Every 30secs someone dies of lung cancer globally. The EU records ~320,000 new lung cancer cases per annum. Early lung cancer diagnosis saves lives through timely and efficient interventions. Lung biopsy is the key method of lung cancer diagnosis. However, lung biopsy comes with an inherent risk of a serious complication; pneumothorax (PTX) - a complete or partial lung collapse.
PTX can cause the patient sudden chest pain and difficulty breathing. On some occasions, a collapsed lung can be a life-threatening event.
On average, 33% of patients undergoing a lung biopsy will suffer from a PTX and approximately 33% of these patients will require hospital admission for an invasive procedure to resolve the PTX.
PTX delays lung biopsy procedures and increases clinician workload. A pneumothorax can lead to the biopsy procedure having to be rescheduled and so a delay in patient diagnosis. PTX sufferers require further radiological scans, monitoring and treatment which can include hospitalisation for an invasive and costly procedure to resolve this hospital acquired complication. The average cost of a lung biopsy with complications is approximately four times higher than a complication-free biopsy. There is a drive to keep respiratory patients out of hospital especially during the Covid pandemic.
Currently there are no devices to successfully prevent PTX associated with lung biopsy procedures.
The patented Selio Sealant System will be the world’s first system specifically designed to reduce PTX occurring before the biopsy even takes place. Used by an interventional radiologist before the lung biopsy procedure, in a 2 min ‘add-on’ to the current biopsy standard of care, the Selio System pre-seals the needle tract in the lung tissue, thereby preventing air leak and a PTX. This will significantly improve the quality of care for lung cancer patients, providing many more patients with access to a safe lung biopsy, prevent hospitals stays and reduce healthcare costs.
This project supports the optimisation of the Selio device design and manufacture process. It also supports the completion of the verification and validation testing necessary to demonstrate device safety and performance for regulatory approval of the technology. This includes pre-clinical and usability studies, biocompatibility testing and sterilisation validation. The project also supports the preparation and submission of regulatory approval documentation. Regulatory approval is required before a medical device can be launched on the market.
Today a patient undergoing a lung biopsy has a high risk of PTX which can lead to additional costs of ~€15K per patient. Currently ~11% of PTX sufferers need additional hospitalisation/treatment resulting in a financial burden of >€2B pa globally. The Selio System will significantly reduce these costs resulting in healthcare cost savings of €1.5B pa globally and €300M pa in the EU.
