BioRestorative Therapies Presents New Preclinical Data at ISCT 2026 Highlighting Source-Specific Exosome Functionality and Commercial Applications in BioCosmeceuticals

Data demonstrate distinct functional signatures across MSC-derived extracellular vesicles supporting targeted regenerative and aesthetic applications

MELVILLE, N.Y., May 13, 2026 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. ("BioRestorative," "BRTX," or the "Company") (Nasdaq: BRTX), a late-stage clinical regenerative medicine company focused on stem cell-based therapies and products, today announces the presentation of new preclinical data at the International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting, which took place May 6-9 in Dublin, Ireland. The data highlight the functional and proteomic differences of extracellular vesicles (“EVs”), including exosomes, derived from multiple mesenchymal stem cell (“MSC”) sources.

Detailed in an oral presentation titled, “MSC Exosome Proteomics Reveal Source-Specific Therapeutic Applications,” the study demonstrates that EVs derived from distinct MSC sources, including umbilical cord, brown adipose tissue, and bone marrow, exhibit unique protein signatures and biological functions that may enable targeted therapeutic and commercial applications. The data were presented on May 6, 2026.

“These findings provide important insight into how we can tailor exosome-based formulations to achieve specific biological outcomes,” said Francisco Silva, Vice President of Research and Development at BioRestorative Therapies. “By identifying distinct functional signatures across different MSC-derived EVs, we are advancing our ability to develop targeted, next-generation regenerative solutions across both clinical and aesthetic applications.”

Proteomic and gene ontology analyses revealed several key functional pathways associated with specific MSC-derived EV populations:

• Proliferation and regenerative signaling: Enrichment in RNA and mRNA metabolic processes supports cellular growth, tissue regeneration, and remodeling
• Cell adhesion and immune modulation: Enhanced signaling related to cell-substrate adhesion, phosphorylation, and immune response regulation supports extracellular matrix remodeling, wound healing, and inflammation control
• Epidermal differentiation and barrier formation: Enrichment in keratinization and cornification pathways supports skin barrier repair, scar modulation, and keratinocyte function
  
  

“Central to our strategy is the development of a fully integrated regenerative platform spanning manufacturing, clinical validation, and commercial execution,” said Lance Alstodt, BioRestorative Therapies Chief Executive Officer. “Exosomes and other extracellular vesicle-based biologics represent a foundational component of that platform, with applicability across both our therapeutic programs and our BioCosmeceutical portfolio. These findings extend our ability to more precisely align biological function with intended application, enabling a more structured and intentional approach to product development. As we integrate these capabilities with our commercial architecture and our clinical validation efforts, including work being advanced with key opinion leaders such as Dr. David J. Goldberg, we are building a platform designed to align biological performance, clinical outcomes, and scalable commercial applications across regenerative medicine and aesthetics.”

Collectively, these findings support the development of differentiated EV-based formulations tailored to specific applications within regenerative aesthetics and dermatology, providing a framework for aligning source-specific biological activity with targeted clinical and commercial use cases. The Company believes these functional insights have direct implications for its BioCosmeceutical platform, enabling the design of targeted product formulations across a range of aesthetic and dermatologic use cases, including:

• Skin rejuvenation and anti-aging applications, leveraging regenerative signaling to support collagen production and epidermal renewal
• Post-procedural recovery solutions, designed to accelerate healing and reduce inflammation following aesthetic treatments
• Scar and wound repair formulations, supporting improved tissue remodeling and barrier restoration
• Barrier repair and hydration therapies, aimed at improving skin integrity and reducing trans-epidermal water loss
• Hair and scalp health applications, targeting follicle activation and regenerative signaling pathways
  
  

“This work represents an important step in advancing our BioCosmeceutical platform from a formulation-based approach to a more structured, biology-driven design framework,” said Crystal Romano, Head of Global Commercialization at BioRestorative Therapies. “By identifying source-specific functional profiles across MSC-derived extracellular vesicles, we are strengthening our ability to align biological mechanisms with targeted product concepts, clinical validation pathways, and commercial deployment strategies. This level of integration is central to how we are building a differentiated, scalable platform across regenerative aesthetics.”

About BioRestorative Therapies, Inc.

BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, the Company's two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and it also operates a commercial BioCosmeceutical platform:

Disc/Spine Program (brtxDISC^™): BioRestorative's 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. The product is intended to 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. The Company has commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from degenerative disc disease. The U.S. Food and Drug Administration ("FDA") has granted Investigational New Drug ("IND") clearance to evaluate BRTX-100 in the treatment of chronic cervical discogenic pain.

Metabolic Program (ThermoStem^®): The Company is 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: BioRestorative has developed a commercial BioCosmeceutical platform. Current commercial products are formulated and manufactured in the Company's cGMP, ISO-7 certified clean room facility. Each product features a cell-based secretome enriched with exosomes, proteins, growth factors, peptides, and other carefully selected active ingredients. This proprietary biologic portfolio has been thoughtfully engineered to support skin health and longevity while addressing visible signs of aging and enhancing overall cosmetic performance. Moving forward, BioRestorative also intends to explore the potential of expanding its commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via 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, 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.

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