Feb 27, 2020, 08:45
Carbiotix (publ) ("Carbiotix") announces today that the company will target the launch of a medical food in the US by H2 2021, thus entering a new gut health modulator category and creating a bridge between its prebiotic ingredient and therapeutic products. This decision to target a medical food will allow the company to bring to market a medically prescribed product three years ahead of schedule and target the management of multiple disease areas in a shorter period of time.
Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States, they are defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments and are subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act. In Europe, the European Food Safety Authority established definitions for "foods for special medical purposes" (FSMPs) in 2015 (1). The global market for medical foods exceeds 15 billion Euros and is growing at 7% per annum (2).
Kristofer Cook, CEO for Carbiotix, comments
"Our decision to target medical food applications using our corn fiber extract ingredient containing AXOS makes perfect sense. With one pure form of the ingredient, we will be able to target the management of multiple disease areas and reach the market already in H2 2021. Moreover, we will be able to leverage our diagnostic platform to personalise the dosing of the medical food for each person, creating a complementary co-intervention to our therapeutic products, increasing their efficacy and thus their likelihood of reaching the market."
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