RheOx is a new system that endoscopically delivers non-thermal pulsed electric field (PEF) energy to the lung airways to reduce mucus-producing cells
Gala Therapeutics Announces First Commercial Cases Worldwide with RheOx System for Chronic Bronchitis. (Credit: kalhh from Pixabay)
Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, today announced the first worldwide commercial procedures using the RheOx® Bronchial Rheoplasty system for the treatment of the symptoms of chronic bronchitis.
The first Bronchial Rheoplasty cases were performed by Professor Stefano Gasparini, Polytechnic University of Marche hospital, and Dr. Lina Zuccatosta, Director Pulmonary Diseases Unit, University Hospital Ancona in Ancona, Italy. Dr. Michela Bezzi, Director of Interventional Pulmonology, University Hospital Brescia in Brescia, Italy, also treated patients in commercial cases in the first week.
RheOx is a new system that endoscopically delivers non-thermal pulsed electric field (PEF) energy to the lung airways to reduce mucus-producing cells. It is the first medical device available for sale in Europe to treat the symptoms of chronic bronchitis.
“For more than 30 years I have witnessed patients with chronic bronchitis struggle with frequent coughing attacks, excess mucus production, and limitations on their quality of life, but we did not have a solution to help them,” explained Prof. Gasparini, who also is Vice Chair, World Association for Bronchology and Interventional Pulmonology. “The RheOx system is a significant advancement in managing chronic bronchitis patients. It is an intuitive, minimally invasive procedure that I believe will change the treatment of chronic bronchitis. I’m excited to be the first in the world to offer patients bronchial rheoplasty to improve their quality of life.”
Chronic bronchitis, a phenotype of COPD, affects an estimated 3-16% of the population worldwide. Patients experience prolonged inflammation and excess mucus in the lung airways, causing severe coughing spells, wheezing, chest pain and shortness of breath.2 Chronic bronchitis 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.
“We are excited to launch the RheOx system in Europe for patients who suffer from chronic bronchitis, and we are already seeing strong demand from the clinical community,” said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics. “We will continue to introduce the therapy at other European respiratory centers of excellence in the coming months while simultaneously conducting the global RheSolve pivotal clinical trial to support FDA approval.”
RheOx is designed to reduce mucus-producing cells in patients with chronic bronchitis through a minimally invasive bronchoscopic procedure called bronchial rheoplasty. The revolutionary RheOx technology 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, making way for new normal cells to redevelop.
In 2019, RheOx received CE Mark in the European Union and U.S. Food and Drug Administration Breakthrough Device Designation. RheOx is limited by U.S. federal law to investigational use only.
Source: Company Press Release