanext ONE® system across additional European markets in the coming months. As part of its commercialization and sales ramp up program, Hemanext recently signed agreements with leading healthcare distributors in Italy and the Nordics.
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 red blood cells (RBCs). The company’s aim is to significantly improve the quality of stored RBCs by limiting oxygen and carbon dioxide levels in the storage environment.
Since its founding in 2008, Hemanext has envisioned a world with fewer and better transfusions. In its early years, multiple grants from the U.S. National Institutes of Health (NIH) enabled the company to demonstrate the feasibility of hypoxic RBC storage, develop its first prototype system, and conduct in vivo research. To date, the company has raised more than $130 million.
On April 13, 2021, Hemanext announced that it had received CE Mark certification for Hemanext ONE® system, clearing the way for the medical device to be sold in European markets.
About Hemanext ONE®
In the European Union, the system 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. 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.[1]
In the United States, the product remains available for investigational use only, pending market authorization from the FDA.
Preclinical data shows that the HEMANEXT ONE system can reduce oxygen saturation of RBCs to 20% or below and maintain this level throughout storage up to 42 days, demonstrating positive impacts on multiple in vitro metrics of RBC quality.[2] 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.[3],[4]
Visit Hemanext.com to learn more about the company.
[1] Hemanext ONE®, Instructions for Use for the European Union (April 2021), DOF
[2] Brouard, D et al. Vox Sang 2018; 113: 153.2018.
[3] Frank, S et al. Anesthesiology 2017;127(5):754-764.
[4] DOF. Document.Calculation.2021
The study in Genoa is a single center, prospective, historical control study designed to assess the safety and efficacy of transfusing hypoxic RBCs in beta thalassemia patients undergoing chronic transfusions. Efficacy in this case is defined as a reduction in volume of RBCs transfused. Additional endpoints such as mean change in hemoglobin and hematocrit, quality of life (QoL), serum ferritin (during first 12 months), and the impact of hypoxic RBCs on iron overload will all be evaluated and compared to this cohort’s results for the same parameters with conventionally stored RBCs.
Dr. Vanessa Agostini, Director, Unit of Transfusion Medicine, IRCCS San Martino University Hospital, and Director, Liguria Regional Blood Center, Genoa, Italy, commented on this event, “We are thrilled to commence this clinical study and are optimistic about the potential of this innovation to ease the struggles faced by those dependent on chronic transfusions, such as thalassemia patients.”
Dr. Gian Luca Forni, Past President of the Italian Society of Thalassemia and Hemoglobinopathies, Director of the Regional Center for Thalassemia and Congenital Hemoglobinopathies, Genoa, Italy, and member of Eurobloodnet, said, "I am eager to see the results from this clinical study and hopeful that transfusion-dependent patients will benefit from this promising new technology."
Dr. Giuliano Grazzini, Hematology and Transfusion Medicine Specialist, former Director of the Italian National Blood Centre of the Istituto Superiore di Sanità, Rome, Italy, shared, "I am excited to be a part of this study and I am looking forward to seeing the impact of hypoxic RBCs on patient outcomes.”
In Bergen, Norway, a post-market clinical study designed to assess the initial safety effects of transfusing hypoxic RBCs in patients with acute burns and hematological malignancies began transfusing patients in the latter part of 2022. As the study progresses, after transfusing patients from the hematological malignancy cohort, the physicians have now transfused the first acute bleeding burn patient in April.
Martin Cannon, CEO of Hemanext said, “This announcement is a significant milestone in our European rollout and is the next step in our quest to bring this innovative RBC therapy to patients burdened by transfusion. The Hemanext technology has the potential to improve patient outcomes and facilitate efficient treatment of patients in need, and we look forward to expanding our global presence and reaching more people.”
Hemanext plans to continue its rollout of the Hemanext ONE® system across additional European markets in the coming months. As part of its commercialization and sales ramp up program, Hemanext recently signed agreements with leading healthcare distributors in Italy and the Nordics.
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 red blood cells (RBCs). The company’s aim is to significantly improve the quality of stored RBCs by limiting oxygen and carbon dioxide levels in the storage environment.
Since its founding in 2008, Hemanext has envisioned a world with fewer and better transfusions. In its early years, multiple grants from the U.S. National Institutes of Health (NIH) enabled the company to demonstrate the feasibility of hypoxic RBC storage, develop its first prototype system, and conduct in vivo research. To date, the company has raised more than $130 million.
On April 13, 2021, Hemanext announced that it had received CE Mark certification for Hemanext ONE® system, clearing the way for the medical device to be sold in European markets.
About Hemanext ONE®
In the European Union, the system 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. 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.[1]
In the United States, the product remains available for investigational use only, pending market authorization from the FDA.
Preclinical data shows that the HEMANEXT ONE system can reduce oxygen saturation of RBCs to 20% or below and maintain this level throughout storage up to 42 days, demonstrating positive impacts on multiple in vitro metrics of RBC quality.[2] 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.[3],[4]
Visit Hemanext.com to learn more about the company.
[1] Hemanext ONE®, Instructions for Use for the European Union (April 2021), DOF
[2] Brouard, D et al. Vox Sang 2018; 113: 153.2018.
[3] Frank, S et al. Anesthesiology 2017;127(5):754-764.
[4] DOF. Document.Calculation.2021
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Hemanext
Stacy Smith
781-301-7461
https://hemanext.com
Stacy Smith
781-301-7461
https://hemanext.com
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