Case Study

Regener8 POC: Safer bone cement nears market

Date: September 10, 2014

A bone cement formulation for middle ear surgery developed by the University of Sheffield is moving closer to market, thanks to guidance from the Medical Technologies IKC.

The original bone cement used in middle ear surgery contained aluminium, which meant that it worked successfully in certain applications, but was neurotoxic in other sites. A re-formulated, safer version that contains less aluminium has been in use for some time, but some remaining risks means that its use is still restricted to a very narrow range of applications.

Professor Paul Hatton of the University of Sheffield’s School of Clinical Dentistry has developed a new bone cement which, crucially, does not contain aluminium. The new material can be used in two patented formulations – a pre-set granular bone substitute or an injectable bone cement – and is made by combining a bioactive glass material with a reactive polymer. The pre-set bone graft substitute is almost ready to place on the medical device market. Its formulation eliminates risks associated with aluminium release whilst stimulating bone tissue regeneration and healing. Professor Hatton is currently working with industry partner Corinthian Surgical Ltd on its commercial production.

The second formulation is an injectable, flowable cement that sets in the body and has potential applications in a wide range of orthopaedic conditions. Even though Professor Hatton already had a patent application for the material, he needed working prototypes and further data to attract commercial interest. Proof of Concept funding from the Medical Technologies IKC allowed his team to prove that the material could be used safely in the body and gather the extra data needed.

“The Medical Technologies IKC not only allowed us demonstrate the material’s potential economic value, but also introduced us to other vital contacts,” say Professor Hatton. “For example, speaking to a spinal expert about commercial and clinical need helped to shape our strategy. This has been so successful that we’re now talking to major orthopaedic companies regarding the liquid cement application. As a result of working with the Medical Technologies IKC, my research is now more valuable and more accessible to industry.”

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