MENLO PARK, Calif.--(BUSINESS WIRE)--Apreo Health, a clinical-stage medical device company pioneering a novel, tissue-sparing approach for treating severe emphysema, today 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.”
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, 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.
Contacts
Investor Contact:
Karun Naga
Apreo Health
karun.naga@apreohealth.com
650-450-8117
Media Contact:
Emma Yang
Health+Commerce
emma@healthandcommerce.com
908-391-7197
