Pulmonary Disease Startup Firm Emerges From Stealth

Medtech startup Apreo Health has officially emerged from stealth and is compiling first-in-human data in preparation for its next stage of clinical development.

Apreo is working to perfect the BREATHE Airway Scaffold, a first-of-its-kind implant designed to relieve pressure in overinflated lungs without removing or sacrificing healthy tissue. Unlike traditional interventions, which are limited regarding the treatable patient population and carry significant complication rates, Apreo’s approach is intended to reach more patients and integrate more seamlessly into clinical practice.

The proprietary scaffold is uniquely designed to resist foreign body reaction and promote durability of effect. The product won U.S. Food and Drug Administration (FDA) Breakthrough Device Designation in May 2024.

The BREATHE (Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung) studies began 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.

Apreo Health is striving to pioneer safe, transformative solutions for lung disease. The privately held company is headquartered in Menlo Park, Calif. Its BREATHE Scaffold is an investigational device and is limited to by U.S. law to investigational use.

“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,” Apreo Health CEO Karun Naga stated. “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.”

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 United States and is a leading contributor to COPD-related disability and mortality.

Apreo Health is a clinical-stage medical device company redefining the role of intervention in severe emphysema. Built at The Foundry (a medtech venture incubator), funded by a syndicate of venture capital investors, and led by a team with deep medtech and pulmonary expertise, Apreo is developing the BREATHE Airway Scaffold.