AIRFLOW-2 randomized, sham-controlled one-year data accepted by AJRCCM
MINNEAPOLIS, Aug. 19, 2019 /PRNewswire/ -- Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, announced today multiple peer-reviewed publications that provide further evidence of the safety, clinical effectiveness, and mechanisms of action of Targeted Lung Denervation (TLD) therapy in COPD.
The company's dNerva® Lung Denervation System is a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma. Nuvaira's proprietary TLD technology has demonstrated safety and feasibility in three completed clinical studies and the company is now enrolling patients in its FDA pivotal trial, AIRFLOW-3.
In a single-center substudy of Nuvaira's IPS-II trial, Valipour and colleagues present physiologic evidence that the lungs of TLD treated patients were successfully denervated, through monitoring of an established neural link between breathing and heart rate. Slebos and colleagues reported one-year data from AIRFLOW-1, a dose and safety study which confirmed 12-month safety and feasibility of TLD in patients with moderate-to-severe COPD. Both manuscripts are accepted for publication in the journal Respiration.
AIRFLOW-2 is a double-blinded, sham controlled, multicenter randomized clinical trial (RCT) to assess respiratory adverse events in 82 moderate-to-severe COPD patients with high symptom burden despite optimal medical management. Shah, Slebos and colleagues found the risk of severe COPD exacerbation requiring hospitalization was significantly lower in the TLD treatment group compared to the sham treatment group through 12.5 months of randomization (p=0.0390). No hemoptysis or pneumothorax was found, consistent with longer-term follow-up of earlier trials. AIRFLOW-2 is accepted for publication in the American Journal of Respiratory and Critical Care Medicine (AJRCCM).
These publications contribute to a growing body of literature supporting the therapeutic potential of Targeted Lung Denervation to meet a significant unmet medical need in patients with symptomatic COPD.
Nuvaira is a privately held company headquartered in Minneapolis, MN. The company's proprietary dNerva® Lung Denervation System addresses airway hyper-responsiveness, a pathophysiologic underpinning of both COPD and asthma, in a procedure called Targeted Lung Denervation (TLD). The dNerva® lung denervation system is CE Mark approved. The dNerva® lung denervation system is under clinical investigation and is not commercially available in the USA . Nuvaira and dNerva are registered trademarks of Nuvaira, Inc.
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