Beyond Air Inc. (XAIR) stock prices were up by 6.91% as of the market closing on September 21st, 2021. This brought the price per share up to USD$12.54 at the end of the trading day. Subsequent premarket fluctuations saw the stock fall by 5.50%, bringing it down to USD$11.85.
XAIR Stock’s Regulatory Update
September 21st, 2021 saw XAIR stock provide an update on the global regulatory approval process for the LungFit PH system. The clinical-stage medical device and biopharmaceutical company successfully completed the Stage 1 Assessment Audit of its quality system. The audit was conducted by the Notified Body for the LungFit PH system, marking a crucial step for achieving CE Mark (European Union approval). This development marks the first part of a two-stage inspection and quality review audit. The company’s LungFit PH is expected to be granted CE Mark in Europe by the first half of the 2022 calendar year.
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US FDA Involvement
The US Food and Drug Administration facility inspections are currently ongoing. These inspections are required for the approval of the premarket application (PMA) for LungFit PH. XAIR stock has reiterated its guidance for the commercial launch of LungFit PH in the United States by the fourth calendar quarter of 2021. The Proprietary technology is designed to address persistent pulmonary hypertension of the newborn (PPHN).
XAIR Stock’s LungFit PH System
XAIR stock’s LungFit PH is a cylinder free, phasic flow nitric oxide generator and delivery system. It has been designated as a medical device by the United States Food and Drug Administration. The ventilator compatible version of the device also has the ability to 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.
Scope of LungFit PH System
The LungFit PH system has the potential to replace large, high-pressure NO cylinders, thereby facilitating significant advantages in hospital settings. These advantages include reduced inventory and storage requirements, as well improvements in overall safety. The LungFit PH system will also allow for the elimination of NO2 purging steps. Severe acute lung infections can also be potentially treated by LungFit PH system’s ability to deliver NO at concentrations above 80 ppm.
Future Outlook for XAIR Stock
XAIR stock has made significant strides in the development of its proprietary LungFit PH system. The company is keen to allocate resources towards the device’s accelerated commercialization and proliferation. Current and potential investors are confident in the company’s ability to usher in unprecedented growth.
