Sirakoss Wins CE Mark for Osteo3 Bone Graft Substitute
SIRAKOSS Ltd, a developer of nanosynthetic bone graft substitutes, announced today it 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. Synthetic bone grafts are used to fuse bones together during surgery to correct congenital or degenerative conditions, such as curvature of the spine, or following a traumatic injury where the bone fails to heal.
Based on proprietary nanoporous technology, Osteo3 consists of an inorganic matrix that is completely reabsorbed into the bone. Osteo3 has a unique surface chemistry designed to catalyse rapid and complete 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.
“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,” said Tom Buckland, Director of SIRAKOSS. “The positive results in studies achieved to date suggests that Osteo3 is a potential gamechanger 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.” 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. “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.”
Osteo3 is an entirely synthetic, nanoporous bone graft substitute composed of novel inorganic granules. Osteo3 is designed to catalyse rapid and complete bone regeneration and is ready for use within minutes. This brings important benefits to patients, who will need less time under anaesthetic and implies savings in theatre time and cost. Successful early studies support the potential for reliably achieving rapid patient recovery using Osteo3.
Press Release by SIRAKOSS
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