In This Article:
NASDAQ:BBLG
READ THE FULL BBLG RESEARCH REPORT
There are approximately 350,000 spinal fusion surgeries done in the US every year with varying degrees of success in alleviating often debilitating back pain. The existing dominant technology, known as rhBMP, has been quite successful in advancing the spinal fusion procedure but there are also challenges that can come along with using that technology. Patients can experience such impacts as rapid, uncontrolled bone growth that causes an unsound structure and unwanted bone formation where bone will grow where it is not intended. Back pain impacts 65 million Americans, with 16 million of those having what would be considered chronic back pain, leading to an estimated $12 billion per year in health care and indirect cost according to the Georgetown Policy Institute. While spinal fusion surgery isn’t the appropriate treatment for every kind of back pain, it can help to relieve the pain associated with a variety of conditions.
The NELL-1 technology is the centerpiece of what Bone Biologics (NASDAQ:BBLG) is developing. It was developed by UCLA TDG and Bone holds the exclusive worldwide rights to that technology. NELL-1 has been reviewed positively in over 45 peer reviewed publications demonstrating technological viability. NELL-1 has shown spine fusion effectiveness across three animal species—rodent, sheep and nonhuman primate and has competed two clinically relevant sheep studies that demonstrated NELL-1 increases the fusion rate and quantity of bone compared to the control group.
Bone Biologics recently announced that it has received approval to begin pilot clinical trials with NB1 in spinal fusion patients. The approval was given by the Human Research Ethics Committee and the trials will take place in Australia. This is an important and exciting step for Bone as the study will evaluate the safety and effectiveness of the company’s bone graft product—NB1. The study will include 30 adults who undergo transforaminal lumbar interbody fusion to treat degenerative disc disease. Importantly, this study design has been reviewed by the FDA’s Division of Orthopedic Devices and is intended to support progression to a clinical study in the US.
That brings us to the recent announcement of the fiscal 2023 financial results, which show a clinical stage company that is pursuing a potential game-changing treatment and getting it to patients as soon as possible.
Among the financial highlights:
• The company has a cash balance of just over $3 million. BBLG will need further funding as that approval process goes along, but the current cash balance will enable the company to continue its pursuit.