AGM Trading Update
London, UK, 12 May 2008 – At today’s Annual General Meeting, Mr Simon Neathercoat, Chairman of Lombard Medical Technologies PLC (“Lombard Medical” or “the Company”), the specialist medical device company, made the following statement:
“Sales of Aorfix™ in Europe in the first four months of the year are in line with expectations with sales in the UK, where Aorfix™ is marketed directly by Lombard Medical’s own field force, being particularly pleasing. Although the unique design of Aorfix™ lends itself to the treatment of abdominal aortic aneurysms in tortuous anatomies, the majority of implants to date have been in regular anatomy where the product competes effectively with grafts from major medical device companies."
Recruitment into the ARBITER II trial to widen the label claim for Aorfix™ in Europe to include patients with aneurysm neck-angulations of up to 90 degrees is going well with 18 of the 30 patients recruited and the trial on course to complete recruitment in Q3 2008.
As regards our PYTHAGORAS trial in the US, we reported last November that the FDA had given us consent to increase the number of endovascular sites from 10 to 30. We have spent much time and effort in the early months of this year progressing the regulatory processes to open these new centres. To date the paperwork has been completed for 27 centres and 20 have now surgeons qualified and trained to implant patients with Aorfix™. These regulatory procedures are time consuming and have caused us to run a little behind our anticipated recruitment rates at this time. Steps are being taken to hasten this process but we are limited by resources. As a consequence of this I believe that to complete full recruitment by the end of the year will be challenging. However, monthly recruitment rates are on an increasing trend and the enthusiasm for Aorfix™ amongst our clinical investigators is as strong as ever.
The US clinical trial for EndoRefix™ commenced on schedule in April and to date four of the ten centres participating in the trial have obtained approval of the trial protocol from their Investigational Review Board (“IRB”) and four cases have been performed out of a total of 95 for the trial.”
The Company also announces that all the proposed resolutions were duly passed.
Enquiries:
Lombard Medical Technologies PLC Tel: +44 (0) 1235 750 800
Simon Neathercoat, Non-executive Chairman
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics Tel: +44 (0) 20 7831 3113
David Yates / Susan Quigley
Nomura Code Securities Limited Tel: +44 (0) 20 7776 1200
Juliet Thompson / Richard Potts
Notes to editors
About Lombard Medical
Lombard Medical Technologies PLC is a medical devices group developing stent grafts and other medical products for use in the treatment of vascular disease. The Company’s lead product, Aorfix™, is an endovascular stent graft for the treatment of abdominal aortic aneurysms (AAAs), a balloon-like enlargement of the aorta which, if untreated, may rupture and cause death. Approximately 1.7 million people have AAAs in the US where it is the 13th largest cause of death. The market for endovascular stent grafts for the treatment of AAA is currently worth over $600 million and is expected to grow to around a $1 billion by 2010. Aorfix™ is currently being commercialised in the EU, with a pivotal clinical trial ongoing in the USA.
The Company’s Polymer Coatings Division has developed a novel hydrophilic surface treatment to reduce friction on catheters called GlideMax™, which is available for licensing, and is using its polymer coating technology in a number of research collaborations developing novel products for the $5 billion drug-eluting stent market.
The Company headquartered in Oxfordshire, with operations in Yorkshire, Ayrshire and Boston, USA employs over 100 people.
Further background on the Company can be found at www.lombardmedical.com.