GeNO’s Clinical Development Strategy

The first GeNO nitric oxide delivery system has been designated a combination product by the FDA’s Office of Combination Products and is overseen by the Agency’s Center for Drug Evaluation and Research (CDER).

GeNO’s technological breakthrough not only allows the generation and delivery of nitric oxide, but also will allow GeNO to leverage numerous clinical trials using nitric oxide that has already been completed. With the exception of the MV-1000 Delivery System, all of GeNO's delivery platforms for inhaled nitric oxide are anticipated to be regulated by the FDA as combination products requiring New Drug Applications (NDAs).