DALLAS--(BUSINESS WIRE)--Bone Solutions, Inc. ("BSI"), a privately held medical device company, announced today the completion of a pilot study indicating that its OsteoCrete™ product may be the first bone void filler (BVF) to be successfully used as a fusion-facilitator in a rabbit posterolateral lumbar spine model. OsteoCrete™ is already FDA-cleared as a bone void filler (BVF). The Company also announced that it intends to commence production of OsteoCrete™ early in the fourth quarter of this year.
OsteoCrete™ Bone Void Filler is a biocompatible magnesium-based bone void filler that is both injectable and moldable. It is indicated for bony voids or defects that are not intrinsic to the stability of the bony structure. OsteoCrete™ is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. OsteoCrete™ provides a bone void filler that resorbs and is replaced with bone during the healing process.
“Selecting a suitable graft material to share in the healing process within a posterolateral fusion is still a formidable challenge for spine surgeons,” said Tom Lally, President. “We have just completed a pilot study that encourages us toward future testing, and we believe OsteoCrete™ may have the potential to become an effective and cost-effective alternative to higher-cost bone growth protein products for spinal fusion procedures. We believe this makes OsteoCrete™ the first bone void filler to show this indication,” said Lally.
“We see even in this short, six-week pilot study indications of new bone formation in the transverse processes to the OsteoCrete in CT scans,” added Lally. “We are planning a second pilot study for further confirmation and to extend the time period to 12 weeks. If results are positive, we will then initiate completing the full 510(k) FDA protocol for spinal applications.
“We also are proceeding with plans to start OsteoCrete™ production and sales by October 1st,” Lally said. “Our production plans are to create 5 cc, 10 cc, and 15 cc self-contained OsteoCrete™ kits for use in orthopedic surgeries with potential sales launches in China and the U.S. While OsteoCrete™ is a BVF that acts like a powerful cement, it also possesses the key attribute of being resorbable, with resorption in 26 weeks at over 85%. It is biocompatible, osteoconductive, and injectable or moldable.
“Currently, the use of bone growth protein in spine surgery is common practice, since it creates bone very rapidly leading to fusion,” added Lally. “But there are risks associated with the use of any growth protein, and it is very costly averaging, $5,000 or more per surgery. There is a need for Bone Graft Material that can work in a spine fusion (1) without the risk of a second surgery to harvest the patient bone , (2) without the risk of using a bone growth protein, and (3) without the additional cost associated with the use of bone growth protein. Based on our follow-up 12-week pilot study to be started soon, we hope results will show that OsteoCrete™ can provide a platform for new bone formation resulting in fusion that is equal to the Gold Standard—i.e., use of a patient’s own bone.”
EVP and COO of Bone Solutions, Tony Copp, Ph.D., added that “no currently available osteoconductive BVF without the addition of autograft (in a 50/50 ratio with some exceptions) will fuse in the posterolateral lumbar spine fusion model.” He cited industry reports that identify more than 40 currently available BVFs have been tested in this model and “none works as a standalone, though some may work as an extender or enhancer,” said Dr. Copp.
“Because of the deficiencies of today’s calcium-based bone void fillers and cements, which result in lower surgical success rates, the industry spends millions of dollars annually on new R&D in an attempt to invent better calcium based products, or better-reinforcing metallic devices such as nails, pins, plates, and screws—some of which are not bioabsorbable,” Dr. Copp said. “On the other hand, BSI’s magnesium-based technology along with other ingredients provides significant compressive strength and possesses Ph-neutral qualities that make it ideal as a delivery system for numerous orthopedic-related indications.”
Dr. Copp also stated that Bone Solutions is continuing to explore strategic partnerships that will enhance the value of the Company.
About Bone Solutions Inc. (“BSI”)
BSI (www.bonesolutionsinc.com) intends to establish its magnesium-based platform as the ‘one stop bone-, tendon- and ligament-injectable, biodegradable adhesive technology’ for surgeries at hospitals, clinics and other private surgical centers within the orthopedic industry. The Company believes its FDA-certified bone void filler, OsteoCrete™, advances a new solution for orthopedic surgeons for human uses with a magnesium-based platform that may attach—for the first time in orthopedic medical history—bone to bone, as well as ligaments and tendons to bone in a tunnel.