Hemanext Inc. Receives CE Mark Certification for Innovative Red Blood Cell (RBC) Processing & Storage System - Seite 2

"We look forward to exploring [Hemanext ONE], including its potential ability to achieve clinically important endpoints," said Geir Hetland, MD, group leader, Department of Immunology and Transfusion Medicine, Oslo University Hospital.

The company anticipates that physicians throughout Europe will seek to publish their findings in medical journals. It encourages investigators to discuss potential studies with RBCs processed and stored by Hemanext ONE.

"By obtaining CE Mark certification, Hemanext ONE promises to make available a red blood cell transfusion therapy to help patients who are in need of lifelong and regular blood transfusions. We, as TIF, are excited about another treatment option for our patients with thalassaemia and other hemoglobin disorders," said Dr. Androulla Eleftheriou, Executive Director, Thalassaemia International Federation (TIF), when asked about the impact of this announcement in Europe.

"For more than a decade, Hemanext has committed its resources to the continuing effort of the transfusion medicine community to save lives and improve patient outcomes. We are eager to offer physicians and their patients throughout Europe an innovation that intends to advance the quality and cost of transfusion therapy," said Hemanext President and CEO Martin Cannon. "We achieved this critical regulatory milestone which is an important step toward delivering on this promise. This is thanks to the dedication of expert researchers across Europe and around the world and our superb multidisciplinary Hemanext teams. I would also like to acknowledge the contribution of our world class clinical advisors and our distinguished investors and Board of Directors. We are now in a position to introduce Hemanext technology to the European market beginning with France, Italy, Norway, and Switzerland.  We are preparing our application to submit to FDA for authorization in the US."

"For many years, transfusion medicine physicians have been reviewing published preclinical data that highlighted the potential benefits of hypoxically stored RBCs. We have eagerly awaited the ability to validate those findings through clinical studies. Now, with the availability of Hemanext ONE, my peers in Europe can examine and report their findings in patients across multiple therapeutic areas," said Paul M. Ness, MD, senior director, Division of Transfusion Medicine, Professor of Pathology, Johns Hopkins University School of Medicine, former editor of Transfusion—the Journal of the American Association of Blood Banks (AABB) and past president of AABB.