Sirakoss granted CE mark for synthetic bone graft substitute

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Sirakoss has been granted CE mark clearance in the European Union (EU) for Osteo3, a novel nanosynthetic bone graft substitute designed to improve patient healing, offering surgeons a more advanced solution for repairing bone fractures.

Based on proprietary nanoporous technology, Osteo3 consists of an inorganic matrix that is completely reabsorbed into the bone. The surface chemistry of Osteo3 is designed to catalyse bone regeneration following a fracture or to support the skeletal system after corrective surgery of a degenerative or deformity condition. Sirakoss is developing further generations of Osteo3 to facilitate intraoperative ease of use by surgeons.

Under its CE Mark, Osteo3 is intended to be used as a bone graft material for filling voids or gaps of the skeletal system. Osteo3 can be used alone or in combination with autograft, the patient’s own bone, or allograft (donor tissue).

“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,” explained Iain Gibson, co-founder and director of R&D at Sirakoss and professor of Acellular Regenerative Medicine at Aberdeen University (Aberdeen, UK).

He continued: “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.”

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