Stimvia's URIS System: Revolutionizing Overactive Bladder Treatment in the U.S.
Introducing Stimvia's URIS System
NYU Stern alumna Stimvia sets sights on the American market for her bladder therapy device, having completed the esteemed school's accelerator program.
Stimvia, a trailblazing MedTech company from the Czech Republic, has developed a groundbreaking solution for managing Overactive Bladder (OAB) — the URIS system. This non-invasive closed-loop neuromodulation device promises to revolutionize OAB treatment, eliminating the need for surgery or drugs.
MDR Certification: A Milestone Achievement
In 2024, Stimvia received MDR (Medical Device Regulation) certification from TÜV SÜD for both its eTNM (peroneal transcutaneous electrical nerve stimulation) and minimally invasive PTNS methods. This certification positions Stimvia as only the third company worldwide, and the first in Europe, with MDR approval for both techniques. This significant milestone paves the way for reimbursement in global markets, including the U.S., where Stimvia is currently awaiting FDA clearance.
A Promising Solution for OAB Patients
Clinical studies show that URIS achieves significant symptom relief in over 90% of patients, boasting a great safety profile without serious adverse events. With the total direct and indirect costs of OAB treatment in the U.S. and Europe exceeding 117 billion USD per year, and many patients still lacking effective care and facing high ongoing costs, the URIS system offers a promising solution.
Stimvia's Journey with Endless Frontier Labs
Stimvia was chosen from over 70,000 science and tech startups across more than 120 countries and regions, and graduated from the Endless Frontier Labs (EFL) program at NYU Stern School of Business. During the program, Stimvia enhanced the URIS system's real-time data integration capabilities, improved AI-driven analytics for predictive insights and automated reporting, and expanded system interoperability with major industrial IoT platforms and healthcare databases.
Future Plans and Expansion
Stimvia plans to launch a full commercial version of URIS targeting hospitals, state regulatory bodies, and manufacturing firms by next year. The company aims to expand sales and business development teams in key U.S. regions to accelerate adoption. Additionally, Stimvia will integrate enhanced cybersecurity features to meet stringent U.S. privacy and data protection standards and develop customizable modules tailored for different verticals, including healthcare compliance and environmental monitoring.
Strategic Collaborations and Regulatory Focus
Stimvia seeks additional partnerships with U.S. government agencies focused on smart city initiatives and infrastructure resilience. The company also plans to collaborate with universities and research centers to advance AI and IoT capabilities within URIS. Aligning product features with evolving U.S. regulatory frameworks is crucial for Stimvia to ensure compliance and facilitate easier adoption. Positioning Stimvia as a trusted partner for regulatory reporting and audit readiness is a key focus area.
The URIS system's innovative approach to OAB treatment and its promising results have sparked interest in potential changes in the wearable medical device market trends. As Stimvia continues to make strides in the U.S. market, the future of OAB treatment looks promising.
- The URIS system, a groundbreaking solution for managing Overactive Bladder (OAB) developed by Stimvia, utilizes medical plastics in its non-invasive closed-loop neuromodulation device, contributing to the advancement of digital health technology.
- With clinical studies showing significant symptom relief in over 90% of patients and a great safety profile, the URIS system presents a promising solution not only for OAB patients but also for the health-and-wellness industry, where the total costs of OAB treatment exceed 117 billion USD annually.
- Stimvia's journey in the U.S. market includes strategic collaborations with organizations focused on smart city initiatives, infrastructure resilience, and research centers to advance AI and IoT capabilities within URIS, underscoring the company's commitment to technology innovation.
- In their efforts to expand in the U.S., Stimvia is also focusing on aligning their product features with evolving regulatory frameworks and enhancing cybersecurity features to meet stringent privacy and data protection standards, which is crucial for securing finance and business opportunities in this sector.
