The clearance enables U.S. blood establishments to use the Hemanext ONE System to process any AS-3 leukocyte-reduced red blood cells, derived from either whole blood or apheresis, processed with the Hemanext ONE System.
The Hemanext ONE System can now process whole blood-derived or apheresis-derived CP2D/AS-3 leukocyte-reduced RBCs, as well as apheresis-derived ACD-A/AS-3 leukocyte-reduced RBCs.
Oxygen exposure during conventional storage contributes to oxidative damage that drives the red blood cell storage lesion.(1-3) The Hemanext ONE System removes oxygen at the start of storage and maintains hypoxic conditions throughout the storage period, helping preserve red blood cell metabolism and structure as blood ages.(3-5)
Hypoxic RBCs have demonstrated improvements in multiple markers of red blood cell quality and performance in preclinical studies, with clinical trials underway to evaluate potential benefits for patient outcomes and healthcare costs.(6-10)
“We are extremely excited about the recent 510(k) clearance expanding the processing conditions for generating hypoxic red blood cells using Hemanext ONE. This milestone reflects the dedication and persistence of our team and strengthens our ability to work alongside our blood establishment and hospital partners to advance transfusion care. By expanding access to this innovation across the United States, we are focused on delivering meaningful clinical and economic benefits to hospitals while supporting the availability of high-quality red blood cells for patients who need transfusions” stated Shane Ray, CEO of Hemanext.
For complete information, please refer to the Hemanext ONE Instructions for Use.
About Hemanext
Hemanext Inc. is a privately held medical technology company based in Lexington, Massachusetts, focused on improving the quality, safety, efficacy, and cost of transfusion therapy. The company develops technologies designed to enable the storage of hypoxic red blood cells with the goal of improving transfusion outcomes for patients worldwide.
About HEMANEXT ONE
Hemanext ONE® is a first-in-class disposable medical device designed to improve the quality of red blood cells for transfusion by removing oxygen and maintaining hypoxic storage conditions. The system is intended to process and store whole blood- or apheresis-derived leukocyte-reduced red blood cells collected in CP2D/AS-3 or apheresis-derived LR-RBC in ACD-A/AS-3.
Hemanext ONE has received marketing authorization from the U.S. Food and Drug Administration and is CE-marked for commercial distribution in the European Economic Area and the United Kingdom.
Learn more at Hemanext.com.
References
1. Mustafa I, Al Marwani A, Mamdouh Nasr K, Abdulla Kano N, and HadwanT. Time dependent assessment of morphological changes: leukodepleted packed red blood cells stored in SAGM. BioMed Research Intl. 2016:4529434. Doi: 10.1155/2016/4529434.
2. Orlov D and Karkouti K. The pathophysiology and consequences of red blood cell storage. Anesthesia. 2015;70 (Suppl. 1):29-37. doi:10.1111/anae.12891.
3. Yoshida T, Shevkoplyas SS. Anaerobic storage of red blood cells. Blood Transfus. 2010;8(4):220-36
4. Karafin MS, Field J, Ilich A, et al. Hypoxic storage of donor red cells preserves deformability after exposure to plasma from adults with sickle cell disease. Transfusion. 2022;1-10. Doi: 10.1111/trf.17163.
5. DʼAlessandro A, Yoshida T, Nestheide S, et al. Hypoxic storage of red blood cells improves metabolism and post-transfusion recovery. Transfusion. 2020;60(4):786-798.
6. 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.
7. 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.
8. 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
9. 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.
10. Reikvam H, Kristofferson E, Felli Lunde T, et al. Transfusion of hypoxic red blood cells to hematologic malignancy patients and acutely bleeding burn patients. Poster presented at: The Association for the Advancement of Blood & Biotherapies; October 19-22, 2024; Houston, TX.
