US-based spine and orthopaedics company Orthofix Medical has announced the US Food and Drug Administration (FDA) full approval, and commercial launch of OsteoCove.
OsteoCove is an advanced bioactive synthetic graft, offered in both putty and strip forms.
Orthofix designed the synthetic graft to provide superior bone-forming capabilities and handling characteristics for a wide range of spine and orthopaedic procedural applications.
Orthofix chief scientific officer Frank Vizesi said: “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.
“OsteoCove is another prime example of leveraging our strengths in product development in combination with our vertically integrated manufacturing expertise.”
OsteoCove is made of biphasic ceramic granules, comprising β-tricalcium phosphate (ß-TCP) and hydroxyapatite (HA), combined with type-I bovine collagen.
It features a specialised granule surface topography to elicit a bone-forming response, as evidenced by its ability to grow bone in a challenging muscle pouch model.
The specialised surface chemistry and microporosity are said to promote enhanced bone formation when compared to other commercially available advanced synthetic grafts.
Orthofix global biologics president Tyler Lipschultz said: “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.
“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 roll-out of OsteoCove follows the company’s recent completion of the first patient procedures and commercial launch of its Galaxy Fixation Gemini system in the US.
Galaxy Fixation Gemini system is a stable external fixation system offered as a rapid off-the-shelf solution for the treatment of fractures that result from trauma in the lower and upper limbs.
