Nuvaira

Executive Summary

Nuvaira is a privately held medical device company developing the dNerva Lung Denervation System, a catheter-based bronchoscopic therapy for chronic obstructive pulmonary disease (COPD). The system delivers targeted lung denervation (TLD) to disrupt overactive parasympathetic nerves in the airways, reducing airway hyperreactivity and inflammation while preserving lung function. The procedure is minimally invasive, one-time, and performed on an outpatient basis. Nuvaira has received CE Mark approval for the dNerva system in Europe, and the company is actively pursuing FDA approval in the United States. With a strong clinical evidence base, including positive results from the AIRFLOW-3 pivotal trial, Nuvaira is well positioned to address the significant unmet need in COPD treatment, where few interventional options exist beyond pharmacotherapy. The company continues to invest in commercial infrastructure and clinical research to expand indications and support market adoption.

Upcoming Catalysts (preview)

• Q3 2026FDA PMA Pre-Market Approval Decision for dNerva System60% success
• Q4 2026Presentation of Long-Term Follow-Up Data from AIRFLOW-3 Trial at Major Medical Conference80% success
• Q1 2027Strategic Partnership or Distribution Agreement for U.S. Commercial Launch50% success