The FDA has granted clearance to Neuspera Medical's integrated sacral neuromodulation (iSNM) system for treating patients with urinary urge incontinence (UUI), marking the first battery-free device of its kind to receive regulatory approval. The innovative system offers an alternative to traditional sacral neuromodulation therapy for patients with UUI, a major component of overactive bladder that affects approximately 1 in 5 women in the United States.
Revolutionary Technology Design
The iSNM system features a smart, miniaturized neurostimulator implanted near the sacral nerve that is activated using an external disc worn against the lower back for approximately 2 hours daily. When not in use, the therapy disc charges wirelessly, similar to smartphone technology. This design eliminates complications related to implanted batteries while maintaining the therapeutic benefits of traditional SNM therapy.
"FDA approval of Neuspera's iSNM system represents a major advancement for millions of patients with UUI," said Dr. Howard Goldman, vice-chairman of Urology at the Cleveland Clinic. "For too long, patients have had to weigh the benefits of SNM therapy against real concerns about complications related to implanted batteries and the need for surgeries to replace it. Neuspera's integrated system provides symptom relief without these additional burdens."
Pivotal Trial Results
The approval is supported by results from the landmark SANS-UUI phase 2 trial (NCT04232696), which enrolled 128 patients with UUI across 34 centers in the US and Europe. The prospective, single-arm study included adult patients who had failed or were not candidates for more conservative treatments.
The six-month pivotal trial data demonstrated efficacy comparable to established SNM therapies:
- 84.2% of patients achieved at least a 50% reduction in urgent leaks, on par with reported rates in recent SNM studies
- 84% of treatment responders were classified as "super responders," experiencing more than 75% reduction in UUI symptoms
- 42% of responders achieved complete dryness with 100% reduction in UUI symptoms
- Patients experienced a 3.5x clinically significant improvement in quality of life
Clinical Development Program
The SANS-UUI study was conducted in two phases. Phase 1 assessed device utilization and determined optimal daily stimulation duration among 34 patients. Results showed that 90% of patients demonstrated at least 50% improvement in UUI symptoms at 6- and 12-month follow-up with 2 hours of daily stimulation, with 52% of patients achieving complete dryness at 12-month follow-up.
Phase 2 further evaluated safety and efficacy using the 2-hour daily stimulation protocol established in Phase 1. The primary efficacy endpoint measured the percentage of patients experiencing at least 50% reduction in UUI episodes from baseline to 6 months, while the primary safety endpoint assessed device-related serious adverse events at 6 months. Final completion of the SANS-UUI trial is expected in December 2026.
Market Impact
"Neuspera is setting a new standard in UUI therapy with the first integrated SNM system," said Dave Van Meter, CEO of Neuspera. "Our mission is to remove barriers to care with a smart, patient-centered solution that truly improves quality of life for the millions impacted by UUI. This FDA approval is a proud and meaningful moment for the entire Neuspera team and our clinical partners, whose passion and dedication made it possible."
The approval addresses a significant clinical need, as UUI has a major impact on quality of life and drives demand for more effective and patient-friendly treatment options. The integrated system's design eliminates the discomfort, surgical risks, and cosmetic concerns associated with implanted batteries while maintaining therapeutic efficacy.
