US approval of bone graft ‘game changer’

Science: Clearance allows for synthetic ‘putty’ to be marketed

US regulatory clearance for a “game-changing” bone graft substitute has been hailed a key milestone for Aberdeen University spinout Sirakoss.

The Foresterhill-based firm said Food and Drug Administration (FDA) approval for its new-type, synthetic bone graft – developed for procedures such as spine and bone trauma surgery – paved the way for commercialisation plans.

Iain Gibson, co-founder and director of research and development at Sirakoss, and also professor of acellular regenerative medicine at Aberdeen University, said: “Our Osteo3 ZP Putty has demonstrated excellent pre-clinical performance in models of spinal fusion and trauma repair.

“Being able to provide surgeons with the synthetic bone graft in a pre-packed syringe saves time and is far easier to handle... in the operating room environment.”

Fellow director Tom Buckland said: “FDA clearance is obviously a major achievement for Sirakoss, enabling us to implement the commercial strategy for this gamechanging product.”

Sirakoss was spun out of the university in 2011, based on the research of Professor Gibson. Its fourstrong full-time team is supported through funding from Epidarex Capital, the Scottish Investment Bank and Innovate UK.

Synthetic 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 body fails to heal.

According to Sirakoss, patients who undergo procedures using its Osteo3 ZP Putty need less time under anaesthetic – creating savings in theatre time and cost. Pre-clinical

“FDA clearance is obviously a major achievement for Sirakoss ”

studies support the potential for “rapid patient recovery”, the firm says.

Life sciences are key to the diversification strategy of economic development body Opportunity North East (ONE).

ONE life sciences sector board chairman Professor Stephen Logan said Sirakoss was a “great example” of the region pioneering technology.

He added: “Industry’s goal is to create and anchor more life sciences companies like this in north-east Scotland.”

PIONEERING: Iain Gibson is a co-founder of Aberdeen University spin-out Sirakoss