Aorfix™ successfully passes 21- patient case review by FDA
London, UK, 19 November 2007 – Lombard Medical Technologies PLC (“Lombard Medical” or “the Company”), the specialist medical device company, today announces that it has successfully passed an FDA review of the first 21 patient cases in the pivotal US clinical trial for its flagship stent graft product, Aorfix™.
Approval of the 21-patient case review by the FDA is a critical milestone on the route to commercialisation of Aorfix™ in the US market. The Company will now be able to immediately extend recruitment from ten centres to all nineteen centres that are currently contracted. In addition, the FDA has permitted the number of centres participating in the trial to be further increased to up to 30 centres, which will expedite patient recruitment.
At an international endovascular symposium held in New York last week, Dr Fillinger, the Principal Investigator of the study, gave a very positive update on progress to date. He commented that:
“The performance of Aorfix™ in the first 21 patients is excellent. The cases followed up to six months, have levels of aneurysm regression on par with the best competitors. I and fellow investigators have started using Aorfix™ in very challenging anatomy and it has been successfully implanted in several cases where no other implant would have been appropriate.”
Aorfix™ has been designed to widen the scope for endovascular abdominal aortic repair (“EVAR”) to provide surgeons with a total solution to the treatment of abdominal aortic aneurysms (“AAAs”), known as the “Silent Killer” and the 13th most common cause of death in the US. The US is currently the largest market worldwide with approx 33,000 EVAR procedures performed annually (Western Europe – 17,000). The worldwide market for EVAR is growing rapidly and is expected to reach $1 billion by 2010 due to a number of factors, including an ageing population, increased screening and growing patient and clinician preference for this minimally invasive approach over the alternative of open surgery.
The improved production procedures put in place by Lombard Medical during the last six months has enabled the Company to increase stock levels which, together with enhanced sales and marketing efforts, has resulted in a significant increase in the rate of implantation of its Aorfix™ stent grafts. The Company has now completed 330 procedures and has a strong pipeline of cases in hand.
With increasing public awareness of AAA, supported by recent coverage in the media, the market for AAA stent grafts is growing strongly. Routine screening of AAA for men in their 60’s (as recommended in principle by the UK National Screening Committee and already in practice in the US for 65 year olds) is further indication of this growth.
In addition to Aorfix™, the Company’s other development product, the EndoRefix™ endovascular stapling system, is also making good progress with the first two cases ‘in man’ having been successfully completed, marking the beginning of European access to the device. The FDA investigational device exemption has been approved to begin recruitment of centres and enrolment of patients upon receiving centre ethics approval; recruitment is expected to commence in the early part of 2008.
Brian Howlett, Chief Executive of Lombard Medical, commented:
“Lombard Medical has moved forward strongly on a number of fronts over the last few months. We are now starting to make excellent progress in the clinical trial programme for our lead Aorfix™ stent graft product and we are on track for full commercialisation of the product in the US, which we anticipate achieving by early 2010. With other products in our pipeline also making good progress, improved production procedures now in place and the Board having been recently strengthened, I am confident that Lombard Medical is well placed to achieve its objectives.”
Enquiries:
Lombard Medical Technologies PLC
Tel: 01235 750 800
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics
Tel: 020 7831 3113
David Yates / Sanjeev Pandya / Susan Quigley
Nomura Code Securities
Tel: 020 7776 1200
Richard Potts
Notes to editors:
About Lombard Medical
Lombard Medical is a medical devices company 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 and US clinical trials are ongoing. 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 US$6 billion market.
The Company, headquartered in Oxfordshire, with operations in Yorkshire, Ayrshire and Boston, USA, employs over 100 people.