FDA Grants Expanded Emergency Use Access for COVID-19 Nitric Oxide Treatment

VERO Biotech LLC, an Atlanta, Ga.-based biotechnology company focused on saving lives, alleviating suffering, and improving the health economics of care, today announced the U.S. Food and Drug Administration (FDA) has granted “expanded access emergency use” allowing its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL DS, to immediately be used for the treatment of cardiopulmonary symptoms associated with COVID-19. GENOSYL (nitric oxide) gas, for inhalation, was recently approved by the FDA for the treatment of persistent pulmonary hypertension of the newborn (PPHN) and is the only tankless inhaled nitric oxide device available in the United States.  
 
Application of VERO’s tankless inhaled nitric oxide system is valuable during a time of crisis when hospital beds and ventilators are in short supply. The ability to have a portable device in either the hospital or home setting enables healthcare providers the flexibility to treat patients with iNO in various settings, and give patients more access to the care they need.
 
“In this time of a global pandemic and public health crisis, it is critical to explore all potential options for treating both the novel coronavirus and its associated cardiopulmonary conditions,” said Brent V. Furse, president and CEO, VERO Biotech. “Inhaled nitric oxide may provide important benefits and we at VERO Biotech intend to expedite and expand our research in this critical area. The application of home use of iNO—which was not been logistically viable until the approval of a tankless and portable system—may itself also play a role in limiting current demand for hospital beds and ventilators by patients suffering from symptoms due to COVID-19.”
 
VERO Biotech is also working with renowned global academic experts in infectious and cardiopulmonary diseases to evaluate the potential clinical benefits of GENOSYL in treating pulmonary manifestations of COVID-19.
 
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.
 
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.
 
Nitric oxide is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, nitric oxide targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs and is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate.   
 
Prior to the approval of the GENOSYL system, the only way to provide iNO was via large, pressurized gas cylinders and complicated delivery systems.
 
GENOSYL DS is VERO Biotech’s lead product specifically designed for the hospital intensive care setting. This proprietary delivery system eliminates the need for large nitric oxide tanks and the associated logistical burden. GENOSYL DS is a tankless and portable system engineered with failsafe, redundant backup features, which delivers a constant concentration of inhaled nitric oxide gas to patients and the easy-to-use interface and portability features.

Earlier this week, the company announced the first treatment of a COVID-19 patient with its iNO delivery system at home. The patient was treated under an emergency IND filed by a qualified investigator and approved by the FDA. “Treating patients at home with a tankless system to deliver iNO represents a new paradigm in the management of pulmonary hypertension,” said Michael Gentile, RRT and vice president of Medical Affairs at VERO Biotech.

The patient was also treated with oxygen via nasal canula and was carefully monitored remotely by clinicians, avoiding hospitalization and more intensive respiratory support.

“Application of VERO’s tankless inhaled nitric oxide system at home under physican supervision is particularly critical during a time of crisis when hospital beds and ventilators are in short supply,” said Furse.