The FDA has approved the Genosyl inhaled nitric oxide (iNO) gas delivery system, according to Vero Biotech LLC. Genosyl is a tankless, portable iNO system that eliminates the need for large nitric oxide tanks.
Genosyl is indicated for use in conjunction with ventilatory support and other appropriate agents to treat term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with pulmonary hypertension. It is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood, according to Vero Biotech.
The Genosyl delivery system is engineered with failsafe, redundant backup features and delivers a constant concentration of inhaled nitric oxide gas to patients. According to Vero Biotech, it enables hospitals to reduce logistical burden as compared to the cumbersome tank-based systems currently available, but could provide greater patient access to this potentially life-saving drug.
“FDA approval is a major milestone for Vero Biotech and represents an alternative technology within the inhaled nitric oxide market,” said Brent V. Furse, President and Chief Executive Officer. “We look forward to making Genosyl DS available to the critical care community and patients who may benefit from treatment. This is the first step towards Vero Biotech executing on its vision to bring innovative, patient-centric therapeutic solutions to market.”
Vero Biotech anticipates launching Genosyl DS in US hospitals in early 2020.
“Genosyl DS is a truly innovative way to create inhaled nitric oxide without tanks and will improve access to this gas that has improved the outcomes of many neonates,” said Brian K. Walsh, PhD, RRT, FAARC, past president of the American Association for Respiratory Care and professor of Health Sciences at Liberty University. “The pediatric respiratory community eagerly looks forward to additional options of inhaled nitric oxide delivery that Genosyl DS brings to our standard of care.”