Apreo Health Raises $130 Million to Advance Pivotal Trial for Novel Emphysema Device
核心洞察
Apreo Health (搜索) secured $130 million in Series B funding co-led by Bain Capital Life Sciences (搜索) and Norwest (搜索) to advance its BREATHE Airway Scaffold (搜索) for severe emphysema (搜索) treatment.
The funding will support BREATHE-3, a multicenter randomized controlled trial evaluating the bronchoscopically delivered implant designed to release trapped air in hyperinflated lungs.
More than three million Americans are affected by severe emphysema (搜索), yet fewer than 1% receive interventional treatment, highlighting significant unmet medical need.
Apreo Health (搜索), a clinical-stage medical device company, has closed an oversubscribed $130 million Series B financing round to advance its novel treatment for severe emphysema (搜索). The funding was co-led by new investors Bain Capital Life Sciences (搜索) and Norwest (搜索), with participation from new investors F-Prime (搜索) and Intuitive Ventures (搜索), alongside returning investors Lightstone Ventures (搜索) and Santé Ventures (搜索).
The Series B financing will primarily support BREATHE-3 (Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung—Study 3), a multicenter, randomized controlled trial designed to evaluate the safety and efficacy of the Apreo BREATHE Airway Scaffold (搜索). The bronchoscopically delivered implant is designed to relieve lung hyperinflation by releasing trapped air in patients with severe emphysema (搜索).
Addressing Critical Unmet Medical Need
"More than three million Americans are affected by severe emphysema (搜索), yet fewer than 1% receive interventional treatment—a stark reflection of limitations of currently available treatments," said Karun Naga, CEO of Apreo Health (搜索). "Our BREATHE Scaffold offers a fundamentally different approach: a novel implant designed to gently release air trapped in affected lungs, with potential for much broader adoption."
Chronic obstructive pulmonary disease (搜索) (COPD (搜索)) 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 (搜索), a severe form of COPD characterized by the destruction of lung air sacs (搜索), affects approximately three million people in the U.S. and is a leading contributor to COPD-related disability and mortality.
Novel Device Technology
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 (搜索). 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.
"Apreo is addressing one of the most underserved populations in chronic obstructive pulmonary disease (搜索) (COPD (搜索)) and doing so with clinical clarity and executional rigor," said Zack Scott, M.D., general partner, Norwest (搜索). "This is a step-change in how we approach emphysema (搜索) care. The solution is both elegant in design and built for broad, scalable delivery."
Pivotal Trial and Commercialization Strategy
The Series B financing will fund regulatory activities related to BREATHE-3 and early commercialization efforts to demonstrate strong market potential. The BREATHE-3 study aims to provide clinical evidence needed to bring the implant closer to regulatory approval and broader access for patients.
"We are excited to partner with Apreo at this key inflection point in the company's evolution as it advances the BREATHE Airway Scaffold (搜索) into late-stage development," said Nicholas Downing, M.D., a Managing Director at Bain Capital Life Sciences (搜索). "The device has the potential to deliver meaningful clinical benefit to a broader patient population—addressing the significant unmet need that exists today in chronic obstructive pulmonary disease (搜索)."
Company Background
Apreo Health (搜索) was formed at The Foundry (搜索), one of the world's premier medtech incubators, and 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 (搜索).
The BREATHE Airway Scaffold (搜索) is currently an Investigational Device—limited by Federal (or United States) law to investigational use.