Persistent Pulmonary Hypertension of the Newborn (PPHN)

About Pulmonary Hypertension in Newborns

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
Ventilator compatible
In-Hospital use for PPHN and cardiac surgery Final preparations for PMA PMA filing 2H 2020

US Launch
1H 2021
>$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

Benefits of Nitric Oxide Treatment<sup>1</sup>

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

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

  • Cylinder Free
  • Nitric oxide generated from ambient air
  • No purging required
  • Integrated backup
  • Smart NO2 filter
  • Lightweight cart 

Significant Benefits to Hospitals

Losing the high-pressure cylinder is an important gain in the hospital setting and reduces costs and logistics.

Advantages to hospitals

Improved operating economics for the hospital

No significant capital investment required for hospitals new to nitric oxide

No burdensome inventory and storage requirements

Nitric oxide supplied as a non-hypoxic gas mixture

No purging procedures or additional safety measures due to NO2 buildup

Reduced training burden

Greatly improved safety for pregnant staff members

Reduced risk of NO2 exposure

Cost Advantages to Beyond Air

Beyond Air does not have any expenses associated with a manufacturing facility for nitric oxide

Beyond Air does not have any expenses associated with logistics related to nitric oxide cylinders

Important Safety Information

Caution - LungFit is an Investigational Device, Limited by Federal (or United States) Law to Investigational Use.