Release date: 2010-03-01
 

An Innovative Path - Oral Eubiotic Certified As A Medical Device
 

(PRZOOM - Press & Newswire) —  Muenster, North Rhine-Westfalia, Germany, 2010-03-01 - German pharma service companies Diapharm and Med Pharma Service have developed a Lactobacillus johnsonii product for the regeneration of intestinal functions for non-specific or antbiotics-induced diarrhoea that works in a purely physical manner

   
 

The pharmaceutical service provider Diapharm (diapharm.com) and the contract manufacturer Med Pharma Service (medpharmaservice.de) have succeeded in developing an innovative medical device that works naturally for the regeneration of intestinal functions for non-specific diarrhoea or for diarrhoea after antibiotics therapy. Together, these two companies have brought the new medical device with the eubiotic Lactobacillus johnsonii to market. The hard capsules will be sold as a class III medical device under the trade names of selected sales partners. “The certification by the notified body is already completed, which means that the product is now marketable,” says Dr Annemarie Jasper, who manages the development project for Diapharm.

The medical device contains the eubiotic strain Lactobacillus johnsonii EU1. It will be used for support in cases of disturbed normal, bacterial population in the human small intestine and for the restoration of the small intestinal mucosa function, e.g. in cases of continual diarrhoea of unknown origin or for cases of diarrhoea after antibiotic therapy. “With this development, an effective medical device against digestion problems can be offered – a clear medical indication, combined with an optimal position on the shelves,” points out Dr. Annemarie Jasper.

In this combination, she sees the main advantage of this device over a typical medicinal product or food supplement: “Due to the non-transparent claims of the EFSA, which have kept, for example, those requiring therapy from participating in clinical studies, significant health claims for food supplements appear to have receded into the distance. And an attempt to get a marketing authorisation for a medicinal product with a pharmacological mode of action would have meant an extremely long delay before authorisation,” explains Jasper.

Diapharm also provides a solution to the obstacle for class III medical devices – the manufacturer certification required by the medical device standard ISO 13485: licensees can transfer the legal function of the manufacturer to Diapharm and thereby bring the product immediately to market without undertaking all the efforts required for certification. At this time, Diapharm is negotiating with partners in several European countries, who would like to bring class III medical devices to market under their own trade names.

More information is available from Dr Annemarie Jasper, Diapharm GmbH; T: +49 (0)251 60935-544, E: annemarie.jasper[.]diapharm.de.

   
 

Agency / Source:

 
 
# # #
 
  Related Link:
 Contact name: Christian Rieke - Co-Operate.net
  Related Link:
 Contact: /
PRZOOM disclaims any content contained in these release. Our complete disclaimer appears on our disclaimer page. Issuers of releases are solely responsible for the accuracy of their content. All trademarks are the property of their respective owners.
© PRZOOM.com - NewswireToday.com - Press Release & Newswire Distribution Network.


Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
 
NewswireToday Celebrates 10 Years in Business
Find business coaching, life coaching, executive coaching and corporate coaching, best selling coaching books, ...



PREMIUM Members


Visit  La Bella Bakery Artisan Bakery Arizona

Visit  Deb Sheppard - Medium Psychic Author Speaker

Visit  JobsWare.com







 
  ©2017 PRZOOM — Limelon Advertising, Co.
Home | About PRZOOM | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneur newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today