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FDA licenses first US freeze-dried plasma product

FDA licenses first US freeze-dried plasma product

New Capabilities

Ezplaz stores at room temperature and reconstitutes in minutes, so plasma can reach combat zones and rural emergencies

Today: FDA licenses Ezplaz, first US freeze-dried plasma

Overview

Updated 1 hour ago

For decades, US plasma transfusions required a freezer and time to thaw. Ezplaz, the first US-licensed freeze-dried plasma, reconstitutes in about 2.5 minutes and sits on a shelf for a year.

The shift moves plasma out of the hospital blood bank and into ambulances, combat zones, and disaster sites. The FDA granted the biologics license to Vascular Solutions, a Teleflex subsidiary, after a 12-year research partnership with the Defense Health Agency. The approval covers adults only, and only when frozen plasma is unavailable.

Why it matters

Bleeding patients in combat zones and rural areas can now receive plasma before reaching a hospital blood bank, buying minutes that can decide survival.

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Key Indicators

2.5 min
Reconstitution time
Ezplaz powder mixes with sterile water in about 2.5 minutes, skipping the thaw step frozen plasma requires.
12 months
Room-temperature shelf life
Stored at 2-25°C (36-77°F) and stable through temperature fluctuations, unlike plasma that must stay frozen.
1
FDA-licensed freeze-dried plasma products in the US
Ezplaz is the first, and Teleflex's first biologics license for a blood component.
270 mL
Plasma volume per reconstituted unit
Each self-contained kit holds one unit of freeze-dried plasma, sterile water, and transfusion sets.
15 years
Years US special operators used French freeze-dried plasma
Before Ezplaz, the only field option was imported French product brought in case by case under special access.

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People Involved

Organizations Involved

Timeline

April 2014 August 2026

4 events Latest: Today
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  1. FDA licenses Ezplaz, first US freeze-dried plasma

    Today Regulatory

    FDA licenses Ezplaz, the first US freeze-dried plasma, for adults when other plasma is unavailable.

  2. Red Cross warns of national blood supply crisis

    Context

    Red Cross warns donations hit a four-year low; O-positive supply under one day.

  3. Congress authorizes military-FDA medical product collaboration

    Policy

    Congress authorizes military-FDA collaboration to speed products for service members.

  4. Vascular Solutions and military sign plasma research pact

    Partnership

    Vascular Solutions and the Defense Health Agency sign a freeze-dried plasma research pact.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

1940-1945

World War II dried plasma (1940s)

The US pioneered dried plasma in World War II, shipping large quantities to field hospitals to treat shock and hemorrhage. The process pooled plasma from many donors.

Then

Hepatitis outbreaks traced to pooled plasma led the US military to abandon dried plasma after the war.

Now

The US shifted to frozen single-donor plasma with viral screening, while some foreign militaries kept freeze-dried plasma in use.

Why this matters now

Ezplaz brings back a technology the US invented and abandoned, this time with single-donor sourcing and modern testing.

December 2017

Public Law 115-92 (2017)

Congress directed the Department of Defense and the FDA to collaborate on speeding up development and review of products for serious conditions facing service members. Freeze-dried plasma was among the first products identified under the law.

Then

The FDA issued guidance in 2019 for manufacturers developing dried plasma products.

Now

The law created a formal review track that carried Ezplaz from a 2014 research pact to a 2026 license.

Why this matters now

It is the institutional mechanism behind this approval.

2000s-2026

French military freeze-dried plasma (2000s-2026)

France's armed forces have used freeze-dried plasma for decades. US special operations forces carried French-made FDP for 15 years, importing it case by case under special access because no US-licensed product existed.

Then

The imported product proved freeze-dried plasma works in the field but lacked a US regulatory license.

Now

US reliance on imports left a supply gap the Defense Health Agency pushed to close with a domestic product.

Why this matters now

Ezplaz replaces an import-dependent workaround with a US-licensed product, changing procurement and supply reliability.

Sources

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