BMEVLP | Biomarkers for clinical assessment of lungs intended for transplantation

Summary
Lung transplantation is the only therapeutic option for selected patients suffering from end-stage lung diseases. 80% of all donated lungs are not used for transplantation. The main reason is uncertainty of the function and quality of the lung.

Ex vivo lung perfusion (EVLP) is a technique used to assess quality of lungs prior to transplantation. In collaboration with leading clinical scientists, XVIVO has developed solutions and systems for EVLP. EVLP has recently become internationally clinically accepted. More than 300 patients have received transplanted lungs that would otherwise not have been used. Centers establishing a clinical program for EVLP increase the number of lung transplantations significantly. Clinical outcomes are at least equivalent to outcomes for patients receiving standard lungs. However, in order to disseminate the EVLP technique to a broader range of hospitals, it is necessary to offer objective metrics assessing lung function in addition to the subjective assessment methods used today.

Exploitation of EVLP has an impact for XVIVO. Each EVLP generates an income of about €15 000. Today about 5000 lung transplantations are performed each year. If we can reach 25% increase, it would contribute to a revenue increase of at least 18 MEUR. It also means that 1250 critically ill patients on the waiting lists will receive new lungs. The true potential is to increase the utilization rate of donated lungs to 40-60%.
The project aims to carefully select optimal biomarkers in phase 1 and confirm validity and clinical relevance in phase 2 through a clinical study. By introducing new biomarkers, XVIVO will be able to commercialize a device that will broaden the company´s product portfolio and fulfill the customer need for validated tools making clinicians more comfortable to use donated organs that are being discarded today. The project will be performed in collaboration with identified biomarker companies and thus also catalyze their access to market.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/651665
Start date: 01-11-2014
End date: 30-04-2015
Total budget - Public funding: 71 429,00 Euro - 50 000,00 Euro
Cordis data

Original description

Lung transplantation is the only therapeutic option for selected patients suffering from end-stage lung diseases. 80% of all donated lungs are not used for transplantation. The main reason is uncertainty of the function and quality of the lung.

Ex vivo lung perfusion (EVLP) is a technique used to assess quality of lungs prior to transplantation. In collaboration with leading clinical scientists, XVIVO has developed solutions and systems for EVLP. EVLP has recently become internationally clinically accepted. More than 300 patients have received transplanted lungs that would otherwise not have been used. Centers establishing a clinical program for EVLP increase the number of lung transplantations significantly. Clinical outcomes are at least equivalent to outcomes for patients receiving standard lungs. However, in order to disseminate the EVLP technique to a broader range of hospitals, it is necessary to offer objective metrics assessing lung function in addition to the subjective assessment methods used today.

Exploitation of EVLP has an impact for XVIVO. Each EVLP generates an income of about €15 000. Today about 5000 lung transplantations are performed each year. If we can reach 25% increase, it would contribute to a revenue increase of at least 18 MEUR. It also means that 1250 critically ill patients on the waiting lists will receive new lungs. The true potential is to increase the utilization rate of donated lungs to 40-60%.
The project aims to carefully select optimal biomarkers in phase 1 and confirm validity and clinical relevance in phase 2 through a clinical study. By introducing new biomarkers, XVIVO will be able to commercialize a device that will broaden the company´s product portfolio and fulfill the customer need for validated tools making clinicians more comfortable to use donated organs that are being discarded today. The project will be performed in collaboration with identified biomarker companies and thus also catalyze their access to market.

Status

CLOSED

Call topic

PHC-12-2014-1

Update Date

26-10-2022
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Horizon 2020
H2020-EU.2. INDUSTRIAL LEADERSHIP
H2020-EU.2.3. INDUSTRIAL LEADERSHIP - Innovation In SMEs
H2020-EU.2.3.1. Mainstreaming SME support, especially through a dedicated instrument
H2020-SMEINST-1-2014
PHC-12-2014-1 Clinical research for the validation of biomarkers and/or diagnostic medical devices
H2020-EU.3. SOCIETAL CHALLENGES
H2020-EU.3.1. SOCIETAL CHALLENGES - Health, demographic change and well-being
H2020-EU.3.1.0. Cross-cutting call topics
H2020-SMEINST-1-2014
PHC-12-2014-1 Clinical research for the validation of biomarkers and/or diagnostic medical devices
H2020-EU.3.1.3. Treating and managing disease
H2020-EU.3.1.3.0. Cross-cutting call topics
H2020-SMEINST-1-2014
PHC-12-2014-1 Clinical research for the validation of biomarkers and/or diagnostic medical devices