Stimvia plans to enter neuromodulation market in the USA after MDR certification

The Czech company says this is the first non-invasive closed-loop neuromodulation system to treat overactive bladder (OAB) without surgery or drugs.

Stimvia is set to enter the multi-billion dollar neuromodulation market in the United States with its innovative URIS device. The Czech company says this is the first non-invasive closed-loop neuromodulation system to treat overactive bladder (OAB) without surgery or drugs.

Stimvia has come to the market with the device after several years of research and three clinical trials.

The URIS device has recently secured the Medical Device Regulation (MDR) certification from TÜV SÜD, covering the non-invasive neuromodulation technique (eTNM) as well as the mini-invasive percutaneous tibial nerve stimulation (PTNS) method. The certification allows Stimvia to enter the European market and opens doors to global reimbursement opportunities. 

The company says this achievement also unlocks the its path to the overactive bladder treatment market, where it says the current cost of neuromodulation treatment is nearly 1 billion USD per year only in the USA.

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