Stimvia, a pioneering medical technology company, has recently secured an MDR (Medical Device Regulation) certification from the German notified body, TÜV SÜD for its URIS device. The MDR allows Stimvia to enter the European market and opens doors to global reimbursement opportunities.
 
URIS is the first non-invasive closed-loop neuromodulation system to treat overactive bladder (OAB) without surgery or drugs. This certification also covers Stimvia’s non-invasive neuromodulation technique (eTNM) as well as the mini-invasive percutaneous tibial nerve stimulation (PTNS) method. 
 
The company is now poised to make a significant impact on the multi-billion-dollar neuromodulation market in the United States with its URIS device. 
 
This certification allows the company the enter the overactive bladder treatment market, where the current cost of neuromodulation treatment is nearly $1 billion per year only in the USA. Overall, the direct and indirect costs of OAB treatment in the EU and the USA are estimated at more than $117 billion per year. 
 
Stimvia aims to dominate a significant portion of this market and is a step away from bringing its breakthrough technology to the US, enhancing the quality of life for millions of OAB patients. 
 
“We are proud to be the first company globally to introduce this innovative closed-loop neuromodulation system,” said Lukas Doskocil, CEO of Stimvia. 
 
The URIS device uses a non-invasive neuromodulation technique (eTNM) combined with closed-loop technology. Specially developed electrodes stimulate the peroneal nerve, correcting brain imbalances and significantly reducing the severe and unpredictable urinary urgencies experienced by OAB patients. 
 
Also, the device is equipped with closed-loop feedback, based on which it is possible to evaluate the effectiveness of stimulation and adjust the stimulation parameters to the specific patient. 
 
Stimvia has also received MDR certification for the mini-invasive percutaneous tibial nerve stimulation (PTNS) method, offering an alternative treatment for incontinence. The company has become only the third company in the world, and the first in Europe, to possess the certification for this technology. 
 
This achievement places the company alongside industry giants like Medtronic and Laborie and paves the way for Stimvia to enter the American market, bringing the company closer to obtaining FDA 510(k) clearance.
 
“Thanks to obtaining MDR certificates for the PTNS method, we enter the system of reimbursement by health insurance companies in Europe and in the USA as well. We already have the first devices in the offices of Czech urologists. At the same time, we are already in the process of delivering our devices to countries in Europe, such as Italy, France, Spain, Denmark, the Netherlands, and the UK,” said Doskocil. “While the PTNS method is recognized globally in the healthcare system, our non-invasive technology is also gaining attention due to the excellent results and high quality of our clinical trials.”