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

摘要 慢性肝病（CLD）每年影响美国数百万人，每年导致数十人死亡。 成千上万的病人。尽管非常积极的研究努力，仍然没有具体的抗纤维化 FDA批准的药物。肝病和药物开发社区目前还没有很好的- 经验证的，易于使用的，非侵入性的工具，用于研究肝纤维化，脂肪变性， 临床前啮齿动物模型中的炎症使得执行高质量的纵向研究具有挑战性。到 解决这一需求，Sonopartum，Inc.开发了一种新型的台式成像仪器， 啮齿类动物肝脏疾病的快速体内测量。第一阶段和第二阶段的研究工作 展示了该设备的技术和科学价值，并将其定位为对世界的广泛影响。 领域以下商业化准备试点计划提案寻求额外资金，以帮助 通过提供关键的技术援助和后期研发来加速Sonoport的发展轨迹， 商业采用的三个障碍：制造可扩展性、营销定位和信息传递，以及 独立交叉验证。第一，满足客户需求，确保产品质量和符合性， Sonoprosthesis必须实施可扩展的、受监管的流程，这将通过实施 质量管理体系、精益生产方法和国家认可的测试 实验室（NRTL）认证。第二，Sonopolitan必须完善信息策略，以营销我们的产品 并开始验证产品定位，以产生潜在客户。最后，独立交叉验证 必须完成最终用户的研究，以提供令人信服的面向客户的示例数据，并确保 对Sonopolitan仪器提供的质量和再现性充满信心。在完成这些 目标，Sonopolitan将很好地定位，以弥合“死亡之谷”面临的许多新技术 公司，并带来了一个强大的体内成像工具，以研究界在大。

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 R&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.