MELVILLE, NY (January 12, 2015) – 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 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.
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
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