March 9, 2010 – GeNO LLC a privately held, advanced development-stage technology company, announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its stand-alone gas cylinder Nitrosyl TM Delivery Platform (NDP). The initial indication to be studied for nitric oxide delivered via the GeNO Nitrosyl delivery 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... [PDF] GeNO's Press Release -
Showing posts with label GeNO. Show all posts
Showing posts with label GeNO. Show all posts
Apr 30, 2010
GeNO LLC : Investigational New Drug Application for Nitric Oxide Delivery System
March 9, 2010 – GeNO LLC a privately held, advanced development-stage technology company, announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its stand-alone gas cylinder Nitrosyl TM Delivery Platform (NDP). The initial indication to be studied for nitric oxide delivered via the GeNO Nitrosyl delivery 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... [PDF] GeNO's Press Release -
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