Home > News > Lung Flute® Receives CE Mark

MA Receives CE Mark clearance

Medical Acoustics’ Revolutionary Diagnostic and Therapeutic Device, The Lung Fluteâ,

Now Registered in the European Union

· Lung Flute^â registered as Class 1 medical device by achieving CE Mark standards

· Opens up European Union market of 26 member countries for sales opportunities

· Lung Flute^âlaunched atMEDICA, world’s largest medical trade fair

BUFFALO, New York – December 3, 2007— Medical Acoustics LLC announced today that it has successfully registered its Lung Flute^â as a Class 1 medical device for sale in the European Union. Medical Acoustics demonstrated conformity with essential health and safety requirements set out in European directives. It is now qualified to apply the CE mark (Conformité Européenne) for marketing the Lung Flute^âin the EU, both for diagnostic and therapeutic applications.

Medical Acoustics officially launched the Lung Flute^â within the European Union at MEDICA, the world’s largest medical trade fair, in Dusseldorf, Germany, in November. Its strategy is to penetrate the EU market through leading medical device distributors, especially those that serve the pharmaceutical, medical and public health markets specializing in lung and respiratory diseases.

“The Lung Flute^â provides EU clinicians with a safe, easy-to-use means of obtaining high quality sputum samples for the improved diagnosis and treatment of a myriad of lung and respiratory diseases,” said Terence Cryan, President of Medical Acoustics. “The applications for our device are far-ranging. They include, for example, public health officials using the Lung Flute^â to quickly and effectively gather sputum samples to screen for tuberculosis (TB), or even health clinics using it to clear the lungs of asthma patients. Our novel technology is now accessible to over 300 million people throughout the European Union.”

The cost effective and easy-to-use device, which is shaped like a flute, creates a specific low-frequency sound when the user blows into it. This creates vibrations in the airways and lung which cause deep lung secretions to thin and be expelled.

The standard method for obtaining lung secretions for testing involves a person breathing hypertonic saline into their lungs. This method is very uncomfortable, and in addition, cannot be done more frequently than every 48 hours.

The Lung Flute^â makes treatment, testing and diagnosis, much easier for the provider; significantly more comfortable for the patient; and costs much less to use. In addition, it may be used much more often—up to every 20 minutes—for varied treatment options and more accurate biomarker testing.

About Medical Acoustics

Medical Acoustics’ mission is to design and develop devices employing acoustic technologies for diagnostic and therapeutic medical applications. It is a privately held, commercial-stage medical device company located in Buffalo, New York, that has been built on ten years of research and development in the science of applied acoustics.

The Company’s first product, the patented and FDA-cleared Lung Flute^®,is a revolutionary medical device which is expected to play a significant role in drug development for asthma, chronicbronchitis, community-acquired pneumonia, lung cancer and tuberculosis.

More information on the Company and the Lung Flute^®can be found at www.medicalacoustics.com.