Three oral presentations highlight sustained reduction in residual volume, airway patency, and improved quality of life, including in patients with incomplete fissures and regardless of disease pattern

Apreo Health, a clinical-stage medical device company pioneering a novel, tissue-sparing approach for treating severe emphysema, today announced the presentation of new data in three oral sessions at the European Respiratory Society (ERS) Congress 2025 in Amsterdam. The data demonstrate that Apreo’s BREATHE Airway Scaffold improves lung function and quality of life, even in patients historically excluded from other interventions.

“These findings reinforce the applicability of our therapy across multiple disease phenotypes,” said Karun Naga, CEO of Apreo Health. “The BREATHE Airway Scaffold represents a potentially meaningful step forward in interventional emphysema care – one that’s designed to expand patient access through a minimally invasive, tissue-sparing alternative to surgery and other more destructive, higher-risk therapies.”

The data are based on outcomes from Apreo’s BREATHE 1&2 First In Human studies, which demonstrated 92.4% technical success and no post-procedural pneumothorax – a common and costly complication associated with other lung volume reduction approaches.

Abstract OA1175: The Impact of Heterogeneity and Fissure Integrity on the Treatment Response of Airway Scaffolds for Emphysema-Related Hyperinflation

This analysis evaluated how emphysema heterogeneity and fissure integrity (FI) impact clinical response to the BREATHE Airway Scaffold. Six-month data from the BREATHE 1&2 trials demonstrated that patients across all subgroups experienced improvements in lung function, quality of life scores, and six-minute walk distance (6MWD). Patients across all disease distribution phenotypes experienced significant benefit, while FI, as an indicator of collateral ventilation status, had no significant impact. These findings support the scaffold’s potential to benefit patients often excluded from other therapies, including those with homogeneous disease or incomplete lobar fissures.

Abstract OA1176: Residual Volume (RV) Change Correlates with Meaningful Outcome Measures in Patients with Emphysema-Related Hyperinflation Following Treatment with Airway Scaffolds

This analysis evaluated whether reductions in RV, a direct measure of lung hyperinflation, correlate more strongly with clinical improvement than the traditional endpoint of FEV₁. Six months after treatment with the BREATHE Airway Scaffold, RV decreased by −0.71 L (±0.11 SEM) and was significantly correlated with improvements in validated patient-reported outcomes, including quality-of-life and symptom severity measures (SGRQ-C, CAT, mMRC), and 6MWD. In contrast, changes in FEV₁ were modest (0.10 L ± 0.02) and not as strongly correlated with patient outcomes – reinforcing a position already held by many clinicians that RV is a more clinically relevant endpoint for assessing therapeutic benefit in emphysema-related hyperinflation.

“These findings reflect a broader reality we’re seeing in emphysema care: patient benefit isn’t always captured by standard lung function tests,” said Dr. Anand Tana, Clinical Researcher at the Royal Brompton Hospital, London. “By focusing on hyperinflation and using a therapy that works across multiple phenotypes, we can potentially expand access to interventional treatment for patients who’ve historically been left out.”

Abstract OA1182: Airway Lumen Patency Improvements from Baseline to 6 Months in Patients with Emphysema-Related Hyperinflation Treated with a Novel Self-Expanding Nitinol Airway Scaffold

This analysis used high-resolution CT imaging to assess airway patency after treatment with the BREATHE Airway Scaffold. At six months, CT imaging confirmed statistically significant increases in the number of measurable airway lumen segments at all scaffold locations (proximal, middle, and distal; p<0.0001), supporting the scaffold’s ability to maintain lumen patency and promote sustained reduction in hyperinflation.

“The imaging data confirm what we see clinically, which is that the scaffold keeps airways open in regions of the lung that would otherwise collapse,” said Dr. Theresa Klemm, Internal Medicine & Pneumology at Wiener Gesundheitsverbund, Vienna. “Maintaining that structural stability is key to achieving sustained reduction in hyperinflation and meaningful symptom relief for patients with emphysema.”

“The data presented at ERS not only highlight a promising new direction in treating severe emphysema, but also reflect Apreo Health’s commitment to advancing medical care and supporting science and thought leadership,” said Dr. Martin Mayse, CSO of Apreo Health. “We are thankful to the ERS Congress and the BREATHE 1&2 investigators, and particularly Drs. Tana and Klemm, for being world-class research partners.”

About Apreo Health

Apreo Health is redefining interventional pulmonology with a non-destructive, tissue-sparing solution for severe emphysema—one of the most under-treated and misunderstood diseases in medicine. Formed at The Foundry, one of the world’s premier medtech incubators, and backed by top-tier investors, Apreo is led by a team with deep expertise in both pulmonary medicine and medical device innovation. The company is advancing a therapy purpose-built to expand access, simplify delivery, and transform the treatment pathway for patients with severe emphysema. Privately held, the company is backed by Bain Capital Life Sciences, Norwest, F-Prime, Intuitive Ventures, Lightstone Ventures, Santé Ventures, OSF Healthcare Ventures and The Foundry.

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 3 million people in the U.S. and is a leading contributor to COPD-related disability and mortality. Today, fewer than 1% of patients with emphysema-related hyperinflation receive interventional care.

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.

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 as measured by pulmonary function, quality of life, and exercise capacity outcomes was also evaluated.

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