BioRestorative Therapies to Seek FDA Approval to Expand the Clinical Application of BRTX-100
March 13 2023 - 7:00AM
BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the
“Company”) (NASDAQ:BRTX
), a clinical stage company
focused on stem cell-based therapies, today announced that it has
entered into an agreement with the Bruder Consulting & Venture
Group (“BCVG”), a full service strategic advisory firm with
focus areas in biologics, tissue repair, biomaterials and
regenerative medicine. BCVG has been engaged to assist the Company
in seeking FDA approval of the expansion of the clinical
application of BRTX-100.
BRTX-100 is the Company’s lead clinical
candidate, a novel cell-based therapeutic engineered to target
areas of the body that have little blood flow. BRTX-100 is
currently being evaluated in connection with a Phase 2 clinical
trial in chronic lumbar disc disease (“cLDD"). The trial is
prospective, randomized, double-blinded and controlled. The trial
will evaluate the safety and preliminary efficacy of a single dose
of BRTX-100, including a specific release criteria of 40 million
cells intradiscally injected into the nucleus of the lumbar disc. A
total of up to 99 eligible patients will be randomized at up to 15
clinical sites in the United States to receive either the
investigational drug (BRTX-100) or control in a 2:1 fashion.
“Finding the right partner such as BCVG is very
meaningful to BioRestorative as they bring a tremendous amount of
domain expertise in managing the regulatory pathway for cellular
therapies. Additionally, we have the opportunity to leverage this
musculoskeletal platform across other indications within the body.
BCVG will assist us in choreographing this process, utilizing their
deep industry insights and expertise within this sector,” said
Lance Alstodt, CEO of BioRestorative
The team at Bruder Consulting & Venture
Group has over 300 years of collective expertise in orthopedics,
spine, wound care, and plastic/reconstructive surgery. BCVG has
worked with numerous companies across these domains in biologics,
device and cell-based technologies.
“We look forward to assisting BioRestorative
with their goal of leveraging the important safety data from their
Phase 2 cLDD trial to seek approval for additional INDs for
BRTX-100,” said Scott Bruder, MD, PhD, CEO of the Bruder Consulting
& Venture Group.
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. 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.
About Bruder Consulting & Venture Group,
LLC. (BCVG)
The Bruder Consulting & Venture Group
(www.bruderconsulting.com) is a full service strategic advisory
firm with expertise in the discovery, development, clinical design
and regulatory approval process of biologics, devices and
combination products in the orthopaedic, wound care and plastic
& reconstructive surgery markets. As veterans of the business
development, licensing and acquisition process, BCVG has led or
supported more than $2 billion of transactions in the USA and
abroad.
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. 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:
For BioRestorative Therapies,
Inc.Email: ir@biorestorative.com
For BCVGEmail: BizDev@bruderconsulting.com
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