Pneuma Therapeutics is a medical device company who has created a one-of-a-kind, patent pending solution for non-invasive ventilation therapy – called the XChange™ Positive Pressure Nasal Dock. The XChange™ System, is a mask-free, positive pressure oxygenation and ventilation device designed to prevent perioperative hypoxemia secondary to upper airway obstruction (“UAO”). The Company has completed their 510(k) submission and expects to conduct market introduction in late-2025.

Technology Overview

Pneuma Therapeutics has developed the XChange™ to prevent hypoxemia during anesthesia and sedation procedures. In 2024, approximately 84M people in the U.S. underwent procedures requiring anesthesia, sedation, and/or analgesia, resulting in an addressable market opportunity of $3.7B.

Hypoxemia is an impairment of a patient’s ventilatory function which causes a reduction in the partial pressure of oxygen in arterial blood. Even in highly advanced surgical and interventional settings, a significant percentage of patients experience hypoxemia for extended periods of time. If untreated, hypoxemia increases risk for serious complications such as respiratory and cardiac failure/arrest, major organ failure/damage, decreased cognitive function, and postoperative nausea and vomiting in the recovery unit, which often leads to unanticipated hospital admissions, delayed discharges and schedule delays. The economic burden of respiratory failure, which is defined as inadequate oxygenation, ventilation, or both, was estimated to be $49.7 billion in the U.S. in 2024.

The most common cause of hypoxemia is airway obstruction, which occurs when anesthetic agents reduce consciousness and relax muscle tone/activation in the pharynx of patients with unprotected airways, causing blockage. Risk for airway obstruction is exacerbated in patients with obesity, sleep apnea, and advanced age. The XChange™ seals the nasal openings, provides oxygen, whereby a positive pressure effect is generated, pneumatically stenting the upper respiratory system. Extensive testing has demonstrated its ability to prevent obstructions in the airway while also providing necessary exhalation samples for monitoring adequate end-tidal CO₂.