|By PR Newswire||
|December 18, 2013 07:00 AM EST||
KONTICH, Belgium, December 18, 2013 /PRNewswire/ --
FLUIDDA develops 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 FDA to present the benefits of this unique technology for the screening of new respiratory drugs.
Functional Respiratory Imaging (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 COPD (Chronic Obstructive Pulmonary Disease). This implies that better drugs could come to market faster.
FLUIDDA has been invited by the renowned US Food and Drug Administration (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.
Jan De Backer, CEO of FLUIDDA, commented: "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."
The FDA hearing is planned for January 17th in Washington DC.
About FLUIDDA (http://www.FLUIDDA.com)
FLUIDDA is the world leader in the field of Functional Respiratory Imaging (FRI) research and development. The company's proprietary FRI technology offers pharmaceutical companies and healthcare providers a unique entry point into personalized medicine for patients suffering from respiratory diseases and sleep-related breathing disorders. Implementation of FRI in the clinical practice creates significant added value to the current healthcare standard in the respiratory field.
About FDA's Biomarker Qualification Program
The Biomarker Qualification Program offers a formal process to guide submitters as they develop biomarkers and rigorously evaluate them for use in the regulatory process.
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