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FDA Grants Orphan Drug Designation To GeNO LLC For Use Of Inhaled Nitric Oxide In Treatment Of Persistant Pulmonary Hypertension Of The Newborn (PPHN)
Date:8/14/2012

ct for use in treating PPHN in neonates is an important step in this direction." 

GeNO is developing three unique nitric oxide delivery platforms: a stand-alone gas cylinder system for hospital and outpatient use, a ventilator-based platform for Intensive Care Unit use, and a pocket-sized ambulatory system for chronic outpatient use. All of the platforms are designed to deliver nitric oxide with an extremely low level of nitrogen dioxide while also addressing the cost, complexity, and lack of portability of approved inhaled nitric oxide delivery systems.  GeNO's nitric oxide 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.

GeNO also recently 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.
At present, GeNO's other delivery technologies are investigational and are not approved by regulatory authorities.

The first human data on the GeNO technology was presented in April 2012 at the ISHLT Conference, studying the safety of the GeNO system for delivering inhaled nitric oxide to patients being evaluated for cardiac transplant.  The GeNO device reproducibly provided nitric oxide with low levels of nitrogen dioxide in air.  The nitrogen dioxide levels were considerably below the FDA limit of 3 PPM and OSHA limit of 5 PPM even in the presence of oxygen which is known to rapidly convert nitric oxide to nitrogen dioxide. 

ABOUT GENO LLC
GeNO LLC, founded in 2006, i
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SOURCE GeNO LLC
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