Beyond Air, Inc. (NASDAQ: XAIR)

Beyond Air, Inc., with its ticker symbol XAIR, is a commercial-stage medical device and biopharmaceutical company that operates in the healthcare industry. The company's main business activities involve the development and commercialization of medical devices and biopharmaceuticals that utilize nitric oxide (NO) to treat various respiratory and pulmonary diseases.

Beyond Air generates revenue through the sale of its primary products, including LungFit PH, LungFit PRO, and LungFit GO. These products are designed to deliver NO to patients with various respiratory and pulmonary diseases, including persistent pulmonary hypertension of the newborn (PPHN), viral community-acquired pneumonia (VCAP), bronchiolitis, and non-tuberculous mycobacteria (NTM) lung infection.

LungFit PH is the company's first FDA-approved system that generates on-demand NO from ambient air. The device uses a medical air compressor to drive room air through a plasma chamber, where pulses of electrical discharge are created between two electrodes. The system uses the power equivalent to a 60-watt lightbulb to ionize the nitrogen and oxygen molecules, which then combine as NO with low levels of nitrogen dioxide (NO2) created as a byproduct. The system then passes the products through a Smart Filter, which removes the toxic NO2 from the internal circuit. LungFit PH is designed to deliver a dosage of NO to the lungs that is consistent with current guidelines for delivery of 20 ppm NO with a range of 0.5 ppm to 80 ppm (low concentration NO) for ventilated patients.

LungFit PRO is designed to treat patients with VCAP and bronchiolitis. The device uses a proprietary delivery system to deliver high concentrations of NO to the lungs, which has been shown to be effective in shortening hospital length of stay and accelerating time to fit for discharge. LungFit GO is designed to treat patients with NTM lung infection. The device uses a proprietary delivery system to deliver high concentrations of NO to the lungs, which has been shown to be effective in reducing microbial load and improving quality of life.

Beyond Air believes that its competitive advantages include its ability to generate NO from ambient air, which eliminates the need for high-pressure cylinders and cumbersome purging procedures. The company's devices also have a lower burden on hospital staff, as they do not require the same level of safety procedures as traditional NO delivery systems.

The company's customers include hospitals and healthcare providers that treat patients with respiratory and pulmonary diseases. The company's products are designed to be used in a variety of settings, including hospitals, clinics, and home care settings.

Beyond Air has a strong intellectual property portfolio, with over 50 pending patent applications worldwide. The company has also entered into a settlement agreement with Circassia Limited and its affiliates, resolving all claims by and between both parties and mutually terminating the agreement.

The company is subject to government regulation in the United States, with the FDA regulating drug and medical device products under the Federal Food, Drug, and Cosmetic Act. The company's products have been designated as devices by the FDA and will be regulated by the Center for Devices and Radiological Health. The company is required to obtain 510(k) clearance or PMA approval from the FDA before commercially distributing its products.

In terms of brand names and/or trade names, Beyond Air has LungFit PH, LungFit PRO, and LungFit GO as its primary products in development and commercialization. These products have the potential to generate significant revenue in the future, with financial projections including U.S. sales potential for LungFit PH in PPHN at $350 million, worldwide sales potential for LungFit PH in PPHN at $700 million, U.S. sales potential for LungFit PRO in VCAP and bronchiolitis at $1.5 billion, worldwide sales potential for LungFit PRO in VCAP and bronchiolitis at $3 billion, U.S. sales potential for LungFit GO in NTM lung infection at $1 billion, and worldwide sales potential for LungFit GO in NTM lung infection at $2.5 billion.