PINEHURST –– The Pinehurst Medical Clinic and FirstHealth Specialty Services are the first in North Carolina and among the first in the world to use experimental new medical technology designed to improve the cough and mucus symptoms of chronic bronchitis.
As part of the pivotal RheSolve trial, Adam Belanger, MD, an interventional pulmonologist trained at Pinehurst Medical Clinic and FirstHealth Specialty Services, performed the first local procedure evaluating the RheOX Bronchial Rheoplasty System in a patient with chronic bronchitis.
The RheOx system from Gala Therapeutics Inc. delivers non-thermal pulsed energy to mucus-producing cells in the airways of the lungs. It received Breakthrough Device designation from the United States Food and Drug Administration in 2019. RheOx is an investigational device in the United States. There are currently no other treatment options that target the mucus-producing cells that cause the disease.
“Chronic bronchitis has a substantial and debilitating impact on patients’ quality of life, and the new RheOx system offers an attractive new therapeutic approach,” said Dr. Bélanger. “I am thrilled to participate in this clinical study and potentially improve the lives of chronic bronchitis patients around the world.”
Chronic bronchitis is a COPD phenotype that involves prolonged inflammation and excessive mucus production in the airways, causing severe coughing spells, mucus, wheezing, chest pain, and shortness of breath.1 Chronic bronchitis, which affects approximately 9 million people in the United States, 1,2 can develop after exposure to cigarette smoke, vaping, airborne chemicals, and other pollutants and irritants. Current treatments focus on bronchodilation and reducing inflammation, without addressing the root cause of mucus overproduction.
The RheOx system includes an electrosurgical generator and a single-use catheter that together deliver non-thermal energy to the airways to reduce the number of abnormal mucus-producing cells in the lungs, allowing normal cells to grow back . The RheSolve trial is a double-blind, randomized, simulation-controlled study in COPD patients with moderate to severe chronic bronchitis. A total of 270 consenting participants will be randomized in a 2:1 ratio to receive treatment using RheOx or a sham procedure, at up to 40 US centers and up to 10 international centers.