Apreo Health today announced first-in-human six-month clinical data supporting the use of its Breathe airway scaffold device.
The data release comes just one week after the company emerged from stealth to unveil its emphysema treatment. It designed the first-of-its-kind implant to relieve pressure in overinflated lungs without removing or sacrificing healthy tissue.
Breathe, a bronchoscopically delivered, self-expanding implant aims to relieve emphysema-related hyperinflation by releasing trapped air in the lungs.
Apreo Health shared its first-in-human data at the American Thoracic Society (ATS) 2025 International Conference in San Francisco. Investigators simultaneously published findings in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). The Breathe trials represent the first clinical evaluation of the airway scaffold. They evaluated 60 patients across five centers in Australia and Europe. Investigators looked at safety, technical feasibility and initial clinical outcomes over a six-month period.
Findings included 92.4% technical success rate in device placement and no post-procedural pneumothoraxes observed. Investigators reported a mean reduction in residual volume (RV) of 753 mL from baseline. They saw clinically meaningful improvements in lung function, quality of life and exercise capacity, irrespective of disease heterogeneity and collateral ventilation status.
Pneumonia (10%) and COPD exacerbation (5%) came in as the most frequently reported serious adverse events. Apreo says the safety profile proved consistent with other interventional approaches for severe emphysema.
“The data from this study reinforces our belief that the Breathe airway scaffold has the potential to become a new standard of care for patients with emphysema-related hyperinflation,” said Karun Naga, CEO of Apreo Health. “We’re developing a minimally invasive, tissue-sparing solution designed to eliminate uncertainty in patient qualification due to disease pattern and collateral ventilation and to relieve the burden of this disease on our healthcare system by enabling a more efficient treatment pathway.”
