SIRAKOSS Receives CE Mark for Osteo3 Synthetic Bone Graft Substitute

SIRAKOSS Ltd., a developer of synthetic bone graft substitutes, has been granted CE Mark clearance in the European Union (EU) for Osteo³, a 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 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 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.”
 
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.
 
SIRAKOSS is developing nanosynthetic graft substitutes to facilitate complete bone repair and transform patient healing. The SIRAKOSS bone graft substitutes utilize advanced and proprietary understanding of nanostructures and nanochemistry to catalyze faster bone regeneration coupled with total graft resorption. SIRAKOSS was spun out of the University of Aberdeen in 2011 based on the research of Gibson and is supported through financing from Epidarex Capital and Scottish Investment Bank, the investment arm of Scottish Enterprise together with grant funding from Innovate U.K.