Important Safety Information
†Caution - LungFit is an Investigational Device, Limited by Federal (or United States) Law to Investigational Use.
Designed for Convenience
Beyond Air’s Nitric Oxide (NO) generator and delivery system (LungFit) is capable of generating nitric oxide from ambient air to a patient’s lungs. This can be done continuously or for a fixed amount of time, with the capability to titrate dose on demand or maintain a constant dose.
For persistent pulmonary hypertension of the newborn (PPHN), our novel Beyond Air NO Delivery System (LungFit PH) is designed to deliver a dosage of nitric oxide to the lungs that is consistent with current guidelines for delivery of 20 ppm with a range of 0.5 – 80 ppm.
For Bronchiolitis, our LungFit BRO device is designed to deliver a NO dosage of 150ppm for 40 minutes 4 times per day. This dose may be increased further (up to 250ppm) with the potential to target serious lung diseases such as nontuberculous mycobacteria (NTM) and COPD using the LungFit NTM device.
Beyond Air have also developed a proprietary system for delivering gaseous nitric oxide at high concentrations to treat solid tumors.
Demonstrated Safety Record
The Beyond Air Nitric Oxide Delivery System has a demonstrated safety record at concentrations of 150-250 ppm.
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.
Beyond Air’s NO delivery system uses NO generated from ambient air with an innovative generator. It is designed to provide patients with a precise gaseous dose of NO (ranging from 1–400 ppm) combined with ambient air. The blend is supplied through a ventilator for concentrations up to 80 ppm and a face mask for concentrations of 150 ppm and higher.
Our product candidates resemble other inhalation systems, making them user friendly, with operation and maintenance we believe will be familiar to medical staff.
Our technology has the following features:
We are advancing a promising pipeline of product candidates with an initial focus on treating PPHN, bronchiolitis and nontuberculous mycobacteria (NTM). We are also assessing the potential to treat COVID-19 (see our press release here) and have developed a separate, novel system for the administration of nitric oxide at ultra-high concentrations directly to solid tumors.View Our Pipeline