BioRestorative to Provide a Positive FDA Update on Clinical Pipeline
February 25 2025 - 7:00AM
BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the
“Company”) (NASDAQ:BRTX
), a clinical stage
regenerative medicine innovator focused on stem cell-based
therapies and products, is pleased to announce that it expects to
provide a positive clinical pipeline update before market open on
Thursday, February 27, 2025.
“We very much look forward to updating investors
on some recent meaningful key developments with respect to our
clinical pipeline and review some additional positive events
related to BRTX-100 on Thursday,” said Lance Alstodt, Chief
Executive Officer of BioRestorative. “We are thrilled to be in a
position that reflects the very solid work of our scientific team
over the last several years come to fruition and excited to see
that positive momentum continue.”
Clinical Pipeline Update Conference Call
& Webcast Details
BioRestorative management will host a webcasted
conference call at 8:00am EST on Thursday, February 27, 2025. To
participate in the conference call by telephone, please dial
888-506-0062 (United States) or 973-528-0011 (International),
participant access code 440089. The call will also be broadcast
live and archived on the Investor section of the Company’s website
at https://www.biorestorative.com/investor-relations/.
About BioRestorative Therapies,
Inc.
BioRestorative (www.biorestorative.com) develops
therapeutic products using cell and tissue protocols, primarily
involving adult stem cells. As described below, our two core
clinical development programs relate to the treatment of disc/spine
disease and metabolic disorders, and we have also recently begun
offering BioCosmeceutical products:
• 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 cell-based therapy candidates to target obesity and
metabolic disorders using brown adipose (fat) derived stem cells
(“BADSC”) to generate brown adipose tissue (“BAT”), as well as
exosomes secreted by BADSC. 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. BADSC secreted
exosomes may also impact weight loss.
• BioCosmeceuticals: We operate a commercial
BioCosmeceutical platform. Our current commercial product,
formulated and manufactured using our cGMP ISO-7 certified clean
room, is a cell-based secretome containing exosomes, proteins and
growth factors. This proprietary biologic serum has been
specifically engineered by us to reduce the appearance of fine
lines and wrinkles and bring forth other areas of cosmetic
effectiveness. Moving forward, we also intend to explore the
potential of expanding our commercial offering to include a broader
family of cell-based biologic aesthetic products and therapeutics
via Investigational New Drug (IND)-enabling studies, with the aim
of pioneering U.S. Food and Drug Administration (FDA) approvals in
the emerging BioCosmeceuticals space.
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, as
amended, and Form 10-Q 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:
Stephen KilmerInvestor RelationsDirect: (646)
274-3580 Email: skilmer@biorestorative.com
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