Apreo Health Announces First Patient Treated in BREATHE-3

Apreo Health, announced that the first patient has been treated in its pivotal clinical trial, BREATHE-3 (Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung—Study 3). The trial is evaluating the safety and efficacy of the Apreo BREATHE Airway Scaffold, a bronchoscopically delivered, self-expanding implant designed to relieve emphysema-related lung hyperinflation in patients who continue to have difficulty breathing despite optimal medical management.

BREATHE-3 will enroll up to 250 patients across 25 sites in the U.S. and Europe, and will follow participants for three years. Outcome measures include changes in lung function, quality of life, and exercise capacity in hyperinflated patients with severe emphysema, regardless of collateral ventilation status. BREATHE-3 builds on compelling early data from the BREATHE 1&2 feasibility studies, which demonstrated 92.4% technical success and no pneumothorax—a common and costly complication associated with other interventional approaches.

“For years, the field has been searching for a safer, more broadly applicable way to address emphysema-related hyperinflation,” said Dr. Gerard J. Criner, chair and professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, director of the Temple Lung Center, and the principal investigator of the BREATHE-3 study. “The BREATHE Airway Scaffold offers a novel approach that allows treatment of the whole lung while eliminating the risk of pneumothorax and procedural complexities that have limited broader adoption of current interventions. This trial is a key step in evaluating a therapy that could meaningfully expand interventional treatment access for patients today who have few options.”

“Treating not only the first patient in our pivotal BREATHE-3 trial, but also the first patient in the United States, marks a defining moment for Apreo and a critical milestone in the path to changing the standard of care for millions of people who’ve been left behind by existing treatment options,” said Karun Naga, CEO of Apreo Health. “With this study, we’re advancing a therapy designed to fit the realities of everyday clinical practice, enabling broader use by physicians, and ultimately better outcomes for patients.”

Source: Apreo