DTIF-funded project, OsStic® technology awarded #BreakthroughDevice designation by the FDA.

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Shannon, Ireland, February 12th 2024: Irish medical device company Biomimetic Innovations Ltd, an affiliate of PBC Biomed, announced ‘Breakthrough Device’ designation from the Food and Drug Administration FDA in January, for the development of a groundbreaking new bio-adhesive bone void filler technology called OsStic®. 

PBC Biomed leads a consortium for this development project, which is comprised of Biodesign Europe and SFI Research Centre for Advanced Manufacturing (I-Form) at Dublin City University, and Dolmen Design & Innovation, a Dublin-based product design company.

The project (2021 – 2024) is funded under the Disruptive Technologies Innovation Fund (DTIF), which is a €500 million fund established under the National Development Plan (NDP) in 2018 and led by the Department of Enterprise, Trade and Employment, and administered by Enterprise Ireland.

The aim of the fund is to drive collaboration between Ireland’s world-class research base and industry, as well as facilitating enterprises to compete directly for funding in support of the development and adoption of these technologies.

 Welcoming the announcement, Dr Imelda Lambkin, Disruptive Technologies and Innovation Department Manager, Enterprise Ireland commented;

“This announcement is a great success for PBC Biomed and is testament to the capability and talent, vibrancy and international competitiveness of the Irish innovation and research system. In line with Enterprise Ireland’s strategy, this success will support the company to build on their existing capabilities, scale and create jobs.

“The collaboration between Dublin City University, Dolmen Design & Innovation, Biomimetic Innovations, and PBC Biomed exemplifies the power of interdisciplinary efforts in research and development. The ‘Breakthrough Device’ designation by the FDA validates the promising trajectory of OsStic®, showcasing Ireland’s capability to lead in cutting-edge medical technologies. This achievement not only highlights the success of the project but also emphasizes the importance of sustained investment in disruptive technologies to foster innovation and elevate Ireland’s global standing in the medical device industry.” Professor Nicholas Dunne, Founding Executive Director of Biodesign Europe, Dublin City University and Funded Investigator in the SFI Research Centre for Advanced Manufacturing and SFI Centre for Advanced Materials and BioEngineering Research.

“This announcement marks a major milestone in the evolution of calcium-based biomaterials. The proposed indication will be unique and for the first time will address all surgeon needs when dealing with complex fractures and allow for faster recovery times and greatly improved results for patients.” Gerard Insley, Chief Science Officer BMI.

Learn more about DTIF here: https://lnkd.in/dHQ3_2vF

About BMI

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.