Coridea NIH I-Corps Program

项目总结： 阿片类药物使用障碍(OUD)是最致命的成瘾。不仅有一个 由于存在严重的过量用药风险，OUD患者的寿命缩短了近20年。 此外，OUD经常与其他疾病并存，如难治性抑郁症。 和慢性疼痛。因此，有必要改进对OUD及其共病的治疗选择 条件。我们的目标是开发一种脑刺激方法来提高治疗反应。 我们的设备名为按需电刺激(ODE)，旨在刺激大脑中 与肥胖、抑郁症和慢性疼痛有关。我们的第一阶段SBIR应用程序提供了 开始开发ODE所需的资源，包括大脑模拟研究和工作台工作 使用人类头骨(作为体模)来测量我们电极产生的电场。这些 研究将用于完成与FDA一起制定的验证和验证计划。 我们申请i-Corps计划的目标是提高我们避免常见陷阱的能力 结束大多数学术/私人合作关系。I-Corps提供的关于医疗的见解 报销、监管策略和临床前开发将用于修改和 加强我们的商业化计划。通过i-Corps计划，我们的团队将定位于 更好地了解我们的潜在客户需求和植入的可接受性 刺激电极。这将不仅包括患者群体经历OUD和共病 条件，还有医生。

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.