European Patients Have Begun Receiving Transfusions with Hemanext ONE® RBC Processing and Storage System
Publisert 15. september 2022
Hemanext, Press Release
LEXINGTON, Mass., September 7, 2022, PR NEWSWIRE – Hemanext Inc., a leading innovator in blood processing, storage, and transfusion technology, today announced that it has initiated the rollout of its Hemanext ONE® RBC (Red Blood Cell) Processing and Storage System in Europe.
Doctors have begun transfusing patients suffering from hematological malignancies using RBCs processed and stored with the Hemanext ONE® system, as part of a post-market clinical study in Bergen, Norway. This is a study designed to assess the initial safety effects of transfusing hypoxic RBCs in patients with acute burns and hematological malignancies, including MDS.
Hemanext received CE Mark Certification for its RBC Processing & Storage System in April 2021 and plans to roll out Hemanext ONE® across additional European markets in the coming months. As part of this commercialization and sales ramp-up program, Hemanext has been strengthening its relationships with distributors, healthcare institutions and blood establishments across Europe.
The Company has recently submitted a De Novo classification request to the US FDA. The De Novo submission is currently pending, and the product is not commercially available in the United States at this time.
Martin Cannon, Co-Founder and CEO of Hemanext, said: “Successfully beginning the treatment of patients in Europe with hypoxically stored RBCs is a tremendous milestone, both for our company and for transfusion patients globally. We believe the road to improved patient transfusions begins with storing RBCs under hypoxic conditions to limit oxidative damage and storage lesions. Our technology has the potential to facilitate efficient treatment of patients in need. We look forward to continuing to expand our presence into additional European markets over the course of 2022.”
Geir Hetland, MD, PhD, group leader, Department of Immunology and Transfusion Medicine, Oslo University Hospital said: “As a physician, it is thrilling to have a powerful new tool available that could improve transfusions. We look forward to seeing the data that results from this clinical study, as we believe these real-world improvements in technology have the potential to transform blood and transfusion therapy.”
Janice Frey-Angel, CEO of Aplastic Anemia & MDS International Foundation (AAMDSIF), said: “This announcement marks a concrete step forward for transfusion patients everywhere. AAMDSIF is proud to partner with companies like Hemanext that work tirelessly with the mission to improve the quality of life for patients who are burdened by chronic blood disorders. We are eager to learn more about the data from the study, as we look to further our support for patients searching for tools to navigate their chronic illnesses.”
Håkon Reikvam, MD, PhD, Professor, Department of Clinical Science, University of Bergen in Norway, and a study investigator, said: “The commencement of this study marks an important step forward in the journey to innovate on behalf of patients suffering from severe blood disorders. As a clinician, I am well-aligned with Hemanext’s mission to provide safer transfusions. I believe this study represents a key stride towards a world with fewer and better transfusions.”
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 $100 million in private equity capital from major US and international investors.
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 Hemanext ONE® system is CE Marked for the processing and storage 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 RBC1.
In the United States, the product remains available for investigational use only, pending marketing authorization from the FDA.
Preclinical data show that the medical device can maintain RBCs at or below 20% oxygen saturation for up to 42 days2, thereby creating hypoxic RBCs. Clinical studies are underway to measure the impact of hypoxic RBCs on patient outcomes and the potential cost savings.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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