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

LEXINGTON, Mass., April 13, 2021 /PRNewswire-PRWeb/ -- Hemanext Inc., a privately held US-based medical technology company dedicated to improving the quality, safety, efficacy and cost of red blood cell (RBC) transfusions, today announced it has received a CE Certificate of Conformity for the CE Mark for the Hemanext ONE Red Blood Cell (RBC) Processing and Storage System, allowing the innovative medical device to be sold in European markets. Blood center validations required for local adoption of the Hemanext ONE RBC Processing and Storage System were completed in Norway in 2020. The company expects blood centers in Italy, Switzerland, and France to complete validations in 2021, opening the door for adoption in those countries as well.

Hemanext plans to secure additional validations and approvals in order to make the device available to healthcare professionals in other select European markets in 2021, and Chile, Brazil, and other South American markets in in future years. Hemanext also plans to submit its De Novo request for marketing authorization from the U.S. Food and Drug Administration (FDA).

The Hemanext ONE RBC Processing and Storage System 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. It limits the O2 and CO2 levels in the storage environment.(1) Blood centers can utilize the device to convert a unit of conventional, leukoreduced RBCs into a transfusion-ready unit of RBCs that based on pre-clinical data, offloads oxygen better than conventional blood(2) and reduces progressive damage that occurs naturally during storage.(3)

CE marking will allow the initiation of clinical studies and real-world experience in Europe to evaluate the potential of the technology. Researchers anticipate that RBCs with limited oxygen and carbon dioxide may fill an unmet medical need by potentially reducing the number of transfusions,(4) related complications,(5) and adverse events,(6) thereby improving the quality of life7 for patients while reducing costs.(7,8,9)

Due to their need for chronic transfusions, people with sickle cell disease (SCD), thalassaemia, and myelodysplastic syndromes (MDS) are among the patient populations that could benefit from RBCs with limited oxygen and carbon dioxide,(10) like Hemanext ONE. European physicians now can generate and publish real-world data about the potential impact of this innovative technology.

"The Hemanext ONE RBC Processing System has the potential to reduce the demands on the blood supply by mitigating the transfusion dosage and frequency of transfusions for the sickle cell disease patient population and other chronically transfused patients," said Paul M. Ness, MD, Senior Director, Division of Transfusion Medicine at Johns Hopkins University, former editor of Transfusion, and an international expert on blood banking, blood transfusion and patient blood management. "We will be eagerly awaiting the real-world results of Hemanext ONE when compared to conventionally-stored blood by our European colleagues."

"We look forward to seeing data that will come out of several countries in Europe, which could potentially demonstrate that the use of Hemanext ONE will result in fewer and better transfusions than conventionally-stored blood for patients who are transfused regularly," said Sickle Cell Disease Association of America President and CEO Beverley Francis-Gibson. "We congratulate Hemanext on its achievement of this significant milestone in Europe."

"Based on its ability to minimize oxidative damage, the Hemanext ONE System has the potential to reduce the transfusion needs of patients that require lifelong red cell transfusions," said Jose Cancelas, MD, Director, Hoxworth Blood Center at the University of Cincinnati College of Medicine, when asked about the impact of this announcement in Europe.

"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."

ABOUT HEMANEXT ONE
The novel Hemanext ONE RBC Processing and Storage System, our initial product offering, is 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 research(11)
• 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 of 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.

HemanextONE, Instructions for Use (April 2021).
2 Whitley et al. ISBT 2018 [Meeting Abstract].
3 D'Alessandro et al. Transfusion 2020;9999:1-13., Yoshida et al. Blood Transfus 2019;17:27-52.
4 D'Alessandro et al. Transfusion 2020;60:786-798.
5 D'Alessandro et al. Transfusion 2020;60:786-798., Yoshida et al. Blood Transfus 2019; 17(1):27-52.
6 D'Alessandro et al. Transfusion 2020;60:786-798., Yoshida et al. Blood Transfus 2019; 17(1):27-52.
7 Stegenga KA, Ward-Smith P, Hinds PS, et al. Quality of life among children with sickle cell disease receiving chronic transfusion therapy. J Pediatr Oncol Nurs 2004; 21 (4): 207-13.
8 Platzbecker U, Hofbauer LC, Ehninger G, et al. The clinical, quality of life, and economic consequences of chronic anemia and transfusion support in patients with myelodysplastic syndromes. Leukemia Research 2012; 36(5): 525-36.
9 Jansen AJ, Essink-Bot ML, Beckers EA, et al. Quality of life measurement in patients with transfusion-dependent myelodysplastic syndromes. Br J Haematol 2003; 121 (2): 270-4.
10 Howard. Hematology Am Soc Hematol Educ Program. 2016; 2016(1):625-631., Galanello et al. Orphanet J Rare Dis. 2010; 5:11., Bennett. Am J Hematol. 2008; 83(11):858-61.
11 Data on file, Hemanext, Inc.

Hemanext Media Contact:
Stacy Smith
Associate Director Marketing Communications
[email protected]

Media Contact

Stacy Smith, Hemanext Inc., +1 (603) 759-0458, [email protected]

SOURCE Hemanext Inc.