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Apreo Health treats first patient in pivotal BREATHE-3 emphysema trial

Apreo Health announced the first patient treatment in its pivotal BREATHE-3 clinical trial for the Breathe airway scaffold device. The milestone follows the company’s public launch in May, promising early human data, and a recent $130 million funding round. BREATHE-3 evaluates the safety and efficacy of the self-expanding implant delivered via bronchoscopy. The device is designed to relieve lung hyperinflation in emphysema patients who remain symptomatic despite optimal medical care. It works by releasing trapped air in the lungs to improve breathing capacity. The trial aims to enrol up to 250 patients at 25 sites across the US and Europe, with three years of follow-up. Endpoints include changes in lung function, quality of life, and exercise capacity in severely hyperinflated patients. Previous BREATHE 1 and BREATHE 2 studies showed 92.4% technical success with no pneumothorax events. Principal investigator Dr. Gerard J. Criner said the device’s design treats the whole lung while avoiding complications that limit existing interventions. CEO Karun Naga called the US-first patient treatment a defining moment and a step toward changing the standard of care for emphysema. The therapy aims to expand access to effective treatment for patients with limited current options.