Granted De Novo Authorization
Designed to Enhance the Clinical Value of Red Blood Cells
The Hemanext ONE® Red Blood Cell (RBC) Processing and Storage system limits oxygen, the fuel for oxidative damage, providing a higher quality blood product.1,2,3
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.
In 2017, NIH awarded another $3 million grant to further develop the Hemanext ONE® RBC Processing and Storage System; the company also completed research that became the pivotal clinical study for obtaining CE Mark certification.
In 2018, in preparation of FDA submission, Hemanext completed a clinical study for the Hemanext ONE® RBC Processing and Storage System.
In 2019, Hemanext and its research colleagues wrote the latest in a series of papers published in prestigious journals that added to the body of scientific evidence supporting the clinical potential of hypoxic RBC storage.
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. On December 30, 2021, Hemanext submitted the Hemanext ONE® system for marketing authorization review by the U.S. Food and Drug Administration (FDA).
On January 24, 2022, Hemanext announced that its innovative blood processing and storage system has been recognized by the Association for the Advancement of Blood & Biotherapies (“AABB”), a leading international association in transfusion medicine and biotherapies, for compliance with its industry-recognized quality and safety standards SCoPE Program. The Hemanext technology is the first system providing both blood processing and storage to receive this designation.
Transfusions have begun in EU using RBCs processed and stored with the Hemanext ONE® system in Bergen, Norway as part of a post-market clinical study.
On September 15, 2023, Hemanext ONE was granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration.
Standard Medical Equipment
The system utilizes readily-available medical equipment in conjunction with its proprietary oxygen reduction and storage bags.
FOUR MAIN STEPS FOR USING HEMANEXT ONE
Hemanext ONE was carefully designed with focus on patients’ well-being and needs
Hemanext ONE has the potential to benefit all patients requiring transfusions.
Transfusions with Hemanext ONE
The Hemanext ONE system is designed to integrate into all current processes and workﬂows, so it will be used no differently than what the team that administers current transfusions are used to. There will be no difference in how patients receive a transfusion, other than the recipient would be receiving hypoxic red blood cells (RBCs) instead of conventional RBCs.
WORLDWIDE PATENT ASSETS
Accepted Scientific Abstracts
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