TIDMLMT 
 
RNS Number : 7956X 
Lombard Medical Technologies PLC 
13 December 2010 
 

Press information 
 
                        Lombard Medical Technologies PLC 
                        ("Lombard Medical" or "Company") 
 
                Lombard Medical Submits Fifth PMA Module to FDA 
 
 
London, UK, 13 December 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 fifth 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 6 
modules.  The first three of these modules, on biological testing, non-clinical 
laboratory studies, and sterilisation and packaging, have already been reviewed 
and accepted by the FDA.  The fourth module on bench testing and shelf life was 
submitted in November and the penultimate module on manufacturing has just been 
submitted. 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: 
 
"We set out clear timelines for submission of the PMA modules required for FDA 
approval of Aorfix(TM) earlier this year and we remain firmly on track to 
achieve them. We look forward to submitting the final PMA module demonstrating 
the clinical evidence for the use of the Aorfix(TM) stent graft in the treatment 
of complex tortuous anatomy during the first half of 2011. The US is the largest 
market for AAA stent grafts, worth over $500 million, and we continue to be 
confident of winning 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 / Bobbie Hilliam          |    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 
 
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