BREAKTHROUGH IN EARLY DETECTION

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Sputum Induction Made Simple: The Lung Flute Cleared By The FDA Via 510(k)

9/11/2006

Buffalo, NY - Medical Acoustics LLC is pleased to announce its revolutionary new device, the Lung Flute, has been cleared by the FDA for sputum induction for diagnostic purposes. This simple, hand-held, disposable device supplements the patient’s natural mucus clearing system by introducing low frequency sound waves into the lungs. The Lung Flute is a novel medical device which will play a significant roll in drug development for asthma, chronic bronchitis, community acquired pneumonia and lung cancer. Deep lung secretions can be obtained to determine drug efficacy and progression of treatment for pulmonary drugs. Currently, sputum induction using hypertonic saline is the standard method, a process that is expensive, time consuming, uncomfortable to the patient and often causes bronchial spasm and inflammation. As a result, sputum samples, using hypertonic saline, cannot be collected more frequently then every 48 hours. The Lung Flute addresses these challenges and will allow sputum samples to be collected every 20 minutes which is important when monitoring inflammatory markers during asthma attacks.

Pulmonary research, including drug development, has been hampered over the past forty years by the lack of a convenient method of obtaining deep lung secretion samples even though the utility of the sputum sample is well documented. “Now that the Lung Flute has received FDA clearance, pharmaceutical companies, active in pulmonary drug development, have a new tool which will aid in drug development, substantially simplify clinical trials and lead to improved data sets.” says Nicolaas Smit PhD, VP Science and Technology. “Currently, lung cancer research is a top national priority, with many of the leading pharmaceutical companies investing heavily in this effort. The Lung Flute will be one of the technologies which will accelerate this effort.”

The above work, including clinical trials, was performed in collaboration with the State University of New York at Buffalo, School of Medicine and the VA Western NY Health System.

SOURCE: Medical Acoustics, LLC