Full Press Release Details
Biologics Receives Human Research Ethics Committee (HREC) Approval for the First Center of a Multicenter Pilot Clinical Trial
to Evaluate NB1 (NELL-1/DBX ) in Australia.
MA., March 25, 2019 - 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 I spondylolisthesis or Grade 1 retrolisthesis at the involved level who undergo transforaminal
lumbar interbody fusion (TLIF).
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.
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.
Biologics (OTCQB: BBLG) was founded to pursue regenerative medicine for 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.
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.
more information, please visit the company's website at www.bonebiologics.com.
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.
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