Neuronoff Breaks New Ground with $5 Million Funding for Innovative Neuromodulation Research

Neuronoff Signs Major Funding Deal for Neuromodulation Innovation

Neuronoff, Inc., a pioneering company in minimally invasive neuromodulation solutions, has recently announced a significant financial milestone that could advance its groundbreaking Injectrode® technology. The company has secured a total of $5 million in funding, which includes grants from the Department of Defense (DOD) and the National Institutes of Health (NIH).

Funding Breakdown

The funding comprises two key grants: one from the DOD amounting to $1.73 million, and another from the NIH totaling $3.2 million. The DOD funding is aimed at facilitating a clinical randomized controlled trial (RCT) focusing on treating neurogenic bladder in patients with spinal cord injuries. This study will be conducted in conjunction with the University of Texas Health Science Center in Houston, Texas, and will assess the safety and effectiveness of the Injectrode technology when implanted along the tibial nerve.

The NIH grant will support preclinical research aimed at improving treatment for overactive bladder, utilizing Neuronoff's unique two-component injectable electrode system designed for nerve interfacing. This development aligns well with the growing need for effective treatments for overactive bladder conditions, which affect millions globally.

Clinical Study Insights

The DOD-funded clinical trial, titled "Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Effectiveness Trial," aims to evaluate the Injectrode Tibial Nerve Stimulation (iTNS) approach. This three-year study will measure the procedure's effectiveness using an 8-week self-administered protocol versus a sham treatment. Additionally, it will focus on assessing the reduction and potential elimination of overactive bladder medications, establishing essential data for FDA presubmission and future pivotal trials.

Dr. Argyrios Stampas, the lead Principal Investigator (PI) of the study, emphasized the significance of improving long-term therapeutic reliability in treating neurogenic bladder, mentioning the difficulties posed by traditional methods that often require invasive procedures. The innovative needle-based delivery system provided by Injectrode aims to simplify the implantation process and minimize risks for patients.

Preclinical Research Collaboration

Simultaneously, the NIH’s five-year, $3.2 million grant supports a preclinical proposal titled "An Injectable Electrode to Better Isolate the Posterior Tibial Nerve to Treat OAB." This collaborative research involves teams from the University of Wisconsin, Case Western Reserve University, and Massachusetts General Hospital, focusing on enhancing treatment reliability using the Injectrode’s advanced technology for nerve engagement.

Dr. Kip Ludwig, who leads this preclinical effort, expressed excitement about validating this innovative tool, which integrates fiber optics for better visualization and facilitates optimized electrode placements for effective stimulation.

With this latest round of funding, Neuronoff now boasts a total of $9.1 million in secured funding, reflecting strong support from federal and state sources for the development of micro-invasive neuromodulation therapies. This funding is in addition to previous grants from NIH HEAL, DARPA, and the Ohio Third Frontier Research initiative.

Moving Forward

Dr. Manfred Franke, Neuronoff's CEO, acknowledged the importance of continuous investment in micro-invasive therapies for chronic conditions, especially as traditional neuromodulation approaches often represent a last resort due to their invasive nature. Neuronoff aims to change this narrative with its self-anchoring lead system, facilitating easier access to neuromodulation therapies for patients.

As more clinical data becomes available, Neuronoff hopes to enable a wider array of treatment options for conditions ranging from chronic pain to bladder and cardiac issues, all while working to significantly reduce healthcare costs.

For more information about Neuronoff and the innovative Injectrode technology, please visit Neuronoff's official website. Note that the Injectrode is currently classified as an investigational device, limited to investigational use only.