Secure Transfusion Solutions (STS) has received approval of its first Biologics License Application (BLA) from the Center for Biologics Evaluation and Research (CBER) division of the U.S. Food and Drug Administration (FDA).
| AUSTIN, Texas, Jan. 3, 2023 /PRNewswire/ -- Secure Transfusion Solutions (STS), a private life sciences company pioneering innovative methods to overcome the nation’s growing blood and platelet shortage, has received approval of its first Biologics License Application (BLA) from the Center for Biologics Evaluation and Research (CBER) division of the U.S. Food and Drug Administration (FDA), allowing for interstate distribution of pathogen reduced apheresis platelets from its Trusting Heart Blood Center located in Edina, Minnesota.
Each day, hospitals around the U.S. require an average of 7,000 platelet doses, and with the national blood and platelet shortage, a significant number of hospitals struggle to meet this need. According to a recent survey of 481 U.S. hospitals, 22.3% of these institutions experience platelet supply challenges on a monthly or more frequent basis.[1] “The BLA approval marks a critical milestone for STS, as we can now offer enhanced platelet supply chain integrity and improved confidence in sourcing for hospitals nationwide,” said Vijai Mohan, Chief Executive Officer of STS. “Through a continued commitment to excellence, obsession with quality, and in appreciation of the collaboration with our counterparts at the FDA, STS is now in position to accelerate the licensure approval process for our newer, and future Trusting Heart Blood Centers.” Laurence Cooper, MD PhD, lead independent board director of STS added “as a pediatric bone marrow transplantation physician, I know firsthand the consequences of an unstable platelet supply and the deleterious effect it has on patient outcomes. We celebrate this important milestone of receiving the first BLA approval and its impact for the blood supply across the US and for our company.” About the Platelet Shortage The national blood and platelet shortage impacts the operations of hospitals and the management of patients. Most platelet transfusions at hospitals are used to prevent bleeding in certain cancer patients and those undergoing cardiac surgeries and organ transplants. Platelets have a shorter shelf life than typical blood components alone and must be transfused within five to seven days from collection, driving a continuous need. Exacerbated by industry challenges to the effective recruitment of blood donors, demand for platelet units continues to exceed available supply. About Secure Transfusion Solutions Secure Transfusion Solutions (STS) is a life sciences company pioneering innovative methods to overcome the nation’s growing blood and platelet shortage. Its purpose is to restore hope, build trust and improve quality of life by increasing patient access to readily available and safe transfusion solutions. An innovative company able to execute strategies out of reach of others in the transfusion space, STS provides healthcare institutions with safe and consistent service and true supply chain diversification. By partnering with STS, hospital systems increase confidence in the sourcing of blood components, better preparing them to meet evolving patient transfusion needs. For more information, visit www.securetransfusion.com.
SOURCE Secure Transfusion Solutions |
View original content to download multimedia:
