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BioRestorative Therapies, Inc., a clinical stage company with a focus on stem cell-based therapies, has recently announced a new partnership with Bruder Consulting & Venture Group (BCVG). This strategic alliance aims to seek FDA approval for the expansion of the clinical application of BRTX-100, BioRestorative's lead clinical candidate.
Bruder Consulting & Venture Group's Role
BCVG, a full-service strategic advisory firm with a focus on biologics, tissue repair, biomaterials, and regenerative medicine, has been engaged to help BioRestorative navigate the complex regulatory pathway to gain FDA approval for expanded clinical indications of BRTX-100.
"BCVG brings a tremendous amount of domain expertise in managing the regulatory pathway for cellular therapies. We look forward to leveraging their deep industry insights and expertise." - Lance Alstodt, CEO of BioRestorative
BRTX-100: The Lead Clinical Candidate
BRTX-100 is a novel cell-based therapy designed to target areas of the body with little blood flow. This innovative therapeutic is currently being evaluated in a Phase 2 clinical trial related to chronic lumbar disc disease (cLDD).
The trial is prospective, randomized, double-blinded, and controlled.
The goal is to evaluate the safety and preliminary efficacy of a single dose of BRTX-100.
A specific release criteria of 40 million cells intradiscally injected into the nucleus of the lumbar disc is being tested.
Up to 99 eligible patients at up to 15 clinical sites in the United States will be involved in the trial.
The Promising Partnership
This partnership represents a significant step forward for BioRestorative. Not only will BCVG's expertise in the regulatory pathway for cellular therapies prove invaluable, but also the opportunity to expand the use of this musculoskeletal platform across other indications within the body is an exciting prospect.
The BCVG team brings over 300 years of collective expertise in orthopedics, spine, wound care, and plastic/reconstructive surgery, having worked with numerous companies in biologics, device, and cell-based technologies.
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. is a pioneer in the development of therapeutic products using cell and tissue protocols, primarily involving adult stem cells. The company's core programs revolve around the treatment of disc/spine disease and metabolic disorders.
Disc/Spine Program (brtxDISCâ„¢): The primary cell therapy candidate, BRTX-100, is a product formulated from autologous (a person's own) cultured mesenchymal stem cells collected from the patient's bone marrow. This product is designed for the non-surgical treatment of painful lumbosacral disc disorders.
Metabolic Program (ThermoStem®): BioRestorative is developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT).
About Bruder Consulting & Venture Group, LLC. (BCVG)
Bruder Consulting & Venture Group is a strategic advisory firm with expertise in the discovery, development, clinical design, and regulatory approval process of biologics, devices, and combination products in the orthopedic, wound care, and plastic & reconstructive surgery markets.
Looking to the Future
This strategic partnership between BioRestorative Therapies, Inc. and BCVG marks the beginning of an exciting journey. As the team works towards FDA approval for additional INDs for BRTX-100, the potential for breakthroughs in the field of regenerative medicine is immense.
"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." - Scott Bruder, MD, PhD, CEO of BCVG
Forward-Looking Statements
This article contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These factors should be considered in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.
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