PINEHURST –– Pinehurst Medical Clinic and FirstHealth Speciality Services are the first in North Carolina and among the first in the world to use a new, investigational medical technology designed to improve the cough and mucus symptoms of chronic bronchitis.
As part of the RheSolve pivotal trial, Adam Belanger, M.D., fellowship-trained interventional pulmonologist with Pinehurst Medical Clinic and FirstHealth Specialty Services, performed the first local procedure evaluating the RheOX Bronchial Rheoplasty System in a patient who has 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 was granted U.S. Food and Drug Administration Breakthrough Device Designation in 2019. RheOx is an investigational device in the U.S. Currently there are no other treatment options targeting 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 appealing new therapeutic approach,” said Dr. Belanger. “I am pleased to participate in this clinical study and potentially improve the lives of chronic bronchitis patients throughout the world.”
Chronic bronchitis is a phenotype of COPD that involves prolonged inflammation and excess mucus production in the airways, causing severe coughing spells, mucus, wheezing, chest pain and shortness of breath.1 Chronic bronchitis, which affects an estimated 9 million people in the U.S.,1,2 can develop after exposure to cigarette smoke, vaping, airborne chemicals, and other pollutants and irritants. Current treatments are directed at bronchodilation and reducing inflammation, without addressing the root cause of the overproduction of mucus.
The RheOx system includes an electrosurgical generator and single-use catheter that together deliver non-thermal energy to the airways to reduce the number of abnormal mucus-producing cells in the lungs, making way for normal cells to redevelop. The RheSolve trial is a double-blind, randomized, sham-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 U.S. and up to 10 international centers.