HEARTguide SIGNED

Project "HEARTguide" data sheet

The following table provides information about the project.

 Partnership

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 Project objective

While transcatheter procedures for heart structural diseases present strong advantages over open-heart surgeries, their adoption remains low. Indeed, the difficulties to predict the optimal size and positioning of the heart implant cause high rate of complication. FEops has developed HEARTguide, a cloud-based pre-operative planning tool that will enhance the use of the transcatheter procedures. HEARTguide simulates virtually the interactions between the implant and the real patient anatomy. HEARTguide predictive power was shown in a retrospective clinical trial on 80 patient cases. HEARTguide is CE marked for two indications. The next generation of HEARTguide will be artificial intelligence-powered and the analysis will be automated. The enhanced platform will be clinically validated through four clinical trials including 700 patients and limited access releases with selected physicians. The data base contains 1000 patient data that surpasses all over tools marketed. Agreements have been established with several worldwide implant manufacturer leaders to run feasibility studies and clinical trials. The commercial launch of HEARTguide is planned for 2024 and intends to be clinically validated for four different applications. HEARTguide will be marketed in EU, US, China and Japan following market approvals by the respective competent authorities. Our business model is to include HEARTguide in the implant package sold by implant manufacturers to hospitals. According to our estimations, the company will grow to 125 employees by 2024 while generating a positive EBITDA of €10M.