BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics Corp. (OTCQB:BBLG), a developer of orthobiologic products
for domestic and international spine fusion markets, today has announced
that it received Human Research Ethics Committee (HREC) approval on
March 20, 2019, for the first center of a multicenter pilot clinical
trial to evaluate NB1 (NELL-1/DBX®) in 30 patients in Australia. The
pilot study will evaluate the safety and effectiveness of NB1 in adult
subjects with degenerative disc disease (DDD) at one level from L2-S1,
who may also have up to Grade 1 spondylolisthesis or Grade 1
retrolisthesis at the involved level who undergo transforaminal lumbar
interbody fusion (TLIF).
The study design has been previously reviewed by the US Food and Drug
Administration’s (FDA’s) Division of Orthopedic Devices in a
Pre-submission and is intended to support progression to a pivotal
clinical study in the United States. The Therapeutic Goods
Administration (TGA) in Australia will be notified of the conduct of the
study through the Clinical Trial Notification Scheme. “This marks a
significant milestone in the advancement of NELL-1/DBX®,” remarked
Company Chief Operating Officer Jeffrey Frelick.
Lumbar DDD is one of the most common causes of low back pain. DDD also
leads to substantial disability, with many patients suffering from
decreased ability to walk, sit, stand, and/or sleep. For some people,
DDD is part of the natural process of growing older and is a significant
medical issue that is increasing as the global population ages.
About Bone Biologics
Bone Biologics (OTCQB:BBLG) was founded to pursue regenerative medicine
for bone.
Bone Biologics Corporation is undertaking groundbreaking work and
building on unprecedented research on the NELL-1 molecule that has
produced a significant number of studies and publications in
peer-reviewed scientific literature.
Bone Biologics is currently focusing its development efforts for its
bone graft substitute product on bone regeneration in spinal fusion.
NELL-1 is a recombinant human protein growth factor that is essential
for normal bone development.
For more information, please visit the company’s website at www.bonebiologics.com.
Forward-Looking Statements
This press release contains forward-looking statements that reflect the
Company’s current beliefs, expectations or intentions regarding future
events. Any statements contained in this press release that are not
statements of historical fact may be deemed forward-looking statements.
Words such as “will,” “will be,” “anticipate,” “predict,” “continue,”
“future,” and similar expressions are intended to identify such
forward-looking statements. These forward-looking statements include,
without limitation, the Company’s expectations with respect to trading
in the Company’s common stock on the OTCQB; expectations regarding the
timing and success of FDA approval, the next phase of the Company’s
development and testing work; the Company’s expectation about moving its
technology forward and setting the stage for future growth and enhanced
shareholder value; and the future need for regenerative bone solutions.
All forward-looking statements involve significant risks and
uncertainties that could cause actual results to differ materially from
those expressed or implied in the forward-looking statements, many of
which are generally outside the control of the Company and are difficult
to predict. Examples of such risks and uncertainties include, but are
not limited to: future revenues, expenditures, capital or other funding
requirements, the adequacy of the Company’s current cash and working
capital to fund present and planned operations and financing needs,
expansion of and demand for product offerings, and the growth of the
Company’s business and operations through acquisitions or otherwise, as
well as future economic and other conditions both generally and in the
Company’s specific geographic and product markets. Additional factors
that could cause actual results to differ materially from those
expressed or implied in the forward-looking statements can be found in
the most recent current report on Form 10-K, filed with the Securities
and Exchange Commission on April 2, 2018, and Form 10-Q, filed with the
Securities and Exchange Commission on November 16, 2018. The Company
anticipates that subsequent events and developments may cause their
views and expectations to change. The Company assumes no obligation, and
they specifically disclaim any intention or obligation, to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Disclaimer
This communication shall not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be any
sale of securities in any jurisdiction in which the offer, solicitation
or sale would be unlawful prior to the registration or qualification
under the securities laws of any such jurisdiction. No offering of
securities shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act of 1933, as amended.
Contacts
Bone Biologics
Jeff Frelick, Chief Operating Officer
jfrelick@bonebiologics.com
Media Inquiries:
Tracy Williams, 310-824-9000
tracy@olmsteadwilliams.com