VentriGel (extracellular matrix hydrogel) / Ventrix - LARVOL DELTA

Injectable bioactive hydrogels as pharmacological drug delivery platforms for post-myocardial infarction cardiac repair: therapeutic cargo engineering, stimuli-responsive release mechanisms, and translational perspectives. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Preclinical studies consistently reported improvements in ventricular remodeling and cardiac function, while early clinical translation with VentriGel established feasibility and procedural safety in human patients. Injectable bioactive hydrogels represent a promising pharmacological strategy for post-MI cardiac repair by integrating biomaterial engineering with localized multi-dimensional drug delivery. Despite substantial preclinical progress, challenges including long-term safety, mechanistic standardization, large-animal validation, and regulatory complexity remain critical barriers to clinical translation."

Journal • Review • Cardiovascular • Fibrosis • Immunology • Myocardial Infarction • AMPK • TGFB1

Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients with Hypoplastic Left Heart Syndrome (HLHS) (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Emory University | Trial completion date: Sep 2027 ➔ Sep 2028 | Initiation date: Oct 2024 ➔ Aug 2025 | Trial primary completion date: Sep 2027 ➔ Sep 2028

Trial completion date • Trial initiation date • Trial primary completion date • Cardiovascular • Pediatrics

Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients With Hypoplastic Left Heart Syndrome (HLHS) (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Emory University

New P1 trial • Cardiovascular • Pediatrics

First-in-Man Study of a Cardiac Extracellular Matrix Hydrogel in Early and Late Myocardial Infarction Patients. (PubMed, JACC Basic Transl Sci) - "The primary endpoints were incidence of adverse events and abnormal clinical laboratory results. This first-in-man study established the safety and feasibility of delivering VentriGel in post-MI patients, thus warranting further evaluation in larger, randomized clinical trials."

Clinical • Journal

A Study of VentriGel in Post-MI Patients (clinicaltrials.gov) - P1; N=15; Completed; Sponsor: Ventrix, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Dec 2018 ➔ Jun 2019

Clinical • Trial completion • Trial completion date

A Phase 1, First-in-Man Trial of Percutaneous Delivery of A Porcine-Derived Cardiac Extracellular Matrix Hydrogel Following ST-Elevation Myocardial Infarction (SCAI 2019) - P1, N=15; NCT02305602; Sponsor: Ventrix, Inc.; "VentriGel was well tolerated with no significant events related to product. There were significant improvements in 6MWT and NYHA class post-delivery (Fig. 1A,B) and LV volumes were either maintained or improved in 11 out of 14 patients (by MRI) at 6 months, especially patients treated >1 year post-MI (Fig. 1C,D)."

P1 data