#United States #San Jose #urinary incontinence #Neuspera Medical #Sacral Neuromodulation

Neuspera Medical's New Landmark Clinical Trial Results

Neuspera Medical, a pioneering company in wireless energy solutions for bioelectronic medicine, recently unveiled innovative six-month clinical trial findings for their latest device addressing urgency urinary incontinence (UUI). Their breakthrough percutaneous sacral neuromodulation (pSNM) system, which is battery-free and ultra-miniaturized, has demonstrated efficacy on par with traditional techniques while prioritizing a better patient experience. The results will be shared at the upcoming 2025 SUFU meeting, marking a major step toward transforming treatment for the estimated 300 million individuals suffering from UUI globally.

Key Features of Neuspera's pSNM System

The pSNM system stands out in a market that has witnessed little innovation in the past few decades, effectively expanding on sacral neuromodulation therapies that have been used since 1997. Neuspera's device circumvents the traditional complications associated with battery-operated systems, such as infections, discomfort from battery positioning, and the need for frequent surgical replacements.

What makes the Neuspera system revolutionary is its compact design and the elimination of the need for an implanted battery, which has long been viewed as an obstacle for patients. Traditional devices require multiple surgical steps — including the insertion of a battery and tunneling to connect to the neurostimulator at the sacral nerve — which increases the risk of complications and postoperative issues.

Clinical Findings That Matter

The clinical trial evaluated 128 subjects, revealing significant results:

• - 84.2% of participants experienced a 50% or more reduction in urgent leaks, aligning well with results from previous studies on sacral neuromodulation products.
• - A striking 84% of these patients were categorized as “super responders,” showing over a 75% decrease in symptoms.
• - 42% of the evaluated patients reported a complete cessation of UUI symptoms, resulting in a dramatic 3.5-fold improvement in their quality of life.

These findings underscore the potential for Neuspera's pSNM therapy to provide consistent and effective relief from UUI, enhancing the lives of millions without burdening them with the difficulties of a traditional system. Dr. Colin Goudelocke, a key investigator in the study, praised the new technology, stating that it offers valuable options to patients that previously weren’t available, eliminating surgery-related concerns that have plagued many.

Innovative Treatment Methodology

The two-component design of Neuspera's pSNM includes a miniature implant positioned near the sacral nerve and an external therapy disc. This disc, which can be used on a schedule of around two hours daily, charges wirelessly, eliminating any battery-related issues. The simplicity of the device's use can lead to enhanced patient compliance and satisfaction—all while avoiding extensive surgical procedures entirely.

According to Dave Van Meter, Executive Chairman of Neuspera, the impending FDA approval, expected later this year, would testify to the significance of this device in UUI management, solidifying a better alternative for existing treatment strategies. If approved, it is projected that this device could redefine the $1 billion overactive bladder market by delivering a less invasive method with substantial cost-effective benefits for patients.

Conclusion

The breakthrough of Neuspera Medical with its battery-free pSNM system is revolutionary not only from a medical engineering standpoint but also through its profound implications for patient care. With reported results indicating substantial improvements in both symptom relief and quality of life for UUI patients, Neuspera is set to usher in a new era of bioelectronic medicine. Enthusiastic anticipation surrounds this clinical advancement as the company prepares for its next regulatory steps.

About Neuspera Medical

Neuspera Medical, Inc. is a leader in developing wireless energy technologies aimed at transforming medical treatment through bioelectronic systems. Their focus on patient-friendly designs aims to enhance sector standards and improve the quality of life for people suffering from various conditions such as urgency urinary incontinence.