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Respirics, Inc. Receives 510(k) Clearance For Its MD Turbo(TM) Device For Use With Metered Dose Inhaler



10/19/2005 5:09:09 PM

RALEIGH, N.C., Aug. 16 /PRNewswire/ -- Respirics Inc. announced receipt of 510(k) clearance from the Food and Drug Administration (FDA) to market MD Turbo(TM), an accessory device for use with pressurized meter dose inhalers (MDIs). The device is scheduled for commercial release later this year.

Up to 70% of patients fail to use MDIs properly. MD Turbo(TM) addresses two of the biggest problems associated with the use of these inhalers: coordination of inhalation and actuation of the drug canister, and accounting for the amount of medication remaining in the canister. The device, when used in conjunction with any number of commercialized MDIs, enables a patient to actuate their inhaler by simply breathing in. This breath-actuation feature can reduce the timing errors many patients experience when they attempt to use their inhalers manually. In addition, knowing exactly how much medication remains in an MDI has always been difficult. MD Turbo(TM) includes an electronic dose counter which shows patients how many doses remain in their inhaler.

"This is an important day for both Respirics and the millions of patients who require the use of MDIs. Not only is this a significant milestone for our company, but commercialization of MD Turbo(TM) will bring patients a tool to resolve two of the biggest challenges they face when using their inhalers," says Gil Mott, President and CEO of Respirics.

There are over 33 million MDIs sold in the U.S. every year, most of which use CFC-based propellants (chlorofluorocarbon). When these CFCs are phased out by the end of 2008 in favor of a safer ozone depleting propellant, these new inhalers will still require the same coordination of inhalation and canister actuation by the patient. MD Turbo(TM) will be available only by prescription at the end of 2005.

About Respirics Inc.

Respirics Inc. is a privately held respiratory drug delivery and development company located in Raleigh, North Carolina. The company has two proprietary delivery platforms, MD Turbo(TM) for use with metered dose inhalers, and Acu-Breathe(TM) single and multi-dose dry powder inhalers. Respirics partners with pharmaceutical and biotechnology companies, bringing proprietary drug delivery technology together with formulation expertise to develop products for commercialization. For more information, visit http://www.respirics.com.

Contact: William Nadel Director, Market Development 919-789-4220 wnadel@respirics.com

Respirics Inc.

CONTACT: William Nadel, Director, Market Development of Respirics Inc.,+1-919-789-4220, or wnadel@respirics.com


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