BioRestorative Therapies Announces Transformative Commercial Agreement with Cartessa, a Global Leader in Medical Aesthetics Technology

— Leading regenerative medicine and aesthetics innovators collaborate to build a vertically integrated, best-in-class biocosmeceutical platform —

— Exclusive, five (5)-year agreement includes BioRestorative supplying its initial commercial product to Cartessa —

— Financial impact from commercial partnership expected to provide flexibility for BioRestorative to become significantly less dependent on the capital markets for future funding —

MELVILLE, N.Y., April 30, 2024 (GLOBE NEWSWIRE) -- . (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:), a clinical stage company focused on stem cell-based therapies, today announced that it has entered into a five-year exclusive supply agreement with Cartessa Aesthetics, LLC (“Cartessa”), a leading North American based aesthetic company focused on delivering best-in-class technologies and unparalleled end-to-end professional customer support.

The goal of this transformative agreement is to combine BioRestorative’s deep cell-based biologics experience, and formulation and clinical manufacturing expertise, with Cartessa’s extensive professional aesthetics market reach, and marketing and distribution capabilities. BioRestorative also intends to explore the potential of expanding the collaborative relationship into a broader family of commercialized biocosmeceuticals and therapeutics via Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (FDA)-approvals in the emerging biocosmeceuticals space.

As part of the exclusive five (5)-year agreement, BioRestorative has agreed to supply pre-set minimum quantities of finished vials of its initial cell-based biologic commercial product to Cartessa annually as private label under Cartessa’s Chronos ExoCR mark. This product, formulated and manufactured by BioRestorative using its cGMP ISO-7 certified clean room, is comprised of a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by BioRestorative to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness.

"Cartessa is known for bringing differentiated, non-invasive technologies to the world’s best aesthetic providers. To that end, we are thrilled to partner with BioRestorative to introduce a novel and proprietary cell-based innovation within this high-demand market category,” said Gabe Lubin, Founder and CEO of Cartessa. “Upon mutual consent, the companies will also pursue opportunities to bring additional cell-based biologic products to existing and new aesthetics markets, both at home and abroad. We look forward to keeping our customers and the aesthetics industry at large updated as we progress toward making state-of-the art biocosmeceuticals more widely available.”

“We believe this strategic agreement with an established aesthetics market leader like Cartessa validates our cell-based biologics platform and represents a transformative step toward our building a strong commercial engine capable of supporting profitable growth while also helping fund the continued advancement of our clinical, BRTX-100, and preclinical, ThermoStem^®, pipeline,” said Lance Alstodt, BioRestorative’s CEO. “The global aesthetic medicine market size was valued at $127.1 billion in 2023, and that is projected to grow at a CAGR of 14.9% from 2024 to 2030.¹ Much of this growth is related to regenerative aesthetics, and therapies containing exosomes and growth factors in particular, which have emerged as a important sub-field of the space.^2,3 We see this trend continuing into the future, primarily as a result of social media driving awareness and acceptance, aesthetics service outlets proliferating globally, and new indications gaining meaningful traction. We are looking forward to working closely with Cartessa to build a significant presence for BioRestorative in this large and growing industry.”

Mr. Alstodt added, “We ended 2023 with approximately $11.1 million in cash, cash equivalents and investments in marketable securities, which did not include net proceeds of $7.6 million from the warrant exchange private placement completed in February. As a result, we are fortunate to have entered into this transformative agreement with Cartessa while in the enviable position of already having cash runway well into 2025. This, combined with the meaningful revenues we expect from the commercialization of Chronos ExoCR, should make us significantly less reliant than most of our clinical-stage life sciences company peers on the capital markets going forward.”

Reference

¹ Grand View Research,

² Trovato F, Ceccarelli S, Michelini S, Vespasiani G, Guida S, Galadari HI, Nisticò SP, Colonna L, Pellacani G. Advancements in Regenerative Medicine for Aesthetic Dermatology: A Comprehensive Review and Future Trends. Cosmetics. 2024; 11(2):49.

³ Goldie K. The evolving field of regenerative aesthetics. J Cosmet Dermatol. 2023 Mar;22 Suppl 1:1-7. doi: 10.1111/jocd.15556. PMID: 36988470.

About Cartessa Aesthetics, LLC.

Cartessa Aesthetics () is a leading North American aesthetic company focused on cutting-edge technology and industry leading customer support. Thanks to an independent business model and established relationships with top global manufacturers, Cartessa's product portfolio offers true competitive advantages for practices and patients across every aesthetics category. Customers benefit from expertly vetted products and end-to-end support to maximize the clinical outcomes and returns of their investment.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. () 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. 

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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