Randomized, shameful, one-year data from the AIRFLOW 2 study were accepted by AJRCCM
MINNEAPOLIS, 19. August 2019 / PRNewswire / – Novaira, developer of new strategies for the treatment of obstructive pulmonary disease, today published several peer-reviewed publications that provide further evidence of the safety, clinical efficacy and targeting mechanisms of Liver Denervation (TLD) in FLD
The company's Lung Reduction System, dNerva®, is a new bronchoscopic procedure that cuts off the lungs responsible for the lungs to reduce the clinical consequences of hyperactivity. This method works on respiratory hyperreactivity, basic pathophysiological support in both COPD and asthma. Nuvaira's own TLD technology has proven safe and viable in three completed clinical trials, and the company is now recruiting patients for an FDA-approved AIRFLOW-3 trial.
In a monocentric sub-task of the Nuvaira IPS-II study, Valipur and his colleagues presented physiological evidence that the lungs of patients treated with TLD were successfully decapitated by monitoring the established neural connection between breathing and heart rate. Slobey and his colleagues published one-year data from AIRFLOW-1, a dose and safety study that confirmed the 12-month safety and feasibility of TDL in patients with moderate to severe COPD. Both manuscripts are for publication in the journal breathing was accepted
AIRFLOW-2 is a double-blind, sham-controlled, multicenter, randomized clinical trial (RCT) for the evaluation of adverse respiratory events in 82 moderately to severely ill COPD patients with high symptom burden despite optimal medical care. Shah, Slebos, and colleagues found that the risk of severe COPD-requiring hospitalization was significantly lower in the TLP treatment group compared to the 12.5-month randomization group (p = 0.0390). No haemoptysis or pneumothorax was observed, consistent with long-term follow-up of previous studies. AIRFLOW-2 was released for publication American Journal of Respiratory and Critical Care Medicine (AJRCCM) accepted.
These publications contribute to a growing body of literature that confirms the therapeutic potential of targeted lung ablation to ultimately meet the urgent medical needs of patients with symptomatic COPD.
Novaira is a privately owned company based in Minneapolis, Minnesota, DNerva® proprietary Lung System dNerva® Company acts on hyperreactivity, pathophysiological reliance on COPD, and asthma treated during the TLD procedure. The dNerva® Lung Redirect System is CE-approved. In United States the dNerva® lung system is still in a clinical trial and is not commercially available. Nuvaira and dNerva are registered trademarks of Nuvaira, Inc.
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