MENLO PARK, Calif. — Apreo Health has announced that the first patient has been treated in its pivotal BREATHE-3 clinical trial, which is evaluating the company’s BREATHE Airway Scaffold as a new, tissue-sparing treatment for severe emphysema. The bronchoscopically delivered, self-expanding implant is designed to relieve lung hyperinflation in patients who remain symptomatic despite optimal medical therapy.
The BREATHE-3 study will enroll up to 250 patients across 25 sites in the United States and Europe, with participants followed for three years. Researchers will assess improvements in lung function, quality of life, and exercise capacity in patients with severe emphysema, regardless of collateral ventilation status. The trial builds on earlier feasibility studies, BREATHE-1 and BREATHE-2, which reported a 92.4 percent technical success rate and no cases of pneumothorax — a frequent and costly complication in 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 of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University and principal investigator of the trial. “The BREATHE Airway Scaffold offers a novel approach that treats the whole lung while eliminating the risk of pneumothorax and procedural complexities that have limited broader adoption of current interventions.”
Apreo Health CEO Karun Naga said treating the first patient in the U.S. as part of BREATHE-3 marks a defining moment for the company. “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,” Naga said.
