OsteoCrete, a biocompatible magnesium-based BVF, is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis).
Bone Solutions president Tom Lally said they see even in this short, six-week pilot study indications of new bone formation in the transverse processes to the OsteoCrete in CT scans.
"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," 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 US.
"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."
Bone Solutions EVP and COO Tony Copp said 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.
"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," Copp said.
Bone Solutions intends to commence production of OsteoCrete early in the fourth quarter of this year.
