Sirakoss, a developer of nanosynthetic bone graft substitutes for treatment of spinal fusions and bone defects, has secured CE Mark clearance in the European Union (EU) for its new bone graft substitute Osteo3.
Osteo3 is a nanosynthetic bone graft substitute designed to improve patient healing and providing surgeons with a more advanced solution for repairing bone fractures.
Synthetic bone grafts are used to fuse bones together during surgery to correct congenital or degenerative conditions like curvature of the spine or failure of bone to heal following a traumatic injury.
Osteo3, which is designed based on nanoporous technology, includes a matrix composed of novel inorganic granules, that is completely reabsorbed into the bone.
Its surface chemistry is designed to catalyze rapid and complete bone regeneration following a fracture or to support the skeletal system after corrective surgery of a degenerative or deformity condition.
The company says Osteo3 brings important benefits to patients, who needs less time under anesthetic and implies savings in theatre time and cost. Early studies on the product support the potential for achieving rapid patient recovery using Osteo3.
Sirakoss director Tom Buckland said: “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 suggest 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 new product.”
Sirakoss said that it is developing next generations of Osteo3 to enable intraoperative ease of use by surgeons.
Under the CE Mark, Osteo3 is expected to be used as a bone graft material for filling voids or gaps of the skeletal system. It could be used single-handedly or in combination with autograft – the patient’s own bone, or allograft -donor tissue.
Acellular Regenerative Medicine Professor at Aberdeen University and Sirakoss co-founder and R&D director Iain Gibson said: “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.”