12 August 2005
Female Lubrication Device - Product development update
Futura Medical plc ("Futura" or "the Company"), the AIM-listed pharmaceutical and medical device group that develops innovative products for the sexual healthcare market, today announced it has completed its clinical assessment programme for the Female Lubrication Device ("FLD500").
Following a review of all the clinical data by Futura's panel of consultants and supported by preliminary feedback from an EU competent authority no further clinical work is planned prior to the submission of the dossier for FLD500 for regulatory approval in the European Union. Work is continuing to finalise the product, develop the manufacturing process and complete remaining supportive data including stability in order to submit the dossier.
James Barder, Chief Executive of Futura Medical, said: "This is further good news for FLD500 and its progress to market, following SSL's exercise of its option for global distribution rights for the product. The present clinical assessment of FLD500 is considered sufficient for regulatory requirements and we avoid the expense and time associated with conducting a further clinical study."
In early July Futura announced that SSL International plc ("SSL"), the consumer healthcare brands company and manufacturer and distributor of Durex®, the world's biggest-selling branded condom, had exercised its option for the global marketing and distribution rights for FLD500.