FDA Approves Beyond Air’s LungFit for Treating Neonates

Beyond Air Inc. has received U.S. Food and Drug Administration (FDA) approval to treat term and near-term neonates suffering from hypoxic respiratory failure (often referred to as persistent pulmonary hypertension of the newborn or PPHN) with LungFit PH. LungFit PH is the initial device from the LungFit therapeutic platform of nitric oxide generators that use the company’s patented Ionizer technology and is the first FDA-approved product for Beyond Air.
 
“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,” said Steve Lisi, chairman and CEO of Beyond Air. “I am 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 (greater than 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.
 
The Beyond Air commercial team will be actively working with select hospitals to make LungFit PH available to them with a broader U.S. hospital launch expected in the first half of 2023. 

Beyond Air Inc. is dedicated to harnessing the power of nitric oxide (NO) through its NO Generator and Delivery System, LungFit, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as community-acquired viral pneumonia (including COVID-19), nontuberculous mycobacteria (NTM) and severe lung infections in other settings. Additionally, Beyond Cancer, an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. 
 
Nitric Oxide (NO) is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in-vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.