BioRestorative Therapies, Inc. engages in the development of therapeutic products and medical therapies using cell and tissue protocols. Its programs provide quality of care for chronic back pain caused by disc degeneration and metabolic disorders, including obesity and diabetes. The company's initial investigational therapeutic product being called BRTX-100 focuses on treating damage by an autologous stem cell product that uses own stem cells that are harvested, cultured, and then injected directly into the affected disc to start the repair process. BioRestorative Therapies was founded on June 13, 1997 and is headquartered in Melville, NY.
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Founded
1997
Recruiting
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100.0%
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- BioRestorative Therapies has formed a strategic partnership with internationally recognized dermatology leader Dr. David J. Goldberg to conduct clinical validation studies for its regenerative BioCosmeceutical platform. - Dr. Goldberg will lead a prospective, controlled human clinical study evaluating the company's secretome-derived biologics enriched with exosomes, growth factors, cytokines, and peptides for skin appearance improvements. - The collaboration aims to generate publication-quality evidence supporting the platform's clinical role across professional and consumer applications while providing access to influential physician networks. - This partnership represents the third pillar of BioRestorative's foundational strategy, complementing its cGMP manufacturing capabilities and commercial execution framework established through previous collaborations.
- BioRestorative Therapies has been granted a Type B meeting with the FDA scheduled for mid-December to discuss an accelerated Biologics License Application approval pathway for BRTX-100 in chronic lumbar disc disease. - The company plans to present consistently positive safety and efficacy signals from its ongoing Phase 2 clinical trial and request an accelerated timeline for entering Phase 3 trials. - BRTX-100 is a novel autologous mesenchymal stem cell therapy that received Fast Track designation from the FDA in February 2025 for treating chronic lumbar disc disease. - The therapy targets a significant unmet medical need, as at least 80% of U.S. adults experience lower back pain during their lifetime, with no current treatments addressing disc degeneration reversal.
- BioRestorative Therapies received a Notice of Allowance from the Japanese Patent Office for its ThermoStem® platform, providing broad protection for brown adipose-derived stem cell technology targeting obesity and metabolic disorders. - The patent covers multiple delivery methods including alginate microcapsules, cellulose hydrogels, and polymer membranes, offering materially stronger protection than previously granted patents. - The company positions ThermoStem® as a potential cell-based alternative to GLP-1 drugs, addressing limitations such as tolerability issues, muscle mass loss, and cardiovascular risks associated with current therapies. - BioRestorative is engaged in ongoing discussions with a commercial-stage regenerative medicine company regarding licensing opportunities for its metabolic intellectual property portfolio.
- BioRestorative Therapies raised $1.085 million through a registered direct offering priced at $1.60 per share, above the previous closing price of $1.50. - The company is advancing BRTX-100, an autologous mesenchymal stem cell therapy currently in Phase 2 trials for chronic lower back pain from degenerative disc disease. - Funding will support clinical trials for BRTX-100, preclinical development of the ThermoStem metabolic program using brown adipose-derived stem cells, and commercial biocosmeceutical platform expansion. - The company has obtained FDA IND clearance to evaluate BRTX-100 for chronic cervical discogenic pain treatment.
- BioRestorative Therapies reported a 175% revenue increase to $401,000 in 2024, with a 24% improvement in operating loss and a strong cash position of $10.7 million with no outstanding debt. - The company's BRTX-100 stem cell therapy for chronic lumbar disc disease received FDA Fast Track designation following positive preliminary Phase 2 data, potentially accelerating its path to market approval. - BioRestorative expanded its clinical pipeline with FDA clearance for BRTX-100 to treat chronic cervical discogenic pain, while continuing discussions for potential licensing of its ThermoStem® metabolic technology for obesity and metabolic disorders.
- BioRestorative Therapies receives FDA Fast Track designation for BRTX-100, accelerating the development pathway for their chronic lumbar disc disease treatment program. - The Fast Track status highlights the significant unmet medical need in chronic lumbar disc disease treatment and potential of BRTX-100 to address this condition. - This regulatory milestone enables more frequent FDA interactions and potential eligibility for priority review, potentially expediting the therapy's path to market.
- BioRestorative Therapies reports positive preliminary data from its Phase 2 trial of BRTX-100 for chronic lumbar disc disease (cLDD). - The trial, involving 10 patients, showed no serious adverse events and no dose-limiting toxicity at 26-52 weeks. - At 52 weeks, 100% of subjects (n=4) reported a >30% improvement in pain (VAS) and function (ODI) versus baseline. - BRTX-100, a cell-based therapy, targets areas with limited blood flow and is being evaluated in a randomized, double-blinded, controlled study.
