MINNEAPOLIS, Minnesota, July 1, 2026
Nuvaira, Inc. has announced the first patient treated in the pivotal AIRFLOW-4 clinical trial evaluating its investigational dNerva® Targeted Lung Denervation (TLD) System for patients with chronic obstructive pulmonary disease (COPD). The milestone marks a significant advancement in the development of a one-time, minimally invasive outpatient therapy designed to improve lung function and reduce disease burden in patients with a specific COPD phenotype characterized by small airways disease and lung hyperinflation. Unlike conventional COPD treatments that rely on daily inhaled medications, dNerva® Targeted Lung Denervation offers a novel mechanism of action by targeting the nerves surrounding the lungs to provide continuous bronchodilation without the need for an additional maintenance inhaler. The AIRFLOW-4 study builds upon encouraging findings from previous clinical research, positioning lung denervation as a potential first targeted interventional therapy for patients whose disease is driven primarily by airway dysfunction rather than severe emphysema.
Targeted Lung Denervation Offers Innovative COPD Treatment Strategy
The investigational dNerva® Targeted Lung Denervation (TLD) System introduces a fundamentally different therapeutic approach for COPD by addressing airway hyper-responsiveness, a key biological driver of chronic airflow limitation. During the one-time bronchoscopic outpatient procedure, targeted energy is delivered to the lung nerves responsible for excessive airway constriction, producing long-lasting bronchodilation while complementing the action of traditional anticholinergic medications, which remain the standard daily treatment for COPD.
Unlike inhaled therapies that require lifelong patient adherence, dNerva® provides continuous 24-hour bronchodilation through a single intervention, potentially reducing treatment burden while improving symptom control. Researchers believe this nerve-targeting strategy could become an important option for patients who continue to experience persistent symptoms despite optimal medical therapy, particularly those with small airways disease, an increasingly recognized COPD phenotype associated with lung hyperinflation and impaired quality of life.
AIRFLOW-3 Findings Support Advancement Into Pivotal AIRFLOW-4 Trial
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The initiation of AIRFLOW-4 follows encouraging post-hoc findings from the previously completed AIRFLOW-3 clinical trial, which identified patients with small airways disease and minimal alveolar destruction as the subgroup most likely to benefit from Targeted Lung Denervation. Clinical analyses demonstrated meaningful improvements in lung function, COPD exacerbation rates, and patient quality of life among individuals treated with dNerva® compared with sham-treated controls after one year of follow-up. These findings, published in the American Journal of Respiratory and Critical Care Medicine, provided the scientific rationale for launching the pivotal AIRFLOW-4 trial.
According to Professor Gerard J. Criner, Chair and Professor of Thoracic Medicine and Surgery at Temple University and Principal Investigator of AIRFLOW-4, patients experiencing lung hyperinflation currently have limited targeted treatment options despite representing a large proportion of the COPD population. The ability to provide sustained symptom improvement through a single intervention may significantly reduce the burden associated with long-term medication adherence while offering a novel therapeutic alternative for appropriately selected patients.
Clinical Development Strengthens Nuvaira’s Interventional Pulmonology Pipeline
The treatment of the first patient also follows Nuvaira’s recent financing round, which supports completion of the pivotal AIRFLOW-4 clinical trial and advances the company’s broader strategy in interventional pulmonology. In conjunction with the financing, Nuvaira appointed Lisa Flaherty as Chief Strategy Officer, bringing more than three decades of medical device industry experience, including extensive expertise in pulmonary interventions. The company’s proprietary dNerva® Lung Denervation System is being developed to address both COPD and asthma by targeting airway hyper-responsiveness through a minimally invasive bronchoscopic procedure.
Although the technology remains under clinical investigation and has not yet received commercial approval in the United States, successful completion of the AIRFLOW-4 trial could establish Targeted Lung Denervation as a first-in-class interventional therapy for patients with a distinct COPD phenotype. As healthcare providers increasingly seek innovative treatments that reduce symptom burden, improve quality of life, and minimize reliance on daily medications, Nuvaira’s dNerva® platform represents a promising advancement in the evolving field of respiratory medical technologies and precision pulmonary care.
Source: Nuvaira press release
