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

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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.