BioRestorative Therapies Reports Positive Phase 2 Blinded Data for BRTX-100 Demonstrating Meaningful Improvements in Pain and Function in Chronic Lumbar Disc Disease
MELVILLE, N.Y., March 30, 2026 — 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.
“Importantly, the results also continue to reinforce the favorable safety and tolerability profile observed to date. In addition, following our recent Type B meeting with the U.S. Food and Drug Administration, we achieved alignment on key elements of a potential Phase 3 clinical trial for BRTX-100, including primary endpoints, statistical powering assumptions, dosing strategy, and the overall development framework. The agency did not raise safety concerns and confirmed that our CMC framework is appropriate for late-stage development.
“Taken together, these developments position the Company to transition from clinical evaluation toward registrational planning. As we move toward the planned unblinding of the Phase 2 study, we have begun preparing for the next stage of clinical development, including protocol planning and other Phase 3 readiness activities, while continuing to generate additional clinical data that may support the advancement and potential commercialization of BRTX-100,” concluded Mr. Alstodt.
Clinically meaningful improvements in both pain and functional outcomes were observed across multiple validated pain and function measures, including the Visual Analog Scale (“VAS”), Oswestry Disability Index (“ODI”), Roland-Morris Disability Questionnaire (“RMDQ”), and Functional Rating Index (“FRI”), with responses sustained for up to two years in patients with longer-term follow-up.
On the VAS for pain, 53.57% of patients reported greater than 50% improvement at 26 weeks (n=28), with the percentage of patients that reported greater than 50% improvement increasing to 75% at 52 weeks (n=12) and remaining 75% at 104 weeks (n=4).
Similar improvements were observed on the ODI, a widely used measure of functional impairment associated with spinal disorders. Blinded results from the abstract showed 53.57% of patients achieved greater than 50% improvement at 26 weeks (n=28), increasing to 74.63% of patients at 52 weeks (n=12), with 50% of patients maintaining that level of improvement at 104 weeks (n=4).
Improvements were also observed on the RMDQ, with 57.14% of patients experiencing greater than 50% improvement at 26 weeks (n=28), 50% of patients at 52 weeks (n=12), and 75% of patients at 104 weeks (n=4).
FRI demonstrated continued improvement over time, with 35.71% of patients achieving greater than 50% improvement at 26 weeks (n=28), increasing to 66.67% of patients at 52 weeks (n=12) and 50% of patients at 104 weeks (n=4).
Finally, at 26 weeks (n=28) 41% of patients reported a 50% improvement in both ODI and VAS, 55% of patients achieved a 50% improvement in both ODI and VAS at 52 weeks (n=12), and at 104 weeks (n=4) 57% of patients met a 50% improvement in both ODI and VAS.