FDA Clears Orthofix’s OstoCove Bioactive Synthetic Graft

Orthofix Medical Inc. has received U.S. Food and Drug Administration 510(k) clearance for and fully launched its advanced bioactive synthetic graft, OsteoCove. Available in both a putty and strip configuration, OsteoCove is carefully formulated to provide superior bone-forming capabilities with best-in-class handling characteristics for various spine and orthopedic procedural applications.
 
“Using the same R&D approach we have historically taken with our internally processed demineralized bone matrix solutions, we created a product that challenges the performance expectations of typical synthetic bone graft substitutes,” Orthofix Chief Scientific Officer Dr. Frank Vizesi said. “OsteoCove is another example of leveraging our strengths in product development in combination with our vertically integrated manufacturing expertise.”
 
Made of biphasic ceramic granule comprised of β-tricalcium phosphate (ß-TCP) and hydroxyapatite (HA) combined with type-I bovine collagen, OsteoCove features a specialized granule surface topography designed to elicit a bone-forming response, as evidenced by its ability to grow bone in a challenging muscle pouch model. This specialized surface chemistry and microporosity have been shown to promote superior bone formation when compared to other commercially available advanced synthetic grafts.¹
 
“…the launch of OsteoCove significantly strengthens our biologics portfolio and builds on our mission to deliver best-in-class products in every major bone grafting category,” said Tyler Lipschultz, president of Orthofix Global Biologics. “With the introduction of OsteoCove, we expect strong growth in this large market segment as we continue to deliver on our commitment to provide surgeons a comprehensive offering of biologic solutions to meet the needs of their patients.”
 
The U.S. synthetic bone graft market is estimated to be $300 million.²
 
Orthofix and SeaSpine merged in January 2023 to form a global spine and orthopedics company with a portfolio of biologics, spinal hardware, bone growth therapies, specialized orthopedic solutions, and a surgical navigation system. Its products are distributed in approximately 68 countries worldwide. The company is headquartered in Lewisville, Texas, where it conducts general business, product development, medical education, and manufacturing, and has primary offices in Carlsbad, Calif., with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics. The combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, Calif.; Toronto; Sunnyvale, Calif.; Wayne, Pa.; Olive Branch, Miss.; Maidenhead, U.K.; Munich; Paris; and São Paulo, Brazil. 

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^1,2 Data on file