Using a regulatory pathway that allows patients with life-threatening conditions to use unapproved therapies, the FDA has granted “emergency expanded access” to Bellerophon Therapeutics’ inhaled nitric oxide delivery system for treating the novel coronavirus.

Also known as compassionate use, the agency’s policy is typically administered on a per-patient basis—at times when clinical trials are infeasible, the benefits are seen to outweigh the risks, and there are no available alternatives.

According to Bellerophon, the FDA’s decision now opens up its INOpulse system for use at high-doses in ventilated COVID-19 patients, immediately.