Carbiotix AB (publ) announced that the Company has received GRAS Self Affirmation (SA) regulatory approval for its first CarbiAXOS prebiotic ingredient based on corn bran. This is a major milestone for the Company and now opens the door to ramp-up commercial sales activities of CarbiAXOS in the US market through direct sales and the building up of distributors, following up on current potential customer and research inquiries, as well as other partner leads. This approval also facilitates the acceleration of GRAS SA approvals for other CarbiAXOS ingredients and paves the way for Novel Foods approval in Europe.

This milestone also paves the way for accelerating the GRAS SA approval for other CarbiAXOS ingredients in the US leveraging the same dossier. Furthermore, it will also accelerate Novel Foods approval in Europe, eventual No Objection status in the US, and compliance with regulations in other key markets around the world. The company will now also ramp up commercial activities through direct sales and the building up of distributors in select markets, following up on current potential customer and research inquiries, and well as other partner leads.

Marketing activities will also ramp up and the company now aggressively position CarbiAXOS as an ingredient that all competitive prebiotic consumer product companies should evaluate as being part of their prebiotic mix. The global market for prebiotics is estimated to be worth over 6 Billion Euros, with Europe being the largest market and Asia the fastest growing market. The global market for nutraceutical prebiotic ingredients, which Carbiotix is targeting, is estimated to be 1 Billion Euros, with the US market estimated to be worth in excess of EUR 300M.