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GeNO LLC Receives FDA Marketing Clearance For Its Inhaled Nitric Oxide Drug Delivery Device
Date:8/9/2012

WALTHAM, Mass., Aug. 9, 2012 /PRNewswire/ -- GeNO LLC (www.genollc.com), a privately held pharmaceutical company developing a line of inhaled nitric oxide drug products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) to market its inhaled nitric oxide (NO) delivery system (GeNOsyl™ MV-1000). 

The GeNOsyl™ MV-1000 delivery system incorporates four components: the primary delivery system, a backup system, the NO gas analyzer, and the NO2 gas analyzer.  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. It provides continuous integrated monitoring of inspired oxygen, NO and nitrogen dioxide concentrations, and a comprehensive alarm system. Prior to reaching the patient, the gas passes through the GeNO Cartridge, which serves two functions: 1) as a mixing chamber, and 2) to chemically convert to NO any nitrogen dioxide which may be present, so as to deliver NO with extremely low levels of nitrogen dioxide, a toxic byproduct. 

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.

"This marketing clearance is a major milestone for our unique NO delivery technology," said GeNO Founder and President Dr. David Fine. "The MV-1000 is GeNO's first delivery apparatus to receive marketing clearance from FDA. We welcome this first approval from FDA as we move all of our platforms forward through clinical development."

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, an
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SOURCE GeNO LLC
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