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

Needle-Delivered Electrode Enables Outpatient Placement and At-Home Stimulation for Spinal Cord Injury Patients With Neurogenic Bladder

CLEVELAND and HOUSTON, June 5, 2026 /PRNewswire/ -- Neuronoff, Inc., a clinical-stage neuromodulation company, today announced the first patient implant in a Department of Defense (DOD) funded clinical trial evaluating the safety and efficacy of the Injectrode for the treatment of neurogenic bladder in individuals with spinal cord injury. The trial is being conducted at UT Health Houston under principal investigator Argyrios Stampas, MD, MS, Professor of Physical Medicine and Rehabilitation at McGovern Medical School (ClinicalTrials.gov NCT07264868).

The study is supported by the Congressionally Directed Medical Research Programs (CDMRP) and the DOD. The double blinded, randomized controlled trial will enroll 21 participants across three study groups: unilateral active stimulation, bilateral active stimulation, and sham stimulation.

A Proven Therapy with an Access Problem

Neurogenic bladder is among the most common and debilitating complications of spinal cord injury, affecting the majority of injured patients and contributing to recurrent urinary tract infections, kidney damage, and reduced quality of life. Tibial nerve stimulation has an established evidence base for this indication. A randomized controlled trial by Dr. Stampas, published in the Journal of Urology in 2024, found that 95% of patients receiving tibial nerve stimulation reduced their overactive bladder medications, compared to 68% in the sham control group.

Existing approaches come with their respective tradeoffs. Edema in the lower extremity, a common complication following spinal cord injury, limits the reliability of transcutaneous stimulation. Achieving reliable tibial nerve stimulation with currently available devices requires surgical incision of one to two inches in length to access the nerve. Wound healing complications are prevalent in this population and have constrained interest in implantable neuromodulation to date.

Injectrode Outpatient Placement with At-Home Therapy

The Injectrode is placed through a single 18-gauge needle under local anesthesia in an outpatient setting, with no incision and no sutures required. Once implanted adjacent to the tibial nerve, the helical electrode conforms to the anatomy, anchoring to tissue and providing a focused conductive pathway between the target nerve and the external pulse generator, a device providing the stimulation signal from the outside of the body.

"For more than a decade, we have been demonstrating that tibial nerve stimulation can reduce or eliminate the medications that people with spinal cord injury depend on for bladder control," said Dr. Stampas. "The challenge has been delivering that therapy reliably without surgery and without the limits of surface stimulation. I am encouraged by how miniscule the entry site is for the procedure. The needle puncture site is nearly imperceptible post-implant, which matters enormously for a patient population already managing significant wound healing challenges."

Co-investigator Ajai Sambasivan, MD, Associate Professor of Physical Medicine and Rehabilitation at McGovern Medical School, added that placement was straightforward once the nerve was located via ultrasound guidance and confirmed with electrical test stimulation. He noted that the Injectrode's unique design enables optimal placement adjacent to the target nerve, with an innovative design that maintains consistent positioning and stability of the implant.

The neurogenic bladder indication is one of several for which the Injectrode platform is being evaluated.

"The Injectrode is designed to enable patients to experience the power of neuromodulation at the beginning of their treatment journey, not as a last resort," said Manfred Franke, CEO of Neuronoff. "This minimally invasive intervention is intended for individuals with a neurogenic or overactive bladder, enabling an outpatient visit to place the device as a needle injection instead of a surgery. The result is a more elegant patient user experience. The injection location is virtually invisible in appearance, the chronic implant provides a reliable interface to the nerves of interest, and the external stimulator allows the user the freedom to apply the therapy anywhere they like, such as the comfort of their home. It is the same architecture we are advancing across chronic pain, autonomic, and inflammatory indications. One platform, any peripheral or autonomic nerve a physician can reach with a needle, compatible with established reimbursement pathways and existing neuromodulation infrastructure."

About the Trial

The trial (ClinicalTrials.gov NCT07264868) will enroll 21 participants with chronic spinal cord injury and neurogenic bladder. Primary endpoints at 4 and 8 weeks assess device performance, including safety, stimulation accuracy and reliability, procedural feasibility, and physician and patient acceptability. Secondary endpoints evaluate bladder function and changes in overactive bladder medication use. Data will inform FDA pre-submission engagement and the design of subsequent pivotal trials for a 510(k) de Novo submission.

About Neuronoff, Inc.

Neuronoff, Inc. (Cleveland, Ohio) is developing the Injectrode, a minimally invasive peripheral neuromodulation platform designed to deliver the benefits of established nerve stimulation therapies without the need for surgical access. The innovative design of the helical platinum-iridium Injectrode facilitates stable placement with 18-gauge needle access, addressing the problem of lead migration that accounts for sub-optimal therapy and a substantial share of neuromodulation device recalls industry-wide.

The platform spans diagnostic trial through chronic implant and IPG-connected therapy across pain, autonomic, bladder, cardiac, and inflammatory indications, all aligned with existing CPT codes. The Injectrode is built on an IPG-agnostic architecture with standard connectors, enabling compatibility across the existing neuromodulation ecosystem.

The Injectrode is limited by Federal (US) law to investigational use only. These statements have not been evaluated by the FDA.

Funding Support

This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency, Research & Engineering Directorate, and the U.S. Army Medical Research Acquisition Activity at the U.S. Army Medical Research and Development Command, in the amount of ($1,730,406), through the (Spinal Cord Injury Research Program (SCIRP) Clinical Translation Research Award - Early-Career Partnership Option under Award No. (HT942524). Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

Contact: Manfred Franke | [email protected]

¹ https://www.auajournals.org/doi/10.1097/JU.0000000000004189

SOURCE Neuronoff