GeNO LLC, a privately held pharmaceutical company developing a line of inhaled nitric oxide drug products, has received clearance from the US Food and Drug Administration (FDA) to market its inhaled nitric oxide (NO) delivery system (GeNOsyl MV-1000).
The GeNOsyl MV-1000 delivery system incorporates four components: the primary delivery system, a backup system, the NO gas analyzer, and the NO2 gas analyzer. The GeNOsyl MV-1000 injects a constant flow of nitric oxide gas into the inspiratory limb of the ventilator circuit to deliver a constant concentration of NO to the patient. It provides continuous integrated monitoring of inspired oxygen, NO and nitrogen dioxide concentrations, and a comprehensive alarm system. Prior to reaching the patient, the gas passes through the GeNO Cartridge, which serves two functions: as a mixing chamber, and to chemically convert to NO any nitrogen dioxide which may be present, so as to deliver NO with extremely low levels of nitrogen dioxide, a toxic byproduct.
The target patient population is controlled by the drug labeling for FDA-approved NO which is currently neonates. The GeNOsyl MV-1000 is intended to be used in hospital settings including the NICU and intra-hospital transport settings.
“This marketing clearance is a major milestone for our unique NO delivery technology,” said Dr David Fine, founder and president GeNO. "The MV-1000 is GeNO's first delivery apparatus to receive marketing clearance from FDA. We welcome this first approval from FDA as we move all of our platforms forward through clinical development."
GeNO is developing three unique nitric oxide delivery platforms: a stand-alone gas cylinder system for hospital and outpatient use, a ventilator-based platform for Intensive Care Unit use, and a pocket-sized ambulatory system for chronic outpatient use. All of the platforms are designed to deliver extremely low levels of the toxic byproduct nitrogen dioxide that are undetectable by conventional means, while also addressing the cost, complexity and lack of portability of approved inhaled nitric oxide treatment systems. GeNO's nitric oxide gas has the potential for treatment of a multitude of serious pulmonary and cardiac diseases, and potentially could reach a much larger group of patients.
GeNO recently completed a phase II pilot study of its nitric oxide for use as a diagnostic in Pulmonary Arterial Hypertension (PAH). The company 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 (PH-IPF). At present, GeNO's other delivery technologies are investigational and are not approved by regulatory authorities.
The first human data on this technology was presented in April 2012 at the ISHLT Conference, studying the safety of the GeNO system for delivering inhaled NO to patients being evaluated for cardiac transplant. The GeNO device reproducibly provided NO with low levels of NO2 in air or O2. The NO2 levels were considerably below the FDA limit of 3 PPM and OSHA limit of 5 PPM even in the presence of oxygen which is known to rapidly convert NO to NO2.
GeNO LLC is focused on applying its technology to delivering inhaled NO to patients in a variety of settings, including ambulatory and in-home use for potential chronic treatment.