Lombard Medical receives conditional FDA approval of its supplemental IDE for Aorfix™
London, UK, 8 November 2006 - Lombard Medical Technologies PLC (“Lombard Medical”) today announces that it has received conditional approval from the FDA for its supplemental Investigational Device Exemption (“IDE”) with respect to the pivotal US clinical trial of the Aorfix™ endovascular stent graft in the treatment of abdominal aortic aneurysms (AAAs).
Originally it was envisaged that the trial would have two endovascular arms, one for aneurysms with neck angulations of up to 60 degrees (“low/moderate angle cases”) and one for aneurysms with neck angulations of between 60 degrees and 90 degrees (“high angle cases”), as well as an open surgery control arm. However the FDA has provisionally accepted arguments in the supplemental IDE submission to have a single endovascular arm in which each centre could recruit patients with any neck angle up to 90 degrees following an initial recruitment of five low/moderate angle cases. This change in trial design allows a reduction of the total number of endovascular cases to be performed in the trial from 385 to 210 which will shorten the time required to recruit patients into the trial. Furthermore, as centres cannot enrol high angle cases (for which there is no licensed endovascular treatment option) until they have completed five low/moderate angle cases, there is now an incentive for centres to recruit low/moderate angle cases quickly which should expedite the overall trial recruitment process.
The supplemental IDE also allows Lombard Medical to use the improved version of Aorfix™ launched in Europe in April 2006 in the trials. This product is much preferred by physicians due to its greater flexibility, longer shelf life and increased visibility under X-ray.
Full approval of the supplemental IDE is expected in Q1 2007 following the submission of further information to the FDA.
The changes to the trial that include an increase of 10 to 120 in the number in the open surgery control arm are not expected to have a material impact on the 2007 operating loss as Lombard Medical expects to continue to sell Aorfix™ to trial centres after recruitment is completed under an access program that will require monitoring of patients similar to that performed in the clinical trial.
Alistair Taylor, Executive Chairman of Lombard Medical, said:
“As a result of the changes outlined in the conditional IDE patients will benefit from earlier access, albeit in a trial, to a device that can be used in high angle cases for which there is currently no approved endovascular treatment option in the USA. We believe that this along with access to our improved device will have a significant impact on recruitment rates resulting in Aorfix™ entering the important US market earlier than previously anticipated.”
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.