The US Food & Drugs Administration has authorised changes to accelerate clinical trials of Lombard Medical's Aorfix endovascular stent graft.

AIM-quoted Lombard has developed the Aorfix stent graft (a tube that reinforces a weak spot in an artery) for use in treating abdominal aortic aneurysms. The company says the FDA's decision to allow one, rather than two, endovascular bases for the trial will cut the number of cases to be performed from 385 to 210 and thus shorten the the time needed to recruit patients for the trial.

Lombard adds that the FDA's ruling allows it to use its improved version of Aorfix, launched in Europe in April, in the US trials. Alistair Taylor, Lombard's executive chairman, declares these developments will 'result in Aorfix entering the important US market earlier than previously anticipated' and company spokesmen suggest 2009 could bring its commercial launch.

This prospect is of key importance for Lombard, which as a development company with virtually no income lost £11.9 million in 2005 and £5.3 million in the first half of this year. Floated a year ago at 159p, Lombard's shares had slumped to 50p before today's FDA ruling provoked a rally to 59p, where the company is valued at £29.5 million.

They remain a gamble, which could pay off if the regulatory hurdles are surmounted and Aorfix establishes a significant market presence.

Lombard Medical Technologies	AIM	£1.18m	0.88p	0.00p
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