Apr 20, 2022, 08:45
Carbiotix (publ) ("Carbiotix" or "Company") announces today a confirmed timeline for the completion of GRAS Self Affirmation (SA) and the date that the Company’s CarbiAXOS nutraceutical ingredient will be launched in the US. The Company’s GRAS consultant dicentra has confirmed a timeline for GRAS SA approval in October 2022, prior to the planned launch of CarbiAXOS at the Microbiome Movement Human Nutrition Summit to be held in Boston, MA, USA, between the 8-9th of November 2022. This timeline and launch date will allow Carbiotix to focus on start-up and process optimization work in the second quarter and begin delivering samples for customer testing and formulation work in the third quarter prior to the commercial launch of CarbiAXOS.
Kristofer Cook, CEO of Carbiotix, comments
"I am extremely happy to announce a confirmed timeline for the completion of GRAS SA and the launch date for our CarbiAXOS nutraceutical ingredient in the US. This timeline and launch date are a second key milestone for the Company during 2022. Achieving GRAS SA in October fits perfectly with our internal start-up and process optimisation timetable. We will submit our first dossier for internal expert review at the end of April and follow this up with an amended dossier for expert panel review between August and October. Although our earlier production runs at Balsgård allowed us to save time by characterising our product and establishing relationships with third-party labs, having our own process in place and producing product from this process was always a prerequisite for submitting the final dossier for expert panel review.
This timeline also fits perfectly with our planned launch date for CarbiAXOS at the Microbiome Movement Human Nutrition Summit to be held in Boston, MA between the 8-9 th of November. This summit will bring together a broad range of potential customers for the Company’s CarbiAXOS nutraceutical ingredient and thus will be a launching pad for sales into the US market around the Smart Prebiotic concept, which includes the Company’s LinkGut gut health testing service. I look forward to following this process during 2022 as this year will be a key transition period for Carbiotix. The Company will soon be in a position to accelerate production and commercial activities in its core business area of prebiotic modulators.”
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 as described in this press release.
For further information:
Kristofer Cook, CEO
Tel: +46 (0)708-796580
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