US Food and Drug Administration clearance will enable SIRAKOSS to pursue commercialisation of its game-changing bone graft substitute.
Aberdeen-based SIRAKOSS has received 510(k) clearance from the US FDA for Osteo3 ZP Putty, its new nanosynthetic bone graft substitute.
Osteo3 ZP Putty has been designed to provide surgeons with an easy-to-use, advanced solution for filling voids or gaps during spine and trauma bone grafting procedures.
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. Osteo3 ZP Putty has a unique surface chemistry designed to catalyse rapid and complete bone regeneration following these procedures.
SIRAKOSS was spun out of the University of Aberdeen in 2011 based on the research of Professor Iain 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 UK.
“Our Osteo3 ZP Putty has demonstrated excellent pre-clinical performance in models of spinal fusion and trauma repair,” explained Iain Gibson, co-founder and Director of R&D at SIRAKOSS and Professor of Acellular Regenerative Medicine at the University of Aberdeen.
“Being able to provide surgeons with the synthetic bone graft in a pre-packed syringe, saves time and is far easier to handle during the procedure in the operating room environment. This product was developed with grant funding support from Innovate UK, part of the United Kingdom Research and Innovation (UKRI) organisation, and we’d like to thank them for their continued support in the development of this more advanced, next generation product.”
Welcoming the development, Prof Stephen Logan, chair of the ONE Life Sciences sector board, said: “This is an important milestone that will allow SIRAKOSS to pursue commercialisation in the US market. SIRAKOSS is a great example of a spinout from the University of Aberdeen that is pioneering technology with significant clinical benefits and commercial potential.
“Industry’s goal is to create and anchor more life sciences companies like this in north east Scotland long term. ONE’s action and investment with partners in the sector aims to maximise clinical and commercial collaboration and innovation, and support the creation and growth of high-potential companies that develop products and solutions that address modern health challenges.”
For more information visit www.sirakoss.com.
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