FDA approves GeNOsyl MV-1000 (GeNo LLC) for neonates

GeNo LLC has received clearance from the FDA to market its inhaled nitric oxide (NO) delivery system GeNOsyl MV-1000. The target patient population is controlled by the drug labeling for FDA-approved NO which is currently neonates. The GeNOsyl MV-1000 is intended to be used in hospital settings including the NICU and intra-hospital transport settings. The GeNOsyl MV-1000 injects a constant flow of nitric oxide gas into the inspiratory limb of the ventilator circuit to deliver a constant concentration of NO to the patient. This is the company's first approval from the FDA, however GeNO recently completed a Phase II pilot study of its system for use as a diagnostic in Pulmonary Arterial Hypertension (PAH). The company is currently performing a dose-escalation trial for the treatment of patients with PAH and Pulmonary Hypertension secondary to Idiopathic Pulmonary Fibrosis (PH-IPF).