DALLAS–(BUSINESS WIRE)–Bone Solutions Inc. (BSI) announced today that it has received FDA 510(k) clearance for the first device in its technology pipeline—a proprietary bone void filler, OsteoCrete™, which represents a critical milestone in the Company’s efforts to establish a platform for its patented magnesium-based technology. The Company expects this milestone to trigger its long-term plan to establish its 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.
“BSI’s OsteoCrete™, now FDA-cleared for long-bone and pelvis applications, establishes a new landscape for expanding breakthroughs in orthobiologics,” said Tom Lally, President of BSI. “Most of today’s leading devices in bone repair or replacement are calcium-based and do not exhibit the combination of features including compressive strength, expandability yielding a major binding quality. OsteoCrete™ is resorbable as it is replaced with bone during the window of healing. OsteoCrete™ is also injectable, osteoconductive, and is non-toxic. 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,” said Lally. “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 possible future applications.”