—BioRestorative to Leverage its Core Competencies in Cell Biology and Manufacturing to Supply Biologics for Cosmetic Applications in Strategic Agreement
–Agreement Represents Initial Venture into the $62.8 Billion Global Aesthetics Market
–Initial Order of 5,000 Vials of Product Represents Controlled Launch and Will Have Positive Financial Impact
MELVILLE, N.Y., Sept. 12, 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 a supply agreement with Evolutionary Biologics, a supplier of biologic-based cosmetics.
Pursuant to the supply agreement, BioRestorative, using its cGMP ISO-7 certified clean room, will manufacture tissue-based biologics for Evolutionary Biologics for cosmetic and aesthetic applications. The first-generation product, that has been formulated and manufactured, is an umbilical cord tissue extract that is highly enriched with factors that address the signs of aging. These factors include cytokines, chemokines, growth factors and exosomes, which are known to play important roles as communication mediators between cells and have been found to have certain anti-aging effects on skin.
Founded in 2020 by former L’Oreal President, Jim Morrison, Evolutionary Biologics is a supplier of cosmetic-focused biologics for plastic surgeons, dermatologists and medical spas across the United States.
With the Company’s expanded manufacturing capabilities, BioRestorative is able to support research and development of biologics from various aspects, especially for exosome manufacturing, engineering, quality control and potential therapeutic applications.
“This is a very exciting time for BioRestorative Therapies as we seek to develop our recent strategic partnerships. Leveraging our ISO-7 certified clean room to formulate and manufacture a commercial product in the $62.8 billion global aesthetics market is not only a thrilling opportunity but it allows us to scale and drive efficiencies going forward as we seek to expand our commercial business model. By no means does this venture disrupt or diminish our clinical stage platforms; rather it helps to provide additional resources and financial support to these ongoing programs. If our initial order is received well in the commercial marketplace, then we can look forward to possible future opportunities at a much larger scale. If accomplished, this would result in significant improvement in our financial condition and liquidity and would make us far less dependent on the fragile capital markets”, stated Lance Alstodt, Chief Executive Officer of BioRestorative.
Jim Morrison, Chief Executive Officer of Evolutionary Biologics, a division of Emergent Health Corp, (EMGE) stated “we are very excited to be working with Biorestorative Therapies. They are a world class manufacturer of biological products, and operate a state-of-the-art Laboratory and manufacturing facility. This partnership will undoubtedly provide Evolutionary Biologics with a competitive advantage in the large and fast-growing biologics cosmetic marketplace”.
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 chronic lumbar disc disease. We are also investigating the expansion of the clinical application of BRTX-100 to other indications within the body.
• 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.
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. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the anticipated closing of the offering and the intended use of proceeds. 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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