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New Data Shows GeNO LLC Nitric Oxide Delivery System Provided Nitric Oxide With Low Levels of Nitrogen Dioxide for Heart Transplant Patient Evaluation
Date:4/19/2012

SHA limit of 5 PPM even in the presence of  oxygen which is known to convert NO to NO2 rapidly," said lead author Dr. Boyle.  "These promising preliminary safety findings, combined with an improved ease of delivery compared with commercially available devices, justify a larger efficacy trial with longer exposure to the device in patients with pulmonary hypertension."

The primary aim of the study was to evaluate the safety, tolerability and device performance of the GeNO NITROSYL Delivery System during RHC. Secondary considerations were to confirm that inhaled NO generated by the system reduces pulmonary vascular resistance (PVR) in patients with reversible pulmonary hypertension and contains levels of NO2 well below the upper level of acceptable exposure. The study title is "An Open Label Non-Randomized Pilot Study To Evaluate the Safety of the GeNO NITROSYL Delivery System in Patients Being Evaluated for Heart Transplantation."

This is the first human data to be presented with the Company's novel NO delivery system that converts nitrogen dioxide in either balance air or oxygen to nitric oxide. The gas is allowed to flow through a proprietary cartridge containing ascorbic acid, which generates nitric oxide immediately prior to inhalation.  A second cartridge is provided for redundancy.

"We are pleased to see these study results, as the purity of nitric oxide produced by our unique technology will be of interest to many health care professionals who use NO to treat a variety of life threatening conditions and diseases," said GeNO LLC Founder and President David Fine. "We remain committed to moving both our in-hospital solution and our ambulatory system through clinical development."

GeNO's NITROSYL Delivery System could add valuable options for clinicians treating a range of serious pulmonary and cardiac diseases with inhaled nitric oxide. GeNO's plan
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