Business
SlimBiome® granted medical device status & CE mark
SlimBiome® granted medical device status & CE mark.
About this update from Optibiotix Health Plc
[{"type":"text","content":"\n \nRNS Number : 5340I OptiBiotix Health PLC 27 November 2018 \n\nOptiBiotix Health plc\n(\"OptiBiotix\" or the \"Company\")\n \nSlimBiome® granted medical device status and CE mark\n \nOptiBiotix Health plc (AIM: OPTI), a life sciences business developing compounds to tackle obesity, high cholesterol and skin care, announces that its award winning SlimBiome® has been granted medical device status and a CE mark. This allows SlimBiome® to be :-\n \ni. Freely marketed as a medical device to all countries in the European Economic Area (EEA) and markets with mutual recognition agreements (e.g. Switzerland, Australia, New Zealand)\nii. Follow shortened medical product registration procedures in other international markets (e.g. China, United Arab Emirates)\niii. Make medicinal or medical claims supported by clinical studies\niv. Extends the application of SlimBiome® from food products into high value medical products\n \nCE marked products will be manufactured in Europe and sold in boxes of 30 single dose sachets as SlimBiome® Medical to pharmacies and major retailers as a clinically proven solution to promote weight loss. Independent clinical studies at a number of universities have shown that when compared to a control group, consumers who took SlimBiome® :- \n \n· Feel fuller and are less hungry\n· Experience less food cravings\n· Change their food choice to eat less sweet and fatty foods\n \nIn addition to clinical studies, independent consumer surveys have shown that 100% of customers who used SlimBiome® in OptiBiotix's GoFigure® products lost weight, on average 2-3lbs per week, but most importantly they experienced a relief from hunger pangs, leading to easier and more successful dieting.\n \nSlimBiome® has attained two industry awards: Weight Management Ingredient of the Year (Vitafoods 2018) and the award for 'Best Functional Ingredient for Health and Well Being' (Food Matters 2017).\n \nStephen O'Hara, CEO of OptiBiotix, commented: \"We are excited that after two years of working with manufacturers and European regulatory bodies, SlimBiome®...