VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering and improving the health economics of care, today announced it has received US Food and Drug Administration (FDA) approval of GENOSYL® (nitric oxide) gas, for inhalation. 

GENOSYL® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.  

GENOSYL® is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood. (See below for additional Important Safety Information.)

VERO Biotech's GENOSYL® Delivery System (DS) is a compact and user-friendly nitric oxide delivery system, that will not only enable 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.

"VERO Biotech's 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."

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