It seems a no-brainer: develop a glue that will help healing after fractures. But this is not an inanimate pipeline or scaffold. Putting anything into the human body can be risky.
Small Shannon-based business Biomimetic Innovations has spent the last few years working on developing just such a bio-adhesive. Philip Procter, one of the business’s co-founders, has been searching far longer for what he calls the “Holy Grail” biomaterial for orthopaedic specialists of all disciplines.
Now Biomimetic has secured “breakthrough device” designation from the US Food and Drug Administration (FDA), regulator to the most important of all healthcare markets for its OsStic bone adhesive as a potential aid in healing peri-articular fractures (fractures of the joints).
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It’s no guarantee of success. Just under one in 10 of the 839 products to be so designated since the programme opened has made it to market. But the programme has only been up and running for four years which, in development terms for properly innovative medical devices, is a relatively short window.
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For now, it means easier access to FDA guidance as Biomimetic continues to develop the product. With no current competition on the market, that support could be invaluable.
Biomimetic expects OsStic to get patients back on their feet more quickly with less need for further surgery. That would cut costs for patients and free up hospital beds more quickly.
Estimates suggest there are 100 complex fractures (the area covered by the FDA designation) per 100,000 people, with that figure on the rise as older people remain more active and the increase in joint replacement among younger patients.
Beyond its current FDA target, osteoarthritis has long been seen as another area with high potential for the device. According to the International Osteoporosis Foundation, such patients suffered 43 million broken bones in 2019 at a cost to the health system of €56.9 billion.
In Ireland, the same report said there were 32,000 broken bones among 209,000 patients that year, at a healthcare cost of €464.3 million. And it expects that figure for fractures to jump by close to 60 per cent just 10 years from now to 51,000 a year.
The potential for OsStic, which also has ambitions in dental care, is clear. The next challenge is to deliver on its promise in an area where neither of the current standard treatments — tissue grafts or artificial scaffolds — is seen as an ideal solution.
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