Beyond Air Inc (NASDAQ: XAIR) is a commercial-stage medical device and biopharmaceutical company that develops nitric oxide generators and delivery systems for therapeutic use. Its revenue model centers on the sale and commercialization of the LungFit® platform, a device that generates nitric oxide from ambient air and delivers it directly to patients or via ventilator. The company's first approved product, LungFit® PH, received FDA premarket approval in June 2022 and is indicated for persistent pulmonary hypertension of the newborn (PPHN) in term and near-term neonates (greater than 34 weeks gestation). Beyond Air commenced U.S. marketing of LungFit® PH in July 2022. The company also operates two preclinical-stage pharmaceutical subsidiaries, Beyond Cancer and NeuroNos, engaged in early-stage research. The PPHN market is described in the FY2025 10-K as highly competitive, with market acceptance at an appropriate price proving difficult. No revenue figures or customer concentration data are disclosed in the available filing excerpts.

Revenue model

Product sales from commercialization of the LungFit® PH medical device in the United States, commenced July 2022. No subscription, royalty, or licensing revenue model is described in the available filing excerpts.

Products and services

LungFit® PH: FDA-approved (June 2022) nitric oxide generator and delivery system for PPHN in term and near-term neonates; capable of generating NO up to 400 parts per million (ppm), delivering continuously or for fixed durations at variable flow rates with dose titration capability. Beyond Cancer and NeuroNos: preclinical-stage pharmaceutical research subsidiaries (as of 10-K filed 2025-06-20).

Customers and end markets

Hospital neonatal units treating persistent pulmonary hypertension of the newborn (PPHN). End-market is term and near-term neonates (greater than 34 weeks gestation) with hypoxic respiratory failure. No customer concentration data disclosed in available filing excerpts.

Value-chain role

Medical device manufacturer and commercial-stage biopharmaceutical developer. Designs, manufactures, and markets nitric oxide generation and delivery hardware directly for clinical use, subject to FDA PMA regulatory framework and healthcare compliance requirements including HIPAA, FCA, and the federal Sunshine Act.

Geographic exposure

United States commercial market for LungFit® PH as of July 2022. No additional geographic revenue data disclosed in available filing excerpts.

Competitors

Mallinckrodt (INOMAX nitric oxide for inhalation, approved in U.S., Canada, Australia, Mexico, Japan), Linde Group (generic INOMAX with NOxBOX delivery system; INOMAX marketing rights in Europe), Air Liquide (KINOX with SoKINOX delivery platform in Europe), EKU, International Biomedical, Cahouet, ITC

Source: SEC 10-K, filed 2025-06-20

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