News & Events zu BioRestorative Therapies Inc (BRTX)BRTXBioRestorative Therapies Inc

BioRestorative Therapies Doses Last Patient in BRTX-100 Clinical Trial

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.

BioRestorative Therapies Presents New Data at International Society for Cell & Gene Therapy Meeting

BioRestorative Therapies announces the presentation of new preclinical data at the International Society for Cell & Gene Therapy 2026 Annual Meeting, which took place May 6-9 in Dublin, Ireland. The data highlight the functional and proteomic differences of extracellular vesicles, including exosomes, derived from multiple mesenchymal stem cell sources. Detailed in an oral presentation titled, "MSC Exosome Proteomics Reveal Source-Specific Therapeutic Applications," the study demonstrates that EVs derived from distinct MSC sources, including umbilical cord, brown adipose tissue, and bone marrow, exhibit unique protein signatures and biological functions that may enable targeted therapeutic and commercial applications. The data were presented on May 6, 2026. Proteomic and gene ontology analyses revealed several key functional pathways associated with specific MSC-derived EV populations:Proliferation and regenerative signaling: Enrichment in RNA and mRNA metabolic processes supports cellular growth, tissue regeneration, and remodeling; Cell adhesion and immune modulation: Enhanced signaling related to cell-substrate adhesion, phosphorylation, and immune response regulation supports extracellular matrix remodeling, wound healing, and inflammation control; Epidermal differentiation and barrier formation: Enrichment in keratinization and cornification pathways supports skin barrier repair, scar modulation, and keratinocyte function. Collectively, these findings support the development of differentiated EV-based formulations tailored to specific applications within regenerative aesthetics and dermatology, providing a framework for aligning source-specific biological activity with targeted clinical and commercial use cases. The Company believes these functional insights have direct implications for its BioCosmeceutical platform, enabling the design of targeted product formulations across a range of aesthetic and dermatologic use cases, including: Skin rejuvenation and anti-aging applications, leveraging regenerative signaling to support collagen production and epidermal renewal; Post-procedural recovery solutions, designed to accelerate healing and reduce inflammation following aesthetic treatments; Scar and wound repair formulations, supporting improved tissue remodeling and barrier; restoration; Barrier repair and hydration therapies, aimed at improving skin integrity and reducing trans-epidermal water loss Hair and scalp health applications, targeting follicle activation and regenerative signaling pathways.