Stimvia

In modern urology, neuromodulation is an effective but underutilized treatment for Overactive Bladder (OAB). Today, patients suffering from OAB often start with pharmacotherapy—yet the reality is that nearly half discontinue within a year due to side effects or lack of efficacy. For those who fail medication, neuromodulation should be the next step. However, current options are too invasive, too complex, or too inefficient, leaving many patients untreated.  

At Stimvia, we are transforming this paradigm. Our URIS therapy—a needle-free, non-invasive neuromodulation solution—is designed to integrate seamlessly into routine clinical practice, making neuromodulation a mainstream, first-line intervention rather than a last resort.  

OAB affects more than 400 million people worldwide, representing a $9 billion market. Pharmacotherapy dominates treatment, but only a fraction of patients tolerate or benefit from it long-term. The alternative—Percutaneous Tibial Nerve Stimulation (PTNS)—is well-established but suffers from poor adoption due to its invasive nature and impractical administration. Patients must visit a clinic weekly for needle-based nerve stimulation, leading to low adherence and limited scalability.  

Despite this, neuromodulation remains one of the most effective and durable treatments for OAB, with a clear path to reimbursement and increasing recognition by urologists. The challenge is accessibility—and that is where Stimvia is changing the equation.  

Stimvia has developed URIS, a non-invasive neuromodulation therapy that eliminates the limitations of traditional PTNS while maintaining superior efficacy. 

Unlike existing options, URIS is:  

• Needle-Free – Enhancing patient comfort and adoption.  
• Clinically Proven – Backed by three clinical trials and seven published studies, including a study in the Journal of Urology.
• Scalable – Designed for broad clinical adoption and at-home use, enabling market expansion beyond specialist centers.  

Commercially Viable – Already generating revenue in Europe, with strong physician demand.  

1. URIS Office – A physician-administered treatment that replaces PTNS in a standard clinic setting, eliminating the need for percutaneous needles while improving operational efficiency.  

2. URIS Home – A self-administered at-home therapy, allowing patients to continue treatment without recurring clinic visits—dramatically improving compliance, outcomes, and scalability.  

We have successfully launched URIS in the European market, secured MDR certification, and established a strong direct-to-physician sales model. Demand from urologists is exceeding expectations, driving the need to scale manufacturing and expand commercial reach.  

Regulatory & Market Access – Preparing for 510(k) clearance in the US, with the goal of establishing URIS as the preferred neuromodulation therapy for OAB.  

Reimbursement & Payor Strategy – Engaging with leading reimbursement experts to secure national-level coverage and drive adoption.  

Commercial Scale-Up – Expanding into non-EU markets that recognize CE certification, including Saudi Arabia, Kazakhstan, Vietnam, Thailand, and Indonesia.  

Parkinson’s Disease Opportunity – Advancing Phase II trials to validate URIS in treating Parkinson’s-related tremors, targeting an underserved multi-billion-dollar market.  

The landscape for neuromodulation is shifting. Reimbursement trends in the US and EU favor non-invasive therapies, and urologists are actively seeking alternatives to pharmacotherapy. Stimvia is positioned at the forefront of this transformation, offering a clinically validated, commercially viable, and scalable neuromodulation solution.  

With a strong IP portfolio (120+ patents), growing commercial traction, and leading medical experts supporting our technology, we are poised to become the new standard of care in neuromodulation.  

We are seeking strategic investment to accelerate market expansion, scale sales, and drive regulatory approvals in key geographies. The funds will be used to:  

• Expand commercialization in Europe and the US.  
• Secure regulatory approvals (510(k) and Breakthrough Device Designation in the US).
• Advance Parkinson’s clinical trials to unlock a multi-billion-dollar neurology market.
• Scale production capacity to meet rising demand.

Neuromodulation is effective, but adoption is hindered by complexity. URIS solves this problem.

We invite investors to join us in transforming neuromodulation into a widely accessible, first-line therapy—a game-changer in urology and beyond.