Beyond Air’s LungFit® PH Receives FDA Approval to Treat Term and Near-Term Neonates with Hypoxic Respiratory Failure

Summary :

• First and only nitric oxide generator and delivery system indicated for the treatment of termand near-term neonates with hypoxic respiratory failure that uses ambient air to provide unlimited, on-demand nitric oxide
• Eliminates the need for traditional nitric oxide tanks from the hospital setting and the associated burdens to providers
• LungFit^® PH is the first FDA-approved product from Beyond Air’s LungFit^® therapeutic platform of nitric oxide generators targeting pulmonary disease

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

About the LungFit™*

• Description -Beyond Air’s LungFit™ is a cylinder-free, phasic flow nitric oxide generator and delivery system and has been designated as a medical device by the US Food and Drug Administration (FDA). 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
• Indication-For the treatment of Persistent pulmonary hypertension of the newborn (PPHN).
• Mode of Action – 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.

About Persistent pulmonary hypertension of the newborn (PPHN)

Persistent pulmonary hypertension of the newborn (PPHN) is a dangerous condition that may cause a baby to not get enough oxygen after birth. During pregnancy, babies get all of the oxygen they from the mother through the placenta. The placenta is an organ in the mother’s womb that is connected to the umbilical cord. Persistent pulmonary hypertension of the newborn, or PPHN, occurs when a newborn’s circulation system doesn’t adapt to breathing outside the womb. While in the womb, the fetus receives oxygen through the umbilical cord, so the lungs need little blood supply.

About Nitric Oxide (NO)
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.

About Beyond Air, Inc.
Beyond Air, Inc. is a medical device and biopharmaceutical company dedicated to harnessing the power of nitric oxide (NO) through its revolutionary 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. The LungFit can generate up to 400 ppm of NO, for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company has received FDA approval for its first system, LungFit PH for persistent pulmonary hypertension of the newborn. 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.

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