Company description

We are a commercial-stage medical device and biopharmaceutical company developing a platform of nitric oxide (“NO”) generators and delivery systems (the “LungFit ® platform”) capable of generating NO from ambient air. The Company’s first device, LungFit ® PH received premarket approval (“PMA”) from the FDA in June 2022. The NO generated by the LungFit ® PH system is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. This condition is commonly referred to as persistent pulmonary hypertension of the newborn (“PPHN”). The LungFit ® platform can generate NO up to 400 parts per million (“ppm”) for delivery to a patient’s lungs directly or via a ventilator. LungFit ® can deliver NO either continuously or for a fixed amount of time at various flow rates and has the ability to either titrate dose on demand or maintain a constant dose. In July 2022, we commenced marketing LungFit ® PH in the United States for PPHN as a medical device.

Read the full filing description · filed 26 Jun 2026

At a glance

Sector

Healthcare

Industry

Surgical & Medical Instruments & Apparatus

CEO

Robert S. Goodman

Employees (2026)

54

Incorporated in

DE

Sector is derived from the SEC industry classification.