At the end of the project, the following work has been performed (by work package):
The activities under WP1, focused on project management. Regular monthly meetings were conducted between the project coordinator and WP leaders, who were responsible for the coordination of all project activities. These meetings served as a platform for comprehensive coordination discussions and updates, which were presented to InVera Medical’s senior management, to ensure transparency and alignment with company goals. To ensure the project’s success, regular monitoring and assessment of risks, the project data management plan and objectives was integral to this WP, leading to necessary adjustments, all incorporated into continuous reporting.
WP2 (Market Activities) Monthly meetings and intensive project efforts continued as we refined our commercial and regulatory strategies for the European and US markets aligned to our clinical regulatory study detailed in WP3. These efforts enhanced our preparedness for engaging with potential investors in future project WPs.
WP3 (Development) Our comprehensive clinical regulatory study is currently well underway. This pilot study was approved for initiation in Budapest, Europe by The National Institute of Pharmacy and Nutrition (OGYÉI), the Hungarian Competent Authority for medical devices. The first cohort patients were enrolled in the Exclusively Mechanical Venous Ablation Gen 2 (EMVA2) clinical study in Q2 2023, marking a significant milestone. Continuing our trajectory, recruitment is ongoing at our second clinical site with further patients treated in Q2 2024 with further patients scheduled for treatment post project. This sequential approach ensures that the progress of our clinical trial was systematic and well-structured. Simultaneously, our accomplished team across regulatory, quality and R&D remained focused on the completion of the design freeze of our commercial product. This milestone signifies the culmination of substantial work and dedication of the project team.
A pivotal moment for the project was the achievement of securing the ISO 13485 Medical devices quality Management System (QMS) certification by the eminent British Standards Institution (BSI) global certification body. This demonstrated our commitment and traction upholding the highest industry standards. To maintain this important certification, future activities will centre around vigilant monitoring and rigorous auditing, ensuring a continuum of excellence post project.
