Sensome, a developer of microsensing technology, has announced positive results from two studies evaluating its investigational Clotild Smart Guidewire System for peripheral artery disease (PAD) treatment.
The system demonstrated its ability to successfully identify fresh clots, rich in red blood cells (RBC), during the SEPARATE and E-SEPARATE studies. It also differentiated these clots from other tissues during PAD procedures.
The Clotild clot-sensing guidewire is said to combine the world’s smallest electrical impedance sensor with machine learning. It has received breakthrough status from the US Food and Drug Administration (FDA).
The guidewire is designed to identify fresh clots and differentiate it from organised clots, plaque, calcium, and other tissues during PAD procedures. This real-time technology aims to support personalised PAD treatment.
Integrated into common devices like guidewires and catheters, Clotild could become the first device to objectively identify fresh clot without altering the current workflow.
The prospective, single-arm SEPARATE study involved 17 patients. The study evaluated the ability of Sensome’s clot-sensing technology to identify fresh clots.
Post-procedure analysis revealed a high level of agreement between the technology’s identification of fresh clot, the expert’s assessment, and the corresponding treatment decisions for fresh clot, Sensome said.
The second study, E-SEPARATE, was conducted with 15 PAD patients at Groupe Hospitalier Paris Saint-Joseph in France.
The study revealed that, Sensome’s technology effectively differentiated fresh clot from other tissue collected from PAD patients and examined ex-vivo.
The healthtech start-up said the investigational microsensor technology predicted the RBC composition in retrieved clots, showing good sensitivity and specificity that aligned with histologic findings.
Sensome CEO Franz Bozsak said: “We have now seen positive outcomes from our initial clinical work in PAD and ischemic stroke and anticipate similarly positive findings from our current study in lung cancer.
“We are enthusiastic about the potential of our real-time, intra-operative tissue analysis technology to enhance the efficacy of a variety of minimally invasive procedures that are currently limited by existing imaging modalities.”
Sensome’s technology is also being assessed for total occlusion characterisation in peripheral vascular disease, and in-situ tool-in-lesion confirmation for lung cancer.
The clinical-stage company plans to partner with medtech companies to design, manufacture, and distribute smart medical devices incorporating its proprietary microsensing technology.
Sensome has partnered with guidewire manufacturer ASAHI INTECC to produce the Clotild Smart Guidewire System.
In July this year, the start-up signed its first distribution agreement with Cosmotec to distribute its smart clot-sensing guidewire for mechanical thrombectomy in Japan.
