Novel ‘bone glue’ product receives key FDA designation
An I-Form-supported research project has recently achieved a significant milestone, with its new bone fracture treatment OsStic® awarded ‘Breakthrough Device Designation’ by the US Food and Drugs Administration (FDA).
OsStic® is an injectable bioadhesive that can be used to treat bone fractures or defects, and is designed for bone issues where standard fixation techniques are not able to return full function and mobility to the joint.
The product is the result of a multi-year research collaboration between Biodesign Europe at Dublin City University (DCU) and Irish Medical Device company PBC Biomed, along with affiliate company Biomimetic Innovations (BMI).
Achieving this ‘Breakthrough Device’ designation from the FDA highlights the OsStic® product as a superior treatment to other medical solutions currently on the market. The designation will also speed up the development, assessment and review of the treatment, accelerating its pathway to market.
Professor Nicholas Dunne, I-Form Funded Investigator and Executive Director of Biodesign Europe, said:
"The partnership between DCU and PBC Biomed demonstrates the effectiveness of cross-disciplinary collaboration, and highlights Ireland's ability to excel in state-of-the-art medical technologies. This recognition from the FDA affirms the promising trajectory of OsStic®, and also demonstrates the importance of stimulating innovation through investment in groundbreaking technologies, to enhance Ireland's global standing in the medical device sector."
Current treatments for bone fractures often involve metal hardware, which can result in poor healing and a lack of integrity, and which may also need to be removed at a later time. There is also currently no convenient method to stabilise small bone fragments. The use of a bioadhesive has the potential to improve outcomes in these types of applications.
In this project, the research team examined the capabilities of the bioadhesive using specialist data analysis software, which yielded an optimised formulation in relation to key clinical properties, and which is also cost effective and can be manufactured at scale.
This project was made possible by €5.4 million in funding from the Disruptive Technologies fund, along with additional funding from the I-Form Centre.
I-Form Centre Director Professor Denis Dowling said:
“I-Form is very happy to provide its support for this research programme which, as highlighted by the recent FDA designation, has demonstrated its potential to achieve significant impact and provide enormous benefits to patients and medical practitioners. We look forward to seeing the exciting future developments of this very promising product.”