Coridea NIH I-Corps Program

Coridea NIH I-Corps 计划

• 批准号: 10541722
• 负责人: Howard Levin
• 金额: $ 5.49万
• 依托单位: CORIDEA, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2022-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10541722
• 关键词: Adopted; Brain; Brain region; Clinical; Devices; Disease; Electric Stimulation; Electrodes; Goals; Human; Implant; Innovation Corps; Longevity; Measures; Medical; Mental Depression; Mental disorders; Neurobiology; Patients; Phase; Physicians; Positioning Attribute; Privatization; Public Health; Resources; Small Business Innovation Research Grant; Substance Use Disorder; United States National Institutes of Health; Work; addiction; chronic pain; commercialization; comorbidity; cranium; design; electric field; experience; improved; insight; neural implant; opioid use disorder; overdose risk; patient population; preclinical development; programs; simulation; treatment response; treatment-resistant depression; verification and validation; Adopted; Brain; Brain region; Clinical; Devices; Disease; Electric Stimulation; Electrodes; Goals; Human; Implant; Innovation Corps; Longevity; Measures; Medical; Mental Depression; Mental disorders; Neurobiology; Patients; Phase; Physicians; Positioning Attribute; Privatization; Public Health; Resources; Small Business Innovation Research Grant; Substance Use Disorder; United States National Institutes of Health; Work; addiction; chronic pain; commercialization; comorbidity; cranium; design; electric field; experience; improved; insight; neural implant; opioid use disorder; overdose risk; patient population; preclinical development; programs; simulation; treatment response; treatment-resistant depression; verification and validation

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.

项目摘要： 阿片类药物使用障碍（OUD）脱颖而出是最致命的成瘾。不仅有一个 过量服药的巨大风险，OUD患者的寿命降低了近20年。 此外，OUD经常与其他疾病合并，例如抗治疗抑郁症 和慢性疼痛。那是有必要改善OUD的治疗选择，并且可以合并 状况。我们的目标是开发一种大脑刺激方法来改善治疗反应。 我们的设备称为按需静电刺激（ODE）旨在刺激大脑区域 在OUD，抑郁和慢性疼痛中隐含。我们的I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板凳工作 使用人体头骨（作为幻象）来测量我们的电子产品产生的电场。这些 研究将用于完成FDA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/私人伙伴关系。 I-Corps提供的有关医疗的见解 报销，监管策略和临床前发展将用于修改和 加强我们的商业化计划。通过I-Corps计划，我们的团队将被定位为 对我们的潜在客户需求有更好的了解和植入的可接受性 刺激电极。这不仅包括经历Oud和合并症的患者人群 条件，也是医生。