Apreo Health, Inc.
The objective of this study is to provide a regional, mechanistic characterization of pulmonary ventilation changes following treatment with the Apreo BREATHE System, using hyperpolarized ¹²⁹Xe MRI, in BREATHE-3 participants. BREATHE-Xe is designed to generate mechanistic signals regarding whether airway scaffolds reduce ventilation defects, improve gas exchange, and correlate with CT and spirometric/plethysmographic changes observed in BREATHE-3. Findings support mechanistic interpretation and future hypothesis generation.
BREATHE-Xe is a prospective, exploratory ancillary sub-study of BREATHE-3 using hyperpolarized ¹²⁹Xe MRI to characterize regional ventilation and gas exchange changes following treatment with the Apreo BREATHE System. The study will evaluate whether treatment reduces whole-lung ventilation defect percent (VDP) and whether changes occur preferentially within implanted airway regions; whether treatment is associated with changes in gas exchange at the alveolar-capillary level; how regional ventilation changes relate to CT, spirometric, and plethysmographic changes observed in BREATHE-3; and whet…
Inclusion Criteria: 1. Enrolled and randomized in BREATHE-3 to the Treatment arm or enrolled as a Control arm participant who has elected crossover treatment following BREATHE-3 Month 12. 2. Separate written BREATHE-Xe informed consent obtained prior to any sub-study procedures. 3. Able to perform coached breath-hold maneuvers of ≥10 seconds, as assessed by the site investigator. 4. Willing and able to travel to KUMC or UAB for all scheduled Xe-MRI sessions. 5. Eligible for MRI per local MRI safety screening, with no contraindications to MRI. Exclusion Criteria: 1. Any absolute contraindica…
Hyperpolarized Xenon MRI (HP ¹²#Xe) is a radiation-free imaging technique that boosts signal strength to create high-resolution images of how gas moves through the lungs. By tracking inhaled gas across separate breath-holds, it measures airflow blockage, tissue transfer efficiency, and gas uptake by red blood cells, while a washout test maps how well the lungs clear gas. It has been applied to characterize pulmonary impairment in COPD and emphysema and to detect regional ventilation changes following bronchoscopic interventions.
The experimental treatment involves placement of up to 6 Apreo BREATHE Airway Scaffolds (up to 3 per lung), in a single procedure using bronchoscopy and fluoroscopy. Treatment group subjects will also receive optimal medical management (OMM). The BREATHE Airway Scaffold implant procedure occurs under the BREATHE-3 main study. This procedure is not part of the BREATHE-Xe study, which focuses on changes in regional ventilation.
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