The approval allows BRT to retrospectively collect and analyze clinical on selected subjects who previously have been treated for bulging or herniated disc disease with the Company's novel brtxDISC™ procedure. These procedures were performed using BRT's proprietary therapeutic delivery device cannula system and its proprietary culture method isolating a selective population of mesenchymal stem cells. BRT expects to complete the study within a six-month period.
"This is a significant milestone in taking our brtxDISC™ procedure closer towards an FDA meeting to seek approval for the commencement of our clinical trial. We look forward to collecting this data with the ambition of meeting the safety requirements necessary for us to receive approval and start our trial," commented Mark Weinreb, Chief Executive Officer of BioRestorative Therapies. "Our goal is to compile and present the necessary data to the FDA with the goal of initiating a Phase I or Phase II clinical trial in the early part of next year."
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. ("BRT"), www.biorestorative.com, develops medical procedures using cell and tissue protocols, primarily involving adult stem cells, designed for patients to undergo minimally invasive cellular-based treatments. BRT is developing the following scientific initiatives:
- brtxDISC™ Program (Disc Implanted Stem Cells), a non-surgical treatment for bulging and herniated discs that addresses the gap between non-invasive and invasive back procedures. This research is still in the non-clinical, investigational stage.
- ThermoStem® Program, a treatment for metabolic disorders (diabetes, heart disease, etc.) and obesity using brown fat stem cells. Initial non-clinical 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 Program, based on the development of a human cellular extract that, per initial in vitro studies, when applied to human skin cells, appears to cause an increase in 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.
This press release and the interview contain "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.
Disclaimer /Disclosure: The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk.
This site is currently compensated by featured companies, news submissions and online advertising. Disclosure: BioRestorative has compensated Investoridea for a six month news program ( five thousand ) to be published on Investorideas.com newswire and syndication and social media partners.
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894