BioRestorative Therapies will present new Phase 2 data for its autologous, hypoxically cultured mesenchymal stem cell therapy, BRTX‑100, at the Orthopaedic Research Society (ORS) Annual Meeting on March 28, 2026 in Charlotte, North Carolina. The presentation follows the company’s completion of patient enrollment in a 99‑subject, randomized, prospective, double‑blind, sham‑controlled trial that enrolled participants across 15 U.S. sites and randomized them 2:1 to BRTX‑100 or placebo. The trial’s primary safety endpoint is the assessment of adverse events, while efficacy endpoints include a >30 % improvement in function (Oswestry Disability Index) and a >30 % reduction in pain (Visual Analog Scale) at week 52.
BRTX‑100 has received FDA Fast‑Track designation in February 2025 for chronic lumbar disc disease (cLDD), a condition that affects millions worldwide and represents a substantial unmet medical need. The company’s CEO, Lance Alstodt, emphasized the significance of the completed enrollment, stating, "This is a defining operational and clinical milestone for BioRestorative. Completing enrolment in what we believe is the largest and most rigorously designed Phase II cell‑therapy trial in chronic lumbar disc disease represents years of disciplined execution and scientific focus."
The company’s recent FDA Type B meeting provided constructive feedback and alignment on key elements of a future Phase 3 trial, including primary endpoints, statistical powering assumptions, dosing strategy, and the overall development framework. Alstodt noted, "Indeed, based on the compelling preliminary blinded Phase II data we have reported to date, together with constructive feedback from our recent FDA Type B meeting, we believe we have a clear and actionable pathway toward Phase III development and a potential BLA submission. We look forward to providing additional updates as we advance the programme in the very near future."
The positive outcome of the Type B meeting, combined with the Fast‑Track designation, gives BioRestorative a clear regulatory pathway toward a Phase 3 trial and a potential BLA submission. The company plans to initiate Phase 3 enabling activities and aims to submit the Phase 3 IND application in the second half of 2026, positioning BRTX‑100 to address a large, unmet market for non‑surgical regenerative therapies in cLDD.
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