Beyond Air, Inc. (XAIR) Announces FDA Approval of LungFit to Treat Term and Near-Term Neonates with Hypoxic Respiratory Failure

Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has approved LungFit® PH to treat term and near-term neonates with hypoxic respiratory failure (often referred to as persistent pulmonary hypertension of the newborn or PPHN) (prescription use only). LungFit PH is the initial device from the LungFit therapeutic platform of nitric oxide generators that use our patented Ionizer™ technology and is the first FDA-approved product for Beyond Air.

LungFit PH is the first FDA-approved product that generates on-demand nitric oxide from ambient air for the treatment of term and near-term neonates with hypoxic respiratory failure

The LungFit platform uses unique patented Ionizer™ technology to generate nitric oxide on-demand from ambient air, designed and built by the same inventors that developed the first nitric oxide delivery system and subsequent systems still in use today as the current global market leader

Steve Lisi, Chairman and CEO of Beyond Air, commented, “The FDA approval of LungFit PH enables a new era of nitric oxide therapy and marks a pivotal event for Beyond Air as we officially enter the U.S. market. As the first and only approved nitric oxide generator and delivery system, LungFit PH empowers healthcare providers to maximize the efficiency of a hospital when treating PPHN by moving beyond their reliance on traditional, inefficient delivery systems and the associated burdensome logistics and safety requirements.”

Mr. Lisi added, “I am immensely proud of the Beyond Air team for navigating a multitude of obstacles over the past five years, especially the last 27 months during the global pandemic, to bring this revolutionary device to market. The approval of LungFit PH validates our patented Ionizer technology and lays out a premarket approval model for our other LungFit platform devices, including LungFit PRO and LungFit GO. We believe that LungFit PH is just the first in a series of our medical devices that, if approved, will become available for treating a wide variety of respiratory diseases as we remain dedicated to our mission of harnessing the power of nitric oxide for all who can benefit from this transformational therapy.”

LungFit PH uses patented Ionizer™ technology to generate unlimited on-demand nitric oxide from ambient air and deliver 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 two electrodes. The LungFit PH system uses power equivalent to a 60-watt lightbulb to ionize the nitrogen and oxygen molecules, forming nitric oxide with low levels of nitrogen dioxide (NO2) created as a byproduct. The gas is then passed through a Smart Filter, which removes the toxic NO2 from the internal circuit.

For the treatment of PPHN, the novel LungFit PH system is designed to deliver a dosage of NO to the lungs that is consistent with the current standard of care for delivery of 20 ppm NO with a range of 0.5 ppm – 80 ppm (low concentration NO) for ventilated patients. Each Smart Filter will last 12 hours regardless of ventilator demands and replacing a filter takes just a few seconds.

NO gas is a vasodilator approved in dozens of countries to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) 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 NO therapy has been the standard-of-care for PPHN for over 20 years in the United States. PPHN is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1,000 live births (0.4–6.8/1,000 live births) with a mortality rate ranging between 4–33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality.

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