European Arbiter II Trial Completes Recruitment
London, UK, 22 September 2008 – Lombard Medical Technologies PLC (“Lombard Medical”, “LMT” or “the Company”), the specialist medical device company, is pleased to announce that recruitment into the Arbiter II trial is now complete.
The Arbiter II trial designed to widen CE Mark approval for Aorfix™ in Europe to include patients with high-angle-neck aneurysms for which there is no approved endovascular device completed the target recruitment of 30 cases, enrolling the last patient on 17 September 2008. Data on the first 25 cases to reach the clinical endpoints will be submitted to our notified body in due course with approval expected in Q2 2009.
Commenting on the results, Brian Howlett, Chief Executive of Lombard Medical, said:
“We are delighted to announce that our European Arbiter II trial has been fully recruited on time. Once approved, Aorfix™ will have a unique label claim to treat patients with aneurysms with up to 90° of neck angulation thus opening endovascular treatment to a new spectrum of patients and providing Aorfix™ with a commercial advantage over other endovascular stent grafts currently on the European market. ”
Enquiries:
Lombard Medical Technologies PLC Tel: 01235 750 800
Simon Neathercoat, Non-executive Chairman
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics Tel: 020 7831 3113
David Yates / Susan Quigley
Nomura Code Tel: 020 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.