BioRestorative Therapies to Seek FDA Approval to Expand the Clinical Application of BRTX-100

Rhea-AI Summary

BioRestorative Therapies (BRTX) has engaged Bruder Consulting & Venture Group to help expand the clinical indication pipeline for BRTX-100, its lead candidate targeting chronic lumbar disc disease (cLDD). Currently in a Phase 2 trial, BRTX-100 is a novel cell-based therapy aimed at areas with limited blood flow. The randomized, double-blinded trial involves 99 patients across 15 sites in the U.S. with a focus on safety and efficacy. BCVG's expertise in regulatory processes will support BioRestorative in obtaining FDA approval for new clinical applications of BRTX-100.

Positive

• Engagement with Bruder Consulting to leverage expertise in regulatory pathways.
• BRTX-100 is undergoing a Phase 2 clinical trial focused on cLDD, targeting a significant market.
• Potential for expansion of clinical applications based on safety data from the ongoing trial.

Negative

• None.

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 Consulting & Venture Group.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

• Disc/Spine Program (brtxDISC^™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cells collected from the patient’s bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient’s damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease.

• Metabolic Program (ThermoStem^®): We are 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”). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. 

About Bruder Consulting & Venture Group, LLC. (BCVG)

The Bruder Consulting & Venture Group (www.bruderconsulting.com) is a full service strategic advisory firm with expertise in the discovery, development, clinical design and regulatory approval process of biologics, devices and combination products in the orthopaedic, wound care and plastic & reconstructive surgery markets. As veterans of the business development, licensing and acquisition process, BCVG has led or supported more than $2 billion of transactions in the USA and abroad.

Forward-Looking Statements

This press release 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, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such 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 as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors 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.

CONTACT:

For BioRestorative Therapies, Inc.
Email: ir@biorestorative.com

For BCVG
Email: BizDev@bruderconsulting.com

FAQ

What is BRTX-100 and its clinical significance?

BRTX-100 is a cell-based therapeutic developed by BioRestorative Therapies for treating chronic lumbar disc disease, currently in a Phase 2 trial.

What is the role of Bruder Consulting in BRTX's strategy?

Bruder Consulting has been engaged to assist BioRestorative in navigating the FDA approval process for expanding the clinical applications of BRTX-100.

What does the Phase 2 trial for BRTX-100 involve?

The Phase 2 trial evaluates the safety and efficacy of a single dose of BRTX-100 in 99 patients at 15 clinical sites.

What market potential does BRTX-100 have?

BRTX-100 targets a growing market for non-surgical treatments for chronic lumbar disc disease, which is a common condition.

What are the key benefits of BRTX-100?

BRTX-100 aims to provide a non-surgical option for patients suffering from chronic pain due to disc disease, potentially reducing the need for surgery.