Effort to be led by Access BIO Founder and Industry Veteran Dr. Joy A. Cavagnaro
JUPITER, Fla, October 9, 2014 – BioRestorative Therapies, Inc. ("BRT" or the "Company") (OTCBB: BRTX), a life sciences company focused on adult stem cell-based therapies for various personal medical applications, announces the engagement of Access BIO, L.C. to provide strategic preclinical and regulatory consulting services related to the Company’s brtxDISC™ program. Initially Access BIO will help the Company prepare for pre-Investigational New Drug (IND) and IND meetings with the U.S. Food and Drug Administration (FDA). This represents the next stage in advancing the Company's brtxDISC™ procedure into the clinic.
Access BIO was founded by Joy A. Cavagnaro, Ph.D. DABT, RAC, Fellow ATS, RAPS Fellow, a long-time senior regulator and policymaker at the FDA’s Center for Biologics Evaluation and Research (CBER).
“The engagement of Access BIO marks an important step in advancing our brtxDISC™ procedure as a treatment for patients with protruding and bulging discs who face the prospect of surgery,” said Mark Weinreb, BioRestorative Therapies’ Chief Executive Officer. “Dr. Cavagnaro and her team have extensive experience in formulating strategies in communicating with the FDA and a deep understanding of the activities BioRestorative will need to receive trial commencement approval from the FDA. Working in concert with Access BIO, we look forward to holding constructive meetings with the FDA and to commencing our clinical trials as soon as possible thereafter, potentially in the second half of 2015.”
About Access BIO, L.C.
Founded in 1999, Access BIO is a consultancy specializing in science-based regulatory strategies and development services to facilitate the translation of biomedical research, emerging technologies and product development. The firm has expertise in product classes including vaccines, cellular (including stem cells) and gene therapies, animal-based and plant-based bio-therapeutics, biotechnology-derived and tissue engineered products, as well as novel small molecule chemical entities. Specific areas of functional focus include due diligence assessments of preclinical data and preclinical development strategies to support first-in-human studies.
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. (www.biorestorative.com) develops products and medical procedures using cell and tissue protocols, primarily involving adult stem cells, including:
• brtxDISC™ (Disc Implanted Stem Cells) is an investigational non-surgical treatment for protruding and bulging lumbar discs that is intended for patients who have failed non-invasive procedures and face the prospect of surgery. The treatment involves culturing a patient’s own stem cells and then delivering them via a proprietary medical device to the damaged region of the 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 statements.
Kim Sutton Golodetz
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