BioRestorative Therapies Announces Clinical Trial Agreement with Second Site for Company’s Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease (cLDD)

Biorestorative Therapies, Inc

MELVILLE, New York, June 22, 2022 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (NASDAQ: BRTX), a clinical-stage company specializing in stem cell therapies, today announced that it has reached an agreement with its second clinical site for its Phase 2 clinical trial targeting chronic lumbar disc disease (cLDD). The Center for Clinical Research, located in North Carolina, is the second clinical trial contract executed by BioRestorative.

BioRestorative’s Phase 2 trial is a randomized, double-blind, controlled study to assess the safety and preliminary efficacy of a single-dose intradiscal injection of the company’s investigational autologous stem cell therapeutic treatment, BRTX -100. A total of up to 99 eligible patients will be randomized at up to 15 sites in the United States to receive either the investigational drug (BRTX-100) or the control in a 2:1 ratio.

“With the signing of our second clinical trial agreement, we are delighted to welcome Dr. Richard Rauck as the Principal Investigator of the Clinical Research Center,” said Lance Alstodt, CEO of BioRestorative Therapies. “Dr. Rauck has extensive clinical experience and brings expertise in the field of cell-based regenerative medicine, which is invaluable to a successful clinical trial.”

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. ( develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two main programs, described below, relate to the treatment of spinal/disc diseases 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) mesenchymal stem cells taken from the patient’s bone marrow. We intend the product to be used for the non-surgical treatment of painful lumbosacral disc disorders or as an adjunct therapy to surgery. The BRTX-100 The production process uses patented technology and involves harvesting a patient’s bone marrow, isolating and culturing bone marrow stem cells, and cryopreserving the cells. On an outpatient basis, BRTX-100 must be injected by a physician into the patient’s damaged disc. The treatment is for patients whose pain has not been alleviated by non-invasive procedures and who are potentially facing the prospect of surgery. In accordance with the authorization received from the Food and Drug Administration, we have started a phase 2 clinical trial using BRTX-100 to treat chronic lower back pain due to degenerative disc disease.

• Metabolic program (ThermoStem®): We are developing a cell therapy candidate to target obesity and metabolic disorders using stem cells derived from brown adiposity (fat) to generate brown adipose tissue (“BAT”). BAT is intended to mimic natural brown adipose deposits that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional calorie 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 of 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 due to various factors and other risks, including, without limitation, those set forth in the Company’s most recent Form 10-K filed with the Securities and Exchange Commission and other public filings. You should consider these factors when evaluating the prospective conditionstatements included herein, and not place undue reliance on such statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company undertakes no obligation to update such statements.

E-mail: [email protected]

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