Research Update (1455F)

TIDMLMT

RNS Number : 1455F

Lombard Medical Technologies PLC

12 June 2012

Lombard Medical Technologies PLC

("Lombard Medical" or "the Company")

US Pythagoras data suggests that Aorfix(TM) has the potential to provide a less invasive treatment option for AAA patients with highly angulated neck anatomy

London, UK, 12 June 2012 - Lombard Medical Technologies PLC (AIM:LMT), the specialist medical technology company focussed on innovative vascular products, today announces the high angle clinical data results from the US PYTHAGORAS trial of its endovascular stent graft Aorfix(TM).

The unique data set, presented at the Society of Vascular Surgery (SVS) Annual Meeting on 7-9 June in the USA by Dr Mark Fillinger of Dartmouth Hitchcock Medical Centre, featured results from the world's first and largest multicentre EVAR (Endovascular Aortic Repair) clinical trial studying patients with angles greater than 60 degrees. 205 patients were recruited in the trial and the data resulted from 143 patients with highly-angulated aortic necks (angles between 60 and 110 degrees). Treatment of this patient group is not indicated in any stent grafts currently available in the USA.

The data presented showed that Aorfix(TM) performed well in extreme aortic neck angulations. Outcomes such as freedom from major adverse events (MAEs, as defined by the SVS) at 30 days and 365 days, were significantly lower than in patients undergoing open surgical repair (81.1% vs. 56.4% p<0.0001 and 75.5% vs. 54.5% p<0.0001 respectively). Although not tested in this trial, Dr Fillinger noted that the outcomes were similar to EVAR trials of other stent grafts in much less severe anatomy.

The PYTHAGORAS trial's results were achieved despite the inclusion of patients with predictors of worse short and long-term outcomes such as:

   --     age (75.4 +/-8 years vs. 69.2 +/-7 years, p=0.001); 
   --     proportion of female patients (35% vs. 20%, p=0.015); 
   --     congestive heart failure (14% vs. 4%, p=0.029); and

-- high neck angles (83 +/- 15 degrees, compared to SVS control group: 48 +/-22 degrees, p<0.05)

Aorfix(TM) is currently commercially available in Europe and the Company expects to launch the stent graft in the USA later this year, subject to FDA approval.

Dr Fillinger commented:

"Aorfix(TM) has produced promising results in this extremely challenging patient group with high neck angles whose only treatment option currently is open surgical repair. Once available in the US, Aorfix(TM) should provide clinicians with a versatile option for treating patients with challenging AAA anatomy, significantly expanding our ability to treat this condition in a minimally invasive fashion."

Simon Hubbert, Chief Executive of Lombard Medical commented:

"We are very pleased with the US PYTHAGORAS data, further evidence that Aorfix(TM) is an excellent treatment option for patients with extremely tortuous anatomy and who previously had no endovascular options. Our work supporting the US approval process for Aorfix(TM) is on track and we continue to anticipate US approval by the end of the year."

The results from the PYTHAGORAS trial have been submitted to the US FDA and form a central part of the Company's pre-marketing authorisation application for Aorfix(TM). Currently all available stent grafts in the US are labelled for treating patients with AAA's (Abdominal Aoritic Aneurysms) with neck angles up to 60 degrees. In Europe, Aorfix(TM) is approved to treat patients with neck angulations up to 90 degrees.

- Ends -

For further information:

 
 Lombard Medical Technologies 
  PLC 
 Simon Hubbert, Chief Executive      Tel: 01235 
  Officer                               750 800 
 Canaccord Genuity Limited 
 Jamie Adams / Mark Dickenson     Tel: 020 7523 
  / Lucy Tilley                            8000 
 FTI Consulting 
 Jonathan Birt / Simon Conway     Tel: 020 7831 
  / Susan Stuart                           3113

NOTES TO EDITORS

About Lombard Medical

Lombard Medical Technologies PLC (AIM: LMT), is a medical device company focused on device solutions for the $1.2 billion dollar per annum abdominal aortic aneurysm (AAA) repair market. AAAs 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 AAAs 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, and has been submitted to the FDA for approval in the US.

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.

About PYTHAGORAS

The PYTHAGORAS trial was designed to show the potential that Aorfix(TM) has to treat a significantly larger patient population than competing devices, including both standard and difficult to treat cases of Abdominal Aortic Aneurysms (AAAs). The trial is the largest prospective controlled study in the world involving AAA patients with highly tortuous aortic and iliac anatomy, and consisted of two groups of patients. The study group consisted of 143 cases with aortic neck angles >= 60[deg] and a 'roll-in' group of 62 patients with aortic neck angles < 60[deg].

The abstract for the presentation made at SVS can be accessed at: https://www.vascularweb.org/educationandmeetings/2012%20Vascular%20Annual%20Meeting/programindetail/Pages/Saturd ay,%20June%209%20Abstracts/LB1.aspx

This information is provided by RNS

The company news service from the London Stock Exchange

END

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