Accuracy of Velacur in Assessing MASLD and MASH Patients Using Biopsy as the Gold Standard

Background/Objectives: Velacur^TM is a novel, point-of-care ultrasound device developed to accurately diagnose patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH). The Velacur system non-invasively assesses liver stiffness, attenuation, and the Velacurdetermined fat fraction (VDFF). In this study, the performance of Velacur was measured against biopsy results in a cohort of MASLD and MASH patients. Methods: This prospective study enrolled adult patients who were scheduled to undergo biopsy within 6 months of enrollment. The primary objective was to validate Velacur's findings against that of histological findings. The secondary objective was to compare Velacur results with those of FibroScan. Results: A total of 78 participants were enrolled, and 70 were included in the analysis. Patients had a mean age of 53.3 ± 13.1 years, with a mean BMI of 35.0 ± 6.24 kg/m². A total of 11, 19, 13, 25, and 2 were characterized as F0 to F4, respectively. The mean Velacur stiffness was 6.48 ± 1.4 kPa, and the mean VDFF was 14.4 ± 5.1%. In patients with significant fibrosis the Velacur AUC [95% CI] was 0.86 [0.76, 0.93] and 0.79 [0.66, 0.88] for patients with advanced fibrosis. For measurements of steatosis, 2, 24, 20, and 24 patients were found to have S0 to S3, respectively. To determine moderate steatosis (≥S2), the VDFF had an AUC of 0.846 [0.716, 0.920]. In the comparison population (n = 59), VDFF (0.85 [0.72, 0.94]) was significantly different than FibroScan CAP (0.50 [0.35, 0.66]) for the detection of moderate steatosis. Conclusions: This study validates the use of Velacur as a non-invasive tool for assessment of steatosis and fibrosis, hallmarks of MASLD and MASH, when compared to histological evidence provided via hepatic biopsy. Further, Velacur outperformed FibroScan in the assessment of steatosis.