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

> **NIH NIH SB1** · SONOVOL, INC. · 2021 · $989,080

## Abstract

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.

## Key facts

- **NIH application ID:** 10258098
- **Project number:** 2SB1DK112492-04A1
- **Recipient organization:** SONOVOL, INC.
- **Principal Investigator:** Tomasz Joseph Czernuszewicz
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $989,080
- **Award type:** 2
- **Project period:** 2016-09-20 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10258098

## Citation

> US National Institutes of Health, RePORTER application 10258098, A preclinical multi-modal system for dynamic noninvasive assessment of liver disease (2SB1DK112492-04A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10258098. Licensed CC0.

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