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6/21/2013 9:52:25 AM
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FDA Approves Next Generation Aorflex™ Delivery System
London, UK, 21 June 2013 – Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, today announces that the Aorflex™ delivery system has been approved for commercial use in the US by the Food and Drug Administration (“FDA”). The Aorflex™ delivery system is the Company’s next generation delivery system for its unique Aorfix™ stent graft, which was recently approved by the FDA in February 2013 (along with the previous generation delivery device) for the endovascular repair of abdominal aortic aneurysms ("AAAs"). Aorfix™ is the only device licensed in the US to treat AAAs with neck angulations up to 90 degrees, a key advantage over other currently available stent grafts. The Company intends to launch Aorfix™ with Aorflex™ in the US in H2 2013; a coordinated launch event will take place at the VEITH symposium in New York City in November 2013.
The Aorflex™ delivery system has been commercially available in Europe since April 2012 and has received positive feedback from clinicians. Aorflex™ offers a range of clinical benefits over the original delivery system aimed at improving the overall ease of use of the Aorfix™ stent graft, including:
• Smoother introduction of the delivery system into blood vessels through the use of a hydrophilic coating
• Greater deployment control with exceptional one-to-one torque
• X-ray marker to give positional feedback to physicians
• Reduced deployment forces
The submission for the approval of the Aorflex™ delivery system was made to the FDA by the Company in April 2013 and approval has been granted in two months.
Lombard Medical recently raised £20.9 million net of expenses through a Placing, Subscription and Offer to qualifying participants of shares. These funds, together with the Company’s existing cash resources of £15.2 million (as of 30 April 2013), will be used, in part, to launch Aorfix™ in the US where the Company is currently building its own marketing infrastructure and direct sales force. Initially Lombard Medical is targeting the c.300 centres which perform approximately 50% of the US EVAR operations.
CEO of Lombard Medical Technologies, Simon Hubbert, commented:
“This is an exciting time in the history of the Company as we prepare for the US launch of Aorfix™, our differentiated stent graft for the treatment of abdominal aortic aneurysms. The approval of the accompanying Aorflex™ delivery system by the FDA is a tactically important achievement that will help ensure that clinicians deploy our stent graft most effectively. This in turn should increase clinician adoption of Aorfix™ as the stent graft of choice, especially in patients with AAAs that present with more challenging anatomies.”
Lombard Medical Technologies PLC Tel: 01235 750 800
Simon Hubbert, Chief Executive Officer
Ian Ardill, Chief Financial Officer
Canaccord Genuity Limited
Lucy Tilley / Tim Redfern /
Henry Fitzgerald O’Connor / Dr. Julian Feneley Tel: 020 7523 8000
Simon Conway / Susan Stuart / Victoria Foster Mitchell Tel: 020 7831 3113
About Lombard Medical
Lombard Medical Technologies PLC (AIM: LMT), is a medical device company focussed on device solutions for the $1.3 billion 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 approved by the FDA in the US It is the only stent graft approved for AAA neck angulations of up to 90 degrees. Plans are currently underway to launch Aorfix™ in the US later this year through the group’s own direct sales force, focussing on patients with tortuous aneurysm neck anatomy between 60 and 90 degrees in line with the products unique label. Aorfix™ is the first AAA stent graft not of US origin to gain FDA approval.
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.
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