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News

BTG plc: Varisolve given FDA approval to recommence US clinical trials

BTG : 26 September, 2006  (Technical Article)
BTG plc, the medical innovations company, today announces that its subsidiary Provensis has received approval from the US Food and Drug Administration to resume clinical development of Varisolve, which is being developed as a novel microfoam treatment for varicose veins.
BTG plc, the medical innovations company, today announces that its subsidiary Provensis has received approval from the US Food and Drug Administration to resume clinical development of Varisolve, which is being developed as a novel microfoam treatment for varicose veins.

Louise Makin, Chief Executive Officer of BTG, commented: We are very pleased that the US clinical development of Varisolve can resume. Now that the pathway for further regulatory development in the US is clear, we look forward to progressing discussions to secure a global development and commercialisation partner for Varisolve.

Provensis submitted data from a one-year programme of preclinical studies aimed at enabling resumption of the US development of Varisolve, together with the protocol for a proposed Phase II clinical study. The FDA requested amendments to the protocol, which were submitted as previously announced. Following review of the amended submission, the FDA has lifted the hold on conducting clinical trials with Varisolve in the US and approved the Phase II study protocol.
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