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BioRestorative Therapies to Seek FDA Approval to Expand the Clinical Application of BRTX-100
Bruder Consulting & Venture Group engaged to expand BRTX-100 clinical indication pipeline MELVILLE, N.Y., March 13, 2023 (GLOBE NEWSWIRE) -- BioRestorative
About this update from Biorestorative Therapies, Inc.
[{"type":"text","content":"Bruder Consulting & Venture Group engaged to expand BRTX-100 clinical indication pipeline MELVILLE, N.Y., March 13, 2023 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that it has entered into an agreement with the Bruder Consulting & Venture Group (“BCVG”), a full service strategic advisory firm with focus areas in biologics, tissue repair, biomaterials and regenerative medicine. BCVG has been engaged to assist the Company in seeking FDA approval of the expansion of the clinical application of BRTX-100. BRTX-100 is the Company’s lead clinical candidate, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow. BRTX-100 is currently being evaluated in connection with a Phase 2 clinical trial in chronic lumbar disc disease (“cLDD\"). The trial is prospective, randomized, double-blinded and controlled. The trial will evaluate the safety and preliminary efficacy of a single dose of BRTX-100, including a specific release criteria of 40 million cells intradiscally injected into the nucleus of the lumbar disc. A total of up to 99 eligible patients will be randomized at up to 15 clinical sites in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion. “Finding the right partner such as BCVG is very meaningful to BioRestorative as they bring a tremendous amount of domain expertise in managing the regulatory pathway for cellular therapies. Additionally, we have the opportunity to leverage this musculoskeletal platform across other indications within the body. BCVG will assist us in choreographing this process, utilizing their deep industry insights and expertise within this sector,” said Lance Alstodt, CEO of BioRestorative The team at Bruder Consulting & Venture Group has over 300 years of collective expertise in orthopedics, spine, wound care, and plastic/reconstructive surgery. BCVG has worked with numerous companies across these domains in biologics, device and cell-based technologies. “We look forward to assisting BioRestorative with their goal of leveraging the important safety data from their Phase 2 cLDD trial to seek approval for additional INDs for BRTX-100,” said Scott Bruder, MD, PhD, CEO of the Bruder...