FDA Asked to Approve LungFit System to Treat Persistent PH in Newborns

Beyond Air filed an application with the U.S. Food and Drug Administration (FDA) requesting approval of its LungFit PH system — an investigational device used to deliver the vasodilator nitric oxide — to treat persistent pulmonary hypertension of the newborn (PPHN).

FDA guidelines allow a 180-day (about six months) review period for this premarket approval (PMA) application.

“Completing this PMA submission is the culmination of years of hard work and dedication … and I am proud that we were able to achieve this despite the challenges of the ongoing COVID-19 pandemic,” Steve Lisi, chairman and CEO of Beyond Air, said in a press release. “Pending approval, we anticipate a U.S. commercial launch for LungFit PH in the second quarter of 2021.”

PPHN is characterized by elevated resistance against blood flow in the lungs, leading to circulatory system problems that can deprive the brain and body of oxygen. Estimates indicate that the disorder, which can be deadly, affects 1 in every 1,250 newborns.

The LungFit PH system is designed to generate nitric oxide (NO) from ambient air. NO is a vasodilator — a molecule that prompts blood vessels to widen, thereby reducing blood pressure — used to help treat newborns with pulmonary hypertension.

Equipment used to administer NO, however, has required bulky, pressurized cylinders to store the NO gas. By generating NO from the surrounding air, the LungFit PH system does away with the need for these cylinders, which is expected to make such treatment more convenient. This feature may also allow NO, typically only used in hospital settings, to be administered at home.

The system can produce varying concentrations of NO, administered at constant or varying doses on demand.

“The PMA filing for the LungFit PH system to treat PPHN is a significant milestone for our company, as it brings us one step closer to revolutionizing nitric oxide therapy,” Lisi said. “LungFit PH generates nitric oxide from ambient air and delivers it to a ventilator creating a safer and more convenient environment for patients and medical staff.”

Beyond Air is also developing the system as a possible treatment for lung infections, including those caused by nontuberculous mycobacteria, and COVID-19.