Aerosol Delivery System (ADS) Technology Platform

Windtree’s proprietary ADS is designed to aerosolize KL4 surfactant. An aerosol is created by pumping KL4 surfactant through a heated capillary, after which the aerosol cools and slows in velocity, yielding a dense aerosol with a defined particle size suitable for respiration. In an AEROSURF® phase 2a clinical program, the company assessed physiological data suggesting that AEROSURF® may be delivering aerosolized KL4 surfactant into the lung (where it needs to act) and reducing the incidence of nCPAP failure. In addition, the ADS has been demonstrated to produce consistent and controlled output rates, particle size, and other aerosol characteristics throughout extended KL4 surfactant dosing periods. Windtree believes that its ADS is capable of delivering KL4 surfactant to the lung of premature infants with RDS without having to resort to invasive intubation and mechanical ventilation, procedures that are currently required to administer surfactants. In addition, Windtree believes that the ADS is a reliable platform to support robust and reproducible clinical development, potential future commercialization if its aerosolized product candidates are approved, as well as future life-cycle product development.

Windtree has demonstrated that its ADS is able to produce aerosolized KL4 surfactant with the following important characteristics:

  • Full retention of the surface-tension lowering properties of a functioning surfactant necessary to restore lung function and maintain patency of the conducting airways.
  • Full retention of the surfactant composition upon aerosolization.
  • Drug particle size believed to be suitable for deposition into the lung.