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GeNO inhaled nitric oxide delivery system wins FDA nod

GeNO has obtained a clearance for its inhaled nitric oxide (NO) delivery system, GeNOsyl MV-1000, from the US Food and Drug Administration (FDA).

GeNOsyl MV-1000 system, which incorporates a primary delivery system, a backup system, the NO gas analyzer, and the nitrogen dioxide (NO2) gas analyzer, is designed for use in neonatal intensive care unit and intra-hospital transport settings.

The GeNOsyl MV-1000 system injects a constant flow of NO into ventilator circuit’s inspiratory limb to deliver a constant concentration of NO to the patient.

Prior to reaching the patient, the gas passes through the GeNO Cartridge, comprising a mixing chamber, to convert any nitrogen dioxide which may be present to NO.

The delivery system also provides continuous integrated monitoring of inspired oxygen, NO and NO2 concentrations as well as a comprehensive alarm system.

The first human trial of GeNO system was designed to study the safety of the GeNO system for delivering inhaled NO to patients being evaluated for cardiac transplant.

The results demonstrated that the GeNO device provided NO with low levels of NO2 in air or O2.

Recently, the company has also completed a Phase 2 pilot study of its NO for use as a diagnostic in pulmonary arterial hypertension (PAH) and is currently performing a dose-escalation trial for the treatment of pulmonary hypertension in patients with PAH and pulmonary hypertension secondary to idiopathic pulmonary fibrosis.