DGAP-News: Avitop Obtains US and EU Authorization for Nutraceutical CorriXTM and Announces Product Launch


DGAP-News: Avitop GmbH / Key word(s): Product Launch/Market launch
Avitop Obtains US and EU Authorization for Nutraceutical CorriXTM and
Announces Product Launch

12.10.2015 / 08:30

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Press Release
Meant only for specialists.

Avitop Obtains US and EU Authorization for Nutraceutical CorriXTM and
Announces Product Launch

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 CorriXTM, 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 CorriXTM 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. "CorriXTM", 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 "CorriXTM".

Contact:

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Avitop GmbH
Dr. Philippe Ulsemer, Director


Robert-Roessle-Str. 10
13125 Berlin, Germany

T: +49 (0) 30 9489 2600
F: +49 (0) 30 9489 2634
E: info@avitop.de

Website: www.avitop.de


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