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Credentis AG Obtains ISO 9001 & ISO 13485 Certificate


6/27/2011 11:22:50 AM

June 27, 2011 -- credentis ag is proud to announce the successful completion of the ISO 9001/13485 certification of the company. The certificates were issued by the Swiss Association for Quality and Management Systems (SQS).

The compliance with ISO 13485 is an important milestone in the regulatory process. As a next step, credentis aims at obtaining market approval for its first product before the end of the year.

About P11-4

The first product of credentis that will be submitted for market approval (CE-label) will be the self- assembling peptide P11-4.

P11-4 provides dentists with a novel technology to regenerate rather than repair carious and other tooth lesions. Applied to a small lesion, P11-4 forms a scaffold of small fibres within the lesion around which new enamel or dentin can form and grow. Ideally, within eight days the lesion will regenerate without the use of burr or filler.

The results from the ongoing study at Leeds are very encouraging: “We want to develop not only a product, but a new approach to caries. This will revolutionize dental care”, explains Dominik Lysek. The ultimate goal is to prevent caries by frequent recalls to dentists and dental hygienists. Within clinical studies credentis continues to optimize and test the application and the range of indications of P11-4.

About credentis ag

credentis has its headquarters in the Technopark Aargau Switzerland, Windisch; it has already won the support of Genilem and presented itself successfully at various events including the Argovian and Swiss Equity Fairs and was one of Swiss Venture Leaders 2011.

CEO Dominik Lysek and CTO Michael Hug have expert knowledge in medicinal technology and a strong network in the dental industry. Dr. Werner Berner (member of the board) and Dr. Erich Platzer (chairman of the board) perfectly complement the know-how of the management and contribute to the success of the young company with their expert industry knowledge.

Contact: Dr. Dominik Lysek, CEO, tel +41 56 560 2040; dl@credentis.com


Read at BioSpace.com


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