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FibroSIGHT™ Plus: Precision in Fibrosis Assessment with AI-based Analysis

Scientific Posters

Conference

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SABCS 2025

Evaluation of Spatial Collagen Morphometry in TNBC versus Non-TNBC Biopsies: A Cross-Sectional SHG/TPEF Imaging and AI-Based Analysis of Tumor and Non-Tumor Regions

Region-Specific Collagen Morphometric Parameters in HER2+ Breast Cancer versus TNBC: Insights from SHG/TPE Imaging and AI-Based Analysis

AASLD 2025

Denifanstat elicited a significant ≥2-stage improvement in fibrosis in F3 MASH patients, and improved liver fibrosis and biomarkers in qFibrosis stage 4 MASH patients: secondary analysis of phase 2b FASCINATE-2 study (Poster of Distinction*)

Impact of PNPLA3 p.I148M variant on qFibrosis-based liver fibrosis features in MASLD biopsies in the Milan Biobank cohort

Combination therapy in Metabolic Dysfunction – associated Steatohepatitis: GLP-1R Agonist with others

Efruxifermin reduced fibrosis and septa area by quantitative digital pathology in participants with compensated cirrhosis due to MASH: Results from the 96-week, placebo-controlled, phase 2b SYMMETRY trial.

AI-assisted digital pathology unveils patient heterogeneity in the antifibrotic response following bariatric surgery

Development and Validation of qInflammation: An AI-Driven Digital Pathology Algorithm for Differentiating Portal and Lobular Inflammation in Metabolic-Associated Steatohepatitis

Second harmonic generated imaging with qFibrosis provides quantitative information on fibrosis severity and predicts the future course of fibrosis in metabolic dysfunction associated steatotic liver disease (MASLD)

Zone-specific fibrosis reductions induced by pegozafermin over 24 weeks are similar in non-cirrhotic (F2/F3) and cirrhotic (F4) MASH (Poster of Distinction*)

Zonal dynamics of fibrosis progression and regression in a murine MASLD-HCC model using AI-Based collagen and steatosis analysis

EASL 2025

Denifanstat improves multiple qFibrosis-based collagen features linked to major adverse liver outcomes in patients with metabolic dysfunction-associated steatohepatitis patients and high polygenic risk

qFibrosis enables earlier detection of fibrosis response in Efruxifermin-treated patients with F2-F3 MASH in 96-week HARMONY study

Utilizing AI digital pathology for quantitative measurement, grading and differentiation of lobular and portal inflammation in MASH: preliminary analysis in liver histology

Artificial intelligence-driven qFibrosis® in alpha-1-antitrypsin deficiency-associated liver disease: correlation with METAVIR and other disease specific features

Fibroblast Activity (PRO-C3) and Liver Stiffness Correlate with spatial distribution of Collagens in MASLD and ALD: Insights from Digital Pathology

Characterization and validation of regional variation in fibrosis within traditional fibrosis stages

Subgroup definition and monitoring of liver fibrosis evolution in patients with MASH bridging fibrosis based on objective measurements of septa parameters using digital pathology with artificial intelligence analyses

Steatosis in Cirrhosis: A Prognostic Marker for Liver-Related Outcomes in MASLD

AASLD 2024

Fibrosis regression after Tirzepatide treatment of Non- cirrhotic MASH for 52 weeks occurred in a zone-dependent manner

Comparative evaluation of zonal fibrosis patterns in pediatric and adult metabolic dysfunction-associated steatohepatitis biopsies using Second Harmonic Generation/Two Photon Excitation-based qFibrosis analysis

Efruxifermin significantly reduced proportion of subjects with at-risk MASH and led to near-complete histological disease reversal at week 96 in the HARMONY study

AI and digital-based pathology corroborate reduction in fibrosis observed by conventional pathology with efruxifermin treatment of patients with F2-F3 MASH in the HARMONY study

Evaluating impact of weight changes on histological patterns of liver fibrosis in MASH: implications for spatial interrogation

Validating pre-identified morphological baseline features for predicting fibrosis progression in MAESTRO-NASH

Stain-free digital pathology imaging provides microarchitecturally-resolved insights into scar evolution and histological injury allowing direct clinical outcome prediction in metabolic dysfunction-associated steatotic liver disease

Evaluation of the consistency and heterogeneity of fibrosis assessment in adjacent virtual liver needle biopsies using AI- based qFibrosis

Independent validation of Second Harmonic Generation/Two- photon excitation imaging and artificial intelligence-based SNOF index for metabolic dysfunction associated steatohepatitis cirrhosis assessment

Application of artificial intelligence algorithm as a vascular evaluation tool for intra-stage assessment in the cirrhotic patients with metabolic dysfunction-associated steatotic liver disease

EASL 2024

Validation of optimal liver biopsy size for reliable quantitation of fibrosis severity in different areas and structure od liver lobule using SHG with AI analyses

Regional fibrosis progression analysed by digital pathology with artificial intelligence is associated with renal dysfunction

qBallooning AI-based ballooned hepatocyte detection and quantification by SHG TPE microscopy

GWAS analysis and digital pathology at patients without MASLD improvements prospective cohort 1 year study

Assessment of fibrosis changes rates in placebo arm of MASH drug trials based on pathologist readouts and qFibrosis continuous values

AI Digital pathology unmasked the No Change in conventional pathological assessment of MASLD patients with one year lifestyle intervention in a prospective cohort study

Stain-free digital pathology imaging provides microarchitecturally-resolved insights into scar evolution allowing direct clinical outcome prediction in metabolic dysfunction-associated steatotic liver disease

Identification and validation of pre-identified morphological baseline features for prediction of fibrosis progression in MAESTRO-NASH

AASLD 2023

Impact of sampling size on variability of fibrosis assessment in liver biopsies using SHG TPE and AI analysis based fibrosis staging

NITs as continuous measure of hepatic fibrosis in NAFLD

Validation of the HI AI DP platform as an aiding tool to increase pathologist concordance on fibrosis staging in NASH

Reducing screen failure rates for NASH clinical trials using ballooning and fibrosis assessment with SHG TPE microscopy and AI analysis – results from the TANDEM trial

Spatial distribution of collagen in MASLD affects levels of N terminal pro-peptide of type III collagen (PRO-C3)

The concomitant zonal quantification of qSteatosis and qFibrosis using HI AI DP improved detection of liver injury regression post-bariatric surgery

Assessment of resmetiron-mediated reductions of steatosis and concomitant ballooning utilizing quantitative SHG imaging

Differential anti-fibrotic effects of semaglutide and lanifranor demonstrated by AI DP in the biopsy-confirmed GAN BIO-MASH mouse model with advanced fibrosis and HCC

Use of multi-parametric measures to differentiate and better assess fibrosis patterns between baselie and EOT patients in NASH clinical trials – Results from the FALCON-1 and 2 clinical trials

EASL 2023

Combination therapy of TERN-501 with TERN-101 in GAN diet-induced and biopsy-confirmed mouse model

Impact of artificial intelligence-based zonal annotations as an additional assistive tool for the histopathologic review of fibrosis in non-alcoholic steatohepatitis patients

Repeatability and reproducibility assessment and its acceptable standard error of means for qFibrosis system in multi-site NASH clinical trials

Advancement of artificial intelligence in digital pathology from exploratory endpoint to primary endpoint in NASH clinical trials

Digital pathology using stain-free imaging indices as a tool for fibrosis quantification in patients with congestive hepatopathy

Artificial intelligence to measure fibrosis change on liver biopsy in MAESTRO-NASH: a Phase 3 52- week serial liver biopsy study in 966 patients with NASH treated with resmetirom or placebo

Hepatic fat and liver volume reductions – Impact on non-alcoholic steatohepatitis trials and potential solutions using concomitant fibrosis with ballooning with qFibrosis

Artificial intelligence assisted qFibrosis as a pathological “biomarker” to evaluate disease severity in patients with hepatocellular carcinoma

A deep exploration of bridging fibrosis evolution and individual septa parameters in NASH using quantitative second harmonic generation imaging reveals fibrosis changes in natural history and treatment-induced not seen with conventional histology

Quantification of vessel and bile duct parameters using Second Harmonic Generation in patients with NAFLD across fibrosis stages

Artificial Intelligence analysis of liver biopsies in pre-cirrhotic NASH: qFibrosis explained

Digital pathology with artificial intelligence analyses provides deeper insights into lifestyle intervention-induced fibrosis regression in NASH

Collagen co-localized with macrovesicular steatosis better differentiates fibrosis progression in non-alcoholic fatty liver disease mouse models

Paris NASH 2023

Digital quantitation of fibrosis, septa parameters and treatment-induced changes in metabolic dysfunction-associated steatohepatitis F3 fibrosis

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Comparing fibrosis distribution in lean versus overweight/obese NASH-cirrhosis patients using SHG/TPE microscopy: An observational analysis

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Artificial Intelligence to Measure Fibrosis Change on Liver Biopsy in MAESTRO-NASH, a Phase 3 52-Week Serial Liver Biopsy Study in 966 Patients With NASH Treated With Resmetirom or Placebo

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Impact of sampling size on variability of fibrosis assessment in liver needle biopsies using second harmonic generation/two photon excitation microscopy and artificial intelligence analysis based fibrosis staging

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