Neuspera Medical reports positive trial results on battery-free neuromodulation system for urinary incontinence

Author(s):

Medical Economics Staff

Key Takeaways

Neuspera's pSNM system shows comparable efficacy to traditional SNM devices in managing urgency urinary incontinence.
The pSNM system offers a less invasive alternative, eliminating the need for an implanted battery and associated complications.
Trial results indicate significant symptom reduction and quality of life improvements for participants.
Regulatory approval for Neuspera's pSNM system is anticipated later this year, potentially offering a new treatment option for patients.

Neuspera Medical's system could offer a less invasive, more patient-friendly approach to treating UUI. The company anticipates regulatory clearance later this year.

Neuspera Medical, Inc. announced pivotal clinical trial results indicating its battery-free percutaneous sacral neuromodulation (pSNM) system performs comparably to traditional implantable sacral neuromodulation (SNM) devices in managing urgency urinary incontinence (UUI).

The six-month phase 2 data — set to be presented March 1 at the Society of Urodynamics Female Pelvic Medicine & Urogenital Reconstruction (SUFU) 2025 winter meeting — highlight the technology’s potential to offer a less invasive, more patient-friendly approach to treating UUI, a major component of overactive bladder (OAB), affecting an estimated 300 million individuals worldwide.

Despite the roughly $1 billion global market, innovation in SNM treatments has remained limited. But Neuspera’s trial results show there may be a promising alternative soon available.

According to the trial results, about 84% of the 128 implanted patients experienced at least a 50% reduction in urgent leaks, which mirrors reported rates from existing SNM therapies. Additionally, 84% of responders were “super responders” who saw greater than 75% reduction in UUI symptoms, and 42% of that group reported being completely “dry.” Participants also showed a 3.5-fold improvement in quality of life, with fewer voids and urgent episodes.

"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, in the news release. "Our device offers a transformative alternative to traditional SNM, removing the stigma and burden of an invasive surgical implant and eventual battery replacement surgery."

Traditional SNM therapy often involves implanting a battery “pocket” in the buttock tissue, a procedure that can be associated with infection, unwanted battery movement, pain, cosmetic concerns, and repeat surgeries for battery replacements.

Neuspera’s pSNM system has two components: A miniaturized neurostimulator, about 100 times smaller than conventional SNM devices, implanted percutaneously near the sacral nerve via a tiny 2.3 mm cannula. The other component is an external disc worn against the lower back for around two hours daily. When not in use, the disc recharges wirelessly.

Neuspera had previously submitted a Premarket Approval (PMA) application to the FDA in September 2024 and anticipates regulatory clearance later this year.

"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 Colin Goudelocke, MD, Clinical Investigator and Urologist at Ochsner Health System, in a Neuspera news release. "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."

Neuspera Medical, Inc. is a San Jose, Calif., developer of wireless, directionally adaptive energy systems that power miniaturized medical implants.