TechsoMed Announces Completion of Full Enrollment in Pivotal U.S trial Evaluating its BioTraceIO Software for Liver Ablation Outcomes Assessment in Liver Cancer Patients

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Oct 24, 2022, 09:00 ET

The completion of this multi-center pivotal study is another major milestone achieved advancing the Company toward its first FDA De-Novo filing

REHOVOT, Israel, Oct. 24, 2022 /PRNewswire/ -- TechsoMed, the developer of first of its kind AI Algorithm powered tissue viability imaging technology, announced today it has successfully completed patient enrollment in U.S. Pivotal trial designed to demonstrate the safety and effectiveness of its flagship product, BioTraceIO, in providing valuable visualization and quantitative insights on procedure outcome in liver cancer patients undergoing ultrasound guided percutaneous ablation procedures.

With its algorithm powered technology, the BioTraceIO software system is the first to provide visualization of the ablated area based on standard real-time ultrasound imaging intended to support interventional radiologists performing tumor ablation with valuable procedure outcomes assessment.

"Intraprocedural limited visibility of the area being treated is a true challenge we are facing when performing percutaneous ablation procedures. I believe this hinders the adoption of thermal ablation for treating liver tumors, and I am pleased that new technologies are addressing this challenge," said Dr. Sadeer Alzubaidi, an interventional radiologist from Mayo Clinic Arizona, principal investigator at the trial. "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".

"Ultrasound imaging is critical imaging modality in providing real-time insights during ablation procedures," adds Dr. Nami Azar, Professor of radiology and principal investigator at University Hospitals Cleveland Medical Center. "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".

The pivotal trial primarily intended to demonstrate that the BioTraceIO Ablation Map generated based on ultrasound imaging during the procedure is effective at estimating the ablation zone as measured 24-hours post-procedure by CT scan, representing the true ablation area. The trial has enrolled 50 patients across 6 leading clinical sites in the U.S. including Mayo Clinic in Arizona and Minnesota, Stanford, Mass General Hospital, UH Cleveland and Houston Methodist Hospital.

"The completion of our first BioTraceIO pivotal trial is a great accomplishment that reflects a milestone in executing our vision of transforming Thermal Ablation from guess-work into precise, real-time feedback dependent treatment", said Yossi Abu, TechsoMed's CEO. "The collaboration with such leading medical centers and physicians indicates the deep recognition of the interventional-radiology community in BioTrcaeIO potential to provide a much-needed clinical value in the liver ablation space".

Upon the study completion, TechsoMed plans to expand its clinical validation program in the U.S to validate its extended end-to-end BioTraceIO360 software solution designed to equip interventional radiologists with advanced patient-specific procedure modeling, planning capabilities and 3D post-procedure assessment.

About TechsoMed

TechsoMed (www.TechsoMed.com) is a medical imaging software company developing the BioTrace platform, designed to enable physicians to detect and visualize tissue viability using standard commercial ultrasound imaging for thermal ablation procedures. TechsoMed's innovative technology is designed for real-time image analysis in multi clinical applications, such as oncology (tumor ablation), cardiology (heart arrhythmia), and pain management (radiofrequency neurotomy). The company's first product, BioTraceIO, primarily targets use in liver tumor ablation procedures. The BioTrace IO solution is not yet approved for sale or distribution in the US and is limited by U.S. law to investigational use. www.TechsoMed.com

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SOURCE TechsoMed