Nuvaira announced multiple peer-reviewed studies that provide further evidence of safety, clinical effectiveness and the mechanisms of targeted lung denervation.
The Plymouth, Minn.-based company’s dNerva system is a bronchoscopic procedure designed to disrupt pulmonary nerve input to the lung, reducing the consequences of neural hyperactivity in chronic obstructive pulmonary disease.
Nuvaira’s IPS-II trial showed successful denervation through monitoring of a neural link between breathing and heart rate. The Airflow-1 trial confirmed 12-month safety and feasibility of TLD in patients with moderate-to-severe COPD.
Airflow-2, a multi-center randomized clinical trial observed respiratory adverse events in 82 patients with moderate-to-severe COPD and high symptom burden. The study showed the risk of COPD exacerbation requiring hospitalization was significantly lower in the TLD group compared to a sham treatment group.
Nuvaira’s TLD technology has now demonstrated safety and feasibility in three clinical trials and is currently enrolling patients in an FDA pivotal trial called Airflow-3, according to a release. In February, Nuvaira said it raised $79 million in equity financing, which was intended to be used for Airflow-3, according to CEO Dr. Dennis Wahr.