Lombard Medical Submits Fourth PMA Module to FDA (5512W)

TIDMLMT

RNS Number : 5512W

Lombard Medical Technologies PLC

22 November 2010

Press information

Lombard Medical Technologies PLC

("Lombard Medical" or "Company")

Lombard Medical Submits Fourth PMA Module to FDA

London, UK, 22 November 2010 - Lombard Medical Technologies PLC (AIM: LMT), a medical device company focused on solutions for the $1 billion abdominal aortic aneurysm (AAA) repair market, today announces that it has submitted the fourth of six pre-market approval (PMA) modules required for the US approval of Aorfix(TM) by the U.S. Food and Drug Administration (FDA).

The Company has FDA permission to file the PMA for Aorfix(TM) in a series of six modules. The first three of these modules on biological testing, non-clinical laboratory studies, and sterilisation and packaging have been reviewed and accepted by the FDA. The fourth module on bench testing and shelf life has just been submitted and the Company remains on track to file the fifth module on manufacturing before the end of the year. The final module containing the clinical data is expected to be filed in the first half of 2011.

Commenting on the submission, Lombard Medical Chief Executive John Rush said:

"I am very pleased that we continue to meet the timelines set out at the beginning of the year for submission of the various PMA modules required for FDA approval of Aorfix(TM). The US is the largest market for AAA stent grafts, worth over $500 million and we remain confident of achieving approval for Aorfix(TM) in this important market."

- Ends -

About Lombard Medical

Lombard Medical Technologies PLC (AIM: LMT), is a medical device company focused on device solutions for the $1 billion dollar abdominal aortic aneurysm (AAA) repair market. AAA's are a balloon-like enlargement of the aorta which, if left untreated, may rupture and cause death. Approximately 4.5 million people are living with AAA's in the developed world and each year 600,000 new cases are diagnosed. The market for endovascular stent grafts for this application is expected to grow to $1.6 billion by 2015. The Company's lead product, Aorfix(TM), is an endovascular stent graft which has been specifically designed to solve the problems that exist in treating complex tortuous anatomy which is often present in advanced AAA disease. Aorfix(TM) is currently being commercialised in the EU, with a pivotal clinical trial nearing completion in the USA.

The Company is headquartered in Oxfordshire, with operations in Ayrshire and Phoenix, USA.

Further background on the Company can be found at www.lombardmedical.com.

For further information:

 
 Lombard Medical Technologies PLC 
 John Rush, Chief Executive Officer    Tel: 01235 750 800 
  Tim Hall, Finance Director 
 Evolution Securities Limited 
 Barry Saint                          Tel : 020 7071 4300 
 Financial Dynamics 
 Jonathan Birt / Susan Quigley        Tel : 020 7831 3113

This information is provided by RNS

The company news service from the London Stock Exchange

END

MSCPGGBWGUPUPGG

Lombard Medical Technologies (LSE:LMT)
Historical Stock Chart
From Jun 2024 to Jul 2024