Shares of Beyond Air Inc. (NASDAQ: XAIR) gained over 3% in midday trade on Thursday. The stock has climbed 5% since the beginning of the year. The company reported a 45% year-over-year decline in revenue for the second quarter of 2021 and is yet to achieve profitability but there are two key areas where it sees significant opportunity in the coming year.
On Wednesday, Beyond Air announced the submission of a premarket approval (PMA) application to the US FDA for its lead product from the LungFit platform, LungFit PH, for the treatment of persistent pulmonary hypertension of the newborn (PPHN).
LungFit PH is a cylinder-free device that generates nitric oxide from ambient air and delivers it to a ventilator. The target indication PPHN is a serious breathing condition wherein the newborn baby is unable to breathe outside the womb and manual ventilation is required. Nitric oxide has been the standard of care for PPHN in the US for the past two decades, helping in improving oxygenation and reducing the need for ventilation.
On its quarterly earnings call, Beyond Air stated that there are currently a little over 850 Level 3 and Level 4 neonatal intensive care units equipped for nitric oxide delivery to treat PPHN and that the sales of nitric oxide in the hospital setting had sales of greater than $500 million in 2019 in the US alone.
The use of nitric oxide has expanded across the global cardiac market and it has been approved in countries like Europe, Australia and Japan for the treatment of PPHN as well as pulmonary hypertension together with cardiovascular surgery.
Beyond Air believes its technology has more advantages than the current cylinder systems that are dominating the US market and if approved by the FDA, the product is expected to be ready for a commercial launch in the US by the second calendar quarter of 2021.
Beyond Air also sees opportunity for the usage of its LungFit technology in the treatment of acute viral pneumonia including infections caused by SARS-CoV-2. LungFit Pro is a direct delivery, non-ventilator compatible system designed to deliver nitric oxide which helps inhibit viral infections.
Studies have shown that nitric oxide is capable of inhibiting the replication of coronaviruses and Beyond Air has submitted its own data that support these findings. The company believes there is opportunity for LungFit Pro to be used in the prevention and treatment of human coronavirus infection.
Beyond Air has received approval from the US FDA as well as healthcare agencies in countries like Canada and Israel to study the use of its LungFit system and nitric oxide to treat COVID-19 patients. The company expects results to be available by the middle of 2021.
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