Periodic Reporting for period 3 - TABLA (Development and Commercialisation of Transbronchial Lung Ablation to Treat Lung Cancer)
Période du rapport: 2022-06-01 au 2023-05-31
The effects of an aging population and rising levels of smoking in developing countries is driving increases in lung deaths, with the total number of deaths worldwide expected to increase from 1.8 million in 2017 to over 3 million in 2035. Despite recent advances in surgery, chemotherapy and radiotherapy, 7 out of 8 patients die within 5 years of diagnosis. The problem is that ~70% of patients are diagnosed at a late stage, after the disease has already spread to other parts of the body, which makes treatment difficult. If lung cancer is found at an earlier stage, when it is small and before it has spread, it is more likely to be successfully treated.
The signs and symptoms associated with lung cancer do not do typically appear until the disease is already at an advanced stage. To combat this, screening programmes are being introduced in EU countries and is already in place in the US, to diagnose lung cancer earlier when a curative treatment may be possible. If a lesion is identified during screening, the patient is sent for a biopsy to diagnose and stage the cancer. Early stage tumours are typically located in the periphery of the lung and are 1-2cm in size, making them perfectly suited to a targeted treatment. ENDOWAVE has developed a technology to enable their treatment using a minimally invasive procedure that will improve both safety and efficacy. We believe that our TABLA device combined with screening, will lead to a paradigm shift in care and outcomes for lung cancer patients.
The overall objective of the project is develop the microwave ablation system including the console, pump and flexible single use ablation catheter. The device will be brought to a first in human clinical study that will form the basis for regulatory approval in EU and other countries.
The consortium have encountered delays which has resulted in the clinical work not being completing within the planned 24 month period. When RP2 reporting is complete, the team will seek a no-cost extension to allow the overarching project objective of completing a clinical study with this new and innovative technology to be completed.
However, the COVID pandemic and associated restrictions relating to travel, access to hospitals / clinicians and need to work from home has delayed the project. Further delays were encountered due to supply chain challenges (linked to COVID), IP freedom to operate concerns and evolving regulatory requirements. These challenges have meant the team were unable to complete clinical work within the planned timeline. We will seek an extension to the project duration that will enable the clinical objective to be achieved and ensure this innovative technology is brought to patients where it will significantly impact on their outcomes.
The TABLA project has developed a flexible microwave ablation catheter that be delivered through the airway to access and destroy lung tumours. This pioneering technology represents a significant advance beyond the existing state of the art percutaneous ablation needle technology. It will provide a minimally invasive treatment that will provide improved outcomes for patents, reduce complications and treatment costs.
The TABLA device outcomes will have significant societal impact by providing a less invasive treatment for lung cancer that can achieve better patient outcomes and reduce treatment costs. Currently, lung cancer kills more patients than breast and colorectal cancer combined. Five-year survival rates for lung cancer remain dismally low. Surgery which is the current gold standard for a curative solution is complex, with high complication rates long recovery times. More than a quarter of lung cancer patients are under 60 years of age. It therefore impacts on family members and carers who carry a heavy burden, often both emotionally and financially. The economic drain on healthcare systems is large, with more than 6 million hospital admissions resulting from lung cancer annually in Europe and €18 billion in economic costs in the EU alone.