Gemnden, Germany, July 16, 2008 –Activaero GmbH, the world leader in controlled breathing technologies for inhaled therapeutic agents, today announced that the US Food and Drug Administration (FDA) has issued 510(K) clearance for the Company’s Watchhaler? spacer, a revolutionary inhalation concept for children. The 510(k) clearance allows Activaero to market the Watchhaler? device in the US. Watchhaler? was previously launched in Europe in April of last year.
Dr Gerhard Scheuch, Founder and CEO of Activaero commented: “Childhood asthma is a growing problem on both sides of the Atlantic and parents need reliable spacers to ensure their children get the right doses of asthmatic medication. The Watchhaler? makes supervision easier for the parent, inhalation more fun for the child and dosing of medication more controlled and accurate. We are delighted to be able to bring this revolutionary spacer to the US Market.”
Watchhaler™ is a reservoir system, or ‘spacer’, controlling the inhalation flow rate and volume to target the aerosol specifically to the lung region, where the drug is needed. This system is particularly tailored to the needs of child patients using asthma medication. The child friendly Watchhaler™ spacer is designed for use with standard metered dose inhalers (MDIs) of the kind often used for inhaled medication.
Activaero is the world leader in controlled breathing technologies for inhaled therapeutic agents. With stand alone inhalation products and inhalation systems available for clinical trials and marketing partnerships, Activaero’s technologies allow for the most precise and efficient patient-tailored pulmonary delivery. Activaero currently has two products on the market, AKITA?, a patient-tailored controlled breathing system with a smartcard that records the patient dosing parameters, and Watchhaler™, a hand held delivery system tailored specifically to children. The Company also has available a range of technologies ideal for the controlled delivery of inhaled therapeutics in the clinical trial setting and tailored to specific partnerships (AKITA2?, LimiX™). Finally, Activaero works with partners on a consultancy basis in the development of ideal inhaled delivery systems and the logistics in clinical trials. Activaero’s technological approach has been validated repeatedly in the clinical setting. The Company is privately held and located in Gem?nden (Wohra) and Munich in Germany and Dublin, Ohio in the USA.
Phone: +49 (0) 6453 64818-0
William C. Zimlich
Activaero America, Inc.
Phone: +1 (614) 761 3555
Dr. Douglas Pretsell
Account Director, Munich Bureau Chief
Phone : +49 (0)89 57 00 18 06