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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - TETUS (Tissue-engineered oral mucosa cells for treatment of urethral strictures)

Teaser

Summary

Urethral stricture is a relatively common disease and an unmet medical need with an associated prevalence of about 200-600 cases per 100,000 males in Europe. Recurrent urethral stricture is a common secondary disease and affects 30% to 90% of suffering patient population depending on the treatment performed for the first time (the chances of recurrence increase by time). The conventional methods are completely incapable of alleviating Recurrent urethral stricture .
MukoCellÂ® is the first and only tissue-engineered Advanced Therapeutic Medicinal Product (ATMP) for treatment of urethral strictures in the world. MukoCellÂ®-Therapy at its current stage decreases the number of necessary surgeries to one (no need to obtain native tissue from the mouth in case of Urethroplasty) and decreases the chance of recurrence (associated with Urethrotomy).
The overal objective of the project is to valid MukoCellÂ® in clincal environement and demonstrate its superiority and benefits compared to the Standard of Care and to make it ready for launch in the European markets by performing a market replication.

Work performed

in the first year of the project the clinical partners were aquired and signed into the cooperation agreement. The positive opinion of the ethical committee was obtained and a S1 Labnoratory was set up to fulfill the requirements of EMA for product safety and quality as the study medication. In paralell, the project was communicated to the public audience and the professionals to make them aware of the benefits of the MukoCell. To make the product available to the market reimbursement was negotiated with publich and proivate insurance companies and obtained the support of two private insurance companies to reimburse treatment with MukoCell.

Final results

It is expected that by the end of this project, MukoCell is ready to enter the European market and investment-ready for market expantion. A Technologly Readiness Level of 8 or 9 is expected to be achieved by the end of this project.