Neuspera Medical, Inc.

Neuspera Medical, Inc. is a San Jose, California neuromodulation company developing implantable medical devices for chronic conditions. Its lead product is the Neuspera integrated sacral neuromodulation (iSNM) system, indicated for urinary urge incontinence (UUI), a symptom of overactive bladder (OAB). The system consists of an ultra-miniaturized pulse generator attached to an electrode array that is implanted near the sacral nerve and sized to fit within the sacral foramen; therapy is delivered via a discreet external battery worn by the patient daily and charged wirelessly, eliminating an implanted battery and the tunneling and separate battery pocket required by traditional SNM devices.

The company describes its platform as a directionally adaptive wireless energy technology capable of powering implants deep within the body, positioning the sacral neuromodulation indication as the first application of a broader neurostimulation platform. The Neuspera System previously held FDA clearance for treating chronic pain of peripheral nerve origin and was studied as an investigational device for UUI in the SANS-UUI clinical program; the FDA approved the iSNM system for UUI in June 2025.

Business model

Neuspera develops and commercializes a proprietary implantable neurostimulation system, sold for use in physician-performed implant procedures and dependent on regulatory approval and payer reimbursement; CMS has confirmed a Medicare payment assignment for the iSNM system under a proposed 2027 rule.

Traction

The SANS-UUI pivotal trial completed its 100th implant in November 2023 and reached full patient enrollment and implantation in December 2023 across 26 centers in the U.S. and Europe, with the final patient completing the primary endpoint visit in July 2024. Six-month pivotal results reported in February 2025 showed efficacy comparable to traditional SNM devices, and 12-month results announced in March 2026 reported that 94% of test-phase responders achieved significant symptom relief with zero serious device-related adverse events. FDA approval of the iSNM system followed in June 2025, and the company reported a first revision case replacing a traditional SNM system with its iSNM system in February 2026.

Latest developments

In June 2025 the FDA approved Neuspera's iSNM system for urinary urge incontinence. In February 2026 the company announced a milestone case in which a traditional SNM system was removed and replaced with its iSNM system, alongside a new patient registry to track such procedures, and in March 2026 it reported 12-month pivotal trial outcomes. In July 2026 the company highlighted that CMS had confirmed the iSNM system would receive the same Medicare payment assignment as legacy implantable SNM devices under a proposed 2027 rule.