BRTX News & Events

BioRestorative Therapies announced the appointment of Zachary Smith as Vice President, VP, of its Biocosmeceuticals Division, further strengthening the Company's commercial leadership team as it expands its presence within the regenerative aesthetics and advanced skincare market.

BioRestorative Therapies shareholder Kaos Capital, a Miami-based hedge fund focused on activist investing, has acquired 4.9% of the issued and outstanding common stock of the company. This ownership stake was acquired in the open market through normal course stock purchases. Kaos Capital believes that BRTX represents a compelling opportunity, as the public vehicle may be better positioned for a strategic pivot into the AI space. Kaoss believes that BRTX shareholders are not currently gaining meaningful value from the existing business and that the company should explore a comprehensive strategic review and consider a pivot into a broader range of AI opportunities. Kaos Capital intends to seek an immediate meeting with the Board to discuss the company's strategy, operations, corporate governance, and potential pathways, including a possible pivot into AI.

BioRestorative Therapies announced that the last patient has been dosed in its fully enrolled Phase 2 clinical trial evaluating BRTX-100 for the treatment of chronic lumbar disc disease, completing treatment administration in the Company's lead clinical program and advancing the study into the next stage of blinded follow-up ahead of expected topline safety and efficacy data in Q2 2027. The prospective, randomized, double-blind, sham-controlled, single-disc Phase 2 study enrolled approximately 99 patients across U.S. clinical sites and is designed to evaluate the safety and preliminary efficacy of BRTX-100 in patients with painful chronic lumbar disc disease. Subjects were randomized in a 2:1 ratio to receive either BRTX-100 or control treatment. The primary safety endpoints for the trial include the frequency and severity of adverse events and serious adverse events, as well as imaging-related findings. The primary efficacy responder endpoint is defined as at least a 30% improvement from baseline in both pain -- as measured by the Visual Analog Scale -- and function --as measured by the Oswestry Disability Index, at week 52. Study follow-up assessments are being conducted at weeks 2, 12, 26, 52 and 104, with MRI evaluations at baseline, week 52 and week 104.