BTG PLC Regulatory Update (3056X)

TIDMBTG

RNS Number : 3056X

BTG PLC

09 August 2018

BTG receives not-approvable letter from the US FDA for ELEVAIR(TM)

London, UK, 9 August 2018: BTG plc (LSE: BTG), the global specialist healthcare company, today announces that PneumRx has received confirmation from the US Food and Drug Administration (FDA) that the Premarket Approval (PMA) application for its ELEVAIR(TM) Endobronchial Coil System for the treatment of people with severe emphysema is not approvable. This follows the FDA Advisory Panel's recommendation in June 2018 not to approve ELEVAIR(TM).

BTG is reviewing options and will provide an update in due course.

For further information contact:

BTG

Andy Burrows, VP Corporate & Investor Relations

[phone]; Mobile: [phone]

Stuart Hunt, Investor Relations Manager

[phone]; Mobile: [phone]

Chris Sampson, Corporate Communications Director

[phone]; Mobile: [phone]

FTI Consulting

Ben Atwell/Simon Conway

[phone]

About BTG

BTG is a global healthcare company focused on Interventional Medicine. Our innovative medical technology helps physicians treat their patients through minimally invasive procedures. We have a growing portfolio of products that advance the treatment of cancer, vascular conditions and severe emphysema. BTG's Pharmaceuticals business provides products that help patients overexposed to certain medications or toxins. To learn more about BTG, please visit: btgplc.com.

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August 09, 2018 02:01 ET (06:01 GMT)