CLEVELAND, Ohio and HOUSTON, Texas, June 5, 2026
Neuronoff has achieved a major clinical milestone with the successful implantation of the first patient in a Department of Defense (DOD)-funded clinical trial evaluating the Injectrode® neuromodulation platform for neurogenic bladder in individuals with spinal cord injury (SCI). The investigational study, being conducted at UT Health Houston, is designed to evaluate the safety, feasibility, and therapeutic effectiveness of the minimally invasive Injectrode technology, which enables targeted tibial nerve stimulation through a needle-delivered implant rather than traditional surgical procedures. Neurogenic bladder remains one of the most common and debilitating complications of spinal cord injury, frequently leading to urinary tract infections, kidney damage, reduced independence, and diminished quality of life. By combining a minimally invasive implantation procedure with convenient at-home stimulation capabilities, Injectrode has the potential to significantly expand access to neuromodulation therapy while reducing the surgical burden traditionally associated with implanted nerve stimulation devices. The milestone underscores growing interest in innovative neuromodulation technologies designed to improve outcomes for patients with chronic neurological disorders.
DOD-Funded Trial Targets Major Unmet Need in Spinal Cord Injury
The randomized, double-blinded controlled trial is supported by the Congressionally Directed Medical Research Programs (CDMRP) and the U.S. Department of Defense. The study will enroll 21 participants with chronic spinal cord injury and neurogenic bladder, divided into unilateral stimulation, bilateral stimulation, and sham-control groups. Neurogenic bladder affects the majority of spinal cord injury patients and often requires lifelong medication management and repeated medical interventions. Previous clinical evidence has demonstrated the effectiveness of tibial nerve stimulation in improving bladder control.
A randomized study published in the Journal of Urology found that 95% of patients receiving tibial nerve stimulation reduced their dependence on overactive bladder medications compared with 68% in the sham control group. However, existing neuromodulation approaches often face limitations, including inconsistent stimulation performance, edema-related complications, and the need for surgical implantation. The new study aims to determine whether the Injectrode platform can overcome these challenges while delivering reliable, long-term therapeutic benefits for patients living with spinal cord injury.
Needle-Delivered Implant Simplifies Neuromodulation Therapy
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A key differentiator of the Injectrode platform is its minimally invasive delivery method. Unlike conventional neuromodulation devices that require surgical incisions and implanted pulse generators, Injectrode is placed adjacent to the tibial nerve using a single 18-gauge needle under local anesthesia in an outpatient setting. No surgical incision or sutures are required, significantly reducing procedural complexity and wound-healing risks. Once implanted, the helical electrode conforms to surrounding anatomy, creating a stable conductive interface between the target nerve and an external stimulation system.
Physicians involved in the trial reported that the implantation process was straightforward and that the needle entry site was nearly imperceptible following placement. This advantage is particularly important for spinal cord injury patients who frequently experience impaired wound healing and elevated infection risks. The platform also enables patients to receive therapy at home, reducing dependence on repeated clinic visits while providing greater flexibility in treatment administration.
Platform Technology Expands Future Neuromodulation Applications
Beyond neurogenic bladder, Neuronoff is positioning Injectrode as a versatile neuromodulation platform capable of addressing a broad range of medical conditions. The technology is currently being explored for applications in chronic pain, autonomic disorders, inflammatory diseases, cardiac conditions, and additional bladder dysfunction indications. The current trial will assess primary endpoints including device safety, stimulation reliability, procedural feasibility, physician usability, and patient acceptance at four and eight weeks following implantation. Secondary endpoints will evaluate changes in bladder function and medication use.
Data generated from the study are expected to support future FDA regulatory discussions and inform the design of pivotal clinical trials leading toward a potential 510(k) De Novo submission. As healthcare increasingly embraces minimally invasive technologies, Injectrode represents a promising advancement in neuromodulation by combining outpatient implantation, home-based therapy, and scalable nerve stimulation capabilities into a single platform designed to improve patient outcomes while reducing procedural burden.
Source: Neuronoff press release
