Vero Biotech gets okay for expanded access to its Genosyl DS iNO system to treat COVID-19 patients

Vero Biotech has announced that the FDA will allow expanded access to the company’s Genosyl DS tankless inhaled nitric oxide (iNO) delivery system so that it can be used for the treatment of cardiopulmonary symptoms of COVID-19. According to Vero, the system can be used in either hospital or home settings.  The FDA approved Genosyl iNO for the treatment of persistent pulmonary hypertension of the newborn (PPHN) in December 2019. 

Vero Biotech President and CEO Brent V. Furse commented, “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. 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.”

Two days prior to this announcement, the company said that a patient with COVID-19 infection and pulmonary hypertension received home treatment with Genosyl DS under an emergency IND.

Read the Vero Biotech press release.