Temporary Suspension of European Clinical Procedures For Second Generation Stent Graft
London, UK, 11 December 2006
Lombard Medical Technologies PLC (“Lombard Medical” or “the Company”) announces that it is temporarily suspending European clinical procedures involving its Generation II Aorfix™ endovascular stent graft following the discovery of a problem with the placement of the graft in a small number of patients. Intensive investigation has isolated the problem to a minor change in the manufacturing procedure of the delivery device for the product. The placement problem has no implication on the effectiveness or durability of the implants once deployed. Data from clinical trials, registries and follow-ups indicate that the implant continues to perform well and no patient has been affected by the deployment issue.
Comprehensive testing of a corrective procedure will be completed over the next few weeks and the Company is working towards the resumption of clinical implants as soon as possible.
Field stocks of the affected product are being recovered from distributors. Clinical procedures involving the Generation I Aorfix™ device and the Aorfix™ Aorto-uni-iliac device are not affected. Trials in the United States of the Generation I device will also continue. Other products of the Group including the Refix™ Endostapler are unaffected by this problem.
Lombard Medical also announces that the issue of credit notes for returned stock and loss of December sales is now expected to reduce sales for 2006 by approximately £0.3m with sales for the year expected to be around £0.5m. Despite these lost sales and additional costs relating to the testing of the new loading procedures, Lombard Medical still expects its loss for the year to be in line with directors’ expectations of between £11.0m and £11.5m.
Enquiries:
Lombard Medical Technologies PLC Tel: 01235 750 800
Alistair Taylor, Executive Chairman
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics Tel: 020 7831 3113
David Yates / John Gilbert
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 a stent graft for the treatment of aortic aneurysms, a balloon-like enlargement of the aorta which, if untreated, may rupture and cause death. Abdominal and thoracic aortic aneurysms are the 13th largest cause of death in the US and the market is estimated to be worth approximately US$2 billion by 2010. Aorfix™ is currently being commercialised in the EU, with US clinical trials having commenced during 2006. The Company’s Polymer Coatings Division primarily develops polymer coatings for use in drug eluting stents and has a number of research collaborations developing novel products for this $6bn market.
Lombard Medical has recently successfully completed its initial public offering on AIM and was admitted to listing in December 2005, raising £23.9 million, net of expenses. The Company, based in Oxfordshire, Yorkshire and Boston, USA, employs over 90 people.
Further background on the Company can be found at www.lombardmedical.com.