BUFFALO, N.Y.--(BUSINESS WIRE)--Medical Acoustics LLC, a commercial-stage medical device company which employs acoustic technologies for diagnostic and therapeutic medical applications, today announced that it has received FDA 510(k) clearance of its Therapeutic Lung Flute®.
The application follows the successful completion of a clinical trial at the University at Buffalo (SUNY) and the Western New York VA Medical Center during 2009. The clinical trial, led by principal investigator, Sanjay Sethi MD, was designed to demonstrate the safety and effectiveness of the Therapeutic Lung Flute®. The trial was completed successfully with the Lung Flute® meeting all primary and secondary endpoints among patients with chronic obstructive pulmonary disease (COPD) with chronic bronchitis. This simple, hand-held, reusable therapeutic device supplements the patient’s natural mucus clearing system by introducing low frequency sound waves into the lungs. Respiratory illnesses such as COPD, tuberculosis, lung cancer, chronic bronchitis, community acquired pneumonia and asthma are on the rise and becoming an increasing burden on the healthcare system.
“Our recent clinical trial has shown that the Therapeutic Lung Flute® effectively helps COPD patients clear respiratory tract secretions, which results in an improved quality of life. For the more than 16 million Americans diagnosed with COPD, this FDA 510 (k) clearance is very good news. According to the World Heath Organization, COPD is the 4th leading cause of death worldwide and we believe the Therapeutic Lung Flute® offers a medical device that better addresses the needs of this large and growing patient population than current technologies,” said Terence Cryan, President of Medical Acoustics. “The Lung Flute® is a safe, effective, low cost and patient friendly method for patients with COPD to maintain their respiratory health through regular use. Our clinical trial results indicate that the Lung Flute® has the potential to make a lasting positive impact on the quality of life of tens of millions of COPD sufferers worldwide.”
Medical Acoustics also announces plans to begin taking orders for the Therapeutic Lung Flute® on February 1, 2010 and notes that a prescription from their physician will be required for all US orders. Shipments to patients in Canada and the European Community do not require a prescription. The Therapeutic Lung Flute® will be sold for $40.00 a unit plus shipping and can be ordered via the company website, www.medicalacoustics.com, or by calling 1-888-820-0970 on or after February 1, 2010. Please see the company website for more details.
About Medical Acoustics LLC
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 Diagnostic Lung Flute®, is a revolutionary medical device which is expected to play a significant role in the treatment, diagnosis of and drug development for lung cancer, tuberculosis, chronic bronchitis, asthma and community-acquired pneumonia. The Lung Flute® has been cleared by the FDA for both diagnostic and therapeutic use in the U.S. and has received the CE mark clearance for use in the European Union. The Lung Flute® was named one of the “Best Innovations of 2009” by Popular Science Magazine. More information on the Company and the Lung Flute® can be found at www.medicalacoustics.com
Medical Acoustics LLC
Sarah Burke, 716-759-6339
Nicolaas J. Smit, Ph.D., 905-346-1876