Safi Biotherapeutics and Functional Fluidics Initiate Collaboration to Validate Health and Quality of Manufactured RBCs

Collaboration to support Safi IND data package for use of mRBCs in sickle cell disease chronic transfusions

CAMBRIDGE, Mass. and DETROIT, July 16, 2025 — Safi Biotherapeutics (Safi), a biotechnology company producing stem-cell derived, manufactured human red blood cell (mRBC) products for civilian and military transfusion needs, and Functional Fluidics, a leader in red blood cell health innovation, announced a collaboration to validate the health and quality of Safi’s mRBCs. This collaboration aims to prepare a comprehensive in vitro pre-clinical data package in support of an IND submission for mRBC use in sickle cell disease (SCD) chronic transfusion therapy.

In December 2024, the FDA granted Safi’s mRBC product Rare Pediatric Disease Designation and Orphan Drug Designation for chronic transfusion use in patients with SCD.

‘Functional Fluidics is a precision diagnostics company pioneering the field of red blood cell health, and their successful track record makes them an ideal partner as we prepare an IND submission using Safi mRBCs for patients requiring regular transfusions,’ said Doug McConnell, CEO and Co-Founder of Safi Biotherapeutics. ‘This collaboration is a key step toward a safe and reliable blood product.’

‘Patients with sickle cell disease relying on chronic transfusion therapy face significant challenges. Safi has developed an innovative approach to produce mRBCs with targeted cell surface antigen profiles, providing a safe and reliable blood supply,’ said Patrick Hines, M.D., Ph.D., Founder and CEO of Functional Fluidics. ‘We are excited to collaborate and improve outcomes for people living with sickle cell disease worldwide.’

Safi’s mRBCs also have potential for universal-donor RBC units in military and civilian settings. In February 2025, Safi announced a collaboration with ARMI | BioFabUSA, focused on transitioning Safi mRBCs to cGMP manufacturing at a meaningful scale.

About Safi Biotherapeutics
Safi Biotherapeutics produces stem-cell derived RBCs to provide a highly characterized cell therapy product for civilian and military needs. Safi’s leadership includes veterans from DARPA, Vertex Pharmaceuticals, and Loughborough University.

About Functional Fluidics
Founded in 2014, Functional Fluidics specializes in red blood cell health, leveraging healthcare data and technologies to accelerate therapy development and support clinical trials globally.