Teleflex’s FDA BLA Approval: Could Freeze-Dried Plasma Change Trauma Care Forever?
(RTTNews) – Teleflex Incorporated (TFX), a provider of medical technologies, announced that the U.S. FDA has approved its BLA for EZPLAZ Freeze Dried Plasma (FDP).
EZPLAZ FDP is indicated for transfusion in adults with bleeding-related conditions requiring replacement of plasma coagulation factors, including uncontrolled hemorrhage, when plasma is needed and other plasma products are not available. This marks the first FDA-licensed freeze-dried plasma product and Teleflex’s first biologics license for a blood component.
Unlike current Emergency Use Authorization FDA products packaged in glass bottles, EZPLAZ uses a patented flexible plastic bag technology, making it easier to transport and store. The product is designed for use in critical settings such as ambulances, hospitals, and battlefields, where rapid access to plasma can be lifesaving.
Hemorrhage remains the leading cause of preventable death among both battlefield and civilian trauma patients. Traditional plasma products face logistical challenges, including the need for freezers, thawing equipment, and post-thaw refrigeration. EZPLAZ FDP addresses these limitations by offering a shelf-stable, easy-to-use option.
The Defense Health Agency (DHA) has prioritized the development of FDA-approved freeze-dried plasma, partnering with Teleflex through its Warfighter Protection and Acute Care (WPAC) program. The collaboration aims to deliver shelf-stable blood products to frontline medical teams where they are most urgently needed.
This approval represents a critical milestone for Teleflex’s emergency medicine portfolio and expands its role in advancing trauma care solutions.
TFX has traded between $100.18 and $139.67 over the past year. The stock closed Wednesday’s trading at $134.65, up 0.34%. In pre-market trading the stock is at $137.00, up 1.75%.
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