Commercialization readiness for a 3D image guidance system to support interventional procedures in the spine and pelvis

支持脊柱和骨盆介入手术的 3D 图像引导系统已做好商业化准备

• 批准号: 10709021
• 负责人: Frank William Mauldin
• 金额: $ 34.2万
• 依托单位: RIVANNA MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-22 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10709021
• 关键词: 3-Dimensional; Ablation; Acceleration; Acute Pain; American; Anatomy; Capital; Certification; Cessation of life; Clinical; Clinical Trials; Clinical Trials Design; Cost Effectiveness Analysis; Detection; Development; Disease; Elements; Equipment; Fluoroscopy; Funding; Future; Generations; Goals; Growth; Hand; Health Expenditures; Healthcare; Healthcare Systems; Hospitalization; Image; Individual; Injections; Intelligence; Intervention; Intuition; Investments; Ionizing radiation; Joints; Manufacturer; Market Research; Marketing; Medical Device; Medicine; Modeling; Needles; Nerve; Nerve Block; Neurology; Oncology; Pain; Pain management; Patients; Pelvis; Penetration; Pharmacologic Substance; Phase; Physicians' Offices; Pilot Projects; Positioning Attribute; Procedures; Production; Resources; Risk; Sales; Secure; Services; Spinal; Sterility; Stream; Substance abuse problem; System; Technology; Three-Dimensional Image; Time; Validation; Vertebral column; Visualization; Work; associated symptom; bone; budget impact; care delivery; chronic back pain; chronic pain; chronic pain management; chronic painful condition; clinical efficacy; commercial application; commercialization; commercialization readiness; common treatment; cost; design; economic value; first-in-human; health care economics; image guided; image reconstruction; imaging platform; imaging system; improved outcome; innovation; intervention cost; manufacture; non-opioid analgesic; opioid epidemic; opioid mortality; opioid therapy; opioid use; prescription opioid; product development; reconstruction; reduce symptoms; research study; standard of care; success; ultrasound

PROJECT SUMMARY/ABSTRACT An estimated 100 million Americans suffer from chronic pain conditions, costing the US economy >$500B/yr. Although chronic pain can be treated non-pharmacologically, long-term opioid therapy remains a common treatment, with accompanying increase in risk of hospitalizations, substance abuse disorders, and death. In 2018, over 10 million patients were prescribed long-term opioid therapy for chronic pain, even though over one-third of opioid-related deaths are directly related to pharmaceutical opioid use for chronic pain. In short, the US healthcare system has not met the demand for non-opioid interventions, which has resulted in continued reliance on long-term opioid use for treating chronic pain. The current non-pharmacological standard of care for chronic back pain intervention (present in >40% of chronic pain cases) consists of targeted joint injections, nerve blocks, and nerve ablation performed under fluoroscopic image guidance. Reliance on fluoroscopy for pain management injections is a key structural barrier in the care-delivery stream due to capital equipment costs, facilities expenses, and staffing constraints. Only modest growth in procedures occurred in recent years despite increased demand for chronic pain services, implying that the healthcare system is operating at full capacity. There is a pressing need for an alternative guidance solution that matches the efficacy of fluoroscopy but can be employed in a physician office setting to increase access to and decrease the cost of interventional pain services. This commercialization readiness pilot (CRP) project focuses on the generation of strategy to demonstrate the clinical and economic value proposition for the Accuro 3S, a mobile, bedside system that produces intuitive fluoroscopy-like reconstructions of spine anatomy and enables real-time needle guidance for pain management injections at the patient bedside while reaching a cost >5x less than fluoroscopy. In the first specific aim, RIVANNA will partner with external experts to conduct a multi-phase market research study, develop a reimbursement strategy, and develop a Budget Impact Model (BIM) and Cost Effectiveness Analysis (CEA). These elements, in combination, are expected to generate an all-inclusive Clinical Evidence Generation Strategy that RIVANNA can execute to best position the Accuro 3S for commercialization via future investment from strategic partners and product-specific reimbursement petitioning. In the second specific aim, RIVANNA will partner with medical device manufacturing experts to expedite the manufacturing, validation, and regulatory approval of a sterile consumable so that it will be available when clinical trials commence. Completion of this commercialization project will bridge critical gaps in the Accuro 3S commercialization path, enabling RIVANNA to maximize early market penetration and work toward the long-term vision of improving outcomes in chronic pain management by changing the standard of care.

项目摘要/摘要 估计有1亿美国人患有慢性疼痛状况，使美国经济造成了损失 > $ 500B/年。尽管慢性疼痛可以非药理学治疗，但长期的阿片类药物疗法仍然是 常见治疗，随附住院风险增加，药物滥用障碍和 死亡。在2018年，超过1000万患者被处方长期的阿片类药物治疗，以缓解慢性疼痛，尽管 超过三分之一的与阿片类药物相关的死亡与用于慢性疼痛的药物治疗直接相关。在 简而言之，美国医疗保健系统尚未满足对非阿片类干预措施的需求，这导致了 继续依赖长期治疗慢性疼痛的长期使用。当前的非药理学标准 护理慢性背痛干预（> 40％的慢性疼痛病例）由目标关节组成 在荧光镜图像指导下进行的注射，神经阻滞和神经消融。依靠 用于疼痛管理注射的透视镜检查是由于资本引起的护理流量流的关键结构障碍 设备成本，设施费用和人员配备限制。程序中只有适度的增长发生在 尽管对慢性疼痛服务的需求增加了近年，这意味着医疗保健系统是 满负荷运行。迫切需要一种替代指导解决方案，该解决方案与 荧光镜检查的功效，但可以在医师办公室设置中使用，以增加访问并减少 干预疼痛服务的成本。 这个商业化准备飞行员（CRP）项目的重点是生成策略 演示精确3S的临床和经济价值主张，这是一种移动的床头系统 产生脊柱解剖结构的直观透视样重建，并实现实时针头指导 患者床边注射疼痛管理，同时比荧光镜少5倍。在第一个 特定目的，里凡娜（Rivanna）将与外部专家合作，进行多相市场研究， 制定报销策略，并制定预算影响模型（BIM）和成本效益分析 （CEA）。这些元素结合在一起，有望产生全包临床证据 Rivanna可以执行的策略以最好的定位准确的3S通过未来的商业化。 战略合作伙伴的投资和特定于产品的报销请愿。在第二个特定目标中， Rivanna将与医疗设备制造专家合作，以加快制造，验证， 并批准可消耗的无菌性批准，以便在临床试验开始时可用。 该商业化项目的完成将弥合精确3S商业化的关键差距 路径，使Rivanna能够最大化早期市场渗透率，并致力于长期愿景 通过改变护理标准来改善慢性疼痛管理的结果。