BioRestorative to Present a BRTX-100 Clinical Update at ISCT 2025

Rhea-AI Summary

BioRestorative Therapies (NASDAQ:BRTX) has announced that its Vice President of Research and Development, Francisco Silva, will present an update on the company's ongoing Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease (cLDD) at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting. The presentation, titled "Phase 2 Clinical Safety/Efficacy Data of Intradiscal Injection of Hypoxic Mesenchymal Stem Cells for Lumbar Disc Disease," will take place on Thursday, May 8, from 3:45-4:45 pm CT at the conference in New Orleans, LA.

MELVILLE, N.Y., May 07, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, is pleased to announce that its Vice President of Research and Development, Francisco Silva, will present an update on its ongoing Phase 2 clinical trial of BRTX-100 in chronic lumbar disc disease (cLDD) at the International Society for Cell & Gene Therapy (“ISCT”) 2025 Annual Meeting, taking place May 7 - 10, 2025 in New Orleans, LA.

“We are very pleased to have been selected to share a BRTX-100 clinical update with clinicians, researchers, and regulators at ISCT 2025, one of the most prestigious and clinically focused regenerative medicine meetings globally,” said Lance Alstodt, BioRestorative’s Chief Executive Officer.

Presentation details:

Title:	Phase 2 Clinical Safety/Efficacy Data of Intradiscal Injection of Hypoxic Mesenchymal Stem Cells for Lumbar Disc Disease
Presenter:	Francisco Silva, Vice President of Research and Development
Date and Time:	Thursday May 8, 3:45-4:45 pm CT

About BRTX-100

BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is BioRestorative’s lead clinical candidate. The safety and efficacy of BRTX-100 in treating chronic lumbar disc disease (“cLDD”) is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. The U.S. Food and Drug Administration (“FDA”) recently granted Fast Track designation to the BRTX-100 program for the treatment of cLDD, reflecting the positive preliminary Phase 2 safety and efficacy data reported to date. Also in February 2025, the FDA cleared the Company’s Investigational New Drug (IND) application for BRTX-100 for the treatment of chronic cervical discogenic pain (cCDP), expanding BioRestorative’s advanced clinical pipeline for BRTX-100 to include the treatment of both chronic lower back and neck pain.

About BioRestorative Therapies, Inc.

BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we have also recently begun offering BioCosmeceutical products:

• 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. We have also obtained U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain.

• Metabolic Program (ThermoStem^®): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (“BADSC”) to generate brown adipose tissue (“BAT”), as well as exosomes secreted by BADSC. 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. BADSC secreted exosomes may also impact weight loss.

• BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics IND-enabling studies, with the aim of pioneering FDA approvals in the emerging BioCosmeceuticals space.

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, as amended, and Form 10-Q 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:

Stephen Kilmer
Investor Relations
Direct: (646) 274-3580
Email: skilmer@biorestorative.com

FAQ

What will BRTX present at ISCT 2025?

BioRestorative will present Phase 2 clinical safety and efficacy data for BRTX-100, their treatment for chronic lumbar disc disease, at ISCT 2025 on May 8, 2025.

Who is presenting the BRTX-100 clinical update at ISCT 2025?

Francisco Silva, BioRestorative's Vice President of Research and Development, will present the BRTX-100 clinical update.

When and where is BRTX's presentation at ISCT 2025?

The presentation will take place on Thursday, May 8, 2025, from 3:45-4:45 pm CT in New Orleans, LA.

What is BRTX-100 being developed to treat?

BRTX-100 is being developed to treat chronic lumbar disc disease (cLDD).