# Neuspera Medical

> Neuspera Medical develops implantable nerve stimulators powered from outside the body. Its FDA-approved sacral neuromodulation system treats urinary urge incontinence with a small implant near the sacral nerve, a wearable transmitter, and patient and clinician controls. The tradeoff is a daily wearable session in exchange for no implanted battery pocket.

- **Founded:** 2013
- **Headquarters:** San Jose, United States
- **Founders:** Alexander J. Yeh (Founder, CTO and VP R&D)
- **Products:** Neuspera Sacral Neuromodulation System, Neuspera Neurostimulation System, Mid-Field Powering technology
- **Notable:** FDA 510(k) clearance for the Neuspera Neurostimulation System in 2021., FDA premarket approval for the Neuspera Sacral Neuromodulation System on June 17, 2025., The SANS-UUI pivotal study enrolled 242 participants at 31 sites; 128 were implanted in Phase II.

## Products & services

- **Neuspera Sacral Neuromodulation System** — FDA-approved integrated implant near the sacral nerve, powered by an external wearable transmitter, with a patient controller and clinician programmer for urinary urge incontinence after conservative treatment is unsuitable or ineffective.
- **Neuspera Neurostimulation System** — Wireless peripheral nerve stimulation platform for pain relief; FDA 510(k) clearance decision dated August 27, 2021, with a company announcement in 2023.
- **Mid-Field Powering technology** — Patented electromagnetic power transfer approach used to energize miniature implants from outside the body.

## Achievements

- FDA 510(k) clearance for the Neuspera Neurostimulation System in 2021.
- FDA premarket approval for the Neuspera Sacral Neuromodulation System on June 17, 2025.
- The SANS-UUI pivotal study enrolled 242 participants at 31 sites; 128 were implanted in Phase II.
- Company-reported 12-month analysis: 94% of test-phase responders achieved at least 50% fewer urgent leaks; zero serious device-related adverse events and zero infections in the 128 implanted patients.

## Latest updates

- **2025-06** — FDA granted premarket approval for the Neuspera Sacral Neuromodulation System.
- **2026-02** — Company reported a first revision case at University of Louisville Health, replacing a conventional SNM system after battery discomfort.
- **2026-03** — Company presented 12-month SANS-UUI outcomes for 128 implanted patients.
- **2026-07** — Company said a proposed 2027 Medicare outpatient rule assigned its procedure to the same payment level as legacy implantable SNM devices; the rule was still proposed.

## Links

- Website: https://neuspera.com/
- LinkedIn: https://www.linkedin.com/company/neusperamedicalinc./
- Twitter/X: https://twitter.com/neusperamedical

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Last updated: 2026-09-28