Accurate Point of Care Liver Disease Diagnostics, Phase II

1 PROJECT SUMMARY 2 Our long-term goal is to obtain FDA 510(k) clearance and to bring to market LiverScope®, a low cost, easy-to- 3 use, table-top, point-of-care (POC) device for use in research and clinical settings to assess quantitative 4 biomarkers of metabolic dysfunction-associated steatotic liver disease (MASLD, formerly nonalcoholic fatty liver 5 disease [NAFLD]). LiverScope® uses novel, noise-free, advanced magnetic resonance (MR)-based technology, 6 requires no room shielding, and can be sited in a standard clinic room for POC access or can be operated in a 7 small van for mobile diagnostic delivery. Our initial focus is to estimate proton-density fat fraction (PDFF), a 8 standardized MRI-based biomarker of hepatic steatosis. Our immediate goals (and the focus of this 9 Phase II SBIR application) are to implement novel, innovative improvements, complete development, and 10 perform performance and compliance testing of the LiverScope® product. The primary specific aims of this 11 proposal are to implement and test LiverScope® accuracy and penetration depth improvements in a phantom 12 and clinical study, and complete compliance testing in preparation for clinical evaluation (Aim 1), and to assess 13 LiverScope® performance in a clinical trial of adults with known or suspected MASLD (Aim 2). Successful 14 demonstration of quantitative metrics of success for Aims 1 and 2 will support application for FDA 510(k) 15 clearance. Likelihood of success in bringing LiverScope® to market is leveraged by initial published data, 16 promising Phase I results, prior conversations with the FDA, and patents to protect Livivos’ intellectual property. 17 After LiverScope is FDA cleared to estimate PDFF, we will investigate its capability to assess other potential 18 biomarkers of MASLD, such as T1 relaxation, T2 relaxation, and diffusivity (proposed biomarkers of liver disease 19 activity and damage).The innovation of the proposed work resides in the creation of novel technology to estimate 20 MR-based quantitative biomarkers of MASLD at low cost and in POC settings while maintaining the accuracy 21 and precision of full-size MRI scanners. The clinical significance of the proposed work is that widespread 22 implementation of this technology will enable earlier diagnosis, more timely referral to specialists, and greater 23 access to monitoring of MASLD. If the aims of this Phase II SBIR are met and FDA 510(k) clearance is obtained, 24 deployment in primary care, rural, underserved, and third-world communities will be possible. Future expansions 25 of LiverScope capability could be transformational to the medical care of patients with known or suspected 26 MASLD. This technology could support POC and mobile clinical application in numerous contexts of use, 27 including early detection, diagnosis, staging, monitoring, and treatment response assessment; early intervention 28 to prevent downstream hepatic and extrahepatic complications of MASLD; large-scale epidemiologic studies to 29 better understand the prevalence and pathophysiology of MASLD; and more efficient screening, enrollment, and 30 execution of clinical trials to accelerate drug discovery.