Important Safety Information
†Caution - LungFit is an Investigational Device, Limited by Federal (or United States) Law to Investigational Use.
Clinical Program
We have completed two double-blind, randomized, single-center, 2-arm studies. The primary objectives were to study the safety and tolerability of 160 ppm nitric oxide intermittent inhalation treatment in 2- to 12-month old subjects admitted to hospital and diagnosed with acute bronchiolitis. The planned secondary objectives were to assess the efficacy of NO intermittent inhalation treatment (in addition to standard O2 treatment) compared to standard O2 treatment alone, assessed as the LOS, clinical score improvement, and length of standard O2 treatment.
Bronchiolitis
Bronchiolitis is an infection of the small airways. It is also the most common manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the leading cause of global child mortality. Viral bronchiolitis is currently the most common reason for pediatric hospital admission in the US, accounting for almost 20% of all-cause infant hospitalizations. Viral etiology is the main cause, and among the respiratory viruses, respiratory syncytial virus (RSV) is believed to be the most important viral pathogen causing ALRI in young children.
Worldwide, it is estimated that 60,000 to 199,000 children younger than 5 years die yearly from RSV-associated ALRI, with 99% of these deaths occurring in developing countries. The disease is common mainly in the first year of life. The clinical signs and symptoms are consistent with hypoxia, difficulty breathing, coryza, poor feeding, cough, wheeze and crepitations on auscultation, and in some cases respiratory failure.
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Simple, safe and convenient
Easy to Use
Portable
One system can treat multiple patients
One Respiratory Therapist (RT) can operate multiple systems
Demonstrated Safety Record
The Beyond Air Nitric Oxide Delivery System has a demonstrated safety record at concentrations of 150-250 ppm.
treatments administered
patients
different clinical settings
serious adverse events (SAEs) related to NO.
Several animal toxicity studies have been completed showing no differences from control up to 400 ppm.
†Caution - LungFit is an Investigational Device, Limited by Federal (or United States) Law to Investigational Use.