AFECTAIR, our lead drug delivery product, is a series of novel ventilator circuit/patient interface connectors.
We are planning to initiate the commercial introduction of AFECTAIR in the U.S. and the European Union in 2012.
AFECTAIR simplifies the delivery of any inhaled therapy to critical-care patients requiring ventilatory support by introducing the inhaled therapy directly
at the patient interface and minimizing the number of connections in the ventilator circuit.
Initially we developed our proprietary ventilator circuit/patient interface connector for AEROSURF®, an aerosolized
KL4 surfactant drug-combination product that we are developing to treat premature infants with respiratory
distress syndrome (RDS) in the NICU. We believe that our ventilator circuit/patient interface connectors could have the potential to benefit all patients
receiving ventilatory support and who require inhaled therapies in a critical care setting and developed AFECTAIR for use in NICUs, pediatric intensive care units (PICUs) and adult intensive care units (ICUs).
The initial AFECTAIR product is registered with the FDA as a Class I, exempt medical device, but is not currently available in the U.S. We are also pursuing
the registration of AFECTAIR in the European Union and other non-U.S. jurisdictions.
We plan to initiate commercial introduction of our initial AFECTAIR device in the United States and the European Union in 2012.
