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New Pre-Clinical and Clinical Data on GeNO LLC's Nitric Oxide Delivery Systems to Be Presented at 2013 American College of Cardiology and American Thoracic Society Medical Meetings
Date:1/29/2013

for filing by the U.S. Food and Drug Administration (FDA).  510(k) clearance was also granted earlier that year for GeNO's MV-1000 Inhaled Nitric Oxide Delivery System, as well as orphan drug designation for the nitric oxide delivered by the GeNOsyl™ MVG-2000 Delivery System for the treatment of persistent pulmonary hypertension in newborns.

GeNO is developing three unique nitric oxide delivery platforms for hospital and outpatient use. Each of the platforms is designed to deliver ultrapure nitric oxide with extremely low levels of nitrogen dioxide, an impurity known to pose serious health risks.  These platforms also address   the cost, complexity and lack of portability of currently approved inhaled nitric oxide treatment systems.  GeNO's nitric oxide gas has the potential for use in the treatment of a multitude of serious pulmonary and cardiac diseases, and potentially could reach a much larger group of patients than the currently approved alternatives.

GeNO has completed a Phase 2 pilot study of its nitric oxide for use as a diagnostic in Pulmonary Arterial Hypertension (PAH) and is currently performing a dose-escalation trial for the treatment of Pulmonary Hypertension in patients with PAH and Pulmonary Hypertension secondary to Idiopathic Pulmonary Fibrosis (PH-IPF). Additional study details can be found on http://clinicaltrials.gov/-- ClinicalTrials.gov Identifier NCT01265888. Other than the 510(k) clearance of GeNO's MV-1000 nitric oxide delivery system, GeNO's nitric oxide delivery technologies are investigational and are not approved by regulatory authorities.

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