BioRestorative Therapies reports preliminary data from Phase 2 trial of BRTX-100

BioRestorative Therapies (BRTX) announced the presentation of preliminary blinded data from the first 36 subjects in its ongoing Phase 2 clinical trial of BRTX-100, an autologous stem cell therapy for chronic lumbar disc disease. This data was shared at the ISSCR 2025 Annual Meeting in Hong Kong by Francisco Silva, Vice President of Research and Development. The U.S. Food and Drug Administration is requiring at least a greater than 30% improvement in function in the Oswestry Disability Index and a greater than 30% reduction in pain on the Visual Analog Scale in determining whether the clinical trial will be allowed to proceed and ultimately gain Biologics License Application approval. Key Highlights: The number of subjects evaluated has increased from 15 to 36 since the Company’s last press release, an important milestone toward full Phase 2 enrollment. Over 74% of subjects showed greater than50% improvement in function by 52 weeks; Over 72% of subjects reported greater than50% reduction in pain by 52 weeks; Combined greater than50% improvement in both ODI and VAS measures was achieved by a meaningful portion of subjects across all timepoints. No serious adverse events or dose-limiting toxicities reported between 26 and 104 weeks at the target dose. Each new data analysis has outperformed prior releases, highlighting an upward trend in efficacy markers.