Periodic Reporting for period 2 - StentGuard (Clinical validation of the First Implantable Sensor System for Wireless detection of stent occlusion/ restenosis)
Okres sprawozdawczy: 2023-12-01 do 2024-03-31
Globally, over 237 million people suffer from peripheral artery disease (PAD), an abnormal narrowing of the arteries. The implantation of stents (spiral wire protheses) is the first-line therapy for PAD with ~ 3.5M stents implanted worldwide every year. Restenosis, the gradual reclogging of the blood vessel after stent implantation, is a major problem leading to high morbidity and mortality which occurs within 6 years after implantation in ~23 % of all cases and is often detected when it is too late.
More frequent surveillance of PAD patients to avoid unnecessary amputations and death is an unmet clinical challenge. VesselSens is an innovative German MedTech startup in the area of angiology and sensor technology and we develop the StentGuard, a smart therapeutic monitoring device that enables rapid, low cost and early diagnosis of in-stent restenosis non-invasively and reliably. Thereby also significantly reducing the number of amputations.
The ‘StentGuard’ device allows stent monitoring at high frequencies with low cost by non-specialist medical practitioners solving the problem of unchecked disease progression and saving the global economy billions of dollars per year.
More frequent surveillance of PAD patients to avoid unnecessary amputations and death is an unmet clinical challenge. VesselSens is an innovative German MedTech startup in the area of angiology and sensor technology and we develop the StentGuard, a smart therapeutic monitoring device that enables rapid, low cost and early diagnosis of in-stent restenosis non-invasively and reliably. Thereby also significantly reducing the number of amputations.
The ‘StentGuard’ device allows stent monitoring at high frequencies with low cost by non-specialist medical practitioners solving the problem of unchecked disease progression and saving the global economy billions of dollars per year.
Since the start of the action in October 2022, we have successfully completed tasks 1.1 and 1.2.
For task 1.1 (StentGuard Geometry and Signal Optimisation) we have successfully
• determined the optimum geometric configuration of the StentGuard through mechanical, electrical and usability testing.
• maximized the signal capture of the read-out unit (ROU) and increasing the signal to noise ratio by designing the electronics for electromagnetic compatibility and applying digital filters.
• developed the final design of the delivery system.
With regard to task 1.2 (Software Optimisation), we have successfully
• optimised the algorithm for diagnostic support to improve the accuracy and speed of the calculation using the NASCET criteria.
• Tested the algorithm to be provided as an approved and compiled library (e.g. DLL) to be integrated into the cloud-based web-service.
For task 1.1 (StentGuard Geometry and Signal Optimisation) we have successfully
• determined the optimum geometric configuration of the StentGuard through mechanical, electrical and usability testing.
• maximized the signal capture of the read-out unit (ROU) and increasing the signal to noise ratio by designing the electronics for electromagnetic compatibility and applying digital filters.
• developed the final design of the delivery system.
With regard to task 1.2 (Software Optimisation), we have successfully
• optimised the algorithm for diagnostic support to improve the accuracy and speed of the calculation using the NASCET criteria.
• Tested the algorithm to be provided as an approved and compiled library (e.g. DLL) to be integrated into the cloud-based web-service.
In order to make our solution available to the world and help people to not lose their limbs or even die due to Critical Limb Ischemia (CLI), while our solution will help reduce this, we still require a lot of capital to push our solution through the regulatory process. Apart from the necessary capital, which will be the basis to move forward, we will require support in the academic world as well as the industry.