FDA Approves LungFit PH to Treat Term and Near-Term Neonates with Hypoxic Respiratory Failure

Officials with the FDA have approved LungFit PH from Beyond Air for the treatment of term and near-term neonates with hypoxic respiratory failure, eliminating the need for traditional nitric oxide tanks from the hospital setting.

The approval marks the first and only nitric oxide generator and delivery system with this indication using ambient air to provide unlimited, on-demand nitric oxide. It uses the company’s patented ionizer technology and is the first FDA-approved product for Beyond Air.

Nitric oxide is a vasodilator approved to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents. Low concentration inhaled nitric oxide therapy has been the standard-of-care for persistent pulmonary hypertension in infants for more than 20 years in the United States.

Persistent pulmonary hypertension in infants is a lethal condition and secondary to failure of normal circulatory transition at birth. It is characterized by elevated pulmonary vascular resistance that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-life shunting of blood.

The instance of persistent pulmonary hypertension in infants has been reported as 1.9 per 1000 live births, with a mortality rate ranging between 4% and 33%. The syndrome complicates the course of about 10% of infants with respiratory failure and remains a significant source of morbidity and mortality.

The technology generates unlimited, on-demand nitric oxide from ambient air and delivers it to a ventilator circuit, regardless of dose or flow. The device uses a compressor to drive room air through a plasma chamber, where pulses of electrical discharge are created between 2 electrodes. This ionizes the nitrogen and oxygen molecules, forming nitric oxide with low levels of nitrogen dioxide as a byproduct. The gas is then passed through a filter to remove the toxic nitrogen dioxide from the internal circuit.

When treating infants with persistent pulmonary hypertension, the LungFit PH system is designed to deliver a dosage of nitric oxide to the lungs that is consistent with the current standard of care for delivery of 20 parts per million (PPM) with a range of 0.5 ppm to 80 ppm for ventilated patients. Each filter in the system will last 20 hours regardless of ventilator demands and the filters can be replaced quickly and easily.

“As the first and only approved nitric oxide generator and delivery system, LungFit PH empowers health care providers to maximize the efficiency of a hospital when treating [persistent pulmonary hypertension in infants] by moving beyond their reliance on traditional, inefficient delivery systems and the associated burdensome logistics and safety requirements,” said Steve Lisi, chairman and CEO of Beyond Air, in a press release.

REFERENCE

Beyond Air’s LungFit PH Receives FDA Approval to Treat Term and Near-Term Neonates with Hypoxic Respiratory Failure. News release. BeyondAir; June 28, 2022. Accessed June 29, 2022. https://www.beyondair.net/investors/news-events/press-releases/detail/168/beyond-airs-lungfit-ph-receives-fda-approval-to-treat