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: 10601686
• 负责人: Frank William Mauldin
• 金额: $ 40.31万
• 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/10601686
• 关键词: 3-Dimensional; Ablation; Acute Pain; American; Anatomy; Capital; 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 Name; Market Research; 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; Readiness; Resources; Risk; Sales; Secure; Services; Spinal; Sterility; Stream; Substance abuse problem; System; Technology; Three-Dimensional Image; Time; Validation; Vertebral column; Vision; Visualization; Work; associated symptom; base; bone; budget impact; care delivery; chronic back pain; chronic pain; chronic pain management; chronic painful condition; clinical efficacy; commercial application; commercialization; 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; 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.

项目总结/摘要 据估计，1亿美国人患有慢性疼痛，这给美国经济带来了损失。 > 500亿美元/年。虽然慢性疼痛可以非阿片类药物治疗，但长期阿片类药物治疗仍然是一个棘手的问题。 普通治疗，伴随住院风险增加，物质滥用障碍， 死亡2018年，超过1000万患者因慢性疼痛而接受长期阿片类药物治疗， 超过三分之一的类阿片相关死亡与用于治疗慢性疼痛的类阿片药物直接相关。在 简而言之，美国的医疗保健系统没有满足对非阿片类药物干预的需求，这导致 长期依赖阿片类药物治疗慢性疼痛。现行非药理学标准 治疗慢性背痛干预（存在于>40%的慢性疼痛病例中）包括靶向关节 注射、神经阻滞和在荧光图像引导下进行的神经消融。依赖 由于资金短缺，疼痛管理注射的荧光透视是医疗服务流中的一个关键结构性障碍。 设备成本、设施费用和人员限制。2004年， 近年来，尽管对慢性疼痛服务的需求增加，但这意味着医疗保健系统 开足马力迫切需要一种替代的制导解决方案， 但是可以在医生办公室环境中使用，以增加进入和减少 介入性疼痛服务的成本。 这个商业化准备试点（CRP）项目的重点是制定战略， 证明了Accuro 3S的临床和经济价值主张，Accuro 3S是一种移动的床边系统， 产生直观的脊柱解剖透视重建，并实现实时针引导， 在患者床边进行疼痛管理注射，同时达到比荧光透视低> 5倍的成本。上 具体目标，RIVANNA将与外部专家合作，进行多阶段的市场研究， 制定报销策略，并制定预算影响模型（BIM）和成本效益分析 （CEA）。这些要素相结合，预计将产生一个包罗万象的临床证据生成 RIVANNA可以执行的战略，以最好地定位Accuro 3S，通过未来的商业化 战略合作伙伴的投资和特定产品的报销申请。在第二个具体目标中， RIVANNA将与医疗器械制造专家合作，加快制造，验证， 以及无菌消耗品的监管批准，使得其在临床试验开始时可用。 该商业化项目的完成将弥补Accuro 3S商业化的关键差距 这条道路，使RIVANNA能够最大限度地提高早期市场渗透率，并努力实现长期愿景， 通过改变护理标准来改善慢性疼痛管理的结果。