Teleflex Announces Submission of Biologics License Application for Its Investigational Freeze Dried Plasma

Rhea-AI Summary

Teleflex Incorporated (NYSE: TFX) announced the submission of a Biologics License Application (BLA) for its investigational freeze dried plasma (FDP) candidate to the FDA. This candidate, developed in collaboration with the U.S. Army Medical Materiel Development Activity, aims to enhance emergency medical responses to battlefield injuries. The application is eligible for priority review and accelerated approval, facilitating potential rapid availability. The FDP is not yet FDA-approved. The announcement underscores Teleflex's innovation focus in medical technologies.

Positive

• Submission of BLA for freeze dried plasma candidate eligible for priority review.
• Collaboration with U.S. Army suggests strong potential for government-related demand.

Negative

• None.

Submission is eligible for priority review and accelerated approval

WAYNE, Pa., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its investigational freeze dried plasma (FDP) candidate. The investigational FDP is a lyophilized (freeze dried) unit of human plasma being developed under a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Medical Materiel Development Activity (USAMMDA).

The investigational FDP is subject to the amendments made to section 564 of the Federal Food, Drug, and Cosmetic Act under H.R 4374 [Public Law No: 115-92]. This law allows for authorization of additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war.¹

“This is an exciting milestone for Teleflex. We look forward to working with the FDA in a timely and efficient manner to address any needs for additional information that may arise,” said Liam Kelly, Chairman, President and Chief Executive Officer of Teleflex.

Teleflex’s freeze dried plasma candidate is an investigational new drug and has not yet been approved by the FDA.

About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Teleflex is the home of Arrow^®, Deknatel^®, Hudson RCI^®, LMA^®, Pilling^®, Rüsch^®, UroLift^®, and Weck^® – trusted brands united by a common sense of purpose.

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.

Reference:
1. Public Law 115-92, Dec. 12, 2017. Congress.gov. https://www.congress.gov/115/plaws/publ92/PLAW-115publ92.pdf. Accessed January 9, 2021.

Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2021 Teleflex Incorporated. All rights reserved. MC-007064

Source:
Teleflex Incorporated
Jake Elguicze
Treasurer and Vice President, Investor Relations
610-948-2836

FAQ

What is the significance of Teleflex's Biologics License Application submitted on February 24, 2021?

The submission of the Biologics License Application is significant as it allows for priority review and could lead to accelerated approval of Teleflex's freeze dried plasma candidate, essential for emergency medical response.

What does the collaboration with the U.S. Army entail for Teleflex's FDA application?

The collaboration with the U.S. Army involves developing the freeze dried plasma candidate, highlighting its application in critical care settings, particularly for military emergencies.

Is Teleflex's freeze dried plasma candidate currently approved by the FDA?

No, Teleflex's freeze dried plasma candidate is still investigational and has not yet been approved by the FDA.