SIRAKOSS Receives CE Mark for Osteo3 Synthetic Bone Graft Substitute

January 31, 2019

ABERDEEN, Scotland--(BUSINESS WIRE)--Jan 31, 2019--SIRAKOSS Ltd, a developer of unique synthetic bone graft substitutes, announced today it has been granted CE Mark clearance in the European Union (EU) for Osteo 3, 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, Osteo 3 consists of an inorganic matrix that is completely reabsorbed into the bone. Osteo 3 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 Osteo 3 to facilitate intraoperative ease of use by surgeons.

“Osteo 3 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 Osteo 3 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 exciting new product.”

Under its CE Mark, Osteo 3 is intended to be used as a bone graft material for filling voids or gaps of the skeletal system. Osteo 3 can be used alone or in combination with autograft, the patient’s own bone, or allograft (donor tissue).

“We designed Osteo 3 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 Osteo 3, which will provide additional benefits to surgeons, in particular little or no prep in the surgical suite.”

About Osteo 3

Osteo 3 is an entirely synthetic, nanoporous bone graft substitute composed of novel inorganic granules. Osteo 3 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 Osteo 3.


SIRAKOSS is developing nanosynthetic graft substitutes to facilitate complete bone repair and transform patient healing. The SIRAKOSS bone graft substitutes utilise 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 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. For more information visit www.sirakoss.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190131005136/en/


Tom Buckland

Tel: +44 1224 437846

pr@sirakoss.comHalsin Partners

Mike Sinclair

Tel: +44 (0)20 7318 2955





Copyright Business Wire 2019.

PUB: 01/31/2019 03:00 AM/DISC: 01/31/2019 03:01 AM


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