TETUS · Tissue-engineered oral mucosa cells for treatment of urethral strictures

TETUS will address commercialisation complexities related to cell products and prepares MukoCell® for accelerated commercialisation by facilitating an EU-wide Market Authorisation. As MukoCell® addresses an unmet medical need, it is eligible to use an EU-accelerated market access pathway. Once Marketing Authorisation is in place, country-specific reimbursement strategies and market access (financial) plans can be developed that are requirments of for MukoCell® ready to go to market.Therefore, after TETUS, a radical increase in the sale of MukoCell® in the EU is expected in 2021 generating a revenue of €4.630 million followed by €13.890 million and €23.150 million from the market in the EU in 2022 and 2023, respectively. The clinical data produced through TETUS can be used to obtain Market Authorisation in other territories such as US and Asia.