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Regulatory Update

9th Aug 2018 07:00

RNS Number : 3056X
BTG PLC
09 August 2018
 

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

 

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 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™.

 

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

 

For further information contact:

 

BTG

Andy Burrows, VP Corporate & Investor Relations

+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605

 

Stuart Hunt, Investor Relations Manager

+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536

 

Chris Sampson, Corporate Communications Director+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178

 

FTI Consulting

Ben Atwell/Simon Conway

+44 (0)20 3727 1000

 

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.

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [email protected] or visit www.rns.com.
 
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