ARTICLE SUMMARY:
Clot features, such as composition and length, have emerged as important factors influencing operators’ ability to achieve the first-pass effect and the best outcomes in stroke patients. Sensome’s technology for real-time analysis of clot features is coming closer to being a commercial reality. Excerpted from our recent feature article.
Sensome, which was spun out of the French National Center for Scientific Research and École polytechnique in 2014 to develop a sensor on a guidewire for measuring clot features, has recently made great strides at a time when the neurology specialty it is targeting recognizes the problem that it solves—the impact of clot features on the efficiency of thrombectomy procedures in patients with acute ischemic stroke.
Many variables can affect the success of stroke treatment. The first is, and always has been, time; that is, time elapsed between the onset of the stroke and reperfusion of the oxygen-starved brain. Numerous factors in the pre-hospital environment prevent patients from arriving at the angiography lab in time to save penumbral tissue, and there’s not much that can be done about some of these challenges.
The so called first-pass effect, another predictor of long-term stroke treatment success, describes the case where the operator successfully gets the clot out on the first and only needed pass of the thrombectomy device.
Conversely, more than three thrombectomy passes are associated with increased complications such as parenchymal hematoma, subarachnoid hemorrhage, and embolization into new territory, which suggests that multiple thrombectomy passes, in addition to lengthening procedure times and time-to-reperfusion, might harm the vasculature and shower distal circulation with debris with the potential to occlude smaller vessels. Today, interventionalists achieve the first-pass effect in less than 40% of cases, and much research is focused on predicting which choices and combinations of stentrievers and aspiration catheters, and in which order, are most likely to get the patient’s clot out in one pass.
Clot features, such as composition and length, have emerged as important factors influencing operators’ ability to achieve the first-pass effect and the best outcomes. Some clots are easier to remove than others, some are more prone to embolization, and the removal of shorter clots is associated with more efficient procedures and better outcomes than longer ones.
Sensome is developing tissue sensors that combine electrical impedance spectroscopy with machine-learning algorithms. The platform employs alternating frequencies of current to provide both cellular- and structural-level data. Among several targeted in situ tissue analysis applications, including lung biopsy and peripheral vascular interventions, for its go-to-market application, Sensome is focusing on the real-time analysis of large-vessel stroke clots causing acute ischemic stroke.
Sensome designed its Clotild Smart Guidewire System to fit seamlessly into the conventional workflow of thrombectomy. Its tiny sensor is integrated into the standard guidewire to provide operating clinicians with real-time information about clot features and where a clot begins and ends, allowing them to determine clot length and heterogeneity.
A prospective, multicenter ex vivo study (Clotbase Pilot), which compared the impedance analysis with postoperative histology of removed clots, demonstrated good correlation A follow-up study is ongoing. Now, the company is conducting a multicenter human feasibility study called CLOT OUT, which is assessing the performance and safety of the Clotild system.
The company expects to submit for the CE mark next year, and in the US, the FDA has granted Sensome its Breakthrough Device designation for Clotild.
A partnership with the Japanese guidewire manufacturer Asahi Intecc, announced in June, brings Sensome’s device closer to a commercial reality. Says Bozsak, “The guidewire we have been using is merely a proof-of-principle device, but now Asahi will put this into a wire with high performance for a commercial device.”
To date, Sensome has raised €17 million in total through its January 2020 Series B round with an additional €6 million in support from the French government. The company plans to raise additional funding in the coming year to support clinical trials, the development of additional clinical applications, and the path to commercialization of the Clotild Smart Guidewire System.
Future investors will find that the company has significantly de-risked its platform. States Sensome CEO Franz Bozsak, “We have addressed the major risk: does this work in humans? For our neurovascular product, we have seen from in vitro and ex vivo research that our measurement is very consistent and coherent and relevant from one environment to another.” Sensome has shown that it is possible to integrate an impedance sensor into a 0.014” guidewire and bring it up into the human brain to make impedance measurements, which no one has done before. And now, with the Asahi Intecc partnership, Bozsak continues, “Based on what we have learned, we are building a device with a partner that can bring better performance and scale up.”
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