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BTG closer to FDA approval for varicose veins treatment

Stephen Foley
Friday 22 April 2005 00:00 BST
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BTG, the technology group privatised in 1995, is close to restarting patient trials of its revolutionary varicose veins treatment, after satisfying some of the US regulator's safety concerns.

BTG, the technology group privatised in 1995, is close to restarting patient trials of its revolutionary varicose veins treatment, after satisfying some of the US regulator's safety concerns.

The product, a foam injected into veins, was once the most exciting in BTG's broad portfolio, but its launch has been delayed by several years amid fears that gas from the foam was escaping into the bloodstream.

The Food & Drug Administration halted US trials last year and demanded additional animal testing before they could resume. It used £27m in a rights issue last year to pay for the remedial work.

BTG shares shot up more than 30 per cent yesterday when the company said the FDA had no further questions after receiving the results of animal studies.

That opens the way for trials to be restarted any time from June - if the FDA okays the rules for conducting the trials - and makes a launch possible by 2010.

BTG is looking for a licensing partner to fund the human trials, having assured disillusioned investors that it would spend no more of its own cash on the product.

Shares in the company peaked at 1,565p in 2000 amid hopes for the sales potential of Varisolve as a quick and painless alternative to surgery. It had originally been hoped that it would be on the market this year. Yesterday, the stock was up 34.75p to 144.5p.

Sir Brian Fender, the chairman, said: "We continue to believe that Varisolve has significant commercial potential in the longer term.

"Subject to FDA approval of the revised protocol, resumption of US clinical development would be a significant step forward."

BTG was formed out of the old National Enterprise Board. It invests in new technologies, adding its commercial nous to the projects, and then licensing them out again to corporate partners in return for one-off fees and royalties.

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