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Activaero's AKITA(R) JET Receives FDA 510(K) Clearance


12/9/2009 11:27:03 AM

Dublin, Ohio, December 9, 2009 – Activaero, the world leader in the design of controlled breathing drug delivery technologies that maximize the efficiency and precision of inhaled drugs, today announced that the US Food and Drug Administration (FDA) has issued 510(K) Clearance for the Company’s AKITA® JET inhalation system. The 510(k) clearance, while for general purpose use, helps to pave the way for Activaero to utilize the AKITA® JET device in clinical trials to develop combination products in the United States. In 2007, Activaero received the 510(k) clearance for the AKITA² APIXNEB inhalation device, which is currently in clinical trials for a variety of new therapies.

William Zimlich, CEO of Activaero America, Inc. commented: “We are pleased to add this revolutionary controlled breathing device to our product offering for the US market. By receiving 510(K) Clearance for the AKITA® JET, we are now well on our way toward enhancing our global strategy of developing best-in-class pulmonary drug delivery devices.”

Clinical studies have demonstrated that Activaero’s AKITA technology increases deposition efficiency of inhalation therapy by controlled breathing. Aerosolized drug is delivered at distinct intervals within the inspiratory cycle to enhance inhaled treatments in patients where the treatment safety and efficacy profile may be improved by drug targeting. The system uses a SmartCard technology that ensures the treatment regimen can be specifically tailored to a patient’s respiratory condition and drug dosing needs.

About Activaero GmbH

Activaero is the world leader in the design of controlled breathing drug delivery technologies that maximize the efficiency and precision of inhaled drugs. These innovative technologies enable safer, more cost-efficient, and effective options for inhaled treatments of respiratory diseases. As a center of excellence in aerosol medicine, Activaero has a track record in supporting its partners in pre-clinical and clinical projects for pulmonary drug development. In addition to AKITA technologies, Activaero markets Watchhaler™, a revolutionary children’s spacer that controls the patient’s inhaled volume and flow-rate. Activaero GmbH is located in Gemuenden/Wohra and Munich (Germany) and Dublin, Ohio (USA). Further information on Activaero can be found at www.activaero.com.


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