BioRestorative Therapies, Inc. Reports Successful Meeting With FDA

MELVILLE, N.Y.--(BUSINESS WIRE)--BioRestorative Therapies, Inc. (“BRT” or the “Company”) (OTCBB: BRTX), a life sciences company focused on adult stem cell-based products and therapies for various personal medical applications, announced that it has had a successful pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (the “FDA”) concerning its lead therapeutic product, brtxDISC™, to be used in a non-surgical treatment for chronic lumbar disc disease.

“The FDA’s input into our development plans with regard to brtxDISC™ was very constructive and we believe that the meeting was both productive and successful. We look forward to submitting our IND and the commencement of our clinical trial.”

The Pre-IND meeting was held on December 19, 2014 between BRT and the FDA’s Center for Biologics, Evaluation and Research’s (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT). At the meeting, clinical, preclinical and manufacturing representatives from the FDA commented on BRT’s plans for an IND submission and clinical trial with regard to brtxDISC™. Based on the FDA’s input, no obstacles were identified that would materially impact the IND plans for a clinical trial with regard to brtxDISC™ in patients with chronic lumbar disc disease.

Mark Weinreb, BRT’s CEO, said, “The FDA’s input into our development plans with regard to brtxDISC™ was very constructive and we believe that the meeting was both productive and successful. We look forward to submitting our IND and the commencement of our clinical trial.”

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops products and medical therapies using cell and tissue protocols, primarily involving adult stem cells, including:

• brtxDISC™ (Disc Implanted Stem Cells), BRT’s lead therapeutic product, is a mesenchymal stem cell product derived from autologous human bone marrow. It is to be used in an investigational non-surgical treatment for protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease and is intended for patients who have failed non-invasive procedures and potentially face the prospect of surgery. The treatment, utilizing brtxDISC™, involves culturing a patient’s own stem cells and then delivering them to the damaged disc in an outpatient procedure.
• ThermoStem® is a treatment using brown fat stem cells that is under development for metabolic disorders including diabetes and obesity. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels.
• brtx-C Cosmetic is based on the development of a human cellular extract that has been demonstrated in in vitro skin studies to increase the production of collagen and fibronectin, which are proteins that are essential to combating the aging of skin. Potential cosmetic uses are being explored with third parties.

The Company also offers plant stem cell-based facial creams and beauty products under the Stem Pearls® brand at www.stempearls.com.

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 those set forth in the Company’s 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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