Neuronoff Implants First Patient in DOD-Funded Trial of Minimally Invasive Injectrode for Neurogenic Bladder in Spinal Cord Injury
核心洞察
Neuronoff has implanted the first patient in a Department of Defense-funded, double-blind, randomized controlled trial evaluating the Injectrode (搜索) for neurogenic bladder (搜索) in spinal cord injury (搜索) patients.
The Injectrode (搜索) 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.
The first patient has been implanted in a Department of Defense-funded clinical trial evaluating Neuronoff's Injectrode (搜索), a needle-delivered electrode designed to treat neurogenic bladder (搜索) in individuals with spinal cord injury (搜索). The double-blind, randomized controlled 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.
The study, registered at ClinicalTrials.gov (NCT07264868), is supported by the Congressionally Directed Medical Research Programs (CDMRP) and the DOD, with funding of $1,730,406 through the Spinal Cord Injury (搜索) Research Program (SCIRP) Clinical Translation Research Award.
A Proven Therapy with an Access Problem
Neurogenic bladder (搜索) is among the most common and debilitating complications of spinal cord injury (搜索), affecting the majority of injured patients and contributing to recurrent urinary tract infections, kidney damage, and reduced quality of life. Tibial nerve (搜索) 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.
However, existing approaches carry significant tradeoffs. Edema in the lower extremity, a common complication following spinal cord injury (搜索), limits the reliability of transcutaneous stimulation. Achieving reliable tibial nerve (搜索) stimulation with currently available devices requires a surgical incision of one to two inches to access the nerve. Wound healing complications are prevalent in this population and have constrained interest in implantable neuromodulation to date.
Minimally Invasive Outpatient Placement
The Injectrode (搜索) is placed through a single 18-gauge needle under local anesthesia in an outpatient setting, requiring no incision and no sutures. Once implanted adjacent to the tibial nerve (搜索), the helical platinum-iridium electrode conforms to the anatomy, anchoring to tissue and providing a focused conductive pathway between the target nerve and an external pulse generator worn outside the body.
"For more than a decade, we have been demonstrating that tibial nerve (搜索) stimulation can reduce or eliminate the medications that people with spinal cord injury (搜索) 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, noted that placement was straightforward once the nerve was located via ultrasound guidance and confirmed with electrical test stimulation. He added that the Injectrode (搜索)'s unique design enables optimal placement adjacent to the target nerve, with an innovative design that maintains consistent positioning and stability of the implant.
Trial Design and Endpoints
The trial will enroll 21 participants with chronic spinal cord injury (搜索) and neurogenic bladder (搜索) across three study groups: unilateral active stimulation, bilateral active stimulation, and sham stimulation. 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 from the study will inform FDA pre-submission engagement and the design of subsequent pivotal trials for a 510(k) de Novo submission.
A Platform Approach to Neuromodulation
"The Injectrode (搜索) 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."
Franke emphasized that the same architecture is being advanced 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," he said.
The Injectrode (搜索) 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 device is built on an IPG-agnostic architecture with standard connectors, enabling compatibility across the existing neuromodulation ecosystem. The Injectrode is limited by Federal law to investigational use only and has not been evaluated by the FDA.