PPHN :: Beyond Air Inc. (XAIR)

Pulmonary Hypertension

About Pulmonary Hypertension in Newborns

Pulmonary hypertension is a life-threatening syndrome from increased pulmonary vascular resistance (PVR) resulting in restricted blood flow through the pulmonary arterial circulation and ultimately in right heart failure and potentially death. Elevated PVR is also a pre-operative risk factor for morbidities. The absence of pulmonary vasoreactivity is associated with worse prognosis.

Product Status and Market Potential

Beyond Air Pipeline & Market Size

Product	Indication	Development Status	Key Dates^*	US Sales Potential^**	Worldwide Sales Potential^**
LungFitPH (Pulmonary Hypertension)	In-Hospital use for PPHN and cardiac surgery	Final preparations for PMA submission	FDA PMA filing 2Q20 US Launch 4Q20	>$300m	>$600m

*All dates are based on projections and appropriate financing, anticipated first launch on global basis pending appropriate regulatory approvals

**All figures are Company estimates for peak year sales: Global Sales Potential includes US Sales Potential

Treatment

Benefits of Nitric Oxide Treatment¹

Nitric oxide has been used as a long-term therapeutic option for patients with pulmonary hypertension. It was approved in the U.S. by the FDA in 1999 for PPHN, and approved in the EU in 2001 for PPHN and cardiac surgery.²

Inhaled nitric oxide increases the concentration of intracellular Cyclic Guanosine Monophosphate (cGMP) and activates soluble guanylate cyclase. By causing smooth muscle relaxation, nitric oxide treatment increases blood flow to the lungs and decreases the workload on the right ventricle.³

¹Pulmonary Hypertension News – “Pulmonary Hypertension and Nitric Oxide”

²Nitric Oxide is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

³Klinger JR and Kadowitz PJ. The Nitric Oxide Pathway in Pulmonary Vascular Disease. Am J Cardiol. 2017;120(8S):S71-S79.y system

Beyond Air’s Cylinder Free System of Care

LungFit PH is Beyond Air’s next-generation phasic flow nitric oxide delivery system. This cylinder free system is designed for the treatment of pulmonary hypertension in the hospital setting.

LungFit PH Key Features