TechsoMed Completes Enrollment in United States Pivotal Trial of BioTraceIO Software for Liver Ablation Outcomes Assessment

October 24, 2022—TechsoMed, an Israel-based developer of artificial intelligence algorithm–powered tissue-viability imaging technology, announced the completion of patient enrollment in the United States pivotal trial evaluating the safety and effectiveness of its flagship product, BioTraceIO. The trial has enrolled 50 patients at six clinical sites in the United States.

According to the company, BioTraceIO is intended for use in liver cancer patients undergoing ultrasound-guided percutaneous ablation procedures. With its algorithm-powered technology, the BioTraceIO software system provides visualization of the ablated area based on standard real-time ultrasound imaging to support interventional radiologists performing tumor ablation with valuable procedure outcomes assessment. The BioTraceIO ablation map is generated based on ultrasound imaging during the procedure.

The pivotal trial is primarily intended to demonstrate that the map is effective at estimating the ablation zone as measured 24 hours postprocedure by CT scan, representing the true ablation area.

The trial’s Principal Investigator is Sadeer Alzubaidi, MD, an interventional radiologist with Mayo Clinic Arizona in Phoenix, Arizona.

“Intraprocedural limited visibility of the area being treated is a true challenge we are facing when performing percutaneous ablation procedures,” commented Dr. Alzbaidi in the company’s press release. “I believe this hinders the adoption of thermal ablation for treating liver tumors, and I am pleased that new technologies are addressing this challenge.”

Dr. Alzabaidi further stated, “The BioTraceIO enables us, the interventional radiologists, to utilize a standard ultrasound for an added layer of accurate visual and quantitative information of the ablation process. This, no doubt, can increase accuracy and contribute to better care for our patients.”

Principal Investigator Nami Azar, MD, Professor of Radiology at University Hospitals Cleveland Medical Center in Cleveland, Ohio, added, “Ultrasound imaging is critical imaging modality in providing real-time insights during ablation procedures. I am happy to participate in this study to introduce innovative ultrasound-monitoring capabilities to the field of tumor ablation. The BioTraceIO solution has the potential to help to see more during the ablation process and to achieve improved procedure outcomes.”

TechsoMed advised that after completion of this study, it plans to expand its clinical validation program in the United States to validate its extended end-to-end BioTraceIO360 software solution designed to equip interventional radiologists with advanced patient-specific procedure modeling, planning capabilities, and three-dimensional postprocedure assessment.

The BioTrace IO solution is not yet approved for sale or distribution in the United States, where it is limited by federal law to investigational use, noted the company.