FDA Clears GeNO IND Application For Nitrosyl Delivery Platform

GeNO said that 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.

Prior to conducting a pivotal study later this year, GeNO is expected to conduct a 10 patient Pilot Study to obtain preliminary safety and feasibility data from short term (15 minute) administration of inhaled nitric oxide via GeNO Nitrosyl delivery 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 our proprietary cartridge containing ascorbic acid, which generates nitric oxide immediately prior to inhalation. A second cartridge is provided for redundancy.

David Fine, founder and president at GeNO, said: “Having our IND application accepted in the 30-day period is an important accomplishment for GeNO, given that we are working on a novel inhaled nitric oxide generation and delivery system. This marks an critical milestone for the company and completes our rapid transition to a clinical-stage organisation. Furthermore, this milestone enables us to move our other novel, patent-protected technology development programs toward clinical trials.”