Freeze Dried Plasma: A Past Solution Helping Solve Today’s Problems

Editor's Note: The FDA and Teleflex declined to provide comments.

The Food and Drug Administration announced its approval of EzPLAZ, a lyophilized plasma product for the treatment of adults who need coagulation factor replacement and volume replacement during uncontrolled hemorrhage, including patients taking warfarin who are bleeding. Vascular Solutions, a subsidiary of Teleflex, partnered with the Department of War and the Defense Health Agency to develop a shelf-stable product for use in locations where blood product availability or cold-chain management is not feasible or sustainable.

What You Need to Know

• EzPLAZ is a lyophilized plasma derivative from an AB or A blood group male donor.
• Shelf-stable for up to 12 months with a temperature range of 36-77 degrees Fahrenheit (2-25 degrees Centigrade).
• Reconstitute with 250ML of Sterile Water for Injection. Total volume is equivalent to 270 mL of plasma. Reported time to reconstitution is 2-3 minutes.
• Must be transfused through a sterile Blood Transfusion Set; it can be administered either IV or IO.
• This is a blood product that must be managed and tracked like all other blood products, including continuous temperature monitoring.
• For adults > 18 years old. Not currently approved for pediatric patients.

Freeze Dried Plasma Is Not a New Idea

The origins of Freeze Dried Plasma (FDP) can be traced back to the beginning of WWII, when there was a need for room-temperature-stable plasma in remote and austere settings. FDP was obtained by pooling donors, and in the survivors, subsequent transfusion-related disease was high. Attempts to develop a pathogen-reduced FDP were difficult, and by the 1960s efforts were stopped in the United States. With overall improvements and advancements in blood donor screening processes, infectious disease testing, and pathogen-reducing technology, FDP has been reintroduced.

Conversely, France has continuously used it since WWII. Other countries in Europe and Africa have also used FDP as a frontline treatment for hemorrhagic shock for decades. In the United States, under an FDA waiver, US Military Special Operations Units on overseas deployments have been able to use the French FDP since 2018, and the Octapharma product was approved for military use only in 2024. Neither is available for widespread use in conventional military or civilian settings.

What You Need to Do

Since EzPLAZ is classified as a blood product, it will fall under the Code of Federal Regulations (CFR 606.122), the Association for the Advancement of Blood and Biotherapies FDA-approved Circular of Information for the Use of Human Blood and Blood Components and state regulations. If your agency is considering EzPLAZ, you will still need to apply the same rigor used by programs that use liquid products, including the key concepts of traceability and lookbacks.

A room temperature of 36-77 degrees Fahrenheit (2-25 degrees Celsius) is not typically found in ambulances, supervisor vehicles, or medics’ packs. Deliberate planning for safe storage will be necessary. The manufacturer's literature indicates that coagulation protein levels remain highest when EzPLAZ is stored at 4 degrees Celsius (39 degrees Fahrenheit).

Conduct a Needs Assessment to see if this is the right product for your agency. The FDA specifies that EzPLAZ is indicated for transfusion in adults when plasma is required, and other plasma products are unavailable or not feasible.

Local and National Readiness

The FDA approval of a lyophilized plasma product is a huge step forward in expanding access to effective resuscitation capabilities in military and civilian prehospital settings. The licensing of EzPLAZ could also lead to the approval of other manufacturing processes for dried plasma products. When widely available, this capability will save individual lives and improve our national readiness for natural and man-made disasters. Recent modeling indicates that the current plasma supply can meet the rapid growth within programs without disrupting other blood product collections. While this is encouraging news, FDP production has limited capacity, may not be widely available when it launches in 2027, and we don’t yet have information on per-bag costs.

Final Thoughts

While there are unknowns about cost/availability/distribution model, and when it can be used for children, etc., this FDA approval, combined with the recent announcement of TRICARE reimbursement for prehospital blood programs, has been a good couple of weeks for the advancement of prehospital blood program efforts and providing medics with the tools they need to decrease death due to hemorrhage.

References and Links:

FDA Announcement: https://www.fda.gov/news-events/press-announcements/fda-licenses-first-ever-freeze-dried-plasma-product-us

Teleflex Announcement: https://www.teleflex.com/usa/en/product-areas/military-federal/trauma/ezplaz/index.html

EzPLAZTM Product Information: https://www.teleflex.com/usa/en/product-areas/military-federal/trauma/ezplaz/EZPLAZ-Circular-of-Information.pdf

The need for dried plasma—Still a national issue: Where are we and recommendations.

https://onlinelibrary.wiley.com/doi/full/10.1111/trf.70187

Prehospital Blood Transfusion Clinical Practice Guidelines: https://prehospitaltransfusion.org/wp-content/uploads/2025/06/Prehospital-blood-transfusion-coalition-clinical-practice-guideline-for-civilian-emergency-medical-services.pdf

Scaling of prehospital blood: A model describing impact on U.S. blood donors, distribution and cost. https://pubmed.ncbi.nlm.nih.gov/42470163/

Tricare Announcement: https://www.federalregister.gov/documents/2026/07/06/2026-13515/tricare-demonstration-project-for-tricare-ambulance-add-on-reimbursement-for-pre-hospital-blood