Category: Investment, Biotech, Pharma

Stem Cell Stock Alert: BioRestorative (OTCBB: BRTX) Engages Consulting Firm to Advance brtxDISC Program Delivery Device through FDA Clearance Process

JUPITER, Fla. - September 30, 2013 (Investorideas.com Newswire) BioRestorative Therapies Inc. ("BRT" or the "Company") (OTCQB: 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. ("BRT"), http://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:

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

Read more:
Stem Cell Stock Alert BioRestorative (OTCBB BRTX) Engages Consulting Firm to Advance brtxDISC Program Delivery Device ...