Periodic Reporting for period 2 - EnVena (Automatic vein wall disruption, triggering the body’s natural cellular healing response to close targeted veins curing Venous Leg Ulcers)
Reporting period: 2023-10-01 to 2024-09-30
Project name: Automatic vein wall disruption, triggering the body’s natural cellular healing response to treat targeted veins curing Venous Leg Ulcers
Problem/Need being addressed:
Chronic venous disease is associated with poor blood circulation and blood pooling in the legs. It is one of the most common diseases in the developed world, affecting up to 60% of adults over the age of 50 with high recurrence, necessitating a new effective alternative treatment. Chronic venous disease is the leading cause of Venous Leg Ulcers which are chronic open sores, usually on the inside of the leg that will not heal without specialist treatment.
The total costs associated with managing venous disease patients across Europe and the US is €33.4 billion per year, representing 2.5% of total healthcare expenditure.
The EnVena device is the world’s first device to mimic the body’s natural healing response to deliver an effective treatment to venous leg ulcer patients.
Objective:
Funded by the European Innovation Council, the objective of the EnVena project is introducing a novel medical device that mimics the body’s natural healing response. The EnVena device provides an effective minimally invasive treatment against both varicose veins and venous ulcers but without harmful side effects. During the procedure the device is well tolerated by patients and early data suggests it has an excellent performance profile.
Problem/Need being addressed:
Chronic venous disease is associated with poor blood circulation and blood pooling in the legs. It is one of the most common diseases in the developed world, affecting up to 60% of adults over the age of 50 with high recurrence, necessitating a new effective alternative treatment. Chronic venous disease is the leading cause of Venous Leg Ulcers which are chronic open sores, usually on the inside of the leg that will not heal without specialist treatment.
The total costs associated with managing venous disease patients across Europe and the US is €33.4 billion per year, representing 2.5% of total healthcare expenditure.
The EnVena device is the world’s first device to mimic the body’s natural healing response to deliver an effective treatment to venous leg ulcer patients.
Objective:
Funded by the European Innovation Council, the objective of the EnVena project is introducing a novel medical device that mimics the body’s natural healing response. The EnVena device provides an effective minimally invasive treatment against both varicose veins and venous ulcers but without harmful side effects. During the procedure the device is well tolerated by patients and early data suggests it has an excellent performance profile.
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.
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.
The EnVena device is the world's first effective non-thermal medical device to utilise the body's biological response to treat chronic venous disease varicose veins and venous ulcers symptoms without harmful side effects. It is a less- invasive, effective, pain-free, and faster minimally invasive endovenous medical device treatment for all chronic venous disease patients.
• Biological Response Treatment: Leveraging the body’s natural biological response is a novel approach that delivers more effective and targeted treatment outcomes.
• Less Invasive and Minimally Invasive: The EnVena device offers a minimally invasive treatment approach that is well received by patients, as it leads to reduced treatment discomfort and faster recovery times.
• Pain-Free: The pain-free approach addresses a common concern among patients undergoing treatment for the disease.
• Faster Treatment: The treatment provided by the EnVena device is advantageous for patients but also optimises healthcare resources and reduces the burden on clinical facilities.
• Clinical Efficacy: The completion of preclinical and EMVA2 clinical trials as part of this project will demonstrate both superior clinical efficacy and the absence of serious adverse effects. Evidence of increased quality of life scores to date strengthens our confidence in the potential impact of the EnVena device to treat our patients.
• Biological Response Treatment: Leveraging the body’s natural biological response is a novel approach that delivers more effective and targeted treatment outcomes.
• Less Invasive and Minimally Invasive: The EnVena device offers a minimally invasive treatment approach that is well received by patients, as it leads to reduced treatment discomfort and faster recovery times.
• Pain-Free: The pain-free approach addresses a common concern among patients undergoing treatment for the disease.
• Faster Treatment: The treatment provided by the EnVena device is advantageous for patients but also optimises healthcare resources and reduces the burden on clinical facilities.
• Clinical Efficacy: The completion of preclinical and EMVA2 clinical trials as part of this project will demonstrate both superior clinical efficacy and the absence of serious adverse effects. Evidence of increased quality of life scores to date strengthens our confidence in the potential impact of the EnVena device to treat our patients.