WAYNE, PA — Teleflex Inc. (NYSE: TFX) has secured U.S. Food and Drug Administration approval for the first licensed freeze-dried plasma product in the country, potentially expanding access to plasma for bleeding patients in ambulances, hospitals and battlefield settings where conventional frozen products can be difficult to deploy.
The FDA approved EZPLAZ Freeze Dried Plasma for transfusion in adults with bleeding-related conditions requiring replacement of plasma coagulation factors when plasma is needed and other plasma products are unavailable. The approval is also Teleflex’s first biologics license for a blood component.
The product addresses logistical constraints associated with traditional plasma, which can require freezers, thawing equipment and refrigeration after thawing. Those requirements can limit its availability in prehospital and combat environments.
EZPLAZ can be stored between 36 and 77 degrees Fahrenheit, has a 12-month shelf life and can be reconstituted in about one to 2.5 minutes, according to Wayne-based Teleflex. Each unit is packaged with components required for transfusion, including sterile water for the initial reconstitution step.
Unlike freeze-dried plasma products currently available under emergency use authorization that use glass bottles, EZPLAZ uses a flexible plastic bag developed with patented technology, according to the company.
“EZPLAZ FDP can potentially enable the transfusion of plasma in situations where it is critically needed, including air and road ambulances, in the hospital, and on the battlefield,” Jake Newman, president and general manager of Teleflex’s Global Vascular and Emergency Medicine business, said.
The product is approved for several circumstances in which other plasma products are unavailable, including management of preoperative or bleeding patients requiring replacement of multiple coagulation factors and patients undergoing massive transfusions who have clinically significant coagulation deficiencies.
It is also indicated for patients taking warfarin who are bleeding or require an invasive procedure before vitamin K can reverse the drug’s effects, as well as patients requiring only temporary reversal of warfarin.
Development of the product traces back more than a decade. Vascular Solutions LLC, now a wholly owned Teleflex subsidiary, entered into a cooperative research and development agreement in April 2014 with a Defense Health Agency team now known as Warfighter Protection and Acute Care.
The Defense Health Agency has identified development of an FDA-approved, commercially available source of freeze-dried plasma as a priority because of the need for blood products that can be transported and used closer to the point of injury.
“Warfighter emergency medical care relies, in part, on bringing shelf-stable and easy to transport blood products to the front lines of the battlefield where they are most needed,” Kendra Lawrence, project manager for the Warfighter Protection and Acute Care program, said.
Teleflex was responsible for product development and establishing manufacturing operations supporting the investigational new drug application and subsequent regulatory process.
The approval expands Teleflex’s emergency medicine portfolio while moving freeze-dried plasma from emergency-use availability to an FDA-licensed commercial product for its approved adult indication.
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