Smart Implant for Magnetic Anastomotic Healing and Leakage Evaluation

ongoing

Colorectal cancer affects over 1.93 million people worldwide each year. In most cases, surgery to remove the tumour is necessary, and intestinal continuity is restored through an anastomosis. However, a serious complication, known as an anastomotic leak, occurs in up to 20% of procedures. This complication is associated with high mortality rates, frequent re-interventions, prolonged hospital stays, increased healthcare costs, and a reduced quality of life. Despite decades of research, the incidence of anastomotic leaks remains high, largely due to poor healing and delayed recognition. Leveraging outcomes from the FET Open project '5D NanoPrinting', and EIC Project 'IV-Lab', Trinity College Dublin and the Istituto Italiano di Tecnologia, in collaboration with Plio Surgical and Amsterdam UMC, aim to integrate the results of micro-sensor and nano-printing technologies into a disruptive smart magnetic anastomosis implant. This innovative implant will offer both healing and sensing capabilities, monitoring physical and chemical parameters that signal inflammation and edema at the anastomosis site. The SMARTHEAL project will advance this technology from TRL 3 to TRL 6 by embedding micro-sensors within the implant to detect key markers of anastomotic leaks. These sensors will be integrated with wireless electronics to transmit real-time data on healing biomarkers, with the implant’s accuracy demonstrated in pre-clinical models. SMARTHEAL represents a groundbreaking advancement, being the first implant to simultaneously enhance healing and enable early leak detection. This innovation has the potential to significantly improve surgical outcomes and reduce healthcare costs globally. It offers a substantial commercial opportunity for Plio Surgical, which aims to undertake the clinical and regulatory activities to bring this technology to market.