Core Insights - BioRestorative Therapies, Inc. presented promising preliminary data for its lead product BRTX-100 at the ORS annual meeting, indicating significant improvements in pain and function for patients with chronic lumbar disc disease [1][5][7] Company Overview - BioRestorative is a clinical stage regenerative medicine company focused on stem cell-based therapies, particularly for musculoskeletal disorders and metabolic diseases [8] - The company is developing BRTX-100, a cell-based therapy targeting areas with low blood flow, currently in a Phase 2 clinical trial for chronic lumbar disc disease [3][8] Clinical Trial Details - The ongoing Phase 2 trial of BRTX-100 involves up to 99 subjects across 16 clinical sites in the U.S., with a randomized 2:1 allocation to treatment or placebo [3] - Preliminary data from the first 15 patients showed no serious adverse events and no dose-limiting toxicity at the 26-52 week mark [4] Efficacy Results - At 26 weeks, the average improvement in the Visual Analog Scale (VAS) for pain was 71.20%, and at 52 weeks, it was 73.58% [5] - The Oswestry Disability Index (ODI) showed an average improvement of 69.04% at 26 weeks and 65.16% at 52 weeks, both significantly exceeding the FDA's minimum threshold of 30% improvement [5] Imaging Analysis - MRI comparisons at 52 weeks indicated potential disc microenvironment remodeling, including increased hydration and reduced protrusion size, suggesting positive morphological changes due to BRTX-100 treatment [6] Future Outlook - The CEO expressed optimism regarding the trial's ability to meet primary and secondary endpoints, which could lead to FDA approval [7]
BRTX-100 Front and Center at ORS 2025