FDA Allows Patients to use VERO’s Nitric Oxide at Home


Genosyl DS system facilitates outpatient use of inhaled nitric oxide in the treatment of cardiopulmonary symptoms associated with COVID-19

The U.S. Food and Drug Administration (FDA) has granted VERO Biotech an "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 FDA for the treatment of persistent pulmonary hypertension of the newborn (PPHN) and is the only tankless inhaled nitric oxide device available in the US.
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 Furse, president and chief executive officer, 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.