Neuronoff, a company pioneering minimally invasive neuromodulation solutions for chronic pain, has successfully completed the first-in-human clinical trial for its Injectrode device. The Lumbar Injectrode Feasibility Evaluation (LIFE study) assessed the safety and effectiveness of the Injectrode in treating chronic pain.
The LIFE study, designed as a safety trial with a secondary effectiveness measure, met all goals and provided valuable insights for future studies. Ten participants received injectable electrodes (Injectrodes) placed near the lumbar dorsal rami, a nerve network that innervates the muscles in the lower back. Peripheral nerve stimulation of these rami may alleviate non-radiating, axial, and facetogenic lower back pain.
The Injectrodes were placed transcutaneously using a 18-gauge needle under local anesthesia. The placement was guided by fluoroscopic visualization and confirmed by electrical test stimulation. Following placement, transcutaneous stimulation (voltages less than 30 V) was applied immediately and again on day 25+/-3 prior to device removal.
The study demonstrated the feasibility of transcutaneous stimulation and the ability of the Injectrode to deliver electrical neuromodulation to the lumbar dorsal rami, activating the erector spinae and multifidus muscles. The device exhibited a strong safety profile with no serious adverse events or need for post-insertion analgesics or sutures.
Dr. , Principal Investigator of the study, emphasized the device’s potential to transform neuromodulation therapies. He highlighted its consistent performance, targeted stimulation, and ease of placement and removal. Dr. further stated that the Injectrode could provide a drug-free, minimally invasive option for chronic pain relief.
Dr. , Chief Scientific Officer at Neuronoff, stressed the significance of the study findings, which build upon prior preclinical testing and establish the feasibility of the Injectrode’s transcutaneous stimulation approach.
CEO of Neuronoff, expressed excitement about the Injectrode’s potential to transform chronic pain management. He noted its small size, allowing for minimally invasive implantation, and the rapid disappearance of the injection site, contributing to improved aesthetics.
Neuronoff plans to present more detailed findings from the LIFE study at upcoming medical conferences. The company remains dedicated to advancing neuromodulation technology and providing hope for patients seeking alternatives to traditional pain therapies.
