Sirakoss said yesterday that it won CE Mark clearance in the European Union for its Osteo3 novel nanosynthetic bone graft substitute.
The Aberdeen, Scotland-based company said that its Osteo3 consists of an inorganic matrix intended to be completely reabsorbed into the bone.
Sirakoss added that the newly cleared bone graft substitute features a unique surface chemistry designed to catalyze rapid and complete bone regeneration following a fracture or for support after corrective surgeries.
“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. 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,” director Tom Buckland said in a prepared statement.
“We designed Osteo3 to address an increasing demand for a bone graft substitute that has the efficacy of autograft but overcomes the well reported problems of donor site pain for a significant number of patients. Our initial studies have confirmed both of these important aspects with our novel, fully nanosynthetic material. We are also working on the next generation of Osteo3, which will provide additional benefits to surgeons, in particular little or no prep in the surgical suite,” ,” co-founder & RAD director Iain Gibson said in a press release.