BioRestorative Therapies Announces Notice of Allowance on Key Patent for its BRTX-100® Disc Program
February 16 2022 - 8:30AM
BioRestorative
Therapies, Inc. (the “Company” or
“BioRestorative”) (NASDAQ: BRTX), a clinical stage company
focused on stem cell-based therapies, today announced that the
United States Patent and Trademark Office has issued a notice of
allowance for a patent application related to the Company’s
BRTX-100® core clinical program.
Claims granted under the key patent cover a
method of preparing BRTX-100®, a stem cell population derived from
bone marrow, grown under hypoxic (low oxygen) conditions, and used
to treat avascular zones, such as the intervertebral disc. The
method of preparing stem cells under low oxygen conditions is
designed to optimize the therapeutic potential of the cells once
implanted in the low oxygen environment of the damaged disc.
“The issuance of this key patent is among the
most significant milestones for the Company as the protection
granted in the claims covers methodologies used in the
manufacturing of our cell-based therapeutic," said Lance Alstodt,
the Company’s CEO. "We intend to continue expanding and fortifying
our intellectual property portfolio for BRTX-100® in the U.S. and
internationally as we advance our clinical development program to
treat chronic lumbar disc disease, which we believe presents a
significant potential market opportunity. Additionally, we believe
this is in line with our promise to continue to build fundamental
value to our business and for our shareholders.”
About BioRestorative
Therapies, Inc.
BioRestorative Therapies, Inc.
(www.biorestorative.com) develops therapeutic products using cell
and tissue protocols, primarily involving adult stem cells. Our two
core programs, as described below, relate to the treatment of
disc/spine disease and metabolic disorders:
• Disc/Spine Program (brtxDISC™): Our lead cell
therapy candidate, BRTX-100, is a product formulated from
autologous (or a person’s own) cultured mesenchymal stem cells
collected from the patient’s bone marrow. We intend that the
product will be used for the non-surgical treatment of painful
lumbosacral disc disorders or as a complementary therapeutic to a
surgical procedure. The BRTX-100 production process utilizes
proprietary technology and involves collecting a patient’s bone
marrow, isolating and culturing stem cells from the bone marrow and
cryopreserving the cells. In an outpatient procedure, BRTX-100 is
to be injected by a physician into the patient’s damaged disc. The
treatment is intended for patients whose pain has not been
alleviated by non-invasive procedures and who potentially face the
prospect of surgery. Pursuant to authorization received from the
Food and Drug Administration, we have commenced a Phase 2 clinical
trial using BRTX-100 to treat chronic lower back pain arising from
degenerative disc disease.
• Metabolic Program (ThermoStem®): We are
developing a cell-based therapy candidate to target obesity and
metabolic disorders using brown adipose (fat) derived stem cells to
generate brown adipose tissue (“BAT”). BAT is intended to mimic
naturally occurring brown adipose depots that regulate metabolic
homeostasis in humans. Initial preclinical research indicates that
increased amounts of brown fat in animals may be responsible for
additional caloric burning as well as reduced glucose and lipid
levels. Researchers have found that people with higher levels of
brown fat may have a reduced risk for obesity and diabetes.
Forward-Looking Statements
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, without
limitation, those set forth in the Company's latest Form 10-K filed
with the Securities and Exchange Commission and other public
filings. 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.
CONTACT:Email: ir@biorestorative.com
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