Hemanext Inc. Receives CE Mark Certification for Innovative Red Blood Cell (RBC) Processing & Storage System - Seite 3

"Based on the body of pre-clinical data published in many peer-reviewed journals, we are eager to start using Hemanext ONE with our patients in Norway," said Tor Hervig, MD, PhD; founding member of the Traumatic Hemostasis and Oxygenation Research (THOR) Network; Chief Medical Officer, Blood bank, Haugesund Hospital: Senior Consultant, Haukeland University Hospital.

ABOUT HEMANEXT ONE
The novel Hemanext ONE RBC Processing and Storage System, our initial product offering, a prescription medical device designed to limit oxygen and carbon dioxide levels in the storage environment. It is CE-marked for the processing and storage of CPD/PAGGSM Red Blood Cells, Leukocytes Reduced (LRRBC) 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. The European Instructions for Use, which include a visual depiction of the device, are available at HemanextONE.com.

The Hemanext ONE remains an investigational device that has not been cleared or approved by the FDA and is not available for sale in the United States.

ABOUT HEMANEXT
Hemanext is a privately held medical technology company dedicated to improving the quality, safety, efficacy, and cost of transfusion therapy. The company's research and development efforts center on the study and future commercialization of hypoxically stored red blood cells (RBCs).

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 protype system, and conduct in vivo research¹¹
• 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 certification¹¹
• In 2018, in preparation for its forthcoming FDA submission, Hemanext completed a clinical study for the Hemanext ONE RBC Processing and Storage System¹¹
• 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 storage¹¹

Visit Hemanext.com to learn more about the company.