London, UK, 2 May 2012 – Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focussed on innovative vascular products, announces that it has received feedback from the U.S. Food and Drug Administration (“FDA”) as a result of its 100 day review. This review is part of the process for the pre-market approval (“PMA”) application for AorfixTM, the Company’s flexible stent graft for the endovascular repair of abdominal aortic aneurysms (“AAAs”). As previously announced the PMA filing was accepted for review in January 2012.
As part of this review process the FDA has requested some additional analyses of the existing clinical data set. The Company is confident that it can provide such analyses to satisfy the FDA’s request, without the need for further patient enrolment into the trial, and now anticipates FDA approval in the fourth quarter of 2012.
As noted in the Company’s announcement on 9th
March 2012, the approval process with a regulatory authority such as the FDA can be subject to delays beyond the control of the Company. To this end, the Company strengthened its working capital position to ensure financing would be available into 2013 should there be such a delay in FDA approval beyond the third quarter of 2012 through the issuance of £3m of convertible loan notes (CLNs). These proceeds, together with the Company’s existing cash resources, will be applied towards general working capital purposes; to ensure that the Company continues operating at current levels and preparations for the US launch of Aorfix™ remain on track.
CEO of Lombard Medical Technologies, Simon Hubbert, commented:
“We are encouraged by the progress made to date towards US approval of Aorfix™. The questions now raised by the FDA look to be readily addressable and we are confident that we remain on track to receive US approval later this year.”
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™, 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™ 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.
For further information:
Lombard Medical Technologies PLC Tel: 01235 750 800
Simon Hubbert, Chief Executive Officer
Ian Ardill, Chief Financial Officer
Canaccord Genuity Limited Tel : 020 7523 8000
Jamie Adams / Mark Dickenson / Lucy Tilley
FTI Consulting Tel : 020 7831 3113
Simon Conway / Susan Quigley/ Victoria Foster-Mitchell
