Beyond Air, Inc. is a commercial stage medical device and biopharmaceutical company that develops a nitric oxide generation and delivery platform called LungFit® capable of producing nitric oxide from ambient air. The LungFit® system can generate nitric oxide concentrations ranging from 0.5 parts per million to 400 parts per million and deliver it continuously or for a fixed amount of time at various flow rates with the ability to titrate dose on demand or maintain a…
Beyond Air, Inc. is a commercial stage medical device and biopharmaceutical company that develops a nitric oxide generation and delivery platform called LungFit® capable of producing nitric oxide from ambient air. The LungFit® system can generate nitric oxide concentrations ranging from 0.5 parts per million to 400 parts per million and deliver it continuously or for a fixed amount of time at various flow rates with the ability to titrate dose on demand or maintain a constant dose. The company’s first product, LungFit® PH, received FDA premarket approval in June 2022 for the treatment of persistent pulmonary hypertension of the newborn and later obtained European CE mark approval in November 2024 for additional indications in neonates, infants, children and adults undergoing heart surgery. Beyond Air also advances pipeline candidates LungFit® PRO for viral lung infections and LungFit® GO for nontuberculous mycobacterial lung disease, while exploring nitric oxide based therapies for solid tumors through its majority owned affiliate Beyond Cancer and neuronal nitric oxide synthase inhibitors for autism spectrum disorder through its affiliate NeuroNOS.
Revenue is generated primarily from the sale of LungFit® PH devices and associated disposables to hospitals and other healthcare providers. The company began marketing LungFit® PH in the United States in September 2022 and has secured distribution agreements covering France, Italy, Turkey, India, Saudi Arabia, Morocco and other regions, anticipating meaningful contribution to revenue starting in fiscal 2026. Based on internal estimates, the US sales potential for LungFit® PH in persistent pulmonary hypertension of the newborn is approximately $350 million and the worldwide sales potential is approximately $700 million or greater. Future revenue streams are expected from the commercialization of LungFit® PRO for viral lung infections, with an estimated US market potential greater than $1.5 billion and worldwide market potential greater than $3 billion, and LungFit® GO for nontuberculous mycobacterial lung disease, with an estimated US market potential greater than $1 billion and worldwide market potential greater than $2.5 billion. Additionally, the company expects to receive royalties and milestone payments from its oncology and neurology subsidiaries and pays a low single digit royalty to NitricGen under the licensed eNOGenerator technology. Manufacturing is outsourced to contract manufacturers Spartronics LLC and Medisize Ireland Limited with finished goods staged from a central warehouse in Atlanta, Georgia.
Beyond Air competes in the nitric oxide therapy market against established players such as Mallinckrodt’s INOMAX®, Linde Group’s NOxBOX®, Air Liquide’s KINOX™, VERO Biotech’s GENOSYL DS and Bellerophon Therapeutics, which are developing NO delivery systems for various respiratory and cardiac indications. The company’s competitive advantage stems from its ability to generate nitric oxide directly from ambient air, eliminating the need for high pressure cylinders and complex purging procedures, which reduces logistical burden on hospital staff. LungFit® systems can deliver nitric oxide concentrations above 150 parts per million, enabling potential antimicrobial applications beyond vasodilation, and include an integrated monitoring system that continuously measures nitric oxide, nitrogen dioxide and inspired oxygen fractions. The device is portable and can be administered non invasive through a facial mask, making it suitable for use in intensive care units, operating rooms and outpatient settings. Beyond Air’s intellectual property portfolio includes a global exclusive license to the eNOGenerator from NitricGen and numerous issued patents and pending applications covering its NO generation, delivery and monitoring technologies.
The company serves hospitals, neonatal intensive care units, pediatric cardiology wards, adult cardiac surgery centers and pulmonary clinics that treat patients with hypoxic respiratory failure, pulmonary hypertension or severe lung infections. While specific customer names are not disclosed in the filing, the target clientele includes major medical centers and community hospitals across the United States and international markets where LungFit® PH has received regulatory clearance, including Australia, New Zealand, Hong Kong, Thailand and countries in Europe, the Middle East and Asia served through distribution agreements with partners such as Getz Healthcare, and direct agreements covering France, Italy, Turkey, India, Saudi Arabia and Morocco. Beyond Air markets its products directly through a field sales team and provides necessary training via a separate team of clinical specialists.
Read more ↓
Sector: Healthcare Industry: Medical Devices CIK: 0001641631