First and only FDA-Approved Freeze Dried Plasma Product

WAYNE, Pa. -- (Business Wire)

Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced it has received Biologics License Application (BLA) approval for EZPLAZ™ Freeze Dried Plasma (FDP) from the U.S. Food and Drug Administration (FDA). EZPLAZ™ FDP is approved for transfusion in adults with bleeding-related conditions requiring replacement of plasma coagulation factors, including uncontrolled bleeding (hemorrhage), when plasma is required and other plasma products are not available. This landmark approval is the first freeze dried plasma licensed by the FDA, and the first biologics license for a blood component for Teleflex.

“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,” said Jake Newman, President and General Manager, Global Vascular and Emergency Medicine at Teleflex. “While current Emergency Use Authorization FDP products use glass bottles as containers, EZPLAZ™ FDP utilizes a patented flexible plastic bag technology. The BLA approval of EZPLAZ™ FDP is a critical milestone for our customers and for Teleflex, as we continue to expand our emergency medicine portfolio.”

Hemorrhage is the leading cause of preventable death for both battlefield and civilian trauma patients.¹ Plasma products contain proteins that help clot blood and can be used for the management of hemorrhage and coagulopathy.² However, the use of traditional plasma products in combat and prehospital settings is limited by logistical and operational challenges, such as the need for freezers and thawing equipment, a long thawing period, and post thaw refrigeration requirements.^3,4

Based on this clinical challenge, the Defense Health Agency (DHA) has made the development of an FDA-approved, commercially available source of freeze dried plasma a top priority. In April 2014, Vascular Solutions LLC (a wholly owned subsidiary of Teleflex) entered a Cooperative Research and Development Agreement (CRADA) with the team now known as Warfighter Protection and Acute Care (WPAC), which is part of DHA.

"The WPAC Program Management Office partners with companies to develop products to address the Department of War’s mission-critical medical priorities,” said Dr. Kendra Lawrence, WPAC’s Project Manager. “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.”

“The approval of EZPLAZ™ FDP marks an important milestone in the availability of freeze-dried plasma in the United States,” said Christopher Ross, MD, Global Medical Safety Director and Interim Head of Clinical and Medical Affairs at Teleflex. “Our clinical development program was designed to generate the evidence needed to support the safety and effectiveness of EZPLAZ™ FDP for its approved indication. We are grateful to the investigators, blood donors, study participants, and our government partner whose collaboration made this achievement possible.”

Teleflex has been responsible for product development and establishing manufacturing operations to support the submission of the Investigational New Drug (IND) application. The freeze dried unit of plasma is kitted with components needed for transfusion, including Sterile Water for Injection (SWFI) for the initial reconstitution step. The product has a storage temperature of 2 to 25°C (36 to 77°F), a 12-month shelf life, and can be reconstituted in about 1-2.5 minutes.

Rx Only

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR EZPLAZ™ FREEZE DRIED PLASMA

INDICATIONS

EZPLAZ™ Freeze Dried Plasma (FDP) is indicated for transfusion in adults when plasma is required and other plasma products are not available. Indications include:

• Management of preoperative or bleeding patients who require replacement of multiple plasma coagulation factors [e.g., liver disease, disseminated intravascular coagulation (DIC)]
• Patients undergoing massive transfusion who have clinically significant coagulation deficiencies
• Patients taking warfarin who are bleeding or need to undergo an invasive procedure before vitamin K could reverse the warfarin effect or who need only transient reversal of warfarin effect

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Do not use EZPLAZ™ FDP:

• In patients with history of hypersensitivity to fresh frozen plasma (FFP), liquid plasma or to plasma-derived products including any plasma proteins
• In patients with IgA deficiency

WARNINGS AND PRECAUTIONS

As with other licensed blood products, EZPLAZ™ FDP may cause adverse events known to be associated with transfusion of blood products. For a complete list and further details not provided below, please refer to the Circular of Information.

Hemolytic Transfusion Reactions
Hemolytic transfusion reactions can occur with ABO blood group mismatches. EZPLAZ™ FDP is provided in blood group type AB or type A low titer Anti-B (< 1:200 by saline tube method).

Transfusion-Related Acute Lung Injury (TRALI)
To mitigate the risk of TRALI, EZPLAZ™ FDP is manufactured from FFP donated by male only donors.

Infection Risk from Human Plasma
Because EZPLAZ™ FDP is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, bacteria, and theoretically the variant Creutzfeldt-Jakob disease (vCJD) agent.

Hypersensitivity Reaction
Hypersensitivity reactions, including anaphylaxis, may occur. Discontinue the transfusion if signs or symptoms of hypersensitivity occur and treat appropriately.

Specific Therapies
EZPLAZ™ FDP may be less effective in correcting certain coagulopathies when therapies targeting specific coagulation factor deficiencies or anticoagulant effects are available. In such situations, clinicians should consider the use of targeted therapies, when clinically appropriate, including vitamin K for urgent vitamin K antagonist reversal, fibrinogen-containing products for hypofibrinogenemia, specific coagulation factor concentrates, or specific reversal agents for non-vitamin K antagonist anticoagulants. Selection of therapy should be based on the patient’s clinical condition, urgency of correction, and availability of alternative treatments.

Volume Expansion
EZPLAZ™ FDP is not intended for routine volume expansion. When administered in the absence of a documented coagulation factor deficiency or plasma protein deficiency, the expected clinical benefit may be limited, and alternative volume expanders are generally more appropriate. Clinicians should consider alternative therapies based on the patient’s clinical needs.

Elevated INR
Transfusion of EZPLAZ™ FDP may not result in meaningful correction of a minimally elevated international normalized ratio (INR), such as values between 1.5 and 1.7. In these situations, the likelihood of achieving clinically significant hemostatic benefit may be low, and alternative management strategies should be considered based on the patient’s overall clinical condition.

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Teleflex at 1-866-246-6990 and FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional Safety Information, please see Full Prescribing Information at www.teleflex.com/EZPLAZPI.

About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in the world of healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit www.teleflex.com.

The information contained in this press release does not necessarily reflect the position or the policy of the U.S. Government and no official endorsement should be inferred.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties, and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, EZPLAZ, LMA, Pilling, QuikClot, Rüsch, UroLift, Vascular Solutions and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2026 Teleflex Incorporated. All rights reserved. MC-005555

References:
1. Brito AM, Schreiber M. x-ABC versus ABC: shifting paradigms in early trauma resuscitation. Trauma Surg Acute Care Open. 2025;10(Suppl 1):e001773. Published 2025 Apr 14. doi:10.1136/tsaco-2025-001773
2. Lawless RA, Holcomb JB. Plasma Transfusion. Trauma Induced Coagulopathy. 2015;323-337. Published 2015 Dec 11. doi:10.1007/978-3-319-28308-1_20
3. Pusateri AE, Given MB, Schreiber MA, et al. Dried plasma: state of the science and recent developments. Transfusion. 2016;56 Suppl 2:S128-S139. doi:10.1111/trf.13580
4. Hervig T, Doughty H, Ness P, et al. Prehospital use of plasma: the blood bankers' perspective. Shock. 2014;41 Suppl 1:39-43. doi:10.1097/SHK.0000000000000144

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Contacts:

Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610-948-2836

Source: Teleflex Incorporated