FLUIDDA, developers of the proprietary Functional Respiratory Imaging (FRI) technology, were invited by the Food and Drug Administration (FDA) to present the study data concerning their novel biomarker for respiratory diseases, according to the company. The 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.
“This invitation is very important for FLUIDDA,” said Jan De Backer, CEO of FLUIDDA. “Positive feedback from FDA regarding FRI will be a strong signal for pharmaceutical companies to include FRI endpoints in their clinical trials.”
FRI, according to FLUIDDA, can generate highly clinically relevant, patient-specific biomarkers. These biomarkers present 3D visualization of the patient’s airway and lung geometry, airway resistance, and aerosol deposition patterns.
The technology can also detect changes in the respiratory system caused by a drug more accurately in fewer patients, according to FLUIDDA. This could, for example, reduce the number of patients needed in clinical trials for asthma and COPD.