Application for central approval submitted to EMA

TETEC AG has submitted an application for centralized approval of a gel-based matrix-associated cartilage cell product as an Advanced Therapy Medicinal Product (ATMP) to the EMA (European Medicines Agency).

By submitting an application for centralized approval in the European Union (EU), TETEC AG has taken a big step towards marketing its cartilage therapy products across Europe. The company management would like to thank all employees for their tireless efforts and excellent cooperation.

TETEC AG has been preparing for several years to make cartilage therapy products available to users and patients in the EU as well. In order for an ATMP to be used in the EU, studies must first be carried out, which are then submitted to the European Medicines Agency. That is why we would also like to thank all our users. This is because without the use of these products and proof of effectiveness and safety in clinical studies and in everyday orthopedic practice, such an approval process would not be possible.

The European Medicine Agency reviews the submitted documents and will then recommend that the European Commission approve the gel-based matrix-associated TETEC product for cartilage therapy in the EU.