Business

Irish company gets support from US regulator for breakthrough bone adhesive

Shannon group Biomimetic Innovations has developed glue to accelerate healing for patients after fractures

A new bone glue developed by Shannon-based company Biomimetic Innovations has secured FDA breakthrough device designation. Photograph: iStock

Dominic Coyle Deputy Business Editor
Mon Jan 22 2024 - 05:00

A bone adhesive to help fractures heal more quickly being developed by a small Irish business has been recognised by the US medicines regulator as a potential breakthrough device in healthcare.

Biomimetic Innovations, based in Shannon in Co Clare, has been working on an injectable synthetic bioadhesive filler, OsStic, which aims to get patients up and moving more quickly, aiding the healing process and reducing costs in the healthcare sector.

OsStic is described by the company as “a structural, mechanically enhanced bioadhesive for reduction, provisional fixation, or void filling of peri-articular [joint] fractures or defects to enhance structural stability where standard fixation alone cannot provide sufficient support for functional mobilisation”.

Reduction means the resetting of bones after a fracture, while void filling relates to material required to fill any gap created or discovered as a result of the break. Provisional fixing refers to metalwork sometimes used to support the healing bone. Biomimetic says its adhesive will reduce the need for the use of such materials.

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The company’s website says the product allows for better repair of poor quality bone in patients with conditions such as osteoporosis, secures bone screws and anchors, fixes fractures that other implants cannot and disappears once the healing is complete.

It has now secured “breakthrough device” recognition from the Food and Drug Administration (FDA), which regulates the world’s biggest healthcare market. To qualify, a proposed device must enable more effective treatment or diagnosis of “life-threatening or irreversibly debilitating human disease or conditions”, and one of four other criteria which, in OsStic’s case, is that it represents breakthrough technology.

The designation means that the Irish business will have access to closer ongoing interaction with the FDA for feedback on OsStic’s development in advance of any application to be approved for use. It also secures priority review of company applications for the device on that pathway.

The Irish business said it would now prepare clinical data to allow it decide, with the FDA, on the best way to proceed to get the adhesive to market. No bone adhesive is available to surgeons currently.

The company is an affiliate of another Clare-based business, PBC Biomed, which was founded in 2010 and describes itself as a business working to help accelerate the commercialisation of ideas in the areas of medical devices, biomaterials and pharmaceuticals. It also works with a related company, GP Bio.

Biomimetic Innovations’ OsStic technology is initially focused on lower limb trauma orthopaedics – essentially hips, legs and ankles – but it has longer term ambitions to broaden the scope of its adhesive for use in dental work as well as in other orthopaedics and spinal procedures. The technology is also considered to have potential to join soft tissue to bone or to other soft tissue.

Dominic Coyle

Dominic Coyle

Dominic Coyle is Deputy Business Editor of The Irish Times

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