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.
dNerva Clinical Program: 5 completed clinical trials
Over 500 dNerva treated patients
18 peer-reviewed publications
Study Design: N=464, 2 year follow up
1:1 Double-blind, Randomized (N=388), Sham-Controlled Trial
Key Findings:
- Primary Endpoint (time to first COPD exacerbation) not met
- Pre-specified measures of lung function and dyspnea improved in ITT analysis
- Patients with lung hyperinflation and low emphysema achieve increased lung function, reduced exacerbations and improved dyspnea at one-year of follow-up (post-hoc analysis)
- Serious Adverse Event profile similar to sham at 1 year; no new related SAE in either group after 90 days
Study Design: N=200, 2 year follow up
1:1 Randomized Controlled Trial
Enrolling in 2025:
- COPD with FEV1 25 – 60% pred.
- High Symptom burden (mMRC>2, CAT>10)
- Lung hyperinflation (RV>175%)
- Low Emphysema (<20% @-950HU)
- On dual or triple maintenance COPD therapy
Primary Endpoint: FEV1 change at 6-months
Secondary Endpoints: One year change in lung function measures, COPD exacerbation rate, dyspnea and quality of life
Study Design: N=46, 3 year follow up
1:1 randomized to energy dose
Key Findings:
- Clinical stability in lung function, qualify of life and exacerbation rates observed out to 3 years of follow-up in TLD patients
- No late-onset adverse events in TLD-treated patients
Study Design: N=82, 2 year follow up
1:1 Double-blind, Randomized, Sham-Controlled Trial
Key Findings:
- Primary Endpoint (respiratory events 3-6 months post treatment) met
- Significant reduction in COPD hospitalization rates sustained at 1 and 2-years of follow-up
- Rate of lung function decline slows in the 3 years following lung denervation (AIRFLOW studies)
Study Design: N=37, 3 year follow-up
1:1 Double-blind, Randomized, Sham-Controlled Trial
Key Findings:
- Bilateral TLD treatment in a single procedure is safe out to 3 years of follow-up