Beyond Air Issues Regulatory Update For LungFit PH System

Beyond Air Inc XAIR announced a regulatory update for the approval process of its LungFit PH system.
The Company said that the FDA facility inspections are currently ongoing. These inspections are required for the approval of the premarket application (PMA) for LungFit PH.
Beyond Air has reiterated its guidance for the commercial launch of LungFit PH in the U.S. by Q4 of 2021.
The Company completed the Stage 1 Assessment Audit of its quality system. The development marks the first part of a two-stage inspection and quality review audit. The LungFit PH is expected to be granted CE Mark in Europe in 1H of 2022.
XAIR stock’s LungFit PH is a cylinder-free, phasic flow nitric oxide (NO) generator and delivery system.
The ventilator-compatible version of the device also can generate NO from ambient air on demand. The NO is delivered to the lungs at concentrations ranging from 1 part per million (ppm) to 80 ppm.
Related content: Benzinga's Full FDA Calendar.
Price Action: XAIR stock slipped 5.50% to $11.85 during after-hours trading on Tuesday.