Biorestorative Therapies Inc Stock Price, News & Analysis

BioRestorative Therapies (NASDAQ: BRTX) has chosen 10 clinical sites for its Phase 2 trial targeting chronic lumbar disc disease. This double-blind, randomized study aims to evaluate the safety and preliminary efficacy of the investigational drug BRTX-100 through a single intradiscal injection. A total of up to 99 eligible patients will be randomized across 15 centers. The selection of high-caliber clinics is highlighted as a significant milestone, indicating BioRestorative's commitment to enhancing treatment options for patients suffering from this condition.

BioRestorative Therapies has completed certification of its clinical grade cell therapy manufacturing facility in Melville, NY, which meets FDA and EMA standards. This facility supports the ongoing Phase 2 trial of BRTX-100, targeting chronic lumbar disc disease. The trial includes up to 99 patients across 15 sites and is set to begin patient treatment in Q2 2022. The facility enhances quality control for BRTX-100 production, critical for the upcoming clinical trial. BioRestorative's focus remains on developing therapies using adult stem cells.

BioRestorative Therapies (NASDAQ: BRTX) has announced a research collaboration with Dr. Tore Bengtsson from Stockholm University to explore brown fat tissue's biology and its role in heat production. The collaboration aims to enhance understanding of the thermogenic response of BioRestorative's proprietary cell lines. This research is expected to benefit the company's ThermoStem program, which targets obesity and metabolic disorders using brown adipose-derived stem cells to promote caloric burning and improve metabolic health.

BioRestorative Therapies (NASDAQ: BRTX) announced a significant milestone with the U.S. Patent and Trademark Office granting a notice of allowance for a key patent related to its BRTX-100 clinical program.

This patent covers methods for preparing a stem cell population aimed at treating chronic lumbar disc disease, enhancing the therapeutic viability of the cells in low oxygen environments typical of damaged discs. CEO Lance Alstodt emphasized this development as crucial for fortifying the company’s intellectual property and clinical advancement in a promising market.

BioRestorative Therapies has announced the initiation of site selection for its Phase 2 clinical trial targeting chronic lumbar disc disease with BRTX-100. This double-blind, randomized trial will evaluate the safety and preliminary efficacy of an intradiscal injection in up to 99 patients across 15 centers in the U.S. The company emphasizes selecting sites with proven experience in similar studies to ensure adherence to good clinical practice standards.

BioRestorative Therapies announced its uplisting to Nasdaq and will celebrate by ringing the closing bell on February 7, 2022. CEO Lance Alstodt emphasized the company's commitment to validating its technology through regulatory processes, aiming to lead in the cellular therapy market. Over the past decade, BioRestorative has established a strong foundation in science and clinical translation while planning to expand its therapeutic pipeline. The company's core programs focus on BRTX-100 for disc/spine disease and ThermoStem for metabolic disorders.

BioRestorative Therapies, Inc. (NASDAQ: BRTX) announced a notice of allowance from the Japanese Patent Office for a patent linked to its ThermoStem® Program. This notice, issued on January 26, 2022, covers implantable three-dimensional scaffolds and brown adipocytes derived from human stem cells, aimed at delivering metabolically active cells for treating metabolic disorders. CEO Lance Alstodt emphasized this strengthens their global patent portfolio and highlights ThermoStem® as a viable treatment for diabetes and obesity, addressing significant unmet medical needs.

BioRestorative Therapies (NASDAQ:BRTX) has appointed Robert Paccasassi as Vice President of Quality Assurance/Regulatory Compliance. With over 25 years of experience in biotech and quality systems, he will oversee quality initiatives as the company begins patient enrollment for a Phase 2 clinical trial targeting chronic lumbar disc disease. Paccasassi’s past roles include significant positions at Merck KGaA, Regeneron, Millennium, and Biogen Idec. This leadership appointment aims to enhance the company's compliance and quality control in its stem cell therapy programs.