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GeNO LLC Initiates Phase 2 Trial For Nitric Oxide Delivery System
Date:12/8/2010

COCOA, Fla., Dec. 8, 2010 /PRNewswire/ -- GeNO LLC (www.genollc.com), a privately held, advanced development-stage technology company, today announced commencement of the Phase 2 clinical trial for its stand-alone gas cylinder NITROSYL System. The initial indication to be studied for nitric oxide delivered via the GeNO NITROSYL System is as a diagnostic agent for administration as an adjunct to right heart catheterization in patients with Pulmonary Arterial Hypertension (WHO Group 1) to add information to improve clinical decision making. No agents are currently approved for this indication. Prior to conducting a Phase 3 registration study, GeNO LLC will first conduct this Phase 2, 10-patient pilot study to obtain preliminary safety and feasibility data from short term (15 minute) administration of inhaled nitric oxide via the GeNO Gas Cylinder NITROSYL System.  

GeNO's stand-alone gas cylinder stores premixed nitric oxide as nitrogen dioxide in either air or oxygen. The gas is allowed to flow through GeNO's proprietary cartridge containing ascorbic acid, which generates nitric oxide immediately prior to inhalation. A second cartridge is provided for redundancy

Leading researchers from four major medical centers will participate in the NITROSYL Phase 2 trial, including: Robert C. Bourge, M.D., Director, Division of Cardiovascular Disease at University of Alabama at Birmingham; Ioana Preston, M.D., Assistant Professor of Medicine at the Tufts University School of Medicine and the Co-Director for the Pulmonary Hypertension Center at Tufts Medical Center; Robert Schilz, D.O., Ph.D., Medical Director of Lung Transplant and Pulmonary Vascular Disease at UH Case Medical Center; and Fernando Torres, M.D., Associate Professor of Internal Medicine- Pulmonary and Critical Care at The University of Texas Southwestern Medical Center.

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