Apreo Health, a clinical-stage medical device company, has announced its emergence from stealth mode and will present first-in-human clinical data for its novel BREATHE Airway Scaffold at the upcoming American Thoracic Society (ATS) 2025 International Conference in San Francisco. The presentation, scheduled for May 19, will showcase results from the company's BREATHE 1&2 feasibility studies as a late-breaking abstract.
The BREATHE Airway Scaffold represents a significant advancement in emphysema treatment as a first-of-its-kind implant specifically designed to relieve pressure in overinflated lungs without removing or sacrificing healthy tissue. This approach stands in contrast to current interventional therapies that have limited applicability and higher complication rates.
"Severe emphysema has remained one of the most vast unmet needs in respiratory care. Existing interventions are limited to a narrow subset of patients and carry meaningful risks," said Karun Naga, CEO of Apreo Health. "Apreo's goal from the start was to break through with a solution that offers physicians a non-destructive therapy designed for broad adoption across the majority of emphysema patients with hyperinflation. We're thrilled to emerge from stealth and share these early data with the clinical community."
Clinical Trial Design and Patient Population
The BREATHE 1&2 feasibility studies (Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung) commenced in 2023 and enrolled 60 patients across five sites in Australia and Europe. The trials evaluated the safety and feasibility of the BREATHE Airway Scaffold in patients with severe emphysema and lung hyperinflation. Secondary assessments included efficacy measures across pulmonary function, quality of life, and exercise capacity outcomes.
The upcoming presentation at ATS 2025 will mark the first public disclosure of clinical data from this program, highlighting the company's progress toward developing a treatment option for patients previously underserved by existing pharmacological and interventional therapies.
The Burden of Emphysema
Chronic obstructive pulmonary disease (COPD) ranks as the fourth leading cause of death and eighth leading cause of poor health worldwide, according to the World Health Organization. The U.S. Centers for Disease Control and Prevention estimates that nearly 16 million Americans have been diagnosed with COPD, with millions more undiagnosed.
Emphysema, a severe form of COPD characterized by the destruction of lung air sacs, affects approximately 3 million people in the United States alone and is a leading contributor to COPD-related disability and mortality. Current treatment options for severe emphysema are limited, creating a significant unmet medical need.
Innovative Technology Approach
The BREATHE Airway Scaffold is designed to release air from hyperinflated lungs associated with severe emphysema. The proprietary scaffold features a unique design to resist foreign body reaction and promote durability of effect. In recognition of its potential clinical impact, the device received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation in May 2024.
Unlike traditional lung volume reduction approaches that permanently remove or destroy lung tissue, Apreo's technology aims to preserve tissue while still addressing the mechanical disadvantages caused by hyperinflation. This tissue-sparing approach could potentially expand treatment eligibility to a broader patient population.
Company Background and Future Plans
Apreo Health was built at The Foundry, an acclaimed medtech venture incubator, and is funded by a syndicate of venture capital investors. The company is led by a team with extensive experience in medical technology and pulmonary medicine.
Following the presentation of the BREATHE 1&2 data, Apreo is preparing for its next phase of clinical development, though specific details about upcoming trials have not yet been disclosed.
The presentation titled "First in Human, Multicenter Experience with Airway Scaffolds for Emphysema-related Hyperinflation" will take place on Monday, May 19, 2025, from 9:51-10:03 AM PT in Room 24, Hall E at the Moscone Center as part of Session B14: "From Inflammation to Infection: Exploring Breakthroughs in Airway Disease."
