FDA Approves Novel Nitric Oxide Gas Delivery System

The US Food and Drug Administration (FDA) has approved nitric oxide gas (GENOSYL) for patients with hypoxic respiratory failure associated with pulmonary hypertension.

The approval, granted to VERO Biotech, indicates the inhalation gas for the improved oxygenation and reduced need of extracorporeal membrane oxygenation in term and near-term neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension.

The therapy is intended to be used in conjunction with ventilatory support and other agents. The GENOSYL Delivery System was designed to be a compact and user-friendly nitric oxide provider that will enable hospitals to reduce logistical needs and bolster their supply.

Brian K. Walsh, PhD, RRT, former president of the American Association for Respiratory Care and Professor of Health Sciences at Liberty University, called the system a “truly innovative way” to create inhaled nitric oxide beyond the conventional tank delivery system.

“The pediatric respiratory community eagerly looks forward to additional options of inhaled nitric oxide delivery that GENOSYL® DS brings to our standard of care,” Walsh said in a statement.

Brent V. Furse, VERO Biotech president and chief executive officer, called the FDA approval a major milestone which represents the mark of alternative therapy in the nitric oxide market.

“We look forward to making GENOSYL® DS available to the critical care community and patients who may benefit from treatment,” he said. “This is the first step towards VERO Biotech executing on its vision to bring innovative, patient-centric therapeutic solutions to market."

The company intends to launch the approved delivery system in US hospitals in early 2020.