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

用于肝病动态无创评估的临床前多模式系统

基本信息

批准号：
10258098
负责人：
Tomasz Joseph Czernuszewicz
金额：
$ 98.91万
依托单位：
SONOVOL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-20 至 2024-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10258098
关键词：
Academia Address Adoption Affect Alcohol abuse Americas Animal Disease Models Animal Model Animals Awareness Biological Markers Bolus Infusion Carbon Tetrachloride Certification Cessation of life Cirrhosis Clinic Clinical Communities Community Developments Contrast Media Core Facility Data Data Set Devices Disease Documentation Engineering Ensure FDA approved Fibrosis Frequencies Funding Generations Guidelines Hand Histology Image Imaging Device Imaging technology Industry Inflammation Infrastructure Institution Laboratories Laboratory Research Lead Left Lesion Liver Liver Fibrosis Liver diseases Longitudinal Studies Malignant Neoplasms Marketing Measurement Methodology Microbubbles National Institute of Diabetes and Digestive and Kidney Diseases Patients Penetration Pharmaceutical Preparations Pharmacologic Substance Phase Physics Positioning Attribute Preparation Process Public Health Readiness Reproducibility Research Research Personnel Robotics Rodent Rodent Model Safety Sales Scanning Serum Site Small Business Innovation Research Grant Staging Surveys System Techniques Technology Testing Thinness Three-Dimensional Image Time Tissues Transducers Ultrasonography United States Validation Viral hepatitis base chronic liver disease commercialization contrast enhanced cost design drug development dynamic system elastography improved in vivo in vivo imaging instrument interest manufacturing process multimodality new technology non-invasive imaging nonalcoholic steatohepatitis novel pre-clinical pre-clinical research programs quantitative ultrasound research and development response skills tissue injury tool validation studies voltage western diet

项目摘要

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.

抽象的慢性肝病 (CLD) 每年影响数百万人，每年导致数十人死亡成千上万的这样的病人。尽管研究工作非常积极，但仍然没有特异性的抗纤维化药物 FDA批准的药物。肝病和药物开发界目前没有很好的经过验证的、易于使用的非侵入性工具，用于研究肝纤维化、脂肪变性和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。到为了满足这一需求，SonoVol, Inc. 开发了一种新型台式成像仪器，能够提供啮齿动物肝脏疾病的快速体内测量。第一期和第二期研究工作已展示了该设备的技术和科学价值，并将其定位为对世界产生广泛影响场地。以下商业化准备试点计划提案寻求额外资金来帮助通过提供关键技术援助和后期研发来加速 SonoVol 的发展，以解决商业采用的三个障碍：制造可扩展性、营销定位和信息传递，以及独立的交叉验证。一、满足客户需求，保证产品质量和符合性， SonoVol 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、精益制造方法和国家认可的测试实验室（NRTL）认证。其次，SonoVol 必须完善消息传递策略来营销我们的产品适当地并开始验证潜在客户开发的产品定位。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 SonoVol 仪器的质量和再现性充满信心。完成这些后目标，SonoVol 将能够很好地弥合许多新技术面临的“死亡之谷” 公司并为整个研究界带来强大的体内成像工具。