Berlin, Germany, October 12, 2015 – Avitop GmbH, a Berlin-based biotech company developing next generation nutraceuticals, announced today that the Company has obtained European Novel Food authorization from the European Commission for CorriX™, a nutraceutical containing the Company’s proprietary strain Bacteroides xylanisolvens DSM 23964 under Regulation (EC) No 258/97 of the European Parliament and of the Council.
Recently, the US Food and Drug Administration (FDA) granted (letter of no objection) B. xylanisolvens DSM 23964 and heat-treated milk products fermented with this strain “Generally Recognized As Safe” (GRAS) status for use in dairy and other food applications (GRAS Notice No. GRN 000457). Based, in part, on GRAS status Avitop then determined that B. xylanisolvens DSM 23964 is appropriate for use as a dietary ingredient in the Company’s new line of CorriX™ supplements.
“Achieving GRAS and Novel Food status is a major milestone for Avitop and allows for accelerated product development and commercialization both in the United States and Europe”, said Dr. Philippe Ulsemer, Director of Avitop GmbH. “Numerous studies have shown that microorganisms naturally inhabiting our body are crucially involved in our health and well-being. We are fully committed to use our know-how, technologies and ingenuity to develop new probiotic, nutraceutical and food concepts with unmet functionality to provide customers with a new generation of functional food that will help to manage health and well-being from the inside-out.”
Potential unique health benefits of Bacteroides xylanisolvens DSM 23964
Avitop invests significant resources in scientific research to investigate the potential health benefit of B. xylanisolvens DSM 23964, a new strain that was primarily characterized in 2012 (Applied and Environment Microbiology, 2012, 78: 528-535).
Avitop recently identified this strain to carry the “Thomsen-Friedenreich antigen” (TF) on its surface. Strains carrying this antigen were reported to be able to induce the development of specific antibodies (IgMs) directed against the TF-antigen in vivo and a higher level of such natural TF-antibodies in humans were reported to benefit the natural function of the immune system. As a consequence, Avitop believes that the regular consumption of a product containing the strain B. xylanisolvens DSM 23964 will support the development of natural TF-antibodies, thereby providing significant health benefit. Avitop is currently running human studies to investigate this assumption.
About Avitop GmbH:
Avitop is a German Biotech Company based in Berlin developing the next generation of nutraceuticals. “CorriX™”, the front running project of Avitop is a heat-treated fermented milk produced with B. xylanisolvens DSM 23964, a proprietary bacterial strain with potential positive effects to the immune system. Parallel to obtaining US and European market authorization, a new industrial-scale production process was established. In a next step, Avitop is building worldwide alliances for marketing and distribution of “CorriX™”.
Dr. Philippe Ulsemer, Director
13125 Berlin, Germany
T: +49 (0) 30 9489 2600
F: +49 (0) 30 9489 2634