DCU co-developed bone bioadhesive progresses to clinical trial
Biomimetic Innovations Ltd, an affiliate of PBC Biomed, announced the approval earlier this month. 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.
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.
Existing solutions, such as autograft, allograft, and conventional synthetic bone substitutes—each have recognised limitations, including donor-site morbidity, inconsistent availability, brittleness, or suboptimal biological integration. Calcium phosphate cement presents an alternative to metal hardware, but it still has inferior physical and biological properties compared to native tissue.
The lack of effective commercially available bone bioadhesives to date is due in part to the complex nature of bone repair, a process which requires mechanical stability in wet conditions, in addition to practical considerations such as sufficient working time for the surgeon.
Crucially, OsStic™ is a 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, produces a biomaterial demonstrating adhesive properties that can stabilise and repair bone fractures.
The forthcoming clinical investigation will be conducted at Leeds University Teaching Hospital in the United Kingdom, the Principal Investigator being Professor Peter Giannoudis.
Gerard Insley, Chief Scientific Officer at PBC Biomed said:
“PBC Biomed has a long track record of bringing biomaterial products to the global Medtech market, translational research of this nature requires strong industrial- academic collaboration to be successful and Professor Dunne and his team at DCU excel in this area. OsStic™ is a disruptive product that will change medicine and we look forward to continuing the collaboration with the DCU team to expand the clinical indications for the OsStic Bioadhesive.”
Ronan Cunningham, Director of DCU Invent said:
"We are incredibly proud at DCU to support research that has the potential to make a real and lasting impact on patients’ lives. OsStic™ is a powerful example of how deep scientific expertise, combined with strong academia-industry collaboration and a clear path to commercialisation, can deliver breakthrough healthcare innovations that can positively impact the lives of millions of people. I would like to warmly congratulate Professor Nick Dunne and the entire PBC Biomed team on reaching this important clinical milestone.”
The study is fully funded and sponsored by Biomimetic Innovations Ltd and represents an important step in building the clinical evidence base for OsStic™ ahead of future, larger comparative trials.
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 Innovate, 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.