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）每年都会影响美国数百万的人，每年杀人数十名这些患者中有成千上万。尽管研究工作非常积极，但仍然没有特定的抗纤维化 FDA批准的药物。肝病和药物开发社区目前没有很好的经过验证的，易于使用的无创工具，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执行高质量纵向研究的挑战。到满足这种需求，Sonovol，Inc。开发了一种能够提供的新型台式成像工具啮齿动物中肝病的体内快速测量。第一阶段和第二阶段的研究工作证明了该设备的技术和科学优点，并将其定位为宽度的影响场地。以下商业化准备性试点计划提案寻求额外的资金来帮助通过提供关键的技术帮助和后期研发，加速Sonovol的轨迹商业采用的三个障碍：制造可扩展性，营销定位和消息传递，以及独立的交叉验证。首先，满足客户需求并确保产品质量和合规性， Sonovol必须实施可扩展的规范流程，这将通过实施来完成质量管理系统，精益制造方法和国家认可的测试实验室（NRTL）认证。第二，Sonovol必须完善消息传递策略以推销我们的产品适当地开始验证潜在客户生成的产品定位。最后，独立的交叉验证最终用户的研究必须完成，以提供引人注目的面向客户的示例数据并确保对Sonovol Instruments提供的质量和可重复性的信心。完成这些目标，Sonovol将有很好的位置，可以弥合许多新技术面对的“死亡谷” 公司并将强大的体内成像工具带到整个研究社区。