RIVANNA®, developers of world-first imaging-based medical technologies, has been awarded a $2.21 million Small Business Innovation Research (SBIR) Direct to Phase II (R44) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to develop an ultrasound guidance solution for pediatric lumbar punctures (LPs) on its Accuro® 3S platform.
Lumbar punctures are critical in treating acute lymphoblastic leukemia (ALL)—the most common childhood cancer, comprising about 25% of pediatric cases. LPs serve a dual purpose: confirming diagnosis and delivering intrathecal chemotherapy. During a typical two-year treatment period, a child may undergo up to 20 LPs.
However, traditional LP procedures can often be challenging, leading to traumatic lumbar punctures (TLPs)—procedures in which cerebrospinal fluid becomes contaminated with blood. TLPs, which affect up to 38% of procedures are associated with poorer patient outcomes. These complications are largely due to procedural difficulty, especially in very young children, or those with a high body mass index (BMI).
Fluoroscopy is often used to improve LP success rates in challenging cases, but reliance on fluoroscopic guidance poses cumulative radiation risks, which is particularly concerning for pediatric patients who undergo multiple LP procedures. Despite evidence that ultrasound guidance reduces TLP rates while eliminating ionizing radiation exposure, blind palpation or fluoroscopy guidance remain the standard of care due to the training and workflow complexity of LP guidance using traditional ultrasound systems. To address this unmet need, RIVANNA will develop dedicated pediatric LP features for its Accuro 3S imaging platform—an advanced, compact, AI-enabled bedside ultrasound system.
Accuro 3S combines cutting-edge hardware innovations with intelligent algorithms that automatically detect spinal anatomy and guide clinicians to the ideal needle insertion site, even in anatomically challenging patients. The platform features novel Dual-Array™ transducer technology supporting “through-the-probe” needle trajectory. A single-use, sterile accessory is also under development to secure the probe on the patient’s back, enabling the clinician to focus fully on needle control and tactile feedback.
The Accuro 3S platform is being adapted to support a broad spectrum of pediatric body sizes, from infants with delicate anatomy to adolescents with higher BMI. The system is designed to shorten the learning curve for ultrasound guidance, enabling procedural proficiency after only a few supervised procedures. By minimizing failed attempts and TLPs, Accuro 3S has the potential to improve treatment outcomes and support increased survival rates for children with ALL, while improving patient and provider satisfaction.
“This project represents a significant step toward safer, more effective spinal interventions for pediatric oncology patients,” said Paul Sheeran, PhD, Director of Research and Development at RIVANNA. “The Accuro 3S platform features our proprietary AI-BoneEnhance® imaging and SpineNav-AI™ anatomical recognition technologies, making it a well-tailored solution to improve care for pediatric ALL patients. These capabilities simplify the procedure, reduce the learning curve, and give clinicians greater precision and confidence when performing lumbar punctures in children with complex or variable anatomy.”
Preclinical development will involve AI features tailored for pediatric populations as well as collaborative usability, accuracy, and learning curve studies to ensure the platform meets clinical needs. RIVANNA acknowledges the following clinical collaborators for their contributions to the grant proposal:
- Michael Engel, MD, PhD — Chief of Pediatric Hematology and Oncology, University of Virginia Health
- Vlad Radulescu, MD — Professor of Pediatrics, Pediatric Hematology and Oncology, University of Kentucky College of Medicine
- Melinda Wu, MD, MCR — Assistant Professor of Pediatrics, Pediatric Hematology/Oncology, Oregon Health & Science University
- Nicholas Brenton, MD — Associate Professor of Pediatrics and Neurology, University of Virginia Children’s Hospital
- David Evans, MD — Chair, Division of Clinical Ultrasound; Professor of Emergency Medicine and Radiology, Virginia Commonwealth University
The research reported in the press release was supported by the National Cancer Institute (NCI) of the National Institutes of Health (NIH) under award number R44CA302033. This funding will total $2.2.1 million and will cover 100% of the project. The content is solely the responsibility of the authors and does not necessarily represent the official view of the National Institutes of Health.
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