Inhalation Device Delivers Nitric Oxide to Newborns

A novel inhaled nitric oxide (NO) delivery system is intended to treat newborns in the neonatal intensive care unit (NICU) and intrahospital transport settings.

The GeNOsyl MV-1000 delivery system injects a constant flow of NO gas into the inspiratory limb of the ventilator circuit to deliver a constant concentration of NO to the patient, providing continuous integrated monitoring of inspired oxygen, NO, and nitrogen dioxide (NO2) concentrations, and a comprehensive alarm system. Prior to reaching the patient, the gas passes through the GeNO Cartridge, which serves both as a mixing chamber--to chemically convert to NO any NO2 which may be present--and to deliver NO with extremely low levels of NO2, a toxic byproduct.


The system is comprised of four components: the primary delivery system, a backup system, the NO gas analyzer, and the NO2 gas analyzer. The device has been found in clinical trials to reproducibly provide NO with low levels of NO2 in air or O2. The NO2 levels were considerably below the US Food and Drug Administration (FDA) limit of 3 PPM and the US Occupational Safety and Health Administration (OSHA, Washington DC, USA) limit of 5 PPM, even in the presence of oxygen, which is known to rapidly convert NO to NO2. The GeNOsyl MV-1000 delivery system is a product of GeNO (Waltham, MA, USA), and has been approved by the FDA.

“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,” said David Fine, MD, founder and president GeNO. “We are committed to advancing the clinical and commercial development of our nitric oxide delivery platforms because of the dramatic benefit they may have on the lives of patients.”

NO has been identified as an important molecule with versatile roles in human physiology, including selective pulmonary vasodilation, bronchodilator, and pulmonary surfactant activities to improve ventilation-perfusion mismatch and hence oxygenation. The clinical effects of NO gas that have been reported include cardio-pulmonary vasodilation, reduction of right heart load, reduction of ischemia, reduction of hypoxemia, inhibition of platelet aggregation, and anti-inflammatory, fungicidal, virocidal, and bactericidal effects, among others.

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