Complex bone fractures present significant challenges in healthcare, often requiring complex surgical intervention and leading to poor clinical outcomes. The Global Burden of Diseases report in 2019 highlighted a substantial increase of approximately 70 % in new bone fracture cases since 1990, with 145 million new cases reported.
Currently, metal hardware is widely used in treating post-traumatic bone injuries. However, this hardware has limitations and can result in poor healing and a lack of mechanical integrity, particularly in fractures occurring in patients with osteoporosis. Bone plates, screws and pins tend to loosen over time, necessitating their removal, which can lead to loss of crucial bone material. Additionally, there is currently no convenient method to stabilise small bone fragments and prevent micromotion in cases involving multiple bone fragments resulting from multiple breaks.
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Current treatments
Calcium phosphate cement presents an alternative to metal hardware, but it still has inferior physical and biological properties compared to native tissue. This inferiority is due to its brittle nature and poor tensile and shear properties resulting from randomly organised networks of entangled crystals. The lack of effective commercially available bone bioadhesives is due in part to the complex nature of bone repair, a process which requires mechanical stability in wet conditions, sufficient working time for the surgeon.
OsStic® is an injectable bioadhesive that can be used to treat bone fractures. It is the result of a longstanding research collaboration between Biodesign Europe at Dublin City University and Irish MedTech company PBC Biomed. The recent ‘Breakthrough Device’ designation means the treatment has been ‘recognised as a superior device to medical solutions currently available on the market.’
Biomaterials and bioengineering
When an orthopaedic surgeon fixes this during an operation by lifting the joint surface back into place, they are often left with an empty space in the bone underneath. This gap needs to be filled with something to hold everything in position and stop the repair from sinking back down over time. This is where OsStic™ comes in.
This innovative bioadhesive has been developed to address these challenges. It is designed to set quickly, and can mould itself to fit the irregular shape of whatever gap or damage is present, and immediately helps support the bone beneath the joint surface. At the same time, it encourages the body's natural bone to gradually grow into and replace it over time.
The new bioadhesive is a also biomaterial, something which has been engineered to interact with biological systems, in this case to heal bone fractures. The bioadhesive uses phosphoserine, a common molecule found in numerous proteins which, when combined with alpha-tricalcium phosphate powder, generates adhesive biomaterial that can stabilise and repair bone fractures.
The underlying research behind this new bioadhesive was published in Acta Biomaterialia. The team used specialist data analysis software to investigate the capabilities of the bioadhesive, hitting upon an optimal formulation in terms of key clinical properties that can be manufactured at scale and is cost-effective.
Progression to clinical trial
Biomimetic Innovations Ltd, an affiliate of PBC Biomed, announced the approval in May 2025. Patient recruitment is expected to begin in the coming weeks, with study completion anticipated by 2028.
The study looks at a particular type of fractures around the knee — specifically fractures at the top of the shin bone (tibia), where the flat surface that forms part of the knee joint gets damaged or pushed down.
The forthcoming clinical investigation will be conducted at Leeds University Teaching Hospital in the United Kingdom, the Principal Investigator being Professor Peter Giannoudis.
Biodesign Europe at DCU
The Biodesign Europe research centre at DCU has been collaborating with PBC Biomed for the last eight years. This research project was made possible by €5.4 million in funding from the Disruptive Technologies fund which the two organisations secured as part of a consortium in 2021. Further funding came from the SFI I-Form research centre. PBC Biomed also has a three year ongoing relationship with DCU Invent, the university’s commercialisation unit. Biomimetic Innovations Ltd, an affiliate of PBC Biomed, made this latest announcement on the 26th January.
Biodesign Europe combines the research strengths of Dublin City University and Arizona State University to find new innovations in bioengineering and biomaterials. Their scientific discoveries and biomaterial innovations are being directed towards the areas of human health, community safety and global sustainability. Further information available here.
Biomimetic Innovations Ltd., is an affiliate of PBC Biomed; a medical device company involved in design, development and manufacturing headquartered in Shannon, Ireland and with offices in Memphis, Tennessee and Chamonix, France.
