The US Food and Drug Administration (FDA) has cleared GeNO's inhaled nitric oxide (NO) delivery system, GeNOsyl MV-1000, designed to treat pulmonary hypertension.
GeNOsyl MV-1000, which incorporates a primary delivery system, backup and NO and nitrogen dioxide (NO2) gas analyser, is designed for use in neonatal intensive care units and intra-hospital transport settings.
MV-1000 injects a constant flow of NO into the ventilator circuit's inspiratory limb to deliver a constant NO concentration to the patient.
Prior to reaching the patient, the gas passes through a mixing chamber that converts any NO2 to NO.
The delivery system also provides continuous integrated monitoring of inspired oxygen, NO and NO2 concentrations as well as an alarm system.
The first human trial of the system was designed to study its safety for delivering inhaled NO to patients being evaluated for cardiac transplant. Results demonstrated that the device provided NO with low levels of NO2 in air or O2.
The company also recently completed a Phase II pilot study of its nitric oxide as a diagnostic in pulmonary arterial hypertension (PAH). GeNO 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.
GeNO founder and president Dr David Fine said; "We welcome this first approval from the FDA as we move all of our platforms forward through clinical development."
The company is also developing a stand-alone gas cylinder system for hospitals and outpatients, a ventilator-based platform for intensive care units, and a pocket-sized ambulatory system for chronic outpatients.