Periodic Reporting for period 1 - BioTrace (World's First Real-Time Monitoring System for Ablation Procedures )
Reporting period: 2019-12-01 to 2020-04-30
Thermal ablation (TA) is an attractive treatment for oncology, heart arrhythmias or chronic pain. It offers shorter hospital stays, faster recovery and less complications than surgery. However, specialists are blind regarding target tissue destruction or collateral damage and high failure rates (e.g. recurrence) or overtreatment are common. TechsoMed has developed BioTrace™, the first real-time monitoring and control software for ablation. It interfaces with ultrasound devices to provide AI-guided image analysis and accurate prediction of tissue damage after 24 hrs (done today with CT or MRI). It has been initially validated for liver tumor ablation (oncology) and now it needs to be optimized and exhaustively validated in clinical trials to reach certification in Europe (CE), USA (FDA) and Japan (PMDA). Other applications of the system (e.g. cardiovascular TA) will gradually scale-up the technology. For market deployment, robust partnerships with ultrasound/ablation devices manufacturers (currently Phillips, GEH, Siemens or J&J.) need to be established.
Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far
TechsoMed's core know-how was developed at Sheba Medical Center (Israel). The company transformed it from concept to a working prototype of the BioTrace™ system. The application for liver tumors is the most advanced, with a clinical study completed in 54 patients from Sheba Medical Center and University of Tokyo Hospital (Japan). Compared with 24 hrs post-treatment CT scans (a gold standard), the system shows a consistent >92% matching. BioTrace™ has been patented and the regulatory roadmap is progressing, with FDA approval process initiated. The feasibility study has allowed to plan further steps, calculate financial needs of the project and quantify the business opportunity for the company.
Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)
In ablation, ultrasound (US) or computed tomography (CT) provide good visualization and control during probe placement, but do not offer in situ monitoring. Moreover, current treatment planning neglects patient-specific parameters that influence ablation zone morphology. BioTrace™ allows to use US imaging to monitor TA procedure in real time and accurately predict tissue damage as it evolves over 24 hrs post procedure, to reach optimal outcomes in target tissue destruction with minimal adjacent damage. Enhancing TA results and avoiding recurrence or complications can help to boost the use of this minimally invasive technique and bring multiple benefits to patients, hospitals and healthcare systems globally.