The REVIVE Pivotal Study

A Prospective, Global, Multicenter, Randomized, Double Blind, Sham Controlled Study to EValuate the Safety and effectIVEness of the Ryme Medical Targeted Lung Denervation (TLD) Catheter in Patients With Moderate and Severe Symptomatic Chronic Obstructive Pulmonary Disease (COPD) - The REVIVE Pivotal Study

The goal of this study is to test whether a new treatment called the Ryme Medical Targeted Lung Denervation (TLD) Catheter is safe and effective for people with moderate to severe chronic obstructive pulmonary disease (COPD).

The main questions it aims to answer are:

1. Does the TLD Catheter improve symptoms in people with COPD?
2. Is the TLD Catheter safe ?

Researchers will compare the group receiving the TLD treatment to the group receiving a sham procedure to see if the treatment improves quality of life.

Participants will:

1. Be randomly assigned to receive either the TLD treatment or a sham procedure.
2. Undergo the assigned procedure in a hospital setting.
3. Attend follow-up visits for health checks and breathing tests.

This study is a prospective, global, multicenter, randomized, double blind, sham controlled study to evaluate the safety and effectiveness of the Ryme Medical Targeted Lung Denervation (TLD) Catheter compared to sham in patients with moderate and severe symptomatic chronic obstructive pulmonary disease (COPD)

Inclusion Criteria:

• Symptomatic chronic obstructive pulmonary disease
• History of COPD exacerbation(s)
• Stable medical therapy
• Candidate for bronchoscopy

Exclusion Criteria:

• Prior lung intervention with device in place
• Using tobacco products, e-cigarettes, vape or other inhaled non-pharmacological substance
• Clinically significant serious or unstable medical conditions (e.g., heart disease requiring treatment, uncontrolled diabetes)
• Pregnant, nursing, or intent to become pregnant during study duration