BioRestorative Engages Consulting Firm to Advance brtxDISC™ Program Delivery Device through FDA Clea
BioRestorative Engages Consulting Firm to Advance brtxDISC™ Program Delivery Device through FDA Clearance Process
JUPITER, Fla.--(BUSINESS WIRE)-- BioRestorative Therapies, Inc. ("BRT" or the "Company") (OTCBB:BRTX), a life sciences company focused on developing stem cell-based therapies for personal medical applications, announced the engagement of the regulatory consultancy firm Phil Triolo and Associates, LC ("PTA") to help advance the Company's brtxDISC™ therapeutic procedure through the U.S. Food and Drug Administration ("FDA") regulatory process. The brtxDISC™ program is the Company's non-surgical investigative treatment for bulging and herniated lumbar discs.
Under the engagement, PTA will assist the Company in its efforts to obtain U.S. regulatory approval and to satisfy FDA regulations applicable to the Company's medical device used in the brtxDISC™ procedure, including the implementation of quality systems procedures. In addition, PTA will assist BRT in its efforts to satisfy FDA regulations relevant to the combination products (biologic plus device) it ultimately plans to commercialize in the U.S. PTA is also available to assist in any international regulatory approval processes the Company may pursue.
"This is an important step in advancing the development of our brtxDISC™ procedure," said Mark Weinreb, chief executive officer of BioRestorative Therapies. "We have developed a minimally invasive, technologically innovative medical device to precisely deliver a patient's own stem cells directly into the damaged region of the herniated and bulging disc, which is a key component of the success of the procedure."
"There are approximately one million aggressive surgical back and spine procedures in the U.S. each year, including discectomies, disc replacements and spinal fusions. Our goal is to offer an alternative to these procedures by providing a cellular procedure to assist the patient's body in repairing the disc. Pending regulatory approval, we look forward to commencing clinical trials in mid-2014," Mr. Weinreb added.
Phil Triolo and Associates, LC provides services to assure compliance with U.S. regulatory requirements during all stages of the product lifecycle, from feasibility, design and development, to manufacturing, post-production vigilance and audits.
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 bulging and herniated 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 in the body.
- 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.
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