UK-based Sirakoss has received CE-Mark clearance for the use of its new nanosynthetic bone graft substitute Osteo, which improves healing in patients who require bone fractures repair.
Synthetic bone grafts are used to fuse bones during surgery in order to correct congenital or degenerative conditions, or after a traumatic injury that has affected the healing of a bone.
Osteo leverages nanoporous technology and features an inorganic matrix that can be completely reabsorbed into the bone.
The graft substitute’s design focuses on catalysis of fast and complete bone regeneration after a fracture, as well as to support the skeletal system following corrective surgery of a degenerative or deformity condition.
Under the CE-Mark, Osteo is indicated as a bone graft material for filling voids of the skeletal system. It can be used alone or in combination with an autograft or allograft.
Sirakoss co-founder and R&D director Iain Gibson said: “We designed Osteo 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.”
The company noted positive results from studies conducted to assess its new synthetic bone graft. Sirakoss intends to provide additional safety and effectiveness of clinical data for the product.
Sirakoss director Tom Buckland said: “The positive results in studies achieved to date suggests that Osteo 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.”
The company is currently developing further generations of the product to offer additional benefits such as intraoperative ease-of-use.