BioRestorative presents Phase 2 data for BRTX-100: >50% improvement in pain/function in >70% of subjects

BioRestorative Therapies, Inc.

Preliminary blinded data from 36 subjects in Phase 2 trial of BRTX-100 for chronic lumbar disc disease presented at ISSCR 2025.
Over 74% of subjects showed >50% improvement in function (ODI) by week 52; over 72% had >50% pain reduction (VAS).
No serious adverse events or dose-limiting toxicities reported between 26 and 104 weeks at target dose of 40 million cells.
Number of evaluated subjects increased from 15 to 36 since last update; FDA requires >30% improvement thresholds.
CEO Lance Alstodt expressed confidence BRTX-100 can meet or exceed FDA thresholds for function and pain.

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