Sirakoss Ltd announced it received CE mark clearance for Osteo³, a nanosynthetic bone graft substitute intended to improve patient healing and provide surgeons an advanced solution for bone fractures, according to a company press release.
“Osteo³ is the first of our new generation of bone substitute products to receive CE mark, a major milestone for Sirakoss. We believe our approach could provide the definitive synthetic bone graft product and feedback from surgeons on performance has been very encouraging,” Tom Buckland, director of Sirakoss, said in the release. “The positive results in studies achieved to date suggests that Osteo³ is a potential game-changer in the synthetic bone graft substitute market, providing significant advantages to patients and surgeons, including in the most challenging bone fracture indications. Sirakoss’ priority is executing on its commitment to delivering robust clinical data demonstrating safety and effectiveness of this exciting new product.”
According to the release, Osteo³ is designed to complete bone regeneration after fracture or support the skeletal system after corrective surgery of a deformity condition. It is to be used as bone graft material to fill gaps of the skeletal system. It can be used by itself or it can be combined with autograft or allograft.