Coridea NIH I-Corps Program

PROJECT SUMMARY: Opioid Use Disorder (OUD) stands out as being the most lethal of addictions. Not only is there a significant risk of overdose, the life span of a patient with OUD decreased by almost 20 years. Furthermore, OUD is frequently comorbid with other disorders, such as treatment resistant depression and chronic pain. Thus, there is a need to improve treatment options for OUD and it’s comorbid conditions. Our goal is to develop a brain stimulation approach to improve treatment response. Our device, called On-Demand Electrostimulation (ODE) is designed to stimulate the brain regions that have been implicated in OUD, depression, and chronic pain. Our phase I SBIR application has provided the resources needed to begin developing ODE, including brain simulation studies and bench work using human skulls (as phantoms) to measure the electrical field generated by our electrodes. These studies will be used to complete a validation and verification plan in place with the FDA. Our goal in applying to the I-Corps program is to improve our ability to avoid the common pitfalls that end most academic/private partnerships. The insight provided by I-Corps regarding medical reimbursement, regulatory strategies, and pre-clinical development will be used to modify and strengthen our commercialization plan. Through the I-Corps program, our team would be positioned to adopt a better understanding of our potential customer needs and the acceptability of implanted stimulation electrodes. This would include not only patient populations experiencing OUD and comorbid conditions, but also physicians.