The FDA has licensed Teleflex’s EZPLAZ, making it the first freeze-dried plasma product approved for use in the U.S. EZPLAZ is approved for adults who require plasma when conventional products are unavailable. Potential uses include uncontrolled bleeding, massive transfusions, coagulation deficiencies, and temporary reversal of warfarin in certain patients.

Conventional plasma must be kept frozen, thawed before use, and refrigerated afterward, limiting its availability in ambulances, combat zones, disaster areas, and other settings outside hospitals. EZPLAZ can be stored between 36 and 77 degrees Fahrenheit for up to 12 months and reconstituted with sterile water in approximately one to 2.5 minutes.

The product is packaged in a flexible plastic bag, while freeze-dried plasma products previously available under emergency use authorization relied on glass bottles. The FDA said the plastic packaging could reduce the risk of breakage during transport and handling.

“Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma,” said Karim Mikhail, Acting Director of the FDA’s Center for Biologics Evaluation and Research.

Teleflex subsidiary Vascular Solutions began developing the product with the Defense Health Agency in 2014. The agency had identified a commercially available, FDA-approved source of freeze-dried plasma as a priority for battlefield medicine.

The FDA is requiring a Phase 4 trial comparing EZPLAZ with conventional plasma products after determining that additional data are needed to assess the potential risk of thrombotic events. The study is scheduled for completion in 2031. Like other plasma products, EZPLAZ also carries risks including transfusion reactions, infection transmission, and hypersensitivity.

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