A preclinical multi-modal system for dynamic noninvasive assessment of liver disease

Abstract Chronic liver disease (CLD) affects millions of people in America every year, and annually kills tens of thousands of these patients. Despite very active research efforts, there still have been no specific antifibrotic drugs approved by the FDA. The liver disease and drug development communities do not currently have well- validated, easy-to-use, noninvasive tools for studying the progression of liver fibrosis, steatosis, and inflammation in preclinical rodent models making it challenging to execute high-quality longitudinal studies. To address this need, SonoVol, Inc. has developed a novel benchtop imaging instrument capable of providing rapid in vivo measurements of liver disease in rodents. Phase I and Phase II research efforts have demonstrated the technical and scientific merit of the device and positioned it for widespread impact on the field. The following Commercialization Readiness Pilot Program proposal seeks additional funding to help accelerate SonoVol’s trajectory by providing key technical assistance and late-stage Randamp;D that will address three roadblocks to commercial adoption: manufacturing scalability, marketing positioning and messaging, and independent cross-validation. First, to meet customer demand and ensure product quality and conformity, SonoVol must implement scalable, regulated processes, which will be accomplished through implementation of quality management systems, lean manufacturing methodologies, and National Recognized Testing Laboratories (NRTL) certification. Second, SonoVol must refine the messaging strategy to market our product appropriately and begin validating product positioning for lead generation. Finally, independent cross-validation studies by end-users must be completed to provide compelling customer-facing example data and ensure confidence in the quality and reproducibility provided by SonoVol instruments. Following completion of these objectives, SonoVol will be well positioned to bridge the “valley of death” facing many new technology companies and bring a powerful in vivo imaging tool to the research community at large.Project Narrative Liver disease research is hampered by a lack of preclinical in vivo imaging tools that are affordable and easy to use. SonoVol has constructed a non-invasive imaging instrument to detect and stage disease in rodent livers. To bring this device to market, we must implement reproducible and compliant manufacturing, ensure marketing strategy and product positioning is optimized, and perform validation studies to assure the device consistently delivers the highest quality data. By bringing this device to market, SonoVol aims to improve public health by increasing the pace of preclinical liver disease research via lower-cost hardware and an automated approach to analyzing tissue injury.