Teleflex Announces Submission of Biologics License Application for Its Investigational Freeze Dried Plasma
February 24 2021 - 6:30AM
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 IncorporatedTeleflex 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 StatementsAny 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 IncorporatedJake
ElguiczeTreasurer and Vice President, Investor
Relations610-948-2836
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