Belgium-based FLUIDDA has developed proprietary functional respiratory imaging (FRI) technology that provides a unique entry point into personalized medicine for respiratory diseases.
FRI reduces significantly the number of patients needed in clinical trials, resulting in better drugs coming to the market faster. FLUIDDA is invited by the US Food and Drug Administration (FDA) to present the benefits of this unique technology for the screening of new respiratory drugs.
FRI is FLUIDDA’s proprietary imaging technology with the unique capability of producing highly clinical relevant patient specific biomarkers. These biomarkers present 3D visualization of the patient’s airway and lung geometry, airway resistance and aerosol deposition patterns.
Extensive patient studies demonstrated that FRI has enhanced sensitivity compared to the conventional tests. FRI detects changes in the respiratory system caused by a drug more accurately in fewer patients.
This allows a significant reduction in the number of patients that are needed in clinical trials for people suffering from respiratory diseases such as asthma and chronic obstructive pulmonary disease. This implies that better drugs could come to market faster.
FLUIDDA has been invited by the renowned FDA to present the study data concerning their novel biomarker for respiratory diseases. This meeting is a part of the critical path initiative by FDA to endorse the development of new biomarkers to increase the efficiency of drug development.
FLUIDDA CEO Jan De Backer noted this invitation is very important for FLUIDDA.
"Positive feedback from FDA regarding FRI will be a strong signal for pharmaceutical companies to include FRI endpoints in their clinical trials," Backer added.
The FDA hearing is planned for 17 January 2014 in Washington DC.