Feb 27, 2020, 08:45
Carbiotix (publ) ("Carbiotix") announces today that the company expects to receive US regulatory approval for its corn fiber extract containing AXOS in 2020. Obtaining GRAS self- affirmation by the end of the year will be two years ahead of schedule and allow the company to begin sales of its prebiotic ingredient in the US already in 2021.
Carbiotix has signed an agreement with dicentra of Toronto, Canada, ("dicentra"), a leading consultancy and clinical research organization in the area of new ingredient compliance and regulatory approval. The GRAS self-affirmation process will begin immediately and is slated to be completed before the end of 2020, two years ahead of what has been previously communicated. Receiving GRAS self-affirmation is a prerequisite to begin commercial sales in the US market.
Kristofer Cook, CEO for Carbiotix, comments
"Obtaining GRAS self-affirmation by the end of 2020 is what we are targeting and will allow Carbiotix to start sales of its prebiotic ingredient already in 2021. As customer formulation activities generally take time, Carbiotix will already start providing corn fiber extract ingredient samples to interested parties during 2020. We are confident that the market will react very well to our new prebiotic ingredient that has a prebiotic effect up to 10 times that of at market alternatives while being competitively priced."
Dr. Karol Wojewnik, M.D., Vice President of Medical Affairs for dicentra, comments
"We are happy to assist Carbiotix with the GRAS self-affirmation process for its corn fiber extract and have planned for this process to be completed before the end of 2020. We look forward to working with Carbiotix during 2020 and going forward in other compliance and clinically related projects."
This information is information that Carbiotix AB is obliged to make public according to the EU Market Abuse Regulation (MAR). The information was made publicly available by the company's contact person set out below on 27 February 2020.
This communication contains forward-looking statements, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their nature, as is research and development work in the biotechnology segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.
For further information:
Kristofer Cook, CEO
Carbiotix AB (CRBX) (www.carbiotix.com) is an award-winning biotechnology company pioneering microbiome healthcare through a range of cost-effective gut health testing services and a portfolio of microbiome modulators covering prebiotic ingredients, medical foods and therapeutics.Go Back