Apreo Health today announced positive study results for its novel, self-expanding Breathe nitinol airway scaffold.
Menlo Park, California-based Apreo shared outcomes at the European Respiratory Society (ERS) Congress 2025 in Amsterdam. Findings demonstrated that Breathe improves lung function and quality of life, even in patients historically excluded from other interventions.
Apreo emerged from stealth to unveil its emphysema treatment in May. A week later, it shared promising first-in-human six-month clinical data supporting the use of the airway scaffold device. Last month, it closed an oversubscribed $130 million Series B financing round to support Breathe.
Data came from Apreo’s BREATHE 1&2 first-in-human studies. Outcomes included 92.4% technical success and no post-procedural pneumothorax.
“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.”
A look at the data presented by Apreo Health
One abstract shared at ESR evaluated how emphysema heterogeneity and fissure integrity (FI) impact clinical response to Breathe. Six-month data included improvements in lung function, quality of life scores and six-minute walk distance (6MWD). Patients across all disease distribution phenotypes experienced significant benefit. FI, as an indicator of collateral ventilation status, had no significant impact.
Apreo said findings support the scaffold’s potential to benefit patients often excluded from other therapies.
The second abstract shared evaluated whether reductions in residual volume (RV), a direct measure of lung hyperinflation, correlates more strongly with clinical improvement than the traditional endpoint of FEV. RV decreased while correlating with improvements in patient-reported outcomes, while investigators saw modest changes in FEV. Apreo said this reinforced a position already held by many clinicians that RV is a more clinically relevant endpoint for assessing therapeutic benefit in emphysema-related hyperinflation.
Finally, the company reported improvements in airway lumen patency with its novel self-expanding nitinol scaffold. The analysis used high-resolution CT imaging to assess airway patency after treatment with Breathe. At six months, CT imaging confirmed statistically significant increases in the number of measurable airway lumen segments at all scaffold locations. This supported the scaffold’s ability to maintain lumen patency and promote sustained reduction in hyperinflation.
“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, chief scientific officer 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.”