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BioRestorative Therapies Announces Filing of Ten Patent Applications Related to its BRTX-100 Program

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BioRestorative Therapies, Inc. (NASDAQ:BRTX) has filed ten patent applications with the USPTO relating to its BRTX-100 program aimed at treating chronic lumbar disc disease. The patents focus on manufacturing methods for stem cells that can survive in low-oxygen environments, crucial for effective therapy. This strengthens the company's intellectual property portfolio. BioRestorative is FDA-authorized to begin a Phase 2 clinical trial for BRTX-100.

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  • Filed ten patent applications to strengthen intellectual property.
  • FDA authorization for Phase 2 trial for BRTX-100.
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MELVILLE, N.Y., Dec. 02, 2021 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the “Company" or “BioRestorative”) (NASDAQ:BRTX), a life sciences company focused on adult stem cell-based therapies, today announced that it has filed ten patent applications related to its BRTX-100 program for treating chronic lumbar disc disease with the United States Patent and Trademark Office (USPTO).

The patent applications are directed towards methods of manufacturing stem cells that are engineered to survive avascular zones (areas where there is little blood flow and nutrients). The ability for cells to survive these harsh environments is critical for cell-based therapies.

“When treating disorders such as chronic lumbar disc disease, where the cellular micro-environment has a low oxygen and nutrient supply, cell survival must be accounted for. The filings of these ten patent applications will further strengthen our intellectual property portfolio and protect our manufacturing process,” said Lance Alstodt, CEO of BioRestorative.

These patent applications cover methodologies used to generate BRTX-100, a stem cell-based therapeutic engineered to treat patients suffering from chronic lumbar disc disease. BioRestorative currently is authorized by the FDA to commence a Phase 2 clinical trial using BRTX-100.

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 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.

CONTACT:

Email: ir@biorestorative.com


FAQ

What is BRTX-100?

BRTX-100 is a stem cell-based therapeutic designed to treat chronic lumbar disc disease.

What recent announcement did BioRestorative Therapies make?

BioRestorative announced the filing of ten patent applications related to its BRTX-100 program.

When will the Phase 2 trial for BRTX-100 start?

BioRestorative has received FDA authorization to commence the Phase 2 clinical trial for BRTX-100.

Why are the patent applications significant?

The patent applications cover manufacturing methods for stem cells that can survive in harsh environments, important for therapeutic efficacy.

BioRestorative Therapies, Inc.

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Biotechnology
Services-misc Health & Allied Services, Nec
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United States of America
MELVILLE