Clinical Evidence

Results across our clinical development program demonstrate the safety and impact of Targeted Lung Denervation (TLD) using the dNerva® Lung Denervation System. Detailed information regarding Nuvaira clinical studies can also be found at www.clinicaltrials.gov.

Studies

Over 500 patients have been treated in Nuvaira’s clinical studies.
Find out more about each of the studies in Nuvaira’s clinical development program.

Study Overview

AIRFLOW-2 was a double-blinded, sham controlled, multicenter randomized clinical trial to assess respiratory adverse events in 82 moderate-to-severe COPD patients with high symptom burden despite optimal drug therapy.

Results: Impact on Two-Year Outcomes²

Significantly Lower Risk of Severe Exacerbations

in COPD Patients with TLD

Published in the International Journal of Chronic Obstructive Pulmonary Disease, November 2020²

The clinical impact of TLD is durable, as it is found to reduce the risk of serious COPD adverse events over 2 years with stabilized lung function. The reduction of severe COPD exacerbations has the potential to improve long-term clinical outcomes and reduce healthcare costs.

Read the Full Report

AIRFLOW-2 Study Conclusions

Robust study design

Positive Safety Profile

TLD demonstrated a significantly lower risk of hospitalized COPD exacerbations

Lung function and quality of life remained stable over 2 years

Nuvaira Clinical Development Program AIRFLOW-1

Study Overview

AIRFLOW-1 was a multicenter safety and dose ranging study of TLD in moderate-to-severe COPD patients.

Published in Respiratory Research, February 2021²¹

TLD in COPD patients demonstrated a positive safety profile out to 3 years, with no late-onset serious adverse events related to denervation therapy. Clinical stability in lung function, quality of life, and exacerbations were observed in TLD treated patients over 3 years of follow up.

Read the Full Report

Results: Observed Clinical Stability after Three Years^21,22

Stable Quality of Life

Stable COPD Exacerbation Rates

Stable Lung Function

Nuvaira Clinical Development Program - AIRFLOW-3

Study Overview

The first major interventional trial targeting reduction of exacerbations in COPD patients with high symptom burden.

1:1 Randomized, Double-Blind, Sham-Controlled FDA Pivotal Trial

Primary Endpoint:

Comparison of the probability of subjects having a moderate or severe exacerbation between the treatment arm and the sham control arm at one year

Clinical Evidence

dNerva® Clinical Development Program

Studies

Study Overview

AIRFLOW-2 Study Conclusions

Robust study design

Positive Safety Profile

TLD demonstrated a significantly lower risk of hospitalized COPD exacerbations

Lung function and quality of life remained stable over 2 years

Study Overview

Results: Observed Clinical Stability after Three Years^21,22

Stable Quality of Life

Stable COPD Exacerbation Rates

Stable Lung Function

Study Overview

1:1 Randomized, Double-Blind, Sham-Controlled FDA Pivotal Trial

Primary Endpoint:

464 patients treated

Multicenter (USA, Europe)

Publications

dNerva Targeted Lung Denervation Bibliography

dNerva Targeted Lung Denervation Mechanism of Action Bibliography

COPD Exacerbations are the Problem.
Be a Part of the Solution.

Clinical Evidence

dNerva® Clinical Development Program

Studies

Study Overview

AIRFLOW-2 Study Conclusions

Robust study design

Positive Safety Profile

TLD demonstrated a significantly lower risk of hospitalized COPD exacerbations

Lung function and quality of life remained stable over 2 years

Study Overview

Results: Observed Clinical Stability after Three Years21,22

Stable Quality of Life

Stable COPD Exacerbation Rates

Stable Lung Function

Study Overview

1:1 Randomized, Double-Blind, Sham-Controlled FDA Pivotal Trial

Primary Endpoint:

464 patients treated

Multicenter (USA, Europe)

Publications

dNerva Targeted Lung Denervation Bibliography

dNerva Targeted Lung Denervation Mechanism of Action Bibliography

COPD Exacerbations are the Problem. Be a Part of the Solution.

Results: Observed Clinical Stability after Three Years^21,22

COPD Exacerbations are the Problem.
Be a Part of the Solution.