News – Bone Biologics

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.

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics (OTCQB: BBLG), a developer of orthobiologic products for domestic and international spine fusion markets, announced today the completion of $5.9 million funding; $3.9 million in equity and a $2 million credit facility. Proceeds will be used for working capital, protein development, animal testing, regulatory and clinical expenses, as well as for other purposes not presently contemplated herein but which are related directly to growing the Company’s current business, research and development activities and the repayment of a secured promissory note in the principal amount of $600,000.

The securities offered have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.

About Bone Biologics

Bone Biologics (OTCQB:BBLG) was founded to pursue regenerative medicine for bone.

Bone Biologics Corporation is undertaking groundbreaking work with select strategic partners, 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 and has rights to trauma and osteoporosis applications. 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.

Bone Biologics trades on the OTCQB venture stage marketplace for early stage and developing U.S. and international companies. OTCQB companies are current in their reporting and undergo an annual verification and management certification process. Investors can find Real-Time quotes and market information for the company on www.otcmarkets.com.

Forward-Looking Statements

Disclaimer

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics (OTCQB: BBLG), a developer of orthobiologic products for domestic and international spine fusion markets, announced today the completion of $500,000 funding with Orthofix Holding, Inc. The funding represents the second round of a previously announced private placement.

About Bone Biologics

Bone Biologics (OTCQB:BBLG) was founded to pursue regenerative medicine for bone.

Bone Biologics Corporation is undertaking groundbreaking work with the three founders and select strategic partners, 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

Disclaimer

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics Corp. (OTC QB: BBLG), a developer of orthobiologic products for the spinal fusion, trauma and osteoporosis markets, today has announced that it has completed a preclinical study, which shows its rhNELL-1 growth factor effectively promotes bone formation in a phylogenetically advanced spine model. In addition, rhNELL-1 was shown to be well tolerated and there were no findings of inflammation.

“We are very encouraged by the results of our Pilot animal study and look forward to commencing our Pivotal animal study by mid-2018 and presenting results at future scientific conferences,” said Steve La Neve, chief executive officer of Bone Biologics.

“In its first clinically relevant sheep study, rhNELL-1 demonstrated increases in fusion and quantity of bone compared to the control,” said Dr. Bill Walsh, professor and director, Surgical and Orthopedic Research Laboratories (SORL).

“We look forward to completing ongoing activities to advance into clinical trials in 2019,” stated La Neve.

About Bone Biologics

Bone Biologics (OTC QB: BBLG) is pursuing regenerative medicine for bone including 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.

For more information, please visit the company’s website at www.bonebiologics.com.

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics Corp (OTC: BBLG), a developer of orthobiologic products for domestic and international spine fusion markets, today has announced that it has expanded its Field of Use definition of the license agreement with the UCLA Technology Development Group on behalf of UC Regents for NELL-1. Additionally, Bone Biologics has entered into an exclusive license agreement with the UCLA Technology Development Group on behalf of UC Regents for the worldwide application of the NELL-1 protein for both osteoporosis and trauma through a technology transfer.

“Following the completion of several key milestones, Bone Biologics is pleased to include two additional indications to its portfolio,” said Stephen LaNeve, CEO and President of Bone Biologics. “In addition to the company’s work in spine fusion, this exclusive license agreement for trauma and osteoporosis, further supports the possibility of NELL-1 becoming a proprietary platform technology.”

Most current osteoporosis therapies are designed to slow bone loss and prevent it from worsening but research involving NELL-1 is being examined to systemically restore bone and prevent further loss.

About Bone Biologics

Bone Biologics (OTC: BBLG) was founded to pursue regenerative medicine for bone.

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 OTC; 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 March 30, 2017 and Form 10-Q, filed with the Securities and Exchange Commission on August 8, 2017. 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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