Orthofix Announces 510k Clearance and Full Commercial Launch of OsteoCove, an Advanced Bioactive Synthetic Graft for use in Spine and Orthopedic Procedures

LEWISVILLE, TEXAS — October 12, 2023 — Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the 510k clearance and full commercial launch of OsteoCove^™, an advanced bioactive synthetic graft. Available in both a putty and strip configuration, OsteoCove was carefully formulated to provide superior bone-forming capabilities with best-in-class handling characteristics for a wide range of spine and orthopedic procedural applications.

“Using the same disciplined 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,” said Dr. Frank Vizesi, Chief Scientific Officer for Orthofix. “OsteoCove is another prime 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 are shown to promote superior bone formation when compared to other commercially available advanced synthetic grafts.¹

“Orthofix is a leader in both the demineralized bone matrices (DBM) and cellular allograft markets, and 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, 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 invites those attending the North American Spine Surgeon Annual Meeting in Los Angeles, October 18-21, 2023, to visit booth #1711 to learn more about the Company’s portfolio of biologic solutions.

^1,2Data on file