FDA acceptance of the first of six modules of PMA filing for Aorfix™
London, UK, 2 September 2009 – Lombard Medical Technologies PLC (AIM: LMT), the specialist medical device company, announces that the U.S. Food and Drug Administration (“FDA”) has accepted and closed the first of six modules of the Company's Pre-market Approval (“PMA”) filing plan for Aorfix™. The first module is one of four modules covering FDA required preclinical testing for the device. Preclinical testing covers device material biocompatibility and toxicity, sterilization, packaging, shelf-life and device functional testing.
The Company is planning to submit the next three PMA modules with preclinical testing before the end of H1 2010. The Company’s manufacturing approval module is set for submission early in the second half of 2010, followed by the clinical data module in Q4 2010.
The modular PMA process is designed to assist medical device companies and the FDA to review completed testing while the clinical data is ongoing. It allows for content of the PMA application to be broken into well-delineated components for concurrent assessments by FDA reviewers. The review timeframe is 90 days for each module which is then closed and "accepted" upon satisfactory review of the data. Each accepted module becomes part of the completed PMA application.
Brian Howlett, CEO of Lombard Medical, commented:
"This PMA filing is another important step towards U.S. market approval for our lead product, the Aorfix™, which we believe offers significant advantages compared with currently marketed stent grafts for the treatment of abdominal aortic aneurysms (“AAAs”). The Company is also developing the next phase of Aorfix™ pre-marketing activities, with the goal of establishing the scientific and clinical reputation of the device and laying down solid foundations for a successful launch post-PMA.”
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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
Jonathan Birt / 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 4.5 million people are living with AAA in the developed world and each year 600,000 new cases are diagnosed. The market for endovascular stent grafts for the treatment of AAA is currently worth over $800 million and is expected to grow to around $1.6 billion by 2015. 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 is headquartered in Oxfordshire, with operations in Yorkshire, Ayrshire and Boston, USA.
Further background on the Company can be found at www.lombardmedical.com