Shares in OptiBiotix Health plc (LON:OPTI) surged in early trading Tuesday after its SlimBiome weight loss product received a CE mark as well as medical device status.
The CE mark allows the product to be freely marketed within the European Economic Area (EEA), as well as providing eligibility for shortened medical product registration procedures in other markets such as China and the United Arab Emirates.
READ: OptiBiotix Health inks distribution deal covering Greece and Cyprus
CE-marked products may also make medicinal or medical claims supported by clinical studies, a factor that would extend the application of SlimBiome from food products to medical products.
The company added that the product will be manufactured in Europe and sold as SlimBiome Medical to pharmacies and major retailers.
Stephen O'Hara, chief executive of OptiBiotix, said the new mark and status for SlimBiome would open up access to consumer healthcare and pharmaceutical markets, adding that in combination with “a number of clinical studies showing SlimBiome's effectiveness, a large IP portfolio [and] two industry awards”, there were now “clear differentiators” from other weight loss products which he hoped would “contribute substantive revenues to OptiBiotix's growth”.
The development follows other European news last week when the firm clinched a three-year distribution contract in Greece and Cyprus for its LPLDL cholesterol and blood pressure product.
Shares were up 17.8% at 86p.
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