RIVANNA®, developers of world-first imaging-based medical technologies, has recently been awarded with a Peer-Reviewed Medical Research Program (PRMRP) Technology/Therapeutic Development Award (TTDA) from the Congressionally Directed Medical Research Program (CDMRP). The award total from this grant is $3 million over a 36-month period.
Annually, nearly 150,000 personnel in the United States (US) armed forces experience back pain and/or spinal injuries. These conditions cause an estimated 6 million limited-duty days and cost around $2 billion annually. An effective treatment that can mitigate inflammation and pain are epidural steroid injections (ESI). While this treatment may allow members to return to active duty more quickly, this approach requires real-time imaging guidance for accurate needle placement. This need was traditionally met with x-ray fluoroscopy, but for forward-deployed military hospitals, this technology is impractical for a number of reasons, such as cost, size, and the need for specialized facilities. Because of these issues, personnel often experience treatment delays and costly evacuations from theatre to access advanced imaging capabilities and specialized medical providers. There is a clear unmet need for a more effective, efficient solution that can be utilized in far-forward scenarios.
In order to address this need, RIVANNA will collaborate with leading military healthcare experts to develop the Accuro® 3S-MIL. For this project, RIVANNA will partner with The Geneva Foundation, a leading non-profit organization, which facilitates the Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) program. MIRROR was established by the Defense Health Agency (DHA) to support the treatment and care of non-combat-related musculoskeletal injury. Together, this collaboration will work to transform the standard of care for back pain and spinal injury in military settings.
This variant of Accuro 3S, a portable ultrasound guidance system, will be optimized for use in military settings by making the system more compact and durable within operational environments. Additional modifications will include integrating the device with military electronic health records systems and adaptation of AI-based imaging innovations for high performance with service member demographics. The 3S-MIL variant will undergo evaluations with military clinicians as well as validation studies to ensure its performance in military medical centers and hospitals.
RIVANNA also intends to file for FDA 510(k) clearance of the Accuro 3S-MIL as a commercial product. Through enabling the administration of ESI in military settings, 3S-MIL carries the potential to improve the military’s capability of addressing back pain, reducing the need for evacuations and allowing service members to return to duty more quickly. Planned follow-on clinical studies will assess the device’s impacts on cost-effectiveness and return to duty rates.
Furthermore, RIVANNA anticipates expanding the 3S-MIL’s indications for support of a wider array of neuraxial anesthesia and pain management applications that could enhance treatment in civilian and military settings. This mobile, radiation-free, easy-to-use device has the potential to become a new standard of care, potentially helping to treat millions of people living with back pain globally.
This initiative is supported by a distinguished team of collaborators, including:
- DoD Co-Principal Investigator: Xiaoning (Jenny) Yuan, Assistant Professor and Vice Chair for Research in Physical Medicine & Rehabilitation at the Uniformed Services University of the Health Sciences (USU); Director of the Musculoskeletal Injury Rehabilitative Research for Operational Readiness (MIRROR) Program; active clinician at Walter Reed National Military Medical Center (WRNMMC).
- DoD Co-Investigator: Dr. Edward Dolomisiewicz, Associate Program Director of the Physical Medicine and Rehabilitation Residency Program at WRNMMC in Bethesda, MD.
- Subject Matter Expert: Steven P. Cohen, Edmond I Eger Professor of Anesthesiology, Vice Chair of Research at Northwestern University; Professor and Director of Pain Research, Walter Reed National Military Medical Center; President-elect of the American Society of Regional Anesthesia and Pain Medicine (ASRA Pain Medicine); retired U.S. Army Colonel; recognized as a leading expert in pain management.
- Subject Matter Expert: Amitabh Gulati, President of the World Academy of Pain Medicine United (WAPMU); Director of Chronic Pain at Memorial Sloan Kettering Cancer Center in New York City.
- Sites: Walter Reed National Military Medical Center and the Uniformed Services University of the Health Sciences.
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