Graduate Stimvia exits NYU Stern's exclusive accelerator, aims U.S. market with bladder treatment equipment
Stimvia’s URIS System: A Promising Solution for Overactive Bladder
In the ever-evolving world of medical technology, one company from the Czech Republic has made significant strides in addressing a common health issue. Stimvia, a MedTech company, has graduated from the prestigious Endless Frontier Labs program at NYU Stern School of Business and received FDA 510(k) clearance for its innovative device, the URIS system.
The URIS system is a non-invasive closed-loop neuromodulation system, designed to treat overactive bladder (OAB) without the need for surgery or drugs. This device, positioned as a minimally invasive neuromodulation therapy, targets patients with OAB who are refractory to first-line treatments.
Stimvia's URIS system is entering a competitive U.S. OAB neuromodulation market, currently estimated at nearly 5 billion USD annually. Established players such as Medtronic’s InterStim and Axonics Therapies’ sacral neuromodulation systems have been leading the market. However, Stimvia is setting itself apart by emphasizing the unique features of its system, such as urinary rhythmic stimulation and portability. These attributes are expected to improve patient compliance and comfort.
As of the latest available information up to mid-2025, market adoption is in the early to mid stages, with ongoing initial commercial rollouts and pilot programs in specialized urology and urogynecology centers. The U.S. OAB neuromodulation market is competitive but growing, driven by increasing prevalence of OAB, unmet needs in patients intolerant or non-responsive to pharmacological treatments, and advancements in device technology.
The wearable medical device market is also undergoing transformative changes, with global initiatives targeting these trends. Stimvia's URIS system, with its non-invasive, patient-friendly approach, is well-positioned to make a significant impact in this growing market.
While the company is currently waiting for FDA clearance to expand into the U.S. market, the successful completion of the Endless Frontier Labs program and the receipt of MDR certification from TÜV SÜD for both its eTNM and minimally invasive PTNS methods in 2024, make it one of the frontrunners in the field.
It's worth noting that the total direct and indirect costs of OAB treatment in the U.S. and Europe exceed 117 billion USD per year, and many patients still lack effective care and face high ongoing costs to manage their OAB symptoms. The potential of Stimvia's URIS system to provide a cost-effective, patient-friendly solution is a promising development in the field of OAB treatment.
In conclusion, Stimvia’s URIS system is FDA-cleared and emerging in the U.S. neuromodulation market for overactive bladder, focusing on providing a patient-friendly alternative amid established competitors. Widespread adoption and market share growth are in progress but not yet at the scale of major incumbents.
For the latest company announcements or clinical trial data related to the URIS system, feel free to reach out.
- The wearable healthcare technology market is experiencing significant transformation, with global initiatives aimed at capitalizing on emerging trends.
- Stimvia, a MedTech company that has received FDA clearance for its URIS system, is one of the frontrunners in the field due to its successful completion of the Endless Frontier Labs program and MDR certification.
- The total costs of overactive bladder (OAB) treatment in the U.S. and Europe annually exceed 117 billion USD, and many patients still lack effective care. Thus, Stimvia's URIS system, offering a cost-effective and patient-friendly solution, presents a promising development in the field of OAB treatment.
- The digital health sector continues to grow with advancements in device technology, driven by the increasing prevalence of medical conditions like OAB, unmet needs in patients intolerant or non-responsive to pharmacological treatments, and ongoing technological innovations.
- Investors seeking opportunities in the healthcare and wellness sector may find businesses involved in medical plastics, neurological disorders, and fitness and exercise technologies, in addition to those focused on digital health solutions, promising avenues for investment.
