Neuronoff, Inc.

Neuronoff Implants First Patient in DOD-Funded Trial of Minimally Invasive Injectrode for Neurogenic Bladder in Spinal Cord Injury

- Neuronoff has implanted the first patient in a Department of Defense-funded, double-blind, randomized controlled trial evaluating the Injectrode for neurogenic bladder in spinal cord injury patients. - The Injectrode is placed through an 18-gauge needle under local anesthesia in an outpatient setting, eliminating the need for surgical incisions and sutures. - The trial will enroll 21 participants across three arms—unilateral active, bilateral active, and sham stimulation—with primary endpoints assessing safety, stimulation accuracy, and procedural feasibility at 4 and 8 weeks. - Data from the study will inform FDA pre-submission engagement and the design of subsequent pivotal trials for a 510(k) de Novo submission.