BioRestorative Therapies Receives License from New York State Department of Health to act as Tissue Bank for Mesenchymal Stem Cell Processing
May 31 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 received a
license from the New York State Department of Health to act as a
tissue bank for the processing of mesenchymal stem cells from
autologous donors.
Licensure is an intensive and diligent process,
and is required for all tissue and cell-related activities in New
York, including collection, processing, storage, and distribution,
as well as for any facility distributing tissues to other states.
Holders of a New York State license are required to comply with
regulations to ensure safe and ethical handling of tissues. Through
a comprehensive on-site survey process, facilities are inspected
and assessed for acceptable standards of practice and regulatory
compliance.
“This is a significant milestone for BRTX as we
now can further optimize our ISO 7 certified clean room and
manufacturing facility. In addition, we are exploring the ability
to do contract manufacturing on behalf of other regenerative
medicine companies. Our state of the art facility along with our
manufacturing capabilities could provide revenues and help us
offset some cash burn related to our laboratory. Finally, what is
most exciting about this license is the ability to act as a tissue
bank. This will enable us to bank BRTX-100 on behalf of future
patients and, if FDA approved, provide those patients with an “off
the shelf” autologous cell therapy product once commercially
available in the United States”, said CEO Lance Alstodt
There are numerous entities that are licensed to
operate tissue banks and non-transplant anatomic banks in New York
State. The Blood and Tissue Resources Program oversees all human
tissue banking activities and services provided in New York State,
from donor solicitation to clinical use. The tissue bank regulatory
program, being the first comprehensive oversight program for tissue
banks in the country, has served as a model for the development of
national and other state oversight programs. BioRestorative is the
first facility in New York State to be licensed to process
mesenchymal stem cells for clinical use.
BRTX-100, a novel cell-based therapeutic
engineered to target areas of the body that have little blood flow,
is the Company’s lead clinical candidate. BRTX-100 is currently
being evaluated in connection with a Phase 2 clinical trial to
treat 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. A total of up to 99 eligible patients will be
randomized at up to 15 clinical sites in the United States. The
patients will receive either the investigational drug (BRTX-100) or
control in a 2:1 fashion.
BioRestorative’s license may facilitate
accelerated enrollment in the BRTX-100 cLDD trial. In addition, it
potentially will allow for easier access to clinicians who are
interested in investigator-initiated clinical studies or exploring
“right to try” uses for patients who qualify.
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.
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:Email: ir@biorestorative.com
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