BioRestorative Reports Compelling Preliminary Data for FDA-Fast-Tracked BRTX-100 – an Autologous Stem Cell Therapy to Treat Chronic Lumbar Disc Disease

Core Insights - BioRestorative Therapies, Inc. presented promising preliminary data for its BRTX-100 therapy at the ISSCR 2025 Annual Meeting, showing over 50% improvement in pain and function for chronic lumbar disc disease (cLDD) patients [1][4][5] - The number of evaluated subjects in the ongoing Phase 2 clinical trial has more than doubled, indicating significant progress towards full enrollment [1][5] Clinical Trial Data - In the Phase 2 trial, 67.57% of subjects showed over 50% improvement in function (ODI) and 73.82% reported over 50% reduction in pain (VAS) at 12 weeks [4] - By 52 weeks, over 74% of subjects demonstrated over 50% improvement in function and over 72% reported significant pain reduction [5] - The trial aims to enroll up to 99 subjects across 16 U.S. sites, with a randomized, double-blinded, placebo-controlled design [6] Safety and Efficacy - No serious adverse events or dose-limiting toxicities were reported between 26 and 104 weeks at the target dose of 40 million cells, indicating an excellent safety profile [5] - Each new data analysis has shown an upward trend in efficacy markers, enhancing confidence in the therapy's potential to meet FDA thresholds for approval [5][4] Company Overview - BioRestorative focuses on developing stem cell-based therapies for serious musculoskeletal conditions, with BRTX-100 as its lead candidate for treating painful lumbosacral disc degeneration [7] - The company also has a metabolic program targeting obesity and metabolic disorders, and a commercial BioCosmeceutical platform aimed at aesthetic applications [8][9]