
Neuromodulation solutions provider Neuronoff has announced $5m in US government funding to advance its minimally invasive neuromodulation platform, Injectrode.
The Department of Defense (DOD) has recommended $1.73m for a clinical randomised controlled trial (RCT) on neurogenic bladder treatment after spinal cord injury.
The National Institutes of Health (NIH) has awarded $3.2m for preclinical research on overactive bladder treatment.
With these new grants, Neuronoff’s total secured funding has reached $9.1m. The company said that the funding highlights federal and state backing for neuromodulation therapies that regulate nerve activity to improve organ function.
Previous funding included support from the NIH HEAL, the Defense Advanced Research Projects Agency (DARPA), Ohio Third Frontier Research, and the IQT In-Q-Tel EEI programme to advance the commercialisation of its technologies.
In January last year, Neuronoff completed the first-in-human implant of the Injectrode. In April, the medical device company announced safety and functionality success in the first-in-human trial of Injectrode.
Neuronoff CEO Manfred Franke said: “Currently, neurostimulation is primarily a ‘therapy of last resort’ due to invasive surgical requirements and associated costs.
“Our elegant, needle-based approach to inject a self-anchoring lead enables chronic therapy options ranging from pain to autonomic, bladder and cardiac uses.
“By allowing patients to try neuromodulation as easily as a drug injection, while reducing healthcare system costs by a factor of 3 to 5, we aim to broaden patient access through a solution that benefits patients, physicians, providers, and payers alike.”
The latest DOD funding will support a three-year clinical trial with the University of Texas Health Science Center in Houston. The trial will evaluate the safety and efficacy of Injectrode when implanted along the tibial nerve in spinal cord injury (SCI) patients.
The study will evaluate Injectrode Tibial Nerve Stimulation (iTNS), focusing on its implantation process and treatment effects.
The trial aims to measure the elimination of overactive bladder (OAB) medications and reductions in OAB medications from baseline to study completion.
As the first human clinical trial in SCI, this phase 1/2 study will provide key data for the US Food and Drug Administration (FDA) pre-submission and guide the design of future trials.
Additionally, a preclinical R01 proposal has received a five-year grant from the NIH.
This project, a collaboration between the University of Wisconsin, Case Western Reserve University, and Massachusetts General Hospital, aims to enhance overactive bladder (OAB) treatment using Injectrode’s two-component, passive injectable electrode system.
The team expects improved nerve interface reliability, better long-term stability, and reduced complications.