We are creating a fully-integrated biotechnology company committed to the development and commercialization of novel Surfactant Replacement Therapies (SRTs™) with potential application across the respiratory disease continuum. Surfactant is produced naturally in the lungs and is essential for normal breathing throughout life. Our product platform is based on a novel pulmonary surfactant technology intended to establish a completely new, therapeutic approach in the treatment of respiratory disease, with a targeted initial application in premature infants.

Pulmonary surfactant is essential for viability at birth and throughout life. In many pulmonary diseases including, respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), acute respiratory failure (ARF) and acute lung injury (ALI), surfactant produced by cells within the respiratory tract is either deficient or may fail to function properly. This deficiency leads to difficulty in breathing, and in severe cases, requires respiratory support via mechanical ventilation in the intensive care unit of a hospital. ^{42,43 ,92}

Our precision-engineered, peptide-containing pulmonary surfactant technology is designed to mimic the essential function of human pulmonary surfactant. The heritage of this technology began at The Scripps Research Institute, where our platform was invented, then exclusively licensed to Discovery Labs.

SURFAXIN^® (lucinactant) for intratracheal suspension, our first product, has received an approvable letter from the US FDA for the prevention of RDS in premature infants. SURFAXIN represents the first of many potential products through the use of our novel technology platform. Our aerosolized SRT™ product, AEROSURF™ (lucinactant) for inhalation, is being developed to treat the broader population of infants in the NICU with respiratory failure -- potentially avoiding the complications associated with traditional mechanical ventilation.