Bone Solutions, Inc. of Dallas, TX, announced at a Dow Jones Lifescience Conference that it had successfully tested its magnesium-based orthopedic adhesive technology in multiple studies to prove full biocompatibility for injection into animals and humans, with powerful mechanical properties that gave its unusual strength and performance beyond current orthopedic industry products.
BSI, an early stage orthopedics technology company, says that its bone void filler/cement/adhesive is expected to be deployed for many significant orthopedic surgeries, enhancing bone, ligament, tendon repairs following FDA 510 (k) approval. BSI said it also had some indications of bone proliferation or formation in addition to its affirmation to its ability to adhere bone to bone, ligaments and tendons to bone for the first time in medical history. The Company is now conducting in vivo studies to affirm indications of bone formation. BSI believes its product will help accelerate recovery of bone, tendon and ligament related injuries.
The Company also announced, that unlike other orthopedic products, its injectable compound that is bioabsorbable, can also be set and hardened with a CO2 laser, allowing each individual orthopedic surgeon the ability to determine when and how fast the compound can be set with each orthopedic operation. BSI expects its product will be initially used to augment the screws, pins, plates and other metallic devices now widely used in surgery, and may replace many of those products over time.
Dr. E. Anthony Copp, Acting CEO at Bone Solutions, Inc. said that the Company was planning to initiate veterinary product sales by year-end and anticipated a second quarter 2006 approval for 510 (k) by the FDA which would accelerate sales into human markets. He indicated that ACL injuries, rotator cuff, extremities, maxillofacial/oral surgery, shoulder and hip surgeries would be the most like initial uses for BSI's product.