OptiBiotix's 'SlimBiome' granted medical device status and CE mark

Life sciences business OptiBiotix Health announced on Tuesday that its ‘SlimBiome’ product has been granted medical device status and a CE mark.

The AIM-traded firm said that now allowed SlimBiome to be freely marketed as a medical device to all countries in the European Economic Area, as well as markets with mutual recognition agreements including Switzerland, Australia and New Zealand.

It would also allow it to follow shortened medical product registration procedures in other international markets, including China and the United Arab Emirates.

OptiBiotix said the achievement would also allow it to make medicinal or medical claims supported by clinical studies, and extend the application of SlimBiome from food products into high value medical products.

The company said CE-marked products would be manufactured in Europe and sold in boxes of 30 single dose sachets as ‘SlimBiome Medical’ to pharmacies and major retailers, as a solution to promote weight loss.

Independent clinical studies at a number of universities had shown that, when compared to a control group, consumers who took SlimBiome felt fuller and were less hungry, experienced less food cravings, and changed their food choice to eat less sweet and fatty foods.

In addition to clinical studies, OptiBiotix said independent consumer surveys showed that 100% of customers who used SlimBiome in its ‘GoFigure’ products lost weight - on average between two and three pounds per week per week - and experienced relief from hunger pangs, leading to easier and more successful dieting.

“We are excited that after two years of working with manufacturers and European regulatory bodies, SlimBiome has been granted medical device status and a CE mark,” said chief executive officer Stephen O'Hara.

“This is a significant achievement as it extends the application of SlimBiome from food products into high value medical products and opens up access to consumer healthcare and pharmaceutical markets.”

O’Hara said SlimBiome Medical could be used by itself, or as part of a calorie restriction diet to reduce hunger and food cravings to improve compliance, and help users achieve sustainable weight loss.

“We are delighted that we now have a number of clinical studies showing SlimBiome's effectiveness, a large intellectual property portfolio, two industry awards, and now a medical device registration and CE mark.

“These are clear differentiators from other weight loss products which we hope will contribute substantive revenues to OptiBiotix's growth in the months and years ahead.”