Periodic Reporting for period 2 - Selio System (Development and commercialisation of a novel needle tract sealant system for pneumothorax prevention during lung biopsy)
Reporting period: 2023-10-01 to 2024-09-30
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.
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.
Excellent progress has been made made across all areas of the project:
Recruitment of an experienced and qualified team.
Monthly Project management meetings.
New supply chain implemented for all components and materials.
New optimised delivery system design and manufacture process with new manufacturing partner.
Complete biomaterial characterisation and process optimisation.
Hydrogel optimised for sealing performance, injectability, stability, sterilisation and manufacture.
New hydrogel design and manufacturing process including new in-line inspections.
3 Patents filed across strategic markets.
Regulatory strategy and path to market optimised.
Ex-vivo lung bench model developed to demonstrate pneumothorax and device performance.
In-vivo pre-clinical model developed and studies conducted to measure device performance.
R&D pre-clinical study completed
GLP pre-clinical study completed
Usability testing completed.
Robust Quality System implemented.
>5,000 prefilled hydrogel syringes manufactured and sterilised.
Mould tool modification completed to optimise delivery device manufacture
Design verification test method validation completed
Design verification testing completed
Sterilisation Validation completed
Biocompatibility testing completed
Regulatory submission completed
Recruitment of an experienced and qualified team.
Monthly Project management meetings.
New supply chain implemented for all components and materials.
New optimised delivery system design and manufacture process with new manufacturing partner.
Complete biomaterial characterisation and process optimisation.
Hydrogel optimised for sealing performance, injectability, stability, sterilisation and manufacture.
New hydrogel design and manufacturing process including new in-line inspections.
3 Patents filed across strategic markets.
Regulatory strategy and path to market optimised.
Ex-vivo lung bench model developed to demonstrate pneumothorax and device performance.
In-vivo pre-clinical model developed and studies conducted to measure device performance.
R&D pre-clinical study completed
GLP pre-clinical study completed
Usability testing completed.
Robust Quality System implemented.
>5,000 prefilled hydrogel syringes manufactured and sterilised.
Mould tool modification completed to optimise delivery device manufacture
Design verification test method validation completed
Design verification testing completed
Sterilisation Validation completed
Biocompatibility testing completed
Regulatory submission completed
The Selio Sealant System is a single use, prophylactic device, comprising a coaxial delivery needle together with a prefilled syringe containing a novel biodegradable hydrogel sealant with unique rheological properties. The Selio Sealant System will enable the radiologist to remotely access the lung before the biopsy procedure and to pre-seal the needle access route thereby reducing pneumothorax (PTX).
There have been many previous attempts to prevent lung biopsy associated pneumothorax however they have limited adoption due to efficacy. Several injectable substances have been trialled and these have all been post-biopsy attempts to seal the lung.
Selio has adopted an innovative pre-sealing approach to overcome the limitations of previous approaches. This is achieved with a viscous hydrogel combining key design specifications that govern the hydrogel sealing, injectability, shear thinning and ability to remain in place following the biopsy procedure.
The technology has been designed for easy integration into existing clinical pathways, providing clinicians with the ability to conduct complication free procedures, more ‘high-risk’ lung biopsy procedures and achieve better diagnostic yields.
The Selio System is a disruptive gateway technology. Lung biopsy enables clinicians to collect sufficient tissue samples to conduct tissue and molecular analysis required both for diagnosis and importantly to design new personalised cancer treatment regimens.
The current risk of pneumothorax is excluding many vulnerable patients from a lung biopsy and so a necessary, valuable diagnosis.
This novel device is a gateway technology; making biopsy a safer procedure thereby opening biopsy to many more patients and so access to new advanced cancer therapies.
There have been many previous attempts to prevent lung biopsy associated pneumothorax however they have limited adoption due to efficacy. Several injectable substances have been trialled and these have all been post-biopsy attempts to seal the lung.
Selio has adopted an innovative pre-sealing approach to overcome the limitations of previous approaches. This is achieved with a viscous hydrogel combining key design specifications that govern the hydrogel sealing, injectability, shear thinning and ability to remain in place following the biopsy procedure.
The technology has been designed for easy integration into existing clinical pathways, providing clinicians with the ability to conduct complication free procedures, more ‘high-risk’ lung biopsy procedures and achieve better diagnostic yields.
The Selio System is a disruptive gateway technology. Lung biopsy enables clinicians to collect sufficient tissue samples to conduct tissue and molecular analysis required both for diagnosis and importantly to design new personalised cancer treatment regimens.
The current risk of pneumothorax is excluding many vulnerable patients from a lung biopsy and so a necessary, valuable diagnosis.
This novel device is a gateway technology; making biopsy a safer procedure thereby opening biopsy to many more patients and so access to new advanced cancer therapies.