GeNO LLC is a privately-held pharmaceutical company that is developing unique nitric oxide generation and delivery technology that will position the company as a worldwide leader in the generation and delivery of inhaled nitric oxide for the treatment of a multitude of human diseases. GeNO is developing three nitric oxide delivery platforms: a stand-alone gas cylinder system for hospital and outpatient use, a ventilator-based platform for Intensive Care Unit (ICU) use, and a pocket-sized ambulatory system for chronic outpatient use. The nitrogen dioxide (NO2) impurity level has been shown to be less than the National Institute for Occupation Safety and Health limit of 1 ppm.
In 2012, the Company’s New Drug Application (NDA) for the GeNOsylTM MVG-2000 Nitric Oxide Delivery System for neonates with hypoxic respiratory failure has been accepted for filing by the U.S. Food and Drug Administration (FDA). Earlier in 2012, GeNO also received clearance from the FDA to market its inhaled nitric oxide (NO) delivery system (GeNOsyl™ MV-1000). The GeNOsyl™ MV-1000 is intended to be used in hospital settings, including the NICU and intra-hospital transport settings. The company has also been granted orphan drug designation for its nitric oxide (delivered via the GeNOsyl MVG-2000 delivery system) for the treatment of persistent pulmonary hypertension in newborns (PPHN). This orphan drug designation was granted based on a plausible hypothesis clinical superiority over the currently approved nitric oxide product.
GeNO also has two Investigational New Drug Applications (INDs) for its stand-alone nitric oxide delivery system. The first clinical study with this system uses NO as a diagnostic agent for administration as an adjunct for right heart catheterization in patients with Pulmonary Arterial Hypertension (WHO Group 1) to add information to improve clinical decision making. The second study is for the treatment of Pulmonary Hypertension in patients with Pulmonary Arterial Hypertension (PAH) and in patients with Pulmonary Hypertension secondary to Idiopathic Pulmonary Fibrosis (PH-IPF). Phase II development programs for both of these indications are ongoing. Detailed information can be found on ClinicalTrials.gov.
CAUTION: The GeNO nitric oxide delivery systems are investigational and limited by federal law to investigational use only.