CAMBRIDGE, MA– Safi Biotherapeutics has received a $4.7 million federal funding extension to advance its stem cell-derived red blood cell technology toward its first human clinical trial, as the company works to develop a manufactured alternative to donor-supplied blood for civilian and military transfusions.
The funding was awarded by the U.S. Department of War through its Defense Health Program’s Combat Casualty Care portfolio and the Medical Technology Enterprise Consortium (MTEC).
The award will support the remaining preclinical and regulatory work required for Safi to submit an Investigational New Drug (IND) application in 2027 for its manufactured red blood cell product, which is being developed to treat acute blood loss.
The latest award brings Safi’s total non-dilutive government funding to more than $27 million.
Safi is developing a manufacturing platform capable of producing human red blood cells from stem cells, with the goal of establishing a scalable supply of transfusion-ready blood that does not depend entirely on traditional blood donations.
The technology is intended to address blood supply shortages affecting hospitals, trauma centers, military medical operations, and emergency response systems.
U.S. hospitals transfuse more than 10 million units of red blood cells annually, but blood availability remains vulnerable to fluctuations in donations, seasonal shortages, and unexpected increases in demand.
The American Red Cross has issued multiple national blood shortage alerts during 2026, including declarations of a blood supply crisis, severe shortage, and emergency shortage.
Manufactured red blood cells could eventually provide an alternative source of transfusion products, particularly in situations where conventional blood supplies are limited or difficult to transport.
One of the principal challenges in developing laboratory-manufactured blood has been producing sufficient quantities at a commercially viable scale.
Safi reported that its manufacturing process can produce more than one full transfusable unit of red blood cells using a single 10-liter bioreactor.
The company said the manufacturing milestone demonstrates progress toward overcoming the production limitations that have historically constrained the clinical and commercial development of manufactured blood products.
The new funding will allow Safi to complete the remaining studies required for its planned IND submission while continuing development of a cryopreserved formulation designed for storage and transfusion.
“A blood supply that depends on donors will always be fragile, whether on the battlefield, in a hospital setting, or in the aftermath of a mass casualty event,” said Doug McConnell, Chief Executive Officer and Co-Founder of Safi Biotherapeutics. “Patients with chronic conditions, people undergoing medical procedures, and trauma victims all depend on a supply that is vulnerable to fluctuations. We believe the future of blood is manufactured, and we’ve shown it can be produced at large scale. This award funding supports the critical work needed to file our IND and initiate our first clinical trial in 2027.”
The company’s platform is being developed as a dual-use technology, with potential applications in both civilian healthcare and military medicine.
For military operations, a manufactured blood supply could provide additional transfusion capacity in combat environments where donor blood may be difficult to obtain or maintain.
Civilian applications could include trauma care, emergency surgery, treatment of acute blood loss, and medical response following mass casualty incidents.
Safi is also pursuing the development of a universal manufactured red blood cell product that could reduce dependence on conventional blood-type matching and expand access to transfusions.
The company has not yet initiated human clinical testing, and the safety and effectiveness of its manufactured red blood cells will need to be established through clinical studies and regulatory review.
The $4.7 million extension was issued through MTEC under the Military Prototype Advancement Initiative, a federal funding mechanism supporting medical technologies with potential military applications.
Safi plans to submit its IND application and initiate its first clinical trial in 2027, subject to completion of the required development work and regulatory authorization.
Safi Biotherapeutics is a biotechnology company developing stem cell-derived red blood cells for transfusion medicine, with a focus on scalable manufacturing and applications in both civilian healthcare and military casualty care.
