NYU Stern accelerator graduate Stimvia sets sights on U.S. market with bladder therapy device innovation
In the realm of medical technology, Czech Republic-based Stimvia is making waves with its innovative URIS system. This non-invasive closed-loop neuromodulation device, designed for overactive bladder (OAB) treatment, has already gained significant traction in Europe.
Stimvia, having undergone rigorous testing and clinical studies, is the first company in Europe to receive MDR approval for both its eTNM and PTNS techniques. This milestone positions Stimvia as only the third company worldwide to achieve such an accolade.
The URIS device utilises Stimvia's proprietary eTNM method, delivering targeted neurostimulation to alleviate OAB symptoms. Clinical studies have shown that URIS achieves significant symptom relief in over 90% of patients, with a great safety profile and minimal adverse events.
The market for wearable medical devices is experiencing growth, influenced by global initiatives, and Stimvia's URIS device is garnering attention. During Urology Awareness Month, the device has been particularly noteworthy.
The high costs associated with OAB treatment in the U.S. and Europe, estimated to exceed 117 billion USD annually, underscore the need for effective and affordable care options. Despite these costs, many patients still lack access to adequate care and face high ongoing costs to manage their symptoms.
Stimvia's MDR certification paves the way for reimbursement in global markets, supporting Stimvia's plan to access the U.S. neuromodulation market, estimated at nearly 5 billion USD annually for OAB alone. This certification is also a significant step towards FDA clearance, which Stimvia is currently pursuing.
As of mid-2025, Stimvia’s URIS system has made significant progress but has not yet publicly announced finalized FDA clearance for U.S. market entry. The company is likely in the late stages of regulatory review, and for the most up-to-date details, it’s advisable to consult Stimvia’s official communications or FDA databases.
Stimvia's journey towards FDA clearance and entry into the U.S. market can be broken down into six stages: development, preclinical and clinical studies, FDA submission, FDA review, potential clearance, and market entry.
With its promising clinical results and strategic positioning, Stimvia's URIS system offers a beacon of hope for those suffering from OAB, potentially revolutionising the treatment landscape and providing a more affordable and accessible solution.
- In the field of medical-conditions like overactive bladder (OAB), Stimvia's revolutionary URIS system, approved by MDR in Europe and pursuing FDA clearance in the United States, promises to bring digital health innovation to medical plastics, potentially revolutionizing health-and-wellness solutions for OAB patients.
- As Stimvia's URIS system, with its significant symptom relief and safety profile demonstrated in clinical studies, advances through its journey towards FDA clearance, the future of science-backed, affordable, and accessible treatments for a wide range of medical-conditions, such as OAB, in the health-and-wellness sector appears increasingly promising.
