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:
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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.
Copyright Business Wire 2013