AirAvant Medical has announced that its flagship product, the Bongo Rx, has received its FDA 510(k) Clearance for the treatment of mild to moderate obstructive sleep apnea (OSA).
Years of painstaking research, development, and testing have yielded a device that is small, portable, and best of all requires no CPAP machine, CPAP hoses, bulky headgear or electricity/battery power. The Bongo Rx seals comfortably in the nose and works by creating back pressure when an OSA sufferer exhales.
After extensive clinical testing, it was demonstrated the Bongo® Rx significantly reduced the Apnea-Hypopnea Index or AHI levels, which is the measurement for the number of apneas and hypopneas recorded per an hour of sleep. AirAvant Medical developed the Bongo Rx to be convenient and transportable. Its small size allows the user to carry it in a shirt pocket or purse, so the device can be used anywhere at any time.
“We recognize that people need to have the ability to treat their sleep apnea comfortably and conveniently, no matter where they are – in a bed, on a train, on a plane, or even catching a quick nap in a chair or on the couch,” said Javier Collazo, Vice-President. “For compliant CPAP patients, the Bongo Rx may provide a supplemental treatment option to complement their lifestyle. For non-compliant CPAP patients, the Bongo Rx may provide a patient-friendly, non-cumbersome treatment option to get them refocused and re-engaged on treating their obstructive sleep apnea.”
The Bongo Rx will be featured at Medtrade in Atlanta, Georgia from October 15th to the 17th. It can be seen in the New Product Pavilion and at the AirAvant Medical booth # 1448
AirAvant Medical (www.airavant.com) is a research-oriented, privately held company that focuses on developing and marketing innovative medical devices to treat obstructive sleep apnea and other breathing disorders. AirAvant Medical holds numerous patents and has several patents pending. This newly formed company was created from the former partners of InnoMed Technologies, Inc., as well as Ron F. Richard formerly of Resmed and SeQual. Their past achievements included a highly acclaimed line of Respiratory and Sleep Devices, such as the Nasal-Aire®, the Hybrid, and the Aloha line of CPAP interfaces.