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Hemanext

Our Technology

PLEASE NOTE

The FDA has not cleared or approved the Hemanext ONE system, and it is an investigational device that is not available for commercial distribution in the United States. If you are a resident of the European Union, please click below for our site for healthcare professionals.

Hemanext History

2008 2008
2017 2017
2018 2018
2019 2019
2021 2021
2022 2022

2008

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.

2017

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.

2018

In 2018, in preparation of FDA submission, Hemanext completed a clinical study for the Hemanext ONE® RBC Processing and Storage System.

2019

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.

2021

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).

2022

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.

Our system reflects years of proprietary R&D on materials, sorbents, bag geometry and deoxygenation kinetics.

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 Research

Learn more about Hemanext and take a closer look at our publications, studies, and posters focused on blood quality and red blood cell characterization.

WORLDWIDE PATENT ASSETS

Accepted Scientific Abstracts

Total Publications