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BioRestorative Therapies Announces SBIR Phase I Grant to Explore the Therapeutic Effects of ThermoStem® Targeting Polycystic Ovary Syndrome as an Indication

--Non-Dilutive Grant Funding to Support Development of Brown Adipose-Based Therapeutic Programs Directed at Polycystic Ovary Syndrome --

MELVILLE, N.Y., Dec. 06, 2022 (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 been awarded a Small Business Innovation Research (SBIR) Phase I grant from the Eunice Kennedy Shriver National Institute Of Child Health & Human Development of the National Institutes of Health. This collaborative research will be conducted in partnership with Dr. Sheng Wu, Associate Professor, Center for Metabolic Disease Research at Temple University, School of Medicine, Dr. Wu has received numerous national and international awards such as the Women in Endocrinology Young Investigator Award, Eugenia Rosemberg Abstract Award, Early Investigator Award from the Endocrine Society; Virendra B. Mahesh Award of Excellence in Endocrinology, and Endocrinology and Metabolism Section New Investigator Award from American Physiology Society.

The specific objective of this NIH grant is to enable the development and evaluation of the Company’s ThermoStem® program for the treatment of polycystic ovary syndrome (PCOS). Therapeutic brown adipocyte transplantation is an emerging and novel therapy for PCOS. BRTX has developed proprietary methods for the generation of metabolically active brown adipocytes.

“This new indication will expand BioRestorative’s current discovery pipeline focused on the novel brown fat therapy at the intersection of innate, adaptive metabolic regulation and women’s health. Our industry expertise in brown fat complements world class research conducted by Dr. Wu’s laboratory and thus strengthen our commitment to discover innovative solutions for patients with unmet medical needs.” said Lance Alstodt, CEO of BioRestorative Therapies.

PCOS affects 6-18% of reproductive age females, representing the most common endocrine disease in women and a $4.36 billion healthcare cost annually in the US. PCOS causes gynecological, dermatologic and metabolic comorbidities, and also imposes long-term risks of diabetes mellitus type 2 (T2D), cardiovascular diseases (CVD) and psychiatric problems including severe depression.

PCOS is commonly associated with metabolic disorders, with 50-70% of PCOS patients showing insulin resistance and 10% with T2D, implying a potential causative link between them. Current standard of care includes lifestyle changes and multiple lines of medications with aims to relieve symptoms. Medications usually have moderate success rates, and have limited effects and long-term risks of T2D, CVD and psychiatric problems

“There is a tremendous gap in the understanding of the metabolic dysfunction of PCOS and the underlying mechanisms remain largely incomplete. In addition, the development of more efficient, even personalized therapeutic strategies for the metabolic management of PCOS patients persists as an unmet need. ThermoStem® may provide a therapeutic option,” said Francisco Silva, Vice President of Research and Development of BioRestorative Therapies.

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 received authorization from the Food and Drug Administration to commence 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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