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HemanextHemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.
Hemanext is a privately held medical technology company specializing in oxygen-controlled red blood cell processing and storage systems for transfusion medicine. The company develops, manufactures, and commercializes innovative storage solutions that preserve the quality and function of red blood cells by limiting oxygen and carbon dioxide exposure, with the goal of improving transfusion outcomes for patients with chronic and acute conditions. Hemanext's products have received FDA De Novo marketing authorization and CE Mark certification, enabling global distribution. The company is recognized for its focus on scientific evidence, operational compatibility, and strategic partnerships with blood establishments and clinical researchers.
Publication Number
US-12089589-B2
Publication Date
2024-09-17
Expiration Date
Abstract
A blood storage system comprising: a collection vessel for red blood cells; an oxygen or oxygen and carbon dioxide depletion device; a storage vessel for red blood cells; tubing connecting the collection vessel to the oxygen or oxygen and carbon dioxide depletion device and the oxygen or oxygen and carbon dioxide depletion device to the storage vessel; and a gamma or X-ray irradiating device is used to irradiate red blood cells stored in the vessel, storing red blood cells under anaerobic conditions.
Core Innovation
The invention describes a blood-storage system and methods that remove oxygen and optionally carbon dioxide from red blood cells prior to and/or during refrigerated storage and gamma or X‑ray irradiation to reduce reactive oxygen species-mediated damage and extend storage life. The system includes a collection bag, a leuko-reduction filter, an oxygen/carbon-dioxide depletion device [procedural detail omitted for safety], oxygen/CO2-scavenging storage bags [procedural detail omitted for safety], additive solutions (OFAS3 or AS-3), and an irradiator.
The background identifies that reactive oxygen species generated during storage and irradiation cause lesions and oxidative damage in stored red blood cells, manifested as loss of ATP and 2,3‑DPG, increased potassium leakage, hemolysis and reduced deformability, which limit functional storage life and post-transfusion recovery. The invention aims to reduce ROS-mediated damage by depleting oxygen and carbon dioxide from RBCs and thereby improve biochemical and functional outcomes during storage and following irradiation.
Claims Coverage
The independent claim discloses four main inventive features centered on a composition of irradiated red blood cells that are depleted of oxygen and carbon dioxide, its preparation, an exclusionary compositional limitation, and an improved functional outcome.
Gamma-irradiated oxygen- and carbon dioxide-depleted red blood cells
A composition comprising red blood cells that are both oxygen depleted and carbon dioxide depleted and that are gamma-irradiated to form the claimed composition.
Preparation by depletion of hemoglobin oxygen saturation and carbon dioxide partial pressure followed by storage and gamma irradiation
The red blood cells are prepared by depleting hemoglobin oxygen saturation (SO2) to [procedural detail omitted for safety] and depleting carbon dioxide partial pressure (pCO2) to [procedural detail omitted for safety], storing the oxygen- and carbon dioxide-depleted red blood cells, and then gamma-irradiating the stored oxygen- and carbon dioxide-depleted red blood cells.
Absence of added L-carnitine or an alkanoyl derivative
The composition is defined to be without added L-carnitine or an alkanoyl derivative as an explicit compositional limitation.
Exhibits reduced potassium leakage relative to conventionally stored irradiated red blood cells
The claimed gamma-irradiated, oxygen- and carbon dioxide-depleted red blood cells exhibit reduced potassium leakage compared to red blood cells gamma-irradiated after having been conventionally stored for a period of time [procedural detail omitted for safety].
The independent claim thus combines a composition of gamma-irradiated RBCs that are oxygen- and carbon dioxide-depleted, a specified preparation sequence of depletion then storage then irradiation, an exclusion of certain additives, and a demonstrated improvement in potassium leakage relative to conventionally stored and irradiated RBCs.
Stated Advantages
Reduces reactive oxygen species-mediated damage to stored red blood cells and thereby aims to extend functional storage life.
Increases biochemical markers associated with red blood cell quality, including ATP and 2,3-DPG (with OFAS3 showing pronounced effects in experimental data).
Reduces potassium leakage in gamma-irradiated red blood cells compared to red blood cells gamma-irradiated after conventional storage.
Enables compatibility of irradiation with anaerobic storage and supports potential extension of usable storage beyond conventional limits.
Provides improved functional outcomes claimed in dependent disclosures, including reduced lesions, reduced oxidative damage, reduced hemolysis, increased deformability, and improved post-transfusion recovery.
Documented Applications
A blood-storage system and methods for removing oxygen and optionally carbon dioxide from red blood cells prior to and/or during refrigerated storage and gamma or X‑ray irradiation to reduce ROS-mediated damage and extend functional storage life.
Use of oxygen- and carbon dioxide-depletion devices and oxygen/CO2-scavenging storage bags in blood banking workflows to prepare red blood cells for storage and subsequent irradiation.
Preparation of gamma-irradiated red blood cell compositions that are intended for transfusion applications with improved biochemical and functional metrics.
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