Sensome Begins Clinical Trial for its Tissue Microsensor Tech

Sensome has enrolled the first patients in the feasibility clinical study of its Clotild Smart Guidewire in peripheral artery disease (PAD). The U.S. Food and Drug Administration granted Clotild breakthrough device designation (for use in brain arteries) in 2021.
 
The clinical trial—SEPARATE—is designed to assess the Clotild sensor’s capability to detect various characteristics of blood vessel blockages in PAD patients. The first five patients have been enrolled at AZ Sint-Blasius Hospital in Dendermonde, Belgium. Preliminary results are expected in the middle of this year.

“After successfully applying our technology to the treatment of ischemic stroke patients, we are excited about the opportunity to build on this work to potentially help millions of patients around the world whose lives have been impacted by PAD,” Sensome Co-Founder/CEO Franz Bozsak said.
 
PAD is a manifestation of systemic atherosclerotic disease estimated to affect more than 200 million patients worldwide. This represents a significant health burden globally, particularly related to the development of blood vessel blockages, which are challenging to treat. A key focus of the SEPARATE clinical trial is evaluating the Clotild sensor’s capability to differentiate between soft and friable “fresh” clots and organized “old” clots. This critical information enables physicians to select the most suitable endovascular therapeutic approach, thereby mitigating complications, avoiding embolization, and enhancing long-term treatment outcomes.
 
“Understanding the makeup of a total occlusion in peripheral artery disease is essential to choose an adequate treatment approach to ensure lower complication rates and more durable long-term outcomes in this complex group of vascular patients,” said Dr. Koen Deloose, head of Vascular Surgery at AZ Sint-Blasius Hospital, and principal SEPARATE trial investigator. “Sensome’s tissue microsensor technology could become a tool to characterize the total occlusion in an objective and simple-to-use way that integrates perfectly with our current existing workflow.”
 
A clinical stage startup, Sensome developed sensor technology that turns invasive medical devices into connected healthcare products. Its patented technology combines the world’s smallest impedance-based microsensors with machine-learning algorithms to characterize biological tissues in real-time. The flagship product of Sensome, the Clotild Smart Guidewire System, is a connected neurovascular guidewire designed to provide blood clot characterization during the endovascular management of acute ischemic stroke. Sensome’s tissue sensing technology could potentially be integrated into minimally invasive medical devices used in other treatment areas, such as peripheral vascular disease and oncology.