Hemanext Inc., a leading innovator in blood processing, storage, and transfusion technology, has been awarded a three-year Small Business Innovation Research Grant (SBIR) Phase II for a project titled, “Efficacy of Hypoxic Red Blood Cells Processed with the Hemanext ONE® System in Patients with Sickle Cell Anemia,” to support and strengthen the clinical efforts of hypoxically stored red blood cells (HRBC) in the United States (NIH RePORTER link). The NIH SBIR program provides competitive funding to small businesses with high-impact ideas that have a strong potential for public health benefit.
Despite several new therapies that have been developed over the past few years, including pharmacologic and gene therapy, they are not available or tolerable to all sickle cell disease (SCD) patients. These anemic patients continue to require RBC transfusions. Chronically transfused sickle cell anemia (SCA) patients are a highly vulnerable population because they are entirely dependent upon frequent transfusions of conventional RBCs to remain healthy. For these patients, blood transfusion therapy is the only viable option for survival. HRBC transfusions have emerged as a promising approach to provide a high-quality blood product to potentially improve treatment outcomes in SCA patients.
The awarded clinical trial will be a multi-center, randomized, controlled study with a cross-over design and will include patients seven years old and older. The primary objective will evaluate the efficacy of HRBC by measuring the rate of decline in %Hemoglobin A and assessing HRBC’s impact on reducing the patients’ transfusion burden. Furthermore, the study will evaluate transfusion-related outcomes, including a comprehensive array of clinical and laboratory parameters and quality of life assessments. Dr. Laurel Omert will be the contact Principal Investigator (PI) with Dr. Biree Andemariam and Dr. Enrico Novelli as co-PIs.
“I am delighted to be able to work with a group of such distinguished investigators in the field of sickle cell anemia to study the effect of large volume red blood cell exchange transfusions of HRBC in this underserved population,” said Laurel Omert, MD, Chief Medical Officer of Hemanext.
Andrew Dunham, CEO of Hemanext stated, “This award marks a significant milestone for our team and validates the promise of our approach to transform transfusion medicine. We are honored and excited to receive this NIH SBIR grant, which underscores the significance of our work and its potential to address unmet clinical needs.”
HEMANEXT ONE received marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration in 2023 and has been CE marked since 2021.
Funding Acknowledgment
This project is supported by the National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Number R44HL178006. The content of this announcement is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About Hemanext
Hemanext is a privately held medical technology company based in Lexington, MA that is dedicated to improving the quality, safety, efficacy, and cost of transfusion therapy. The company’s research and development efforts focus on the study of hypoxically stored red blood cells. The company’s aim is to significantly improve the quality of stored RBCs worldwide.
About Hemanext ONE
HEMANEXT ONE is a first in class device to improve the quality of RBCs for transfusion dependent patients. HEMANEXT ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration further exhibiting the product’s innovation and commercial impact. In Europe, HEMANEXT ONE is CE marked, allowing commercial distribution within the market of the European Economic Area.
Hemanext Media Contact
Robert Haime
Vice President, Commercial
robert.haime@hemanext.com
(781) 301-7474