RNS & Investor News
SlimBiome® granted medical device status and CE mark
27 November 2018
OptiBiotix 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 :-
i. 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)
ii. Follow shortened medical product registration procedures in other international markets (e.g. China, United Arab Emirates)
iii. Make medicinal or medical claims supported by clinical studies
iv. Extends the application of SlimBiome® from food products into high value medical products
CE 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® :-
- Feel fuller and are less hungry
- Experience less food cravings
- Change their food choice to eat less sweet and fatty foods
In 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.
SlimBiome® 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).
Stephen O'Hara, CEO of OptiBiotix, commented: "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. 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. SlimBiome® Medical can 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 IP 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."
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
For further information, please contact:
|OptiBiotix Health Plc
Stephen O'Hara, Chief Executive
Contact via Walbrook below
|Cairn Financial Advisers LLP
Liam Murray / Jo Turner
|Tel: 020 7213 0880|
Geoff Nash / Scott Mathieson / Kate Bannatyne (Corporate Finance)
Camille Gochez (Corporate Broking)
|Tel: 020 7220 0500|
|Walbrook PR Ltd
|Tel: 020 7933 8780 or email@example.com
Mob: 07876 741 001
About OptiBiotix - www.optibiotix.com
OptiBiotix Health plc (AIM: OPTI), which was formed in March 2012, brings science to the development of compounds which modify the human microbiome - the collective genome of the microbes in the body - in order to prevent and manage human disease and promote wellness.
OptiBiotix has an extensive R&D program working with leading academics in the development of microbial strains, compounds, and formulations which are used as active ingredients and supplements. More than twenty international food and healthcare supplement companies have signed agreements with OptiBiotix to incorporate their human microbiome modulators into a wide range of food products and drinks.
OptiBiotix is also developing its own range of consumer supplements and health products. The Company's current areas of focus include obesity, cardiovascular health, and diabetes.
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