Activaero, a world leader in the design of controlled breathing drug delivery technologies that maximize the efficiency and precision of inhaled drugs, recently announced that the US 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 US. In 2007, Activaero received the 510(k) clearance for the AKITA APIXNEB inhalation device, which is currently in clinical trials for a variety of new therapies.

“We are pleased to add this revolutionary controlled breathing device to our product offering for the US market,” said William Zimlich, CEO of Activaero America, Inc. “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 in which 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.

Activaero is a 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 preclinical 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.