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.
Public Health Relevance Statement: PROJECT NARRATIVE Chronic pain conditions impact an estimated 100 million Americans, result in total healthcare expenditures of more than $500 billion per year, and are a key contributor to the US opioid epidemic. Expanding access to interventional pain medicine services is crucial for decreasing the use of long-term prescription opioid treatments for managing chronic pain, but the reliance on fluoroscopic imaging guidance places bottlenecks in the care-delivery stream and significantly limits patient access to these interventional procedures. Therefore, the goal of this project is to develop commercialization strategies that will maximize early market penetration of a mobile, bedside system that provides intuitive fluoroscopy-like visualization of spine anatomy without the use of ionizing radiation, enables real-time needle guidance during interventional procedures performed in the spine, and increases patient access to non-opioid based therapies for alleviating symptoms associated with chronic pain.
Project Terms: Pain management; Pain Control; Pain Therapy; pain treatment; Anatomy; Anatomic; Anatomic Sites; Anatomic structures; Anatomical Sciences; bone; Capital; Clinical Trials; Cessation of life; Death; Disease; Disorder; Elements; Equipment; Health Expenditures; health care expenditure; healthcare expenditure; Fluoroscopy; Future; Goals; Growth; Generalized Growth; Tissue Growth; ontogeny; Hand; Healthcare Systems; Health Care Systems; Hospitalization; Hospital Admission; image reconstruction; image construction; image generation; Intelligence; Investments; Joints; Market Research; Medical Device; Medicine; Needles; Nerve; Neural Block; Neural Blockade; Nerve Block; Neurology; Painful; Pain; Patients; Pelvic; Pelvic Region; Pelvis; Physicians' Offices; pilot study; Pilot Projects; Production; Ionizing Electromagnetic Radiation; Radiation-Ionizing Total; ionizing output; Ionizing radiation; Research Resources; Resources; Risk; Sales; Spinal Column; Spine; backbone; Vertebral column; Technology; Time; Vision; Sight; visual function; Work; Generations; Healthcare; health care; chronic pain; base; Acute Pain; Procedures; Clinical; Penetration; Phase; Intuition; Individual; non-narcotic analgesic; non-opiate analgesic; non-opioid; non-opioid therapeutics; nonnarcotic analgesics; nonopiate analgesic; nonopioid; nonopioid analgesics; non-opioid analgesic; Funding; Oncology Cancer; Oncology; Stream; System; 3-D; 3D; three dimensional; 3-Dimensional; Spinal; Ablation; Services; American; success; care delivery; sterile; Sterility; healthcare economics; health care economics; research study; Position; Positioning Attribute; abuse of substances; substance abuse; Substance abuse problem; Modeling; Intervention Strategies; interventional strategy; Intervention; Manufacturer Name; Manufacturer; 3-D Images; 3-D image; 3D image; 3D images; Three-Dimensional Image; Pharmaceutical Agent; Pharmaceuticals; Pharmacological Substance; Pharmacologic Substance; Preparedness; Readiness; cost efficient analysis; cost-effective analysis; Cost Effectiveness Analysis; Detection; Clinical Trials Design; Validation; Development; developmental; Image; imaging; cost; reconstruction; economic value; monetary value; design; designing; clinical efficacy; innovation; innovate; innovative; commercial application; commercialization; standard of care; common treatment; chronic back pain; product development; prescription opioid; licit opioid; opiate medication; opioid medication; prescribed opiate; prescribed opioid; prescription opiate; Secure; image guided; image guidance; imaging platform; imaging system; improved outcome; opioid use; opiate consumption; opiate drug use; opiate intake; opiate use; opioid consumption; opioid drug use; opioid intake; reduce symptoms; alleviate symptom; ameliorating symptom; decrease symptom; fewer symptoms; relieves symptoms; symptom alleviation; symptom reduction; symptom relief; associated symptom; co-morbid symptom; co-occuring symptom; comorbid symptom; concurrent symptom; cooccuring symptom; symptom association; symptom comorbidity; opioid epidemic; opiate crisis; opioid crisis; opioid therapy; opiate therapy; opioid mortality; opiate deaths; opiate mortality; opioid deaths; opioid overdose death; opioid related death; intervention cost; chronic painful condition; chronic pain condition; chronic pain disorder; Injections; first-in-human; first in man; Visualization; budget impact; chronic pain management; chronic pain control; chronic pain intervention; chronic pain therapy; chronic pain treatment; treat chronic pain; ultrasound
