Neuspera Medical Announces Landmark Six-Month Clinical Trial Results for the First Battery-Free Percutaneous Sacral Neuromodulation (pSNM) System for Urgency Urinary Incontinence Management

Pivotal Study Data Show Comparable "Gold Standard" Efficacy to Traditional Sacral Neuromodulation (SNM) Devices – Eliminating Burdens of a Battery Implant

, /PRNewswire/ -- Neuspera^® Medical, Inc., the leading developer of wireless energy technology powering the future of bioelectronic medicine, today announced six-month pivotal clinical trial results showing that the efficacy of its battery-free percutaneous sacral neuromodulation (pSNM) system has comparable efficacy to published rates for traditional sacral neuromodulation (SNM) devices,^1,2 while aiming to offer a significantly better patient experience for the treatment of urgency urinary incontinence (UUI). The landmark results will be presented at the 2025 winter meeting of the Society of Urodynamics Female Pelvic Medicine & Urogenital Reconstruction (SUFU) on March 1, 2025. 

In a market that has gradually grown to $1 billion worldwide, despite negligible innovation since its inception in 1997, Neuspera has developed the first wireless, battery-free, ultra-miniaturized percutaneous SNM device for the treatment of UUI. The pSNM approach aims to address the most common complaints reported in patient forums: painful infections around the battery pocket, unwanted battery movement, persistent discomfort, visible bulging, and additional required surgeries for battery replacement.

UUI is a major component of OAB (Overactive Bladder), a condition that affects approximately 300 million people worldwide, including 1 in 5 women in the U.S., and has a major impact on quality of life (QOL), driving the demand for more effective and patient-friendly treatment options. 

Results Show Proven Efficacy and Significant UUI Symptom Relief

Six-month data from the Phase II pivotal clinical study of 128 patients implanted with Neuspera's pSNM therapy found:

• 84.2% of implanted patients had a 50% or greater reduction in urgent leaks – on par with reported rates in recent SNM studies^1,2
• 84% of patients who responded to treatment were classified as "super responders," meaning they experienced more than a 75% reduction in UUI symptoms
• 42% of patients who responded were completely "dry," with 100% reduction in UUI symptoms
• 3.5x clinically significant improvement in QOL, with a reduction in voids and urgent episodes

"These results demonstrate that Neuspera's pSNM technology provides similar effectiveness to traditional SNM devices while offering an alternative to a traditional implanted battery," said Dr. Colin Goudelocke, MD, Clinical Investigator and Urologist at Ochsner Health System. "Having options available for our patients is so crucial, and pSNM provides consistent relief from UUI while removing what can be an obstacle for some. I look forward to offering this option to my patients once it receives regulatory approval."

Beyond Legacy Limitations: Wireless Innovation Modernizes a Proven Therapy

Conventional SNM systems require three surgical steps: 1) implanting the neurostimulation device at the sacral nerve, 2) creating a "pocket" in the buttock tissue to house the Oreo-sized metal battery, and 3) surgically creating a "tunnel" from the lower back to the lower abdomen to connect the implanted stimulation device to its battery. Complications related to the implanted batteries include infection at the battery site, battery flipping and movement, chronic pain, battery visibility, and the need for battery replacement surgeries.

"The pivotal trial results validate the founding vision of Neuspera - that we could revolutionize SNM therapy by eliminating the need for an implanted battery," said Alexander Yeh, Ph.D, Neuspera Founder and Chief Technology Officer. "Our device offers a transformative alternative to traditional SNM, removing the stigma and burden of an invasive surgical implant and eventual battery replacement surgery."

How the Battery-Free Wireless Sacral Neuromodulation [pSNM] Therapy Works:

The mini neurostimulator is implanted percutaneously near the sacral nerve through a tiny 2.3mm canula — requiring no stitches and minimal recovery. Patients activate the therapy by placing the Neuspera disc against their lower back for generally just two hours daily, using a discreet wearable belt compatible with most activities. When not in use, the therapy disc charges wirelessly, like a smartphone. Neuspera's pSNM eliminates all battery complications and associated body image concerns voiced by many patients.

"Sacral neuromodulation has delivered life-changing symptom relief for decades, but implanted batteries remain a significant limitation," said Dave Van Meter, Neuspera Executive Chairman. "Neuspera is poised to offer a more patient-friendly solution to the millions of patients waiting for a better option. With FDA approval expected this year, we believe the pSNM technology will establish a new standard in UUI therapy."

Neuspera submitted its Premarket Approval (PMA) to the FDA in September 2024 and, pending regulatory review, anticipates approval later this year.

About Neuspera Medical 
Neuspera^® Medical, Inc. is the leading developer of wireless, directionally adaptive energy systems that power tiny medical implants deep within the body. Their technology is enabling a new class of bioelectronic medicine. The company's initial innovation is the first battery-free percutaneous sacral neuromodulation (pSNM) device for urgency urinary incontinence (UUI), currently pending FDA approval. Neuspera's pSNM device stands to expand the $1 billion overactive bladder market by providing a less-invasive, battery-free option to millions more UUI patients within the next 10 years. Learn more at neuspera.com and LinkedIn.

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References

1. Axonics Artisan Study: McCrery, Rebecca, et al. "Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study." The Journal of Urology, vol. 203, no. 1, 2020, pp. 185-192.
2. Medtronic Interstim Micro Study: Goudelocke, Colin, et al. "Evaluation of Clinical Performance and Safety for the Rechargeable InterStim Micro Device in Overactive Bladder Subjects: 6-Month Results from the Global Postmarket ELITE Study." Neurourology and Urodynamics, vol. 42, no. 4, 2023, pp. 761-769.

SOURCE Neuspera Medical