Neuronoff has announced two fundings from the US Department of Defense (DOD) and National Institutes of Health (NIH) totalling $5m, to further the development of its Injectrode technology.
DOD has proposed $1.73m for a clinical trial focused on treating neurogenic bladder following spinal cord injury (SCI) while the NIH has granted $3.2m for preclinical research into overactive bladder treatment.
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The funding will facilitate a three-year randomised controlled trial (RCT) in partnership with the University of Texas Health Science Center in Houston, Texas.
This trial will evaluate the Injectrode’s efficacy and safety when it is implanted along the tibial nerve in individuals with SCI.
It introduces Injectrode tibial nerve stimulation, assessing its implantation process and measuring treatment effects through a self-administered protocol against a sham treatment for eight weeks.
The clinical evaluation will investigate the Injectrode’s mechanisms of action.
Using the neuromodulation platform as the active intervention, the clinical trial will measure the complete elimination of overactive bladder medication, as well as the percentage reduction in such medications from baseline to completion.
This Phase I/II study, being the first-in-SCI human study, will yield essential data for FDA presubmission discussions and will guide the design of future pivotal trials.
Simultaneously, the NIH funded a preclinical R01 proposal with a five-year, $3.2m grant. This collaborative effort between the University of Wisconsin, Massachusetts General Hospital, and Case Western Reserve University aims to enhance treatment for overactive bladder using the Injectrode’s two-component injectable electrode system.
The teams expect this method to significantly improve the nerve interface reliability, resulting in better long-term stability and fewer complications.
These grants increase the company’s total secured funding to $9.1m.
Neuronoff CEO Dr Manfred Franke said: “We appreciate the continued state and federal investment in developing micro-invasive neuromodulation therapies for chronic conditions. Currently, neurostimulation is primarily a ‘therapy of last resort’ due to invasive surgical requirements and associated costs.”
Last year, the company completed the first implants of its Injectrode device in a first-in-human study for chronic pain management.
