BioRestorative Therapies Reports Positive Phase 2 Blinded Data for BRTX-100 Demonstrating Meaningful Improvements in Pain and Function in Chronic Lumbar Disc Disease

Data showed 50% or more of patients reporting >50% improvement in key pain and function scales 

No adverse events related to dose-limiting toxicities associated with hypoxic-cultured mesenchymal stem cells

Presented at the 2026 Orthopaedic Research Society Annual Meeting

MELVILLE, N.Y., March 30, 2026 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative,” “BRTX,” or the “Company”) (Nasdaq:BRTX), a late-stage clinical regenerative medicine company focused on stem cell-based therapies and products, today announced blinded data from its Phase 2 clinical trial evaluating hypoxic-cultured mesenchymal stem cells for the treatment of chronic lumbar disc disease, with 50% or more of treated patients reporting improvements >50% across key pain and functional outcome measures and no adverse events related to dose-limiting toxicities. Importantly, the Phase 2 study efficacy endpoint is a greater than a 30% improvement in both the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) at 52 weeks, which is the minimum improvement needed to meet clinical efficacy success. Chronic lumbar disc disease is a leading cause of chronic lower back pain and disability, affecting millions of patients globally and representing a significant unmet need for non-surgical regenerative therapies.

These data were presented at the 2026 Orthopaedic Research Society Annual Meeting on March 28, 2026 at the Charlotte Convention Center in Charlotte, North Carolina. The Company delivered these data in a presentation titled, “Late-Stage Phase 2 Clinical Safety and Efficacy Data on Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells: Study Update.”

“These blinded data further support the therapeutic potential of our hypoxic-cultured mesenchymal stem cell technology, with patients demonstrating meaningful improvements across key pain and functional outcome measures,” said Lance Alstodt, BioRestorative Therapies President, Chief Executive Officer, and Chairman. “Even with blinded data, this signal provides us with confidence in the ultimate outcome of the study, and optimism moving forward with regard to the ultimate potential for meeting a medical need that has, to date, been inadequately addressed.

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