MENLO PARK, Calif.–(BUSINESS WIRE)–Apreo Health, a clinical-stage medical device company developing a novel, tissue-sparing treatment for severe emphysema, today announced the presentation of first-in-human six-month clinical data from the BREATHE 1&2 trials in a late-breaking abstract session at the American Thoracic Society (ATS) 2025 International Conference in San Francisco. The study was simultaneously published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM).
The BREATHE trials represent the first clinical evaluation of Apreo’s BREATHE Airway Scaffold, a bronchoscopically delivered, self-expanding implant designed to relieve emphysema-related hyperinflation by releasing trapped air in the lungs. The studies enrolled 60 patients across five centers in Australia and Europe and evaluated safety, technical feasibility, and initial clinical outcomes over a six-month period.
«These first-in-human data demonstrate early feasibility, safety, and efficacy of the Apreo BREATHE Airway Scaffold,” said Professor Dirk-Jan Slebos, Head of Pulmonary Medicine & Tuberculosis at University Medical Center, Groningen, Netherlands, and presenter of the BREATHE first-in-human study data. “We observed meaningful improvements in lung function, symptoms, and quality of life — all without the risk of pneumothorax. For patients who have historically had few or no interventional options, this represents a promising new path forward.”
“We are impressed by the initial outcomes of this first-in-human study and are looking forward to partnering with our global clinical colleagues as we work toward developing a meaningful, safe solution for these patients with advanced disease,” said Dr. Anand Tana, Clinical Researcher at the Royal Brompton Hospital, London, lead author of the AJRCCM article.
Key Six-Month Findings from the BREATHE 1&2 Studies
- 92.4% technical success rate in device placement
- No post-procedural pneumothoraxes were observed
- Mean reduction in residual volume (RV) of 753 mL from baseline at six months (p<0.0001)
- Clinically meaningful improvements observed in lung function, quality of life, and exercise capacity irrespective of disease heterogeneity and collateral ventilation status
- The most frequently reported serious adverse events were pneumonia (10%) and COPD exacerbation (5%). Importantly, no pneumothoraxes were observed during follow-up — a common complication with current endobronchial therapies. The safety profile was 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. We are very grateful to these leading research institutions and investigators for their partnership and look forward to advancing this therapy to the next phase of clinical development.”
The AJRCCM publication, titled “Airway Scaffolds for Emphysema-Related Hyperinflation – Six-Month Results from the BREATHE trial,» is available online here.
About Apreo Health
Apreo Health is a clinical-stage medical device company redefining the role of intervention in severe emphysema. Built at The Foundry, an acclaimed medtech venture incubator, funded by a prestigious syndicate of venture capital investors and led by a team with deep medtech and pulmonary expertise, Apreo is developing the BREATHE Airway Scaffold — a tissue-sparing therapy designed to expand access to meaningful treatment.
About Chronic Obstructive Pulmonary Disease & Emphysema
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death and the eighth leading cause of poor health worldwide, according to the World Health Organization (WHO). The U.S. Centers for Disease Control and Prevention (CDC) 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 three million people in the U.S. and is a leading contributor to COPD-related disability and mortality.
About BREATHE 1&2 Trials
The BREATHE (Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung) studies were commenced in 2023 in Australia (BREATHE-1) and Europe (BREATHE-2). Apreo partnered with world-renowned COPD research institutions to evaluate safety and feasibility of the BREATHE Airway Scaffold. Efficacy across pulmonary function, quality of life, and exercise capacity outcomes was also evaluated.
About BREATHE Airway Scaffold
The BREATHE (Bronchoscopic RElease of Air THErapy) Airway Scaffold is a lung implant designed to release air from a hyperinflated lung associated with severe emphysema. The proprietary scaffold is uniquely designed to resist foreign body reaction and promote durability of effect. The device was granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation in May 2024.
The BREATHE Airway Scaffold is an Investigational Device – Limited by Federal (or United States) law to investigational use. Exclusively for Clinical Investigations.
Contacts
Investor Contact:
Karun Naga
The Foundry
[email protected]
650-450-8117
Media Contact:
Emma Yang
Health+Commerce
[email protected]
908-391-7197
