Development and Commercialisation of Transbronchial Lung Ablation to Treat Lung Cancer

Project Information

TABLA

Grant agreement ID: 950943

DOI

10.3030/950943

Project closed

EC signature date 26 March 2020

Start date 1 June 2020

End date 31 May 2023

Funded under

• Horizon 2020 Framework Programme

Total cost

€ 4 243 922,50

EU contribution

€ 2 994 613,00

Coordinated by

ENDOWAVE LIMITED
Ireland

Periodic Reporting for period 3 - TABLA (Development and Commercialisation of Transbronchial Lung Ablation to Treat Lung Cancer)

Reporting period: 2022-06-01 to 2023-05-31

Summary of the context and overall objectives of the project

Currently, over 1,000 patients die from lung cancer every day in Europe. In 2018, it was estimated that there were more than two million new cases worldwide, representing 11.6% of all new cancers, with someone dying of lung cancer every 30 seconds globally. In the EU, lung cancer causes 267,700 deaths annually2, which is more deaths than that caused by the two most common cancers, breast and colorectal, combined. The high mortality rate is demonstrated by its dismal 5-year survival rate of just 18%, compared to 89% for breast cancer and 65% for colorectal cancer.

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The aim of the TABLA project is to develop the Endowave flexible microwave ablation system for non-invasive treatment of lung cancer. The project plan has been prepared to achieve this aim and meet regulatory requirements, which will enable clinical use. The consortium have worked together to “lock down” the design for both the disposal / single use element (i.e. flexible catheter) and the console which includes the microwave generator, control system and pump for the coolant. This key phase of the product development process involves detailed planning, careful analysis of design inputs and design / prototype / test cycles. The team have developed test methods to simulate clinical use, ex-vivo and carried out “design for manufacture” reviews to ensure a clear path to manufacturing at volume exists. An ex-vivo lung cancer model has been developed to enable the de-risking of design with input from a leading pulmonologist. A clinical evaluation plan has been prepared with input from a leading contract research organisation with expertise in the field of ablation. This will form the basis for clinical work planned in the next phase of the project. Significant advances have been made in the catheter design to enable higher power to be delivered through the device. A low resistance helical coolant path has been implemented and linked to a novel radiating section design, which has been informed by dielectric research with NUIG on excised tumours. The combination of these elements provides a market leading device which can be used to target large tumours anywhere in the lung.
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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The current state of the art microwave ablation probes are short, rigid and only suitable for percutaneous lung ablation. These probes were originally developed to treat lesions in the liver, but it quickly was extended to include the kidney, spine and lung. Percutaneous access to the lung is achieved by inserting the probe through the chest wall, piercing through the pleura to reach the target lesion. Although studies have shown that microwaves can be used to effectively destroy lung tumours, percutaneous access results in a collapsed lung in up to 50% of cases. Existing percutaneous devices are too short and rigid for transbronchial delivery.
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.

Overview of TABLA device delivery through airways to destroy tumour